Tuch v South Eastern Sydney and Illawarra Area Health Service

CATCHWORDS : ADMINISTRATIVE LAW - claim for certiorari and declaratory relief - clinical trial of transplantation of encapsulated human islets into people with diabetes - plaintiff in charge of clinical trial - clinical trial suspended - chief executive of Area Health Service establishes Review Committee under ss.24 and 29B Health Services Act 1997 - Review Committee to review suspension of clinical trial and to report and make recommendations - Review Committee report makes serious criticisms of plaintiff - chief executive accepts report and implements recommendations - report provided to third parties - application to quash report and decision of chief executive to accept report and to provide it to third parties - claim of denial of procedural fairness - apprehended bias - claim that persons were acting as both accusers and decision makers - prejudgment - claim upheld in part - whether certiorari available to quash report and acceptance decision - relief in nature of certiorari and declaratory relief granted

Supreme Court Act 1970 LEGISLATION CITED : Health Services Act 1997 Health Care Complaints Act 1993 Medical Practice 1992

Roos v Director of Public Prosecutions (NSW) (1994) 34 NSWLR 254 Stollery v Greyhound Racing Control Board (1972) 128 CLR 509 Rendell v Release On Licence Board (1987) 10 NSWLR 499 Re Macquarie University; Ex parte Ong (1989) 17 NSWLR 113 Webb v The Queen (1994) 181 CLR 41 Johnson v Johnson (2000) 201 CLR 488 Ebner v Official Trustee (2000) 205 CLR 337 Re JRL; Ex parte CJL (1986) 161 CLR 342 Hall v New South Wales Trotting Club Limited (1977) 1 NSWLR 378 Re Minister for Immigration and Multicultural and Indigenous Affairs; Ex parte Lam (2003) 214 CLR 1 Musumeci v Attorney General of NSW (2003) 57 NSWLR 193 Commissioner of Corrective Services v Government & Related Employees Appeal Tribunal [2004] NSWCA 291 Greyhound Racing NSW v Cessnock & District Agricultural Association [2006] NSWCA 333 White v Ryde Municipal Council [1977] 2 NSWLR 909 McGovern v Ku-Ring-Gai Council [2008] NSWCA 209; 251 ALR 558 Balmain Association Inc v Planning Administrator for the Leichhardt Council (1991) 25 NSWLR 615 Kioa v West (1985) 159 CLR 550 Carver v Law Society of NSW (1998) 43 NSWLR 71 CASES CITED : Hedges v Australasian Conference Association Limited [2003] NSWSC 1107 Graham v Baptist Union of New South Wales [2006] NSWSC 818 Roylance v General Medical Council (No. 2) [2000] 1 AC 311 Laws v Australian Broadcasting Tribunal (1990) 170 CLR 70 R v Lusink; Ex parte Shaw (1980) 2 ALR 47 Applicant VEAL of 2002 v Minister for Immigration and Multicultural and Indigenous Affairs (2005) 225 CLR 88 Minister for Aboriginal Affairs v Peko-Wallsend Limited (1986) 162 CLR 24 Minister for Immigration and Multicultural Affairs v Yusuf [2001] 206 CLR 323 Saville v Health Care Complaints Commission [2006] NSWCA 298 State of South Australia v O'Shea [1987] 163 CLR 378 Ainsworth v Criminal Justice Commission (1992) 175 CLR 564 Johns v Australian Securities Commission (1993) 178 CLR 408 Consolidated Press Holdings Limited v Federal Commissioner of Taxation (1995) 57 FCR 348 R v Collins; Ex parte ACTU Solo Enterprises Pty Limited (1976) 8 ALR 691 Greiner v Independent Commission Against Corruption (1992) 28 NSWLR 125 Hot Holdings Pty Limited v Creasy (1996) 185 CLR 149 Police Integrity Commission v Shaw (2006) 66 NSWLR 446 Cox v Corruption and Crime Commission [2008] WASC 199 Calvin v Carr [1979] 1 NSWLR 1

PARTIES : Bernard Edward Tuch (Plaintiff) South Eastern Sydney and Illawarra Area Health Service (Defendant)

COUNSEL : Mr J Simpkins SC; Ms M Allars (Plaintiff) Ms NL Sharp (Defendant)

SOLICITORS : Harris Freidman Hyde Page (Plaintiff) Bartier Perry (Defendant)

IN THE SUPREME COURT OF NEW SOUTH WALES COMMON LAW DIVISION ADMINISTRATIVE LAW LIST

30009/09 Tuch v South Eastern Sydney and Illawarra Area Health Service

JUDGMENT 1 JOHNSON J: By Summons filed on 15 February 2009, the Plaintiff, Bernard Edward Tuch, seeks declaratory and prerogative relief under ss.69 and 75 Supreme Court Act 1970. The proceedings were brought initially against the First Defendant, South Eastern Sydney and Illawarra Area Health Service, and the Second Defendant, University of New South Wales. Thereafter, the Plaintiff discontinued his claim for relief against the Second Defendant. As there is a single Defendant remaining in the proceedings, I will refer to the First Defendant as the "Defendant". 2 At the outset, it is important to observe what is, and what is not, determined in these proceedings. The issues raised in this case concern administrative processes undertaken with respect to the Plaintiff in 2008, and determination of his complaint that these processes did not comply with the requirements of the law. These proceedings do not address the medical and scientific merits of the Plaintiff's research concerning the treatment of diabetes, nor the efficacy of that research.

Nature of Proceedings 3 The Plaintiff seeks relief with respect to:

(a) a report containing findings and recommendations made on 20 October 2008 by the Diabetes Transplant Unit Review Committee ("the Review Committee") established by the Defendant;

(b) a decision made on 21 November 2008 by Mr Terry Clout, the Chief Executive of the Defendant, to accept the Review Committee report and to implement its recommendations;

(c) action taken by the Defendant, through Mr Clout and Mr Andrew Bernard, the General Manager of the Northern Hospital Network ("NHN") of the Defendant, to disclose the Review Committee report and Mr Clout's decision in November-December 2008 to the University of New South Wales and to the New South Wales Medical Board. 4 The Review Committee comprised Professor Terry Campbell as Chair, with Ms Marie Malica and Ms Carmel Edwards as members. The Review Committee was authorised to make a report by Mr Clout. 5 The Plaintiff presses his claim for the following relief (paragraphs 1-4 of the Summons):

(a) an order in the nature of certiorari quashing the report of the Review Committee;

(b) a declaration that the Review Committee denied the Plaintiff procedural fairness;

(c) an order in the nature of certiorari quashing the decision of Mr Clout to accept the Review Committee report and to implement its recommendations;

(d) a declaration that the Defendant denied the Plaintiff procedural fairness in making the decision to accept the Review Committee report and disclosing the report to the New South Wales Medical Board and the University of New South Wales. 6 As will be seen, the Plaintiff has mounted an elaborate and multi-faceted challenge to the processes which affected him in 2008. The grounds of review in relation to the report of the Review Committee is that the Review Committee: (a) denied the Plaintiff procedural fairness, by reason of: (i) an appearance of bias; and

(b) acted ultra vires by: (i) determining issues and making findings beyond its terms of reference;

(ii) failing to take into account relevant considerations; and

(iii) taking into account irrelevant considerations.

7 The grounds of review in relation to the decision by Mr Clout accepting the Review Committee report are that the Defendant:

(a) denied the Plaintiff procedural fairness, by reason of: (i) an appearance of bias; and

(ii) failure to afford a fair hearing. 8 The ground of review in relation to the notification of the Review Committee report and Mr Clout's decision to the University of New South Wales and the New South Wales Medical Board is that the Defendant denied the Plaintiff procedural fairness, by reason of failure to afford a fair hearing.

Evidence Adduced at the Hearing in this Court 9 At the hearing in this Court, the Plaintiff was represented by Mr Simpkins SC and Ms Allars of counsel. The Defendant was represented by Ms Sharp of counsel. 10 Affidavits of the Plaintiff sworn on 12 February 2009, 11 March 2009 and 13 March 2009 were read in the Plaintiff's case. In addition, three volumes of documents were tendered as an agreed tender bundle (Exhibit A). A number of other documents were admitted into evidence. The Plaintiff was required for cross-examination and his evidence constituted the only oral evidence adduced at the hearing. 11 The Defendant did not file any affidavit nor adduce oral evidence at the hearing. 12 As will be seen, a large number of emails are amongst the tendered documents, all admitted without objection. The Plaintiff placed substantial reliance upon statements made in emails which passed between members of the Review Committee and others. An examination of the email communications and other documents, and submissions made by reference to them, will be undertaken to determine the Plaintiff's claim for relief. 13 Of course, the Plaintiff bears the onus of proving, on the balance of probabilities, facts grounding an entitlement to relief in the nature of prerogative relief or declaratory relief: Roos v Director of Public Prosecutions (NSW) (1994) 34 NSWLR 254 at 259.

Relevant Statutory Provisions 14 The Defendant is constituted as a body corporate by s.17 Health Services Act 1997 ("HS Act"), when read together with Schedule 1 to that Act. The functions of the Defendant are set out in s.10 HS Act, which relevantly provides: "10 Functions of area health services

The functions of an area health service are as follows:

(a) generally to promote, protect and maintain the health of the residents of its area,

(b) to conduct and manage public hospitals, health institutions, health services and health support services under its control,

(d) to achieve and maintain adequate standards of patient care and services,

(e) to ensure the efficient and economic operation of its health services and health support services and use of its resources,

(f) generally to consult and co-operate (as it considers appropriate) with any one or more of the following: (i) the Health Care Complaints Commission constituted under the Health Care Complaints Act 1993,

(i) to establish and maintain an appropriate balance in the provision and use of resources for health protection, health promotion, health education and treatment services,

(m) to undertake research and development relevant to the provision of health services,

(o) to carry out such other functions as are conferred or imposed on it by or under this or any other Act or as may be prescribed by the regulations." 15 Provision is made for the control and management of area health services, including the Defendant, in Part 2 (ss.22-29B) HS Act. Section 23(1) provides that a chief executive is to be appointed to each area health service. At all relevant times, Mr Clout was the Chief Executive of the Defendant. Section 24 HS Act states: "24 Chief executive to manage and control affairs of area health service (1) The affairs of an area health service are to be managed and controlled by the chief executive of the service.

(2) Any act, matter or thing done in the name of, or on behalf of, an area health service by its chief executive is taken to have been done by the service." 16 Section 29B provides: "29B Other committees and councils

The chief executive may establish such committees and councils as he or she considers appropriate to assist the area health service in the exercise of its functions." 17 It was common ground in these proceedings that the Review Committee was established by Mr Clout under s.29B and was authorised to report to him in exercise of his general powers of administration under s.24 HS Act. Likewise, the parties accepted that the decision by Mr Clout to accept the Review Committee report, and to implement some or all of its recommendations, was a decision made in exercise of the power under s.24 of the Act. 18 Reference should also be made to s.117A HS Act: "117A Duty of chief executive to report certain conduct (1) The chief executive of a public health organisation is to report to a registration authority any conduct of a member of staff that the chief executive suspects on reasonable grounds may constitute professional misconduct or unsatisfactory professional conduct under the health registration Act by which the registration authority is constituted.

(2) In this section, health registration Act and registration authority have the same meanings as in the Health Care Complaints Act 1993." 19 The Health Care Complaints Act 1993 ("HCC Act") defines the terms "health registration Act" and "registration authority". Section 4 HCC Act provides that a "health registration Act" includes the Medical Practice Act 1992. Section 4 defines a "registration authority" to mean "the person who has the function, under a health registration Act, of determining an application for registration under the Act". 20 The New South Wales Medical Board is constituted under s.129 Medical Practice Act 1992. The functions of the Board are set out in s.132 of that Act. Section 22 and Schedule 1 to the Medical Practice Act 1992 make provision with respect to registration under that Act. The terms "unsatisfactory professional conduct" and "professional misconduct" are defined respectively in ss.36 and 37 Medical Practice Act 1992. 21 It was submitted for the Defendant that notification of the Review Committee report and Mr Clout's decision to the New South Wales Medical Board were made for the purposes of s.117A(1) HS Act. It is not contended that the notification of the report and decision to the University of New South Wales was made under this provision. I will return to these issues later in the judgment.

Factual Matters 22 There were limited areas of factual dispute in this case. In reality, the course of events revealed by the documents is reasonably clear. The question to be determined is whether the Plaintiff has established his claim for relief by application of relevant legal principles to the factual circumstances of the case. 23 This part of the judgment refers to events, in chronological order, with extracts from emails and other documents being set out where necessary. From time to time, brief reference will be made to submissions of the parties so as to place particular documents into context. Detailed submissions were made by reference to the documents. Submissions of the parties are set out later in the judgment, together with my conclusions with respect to the various grounds for relief pressed by the Plaintiff. 24 The following recital may be taken as findings of fact by the Court, unless it is otherwise indicated. 25 The Plaintiff is a medical practitioner who has practised since the early 1990s as a specialist endocrinologist. He was employed by the Defendant, since 1994, as a Senior Staff Specialist in Endocrinology. 26 At all relevant times, the Plaintiff was the Director of the Diabetes Transplant Unit ("DTU") which operates out of the Prince of Wales Hospital ("PoW Hospital") in Randwick, Sydney. The Defendant has responsibility for administering the PoW Hospital, which is part of the Defendant's NHN. 27 In 2006, following approval on 23 November 2005 by the Human Research Ethics Committee ("HREC") of the NHN, the DTU commenced a stage 1 human clinical trial known as "Protocol 05/151 Transplantation of Encapsulated Human Islets Into People with Diabetes" ("Clinical Trial"). The Plaintiff was the Investigator for the purpose of the Clinical Trial. 28 The Clinical Trial involved persons with Type 1 (insulin dependent) diabetes. These persons require regular insulin injections to normalise their blood glucose levels. A potential treatment for Type 1 diabetes is the transplantation of insulin-producing cells, known as islets. The aim of such treatment is to avoid the need for regular injections of insulin to improve quality of life, even if it is not a cure for diabetes (affidavit, BE Tuch, 12 February 2009, paragraphs 7-8). 29 In October 2007, Professor Robyn Ward commenced as the Director of Research at the NHN. In March 2008, a new organisational structure was approved for the support of research activities in the NHN. The Research Support Office ("RSO") was headed by Professor Ward. 30 On 26 March 2008, the Plaintiff attended a meeting with Professor Campbell to discuss issues arising as between the Plaintiff and Associate Professor Kuldip Sidhu, a member of staff of the DTU. 31 On 26 March 2008, Professor Ward emailed Mr Bernard to advise that an external review in November 2007 had raised patient safety concerns about the Clinical Trial. She strongly recommended that the Clinical Trial be suspended, and that the matter be referred to NHN HREC for further consideration (Exhibit A, page 49). 32 On 27 March 2008, Mr Bernard wrote to the Plaintiff noting that an external review had found that the DTU was "inadequate in design to produce sterile human therapeutics for clinical trial and there was insufficient quality oversight to justify the release of [encapsulated islet cells]". Mr Bernard's letter to the Plaintiff utilised a draft provided to him by Professor Ward. As the delegate of the Chief Executive (Mr Clout), Mr Bernard suspended the Clinical Trial and advised the Plaintiff that he had asked the NHN HREC to review the matter and advise on the way forward. 33 Around 31 March 2008, the RSO commenced initial investigations into the paperwork held by the HREC and others in relation to the Clinical Trial. 34 On 4 April 2008, the Plaintiff wrote to Mr Bernard requesting that he reconsider the decision to suspend the Clinical Trial. 35 In an email from Professor Ward to Mr Bernard dated 10 April 2008 concerning a proposed visit by a Member of Parliament to the DTU, Professor Ward stated (Exhibit A, page 70) (emphasis added): "Whether the member meets with us separately or not I think someone will need to be with Bernie [the Plaintiff] at all times. I don't think we should leave Bernie alone with the member for even a moment . My suggestions would be that the visit is accompanied by you, me or Jim Mackie."

This is the first of a number of emails which shed some light upon the relationship between some of the principal protagonists to be referred to in this judgment. 36 On 21 April 2008, the Executive of the NHN HREC met and discussed the suspension of the Clinical Trial, and concluded that the matter ought to be considered by the PoW Hospital Executive, which in turn decided to establish a small ad hoc committee of review. As General Manager of the NHN, Mr Bernard was responsible for establishing the Review Committee, determining its membership and its terms of reference. 37 On 28 April 2008, Professor Ward sent an email to Mr Bernard in the following terms (Exhibit A, page 82) (emphasis added): "I discussed this email with Carmel [Edwards] today and asked her for a verbal update on progress. As flagged with you the ethics executive committee have reviewed the paperwork (or what there is of it!!) and have indicated that the first issue which needs to be addressed is one of governance related to the manufacture of the 'goods or device'. They have suggested that you need to convene a small subcommittee of experts to firstly get advice on the manufacturing issues (both past and present). This committee will need lots of information from BT and will probably need to inspect the facility. After this has been completed it will then go to the ethics committee to handle the rest of the issues.

Unfortunately this issue like most things related to BT is going to require time-consuming input from unpaid experts - I doubt that they would view the 'urgency' from the same perspective as BT .

Let me know how I can help but Carmel will endeavour to get the official letter to you very shortly (sorry the office is as you know seriously understaffed and Carmel is only here 2 days per week)." 38 On 5 May 2008, Mr Bernard sent an email to Mr Clout, copied to Professor Ward, concerning a meeting he had with the Plaintiff that morning, in which he had raised the issue of applying for a Commonwealth grant in partnership with Monash University for stem cell research. Mr Bernard stated that he had sought advice from Professor Ward, and that a letter had been sent to the Plaintiff since the meeting. Mr Bernard continued as follows in his email (Exhibit A, page 102) (emphasis added): "In making application for this grant, he requires signature of support from the appropriate Executive, which I have advised Bernie is yourself. I have advised him that we would probably be seeking advice from Prof Ward in her role as Director of Research in determining whether this support would be given. Bernie was generally not pleased. The completed submission is due to the Commonwealth by Wednesday COB and he sees this process as unnecessarily obstructive. You are generally aware of the difficulties with managing Prof Tuch, and he is particularly concerned that the Area HS and I as Network GM are placing too much reliance on advice from Professor Ward, and that this advice may not be balanced and objective ."

Once again, this email provides some understanding of the relationship between persons relevant to this case, and in particular, Professor Ward and the Plaintiff. 39 On 5 May 2008, Ms Edwards wrote to Mr Bernard on behalf of the NHN HREC Executive to advise him of the Executive's view that the matter was one of research governance, and that a small ad hoc committee should be established to review the matter. 40 On 7 May 2008, Ms Malica commenced employment as the Manager of the RSO within the NHN. Before then, Ms Malica had been employed for seven years at the New South Wales Cancer Council. 41 From February 2008 to May 2008, Ms Edwards worked as Research Advisor in the RSO. She ceased employment with the RSO in May 2008. 42 During June 2008, Mr Bernard took advice about proposed terms of reference and proposed members of the ad hoc committee from Professor Margaret Rose, the Director of Research Governance, Professor Ward and Ms Malica. 43 In an email dated 2 June 2008, Professor Ward makes suggestions to Mr Bernard concerning the membership of the ad hoc committee. Professor Ward indicated that she had raised the need for a review with Professor Campbell, and that he was happy to help and he would be "a good chair". She suggested that Ms Malica should be part of the committee. Professor Ward said in the email (Exhibit A, pages 133-134) (emphasis added): "With due respect, I don't think Jim Mackie or other non-research clinicians on the campus are appropriate - we need very specific content advice from experts. You recall the HREC executive did not feel they had enough expertise either in the SAC or the HREC proper to address the first set of issues in this matter ie those related to the manufacture. Once advice is forthcoming on the manufacturing issues there are other issues which will require attention by both the HREC and the scientific review committee.

I caution against trying to do this with great haste - the minister cannot override your decision to halt the trial. Our priority is patient safety and research integrity. The process will take as long as it takes - no one is harmed by delays.

Given that this matter involves Bernie Tuch I also think we need to give some thought to the protections we put in place for the ad hoc committee, particularly if they make a decision which adversely affects Bernie .

Margaret, like you I suspect it would be best if we could both stay away from this ad hoc committee . It is expert content advice that is sought - the committee will provide a recommendation to Andrew Bernard and he may seek the views of others in interpreting this advice and formulating his next steps eg Jim, yourself etc. In my mind being part of the ad hoc committee disqualifies you from assisting in the interpretation of the advice . I also think that this trial is an issue about ethics, scientific merit and governance - this should be assessed locally through due process - which as you know we have only just established. Adhering to these processes is very important, not only for our own integrity but also to maintain (gain in our case) credibility with the external research community. To undermine our processes now because of external pressures will be to our long lasting detriment." 44 On 7 June 2008, Professor Ward sent an email to Mr Bernard concerning the proposed ad hoc committee (Exhibit A, page 141) (emphasis added): "I met with Terry Campbell on Friday and he has agreed to act as chair of the committee. He has a preference for how he would like to run the agenda and I told him this would be fine with us. Briefly he wants to commission a couple of background documents before the committee meets face to face. One of these is a laboratory inspection and the other is an audit of the trial's CRFs etc. He understands that the primary role of the committee is to advise on whether the decision to stop the trial were correct - but the short summary is that 'you don't need a committee to tell you this - you had no other choice '. Provided you are comfortable, Terry would like Carmel Edwards to serve as a member of the committee with Marie as the support person."

As will be seen, the Plaintiff placed particular emphasis on the role of Professor Ward in the selection of Professor Campbell, and the latter's reported comments concerning the merit of the suspension, as disclosed in this email. 45 In an email dated 26 June 2008, Professor Ward suggested to Ms Malica, Professor Campbell and Mr Bernard that Dr Alison McLean be approached to review the laboratory manufacturing process used for preparation of islet cells, noting that she had already reviewed the facilities (Exhibit A, page 152). It was Professor Ward who passed on to Ms Malica the names of possible auditors who might be used by the Review Committee, including the name of Dr David Sarson (Exhibit A, page 156). 46 On 28 July 2008, Ms Malica emailed Mr Bernard in relation to the ad hoc committee, and said that the Plaintiff should be advised of the review and its terms of reference. Accordingly, on 29 July 2008, Mr Bernard wrote to the Plaintiff advising that "In order to make a determination on whether the project may resume, I have requested that a Committee be established to review issues of research governance arising from the conduct of the project within the Diabetes Transplant Unit". 47 The same letter advised the Plaintiff that members of the Review Committee would be:

(a) Professor Campbell as chair - Professor Campbell was Clinical Associate Dean and head of the Department of Medicine, Faculty of Medicine, University of New South Wales;

(b) Ms Edwards, who by that time was a Consultant, Research Management; and

(c) Ms Malica, Manager, Research Governance Officer, RSO, NHN. 48 Mr Bernard enclosed the proposed terms of reference of the Review Committee and invited comment from the Plaintiff on those terms by 12 August 2008. 49 On 13 August 2008, the Plaintiff met with Mr Clout and requested one amendment to the terms of reference. On the following day, the Plaintiff emailed Mr Clout to thank him for "allowing the issues that have been frustrating me and the Diabetes Transplant Unit to be aired" and set out the additional term of reference that he sought (Exhibit A, pages 191-192). That amendment to the terms of reference was duly made, with the addition of clause 5.1.7 concerning patient safety. 50 The terms of reference of the Review Committee required it to review the research being undertaken in the DTU using human tissue as a component of a product for transplantation into humans with diabetes, in particular the Plaintiff's study NHN Ref 05/151 and the conditions of manufacture of encapsulated islet cells. The terms of reference were lengthy, requiring review of procedures, documentation and safety outcomes in patients and compliance with regulatory requirements and standards for the manufacture of products for use in humans. With regard to documentation, clause 5.5 of the terms of reference gave the Review Committee power to review documentation. The Review Committee was also given power to make findings in certain respects. 51 Given the issues raised in these proceedings, it is appropriate to set out in full the terms of reference of the Review Committee: "TERMS OF REFERENCE Diabetes Transplant Unit Review Committee

1. Title The name of the Committee shall be the Diabetes Transplant Unit (DTU) Review Committee (The Committee). . 2. Purpose To review the research being undertaken in the DTU that uses human tissue as a component of a product tor transplantation into humans with diabetes. Particular reference will be made to the study entitled 'Transplantation of encapsulated human islets into people with Diabetes' (SESIAHS NHN HREC Ref 05/151), and the conditions of manufacture of 'encapsulated islet cells'.

The General Manager, NHN, SESIAHS has requested a review of this research protocol. Specifically, the GM requires: 2.1 Advice as to whether his Directive of 27 March 2008 to cease the Encapsulated Islet Trial was justified. 2.1.1 An outline of the conditions which would need to be in place for the Encapsulated Islet Trial to be undertaken,

2.1.2 Advice, it relevant, on any possible negative impact of the study on the subjects and institution over the last three years.

2.1.3 Advice as to whom the GM should inform of the findings of the review.

3. Governance and Resources 3.1 This ad hoc committee has been established under the auspices of the General Manager, Northern Hospital Network, SESIAHS.

3.2 The Committee will provide detailed advice and recommendations to the General Manager, NHN, SESIAHS.

3.3 The Committee will be supported by a Secretariat within the Research Support Office, NHN. The Secretariat will provide ongoing support to the Committee as necessary. This Secretariat will undertake at least the following prior to the first meeting of The Committee: 3.3.1 Prepare a summary of the status of all research currently being undertaken within the DTU.

3.3.2 Seek expert advice from the Therapeutic Goods Administration (or other expert) about the appropriate national regulatory requirements of this study.

3.3.3 Provide to The Committee all documentation relating to the above as well as a catalogued copy of all documentation relating to the study that is held by the Research Support Office, including HREC submission and all subsequent correspondence.

3.3.4 Review of study documentation held by the investigator. [This may be sub-contracted to a Contract Research Organisation (CRO) or other expert with experience in reviewing and making recommendations about such documentation.]

3.3.5 Review the laboratory manufacturing processes used for the preparation of the islet cells

3.3.6 Any other documentation as requested by the Chairperson of The Committee.

4. Membership 4.1 The Committee membership shall be adequate to ensure appropriate expertise to undertake the review as outlined in the Purpose at Clause 2. Members will declare any potential conflicts of interest and may be excluded if the General Manager, NHN considers such potential conflicts to be significant. 4.2 Membership will at least include: • Chairperson • A person(s) with experience in research management • A person(s) with experience in research governance. Any member may have expertise across one or more of the above categories, there will be at least 3 members. 4.3 The Chairperson and Members will be appointed by the General Manager, NHN, SESIAHS.

4.4 All members of The Committee must be present at meeting(s) or must provide written comments.

4.5 Persons may be invited to provide expert advice by The Committee at the request of the Chairperson on behalf of The Committee. Such persons have no voting rights.

4.6 The Committee may seek the assistance of professional organisations or individuals In the review of study documentation or when necessary.

4.7 Decisions and recommendations will be made by consensus where possible, and alternatively by a simple majority vote of the membership of The Committee members only.

5. Scope 5.1 Review the project entitled 'Transplantation of encapsulated human Islets into people with Diabetes' (SESIAHS NHN HREC Ref 05/151) in relation to the following: 5.1.1 Procedures and facilities for the procurement of islet cells including approval, harvesting, maintenance of sterility, testing for pathogens, storage and quality assurance.

5.1.2 Procedure for encapsulation of islet cells including methodology, facilities, maintenance of sterility, adherence to appropriate directives/guidelines (eg ICH GCP, GMP).

5.1.3 Procedure and facilities for the transplantation of encapsulated islet cells into humans.

5.1.4 Procedures for Quality Assurance monitoring and ensuring protocol adherence.

5.1.5 Procedures for monitoring participants post transplantation.

5 1.6 All documentation relating to the study including protocol, ethics submissions and approvals, case report forms, adverse events, patient information statements and consent forms, quality assurance documents etc (this may be undertaken by a CRO).

5.1.7 Safety outcome in patients already treated in the trial, specifically in relation to Incidence of Infection. 5.2 Review adherence to national regulatory requirements for this research by the investigator, the Human Research Ethics Committee and the Institution.

5.3 Review national and international standards for the manufacture of such products for human use (should national regulatory requirements be ambiguous)

5.4 Review the broader implications for other research being undertaken in the DTU. 5.4.1 Should this review Indicate that other research being undertaken within the DTU does not meet appropriate regulatory standards then The Committee may propose to the GM NHN that he endorse the extension of these Terms of Reference to Include review of such research projects. 5.5 In undertaking this review The Committee may seek to review any documentation relating to the study that is held by the Investigator, the HREC, the Institution, and regulatory bodies eg TGA. 6. Outcomes The committee will provide the General Manager, NHN, with a detailed report on the current status of the study 'Transplantation of encapsulated human islets into people with Diabetes' (SESIAHS NHN HREC Ref 05/151). This report will include detailed findings of the review and advice and recommendations about how to ensure research undertaken in the DTU meets appropriate regulatory standards. The report will also include detailed advice about the responsibilities of the investigator, the HREC and the Institution in respect of such research. The broader implications for other research within the DTU and across NHN campus will also be presented.

The Committee will provide a Report that includes: 6.1 Current status of the study with respect to: • Procurement of islet cells • Manufacture of encapsulated islet cells • Procedures for transplantation • Quality assurance methodology • Monitoring of participants • Adverse events • Adherence to study protocol The Report will document the current status of each element above, current national and international standards relating to each element and provide advice about whether these standards are being met. Recommendations will be made to ensure standards are implemented.

6.2 The national regulatory requirements for the research and whether these requirements have been implemented. Any such requirement(s) may have Implications not only for the conduct of the research and the investigator but also the role of the Human Research Ethics Committee and the Institutional administration (as the sponsor of investigator initiated clinical research). The Committee will clearly document the responsibilities of each party and make recommendation(s) about these responsibilities. 6.3 Advice and recommendations about appropriate facilities for, and the manufacture of, 'encapsulated islet cells', based on national and international standards. This is particularly important should the Therapeutic Goods Act not specifically require adherence to ICH GCP. 6.4 The Committee will provide recommendation about: • the terms under which the research entitled 'Transplantation of encapsulated human islets into people with Diabetes' (SESIAHS NHN HREC Ref 05/151) could proceed, or

• whether the current withdrawal of authorisation for the research should be made permanent. Full documentation will be provided in support of either recommendation. 6.5 Implications for other research being undertaken in the DTU. The Committee may make recommendation that other research studies be reviewed with similar terms of reference.

7. Other 7.1 The investigator, Professor Bernie Tuch, will be informed of these Terms of Reference, his responsibilities in providing access to Information as requested by The Committee in undertaking this review." 52 The Review Committee made formal requests for information from the Plaintiff on 14 and 22 August 2008. In response to those requests, the Plaintiff supplied information on 21 and 28 August 2008 respectively. There was also ongoing dialogue between those acting for the Review Committee and the Plaintiff, which involved further exchange of information. 53 Between 14 and 19 August 2008, the Plaintiff exchanged emails with Mr Bernard, Mr Clout, Professor Ward and Ms Malica about whether the Therapeutic Goods Administration ("TGA") had approved the 2005 clinical trial notification for the Clinical Trial. On 19 August 2008, the Plaintiff emailed Ms Malica stating (Exhibit A, page 199): "Your advice about how to handle the '2005 CTN', in light of what has been uncovered in the last few days, is appreciated. I am happy to wait for instructions from Andrew on this matter. No doubt his administrative experience will be very helpful in guiding a future path." 54 In a letter dated 21 August 2008 to Ms Malica enclosing documents sought by the Review Committee, the Plaintiff requested an early inspection be arranged of the DTU laboratory (Exhibit A, page 210): "You have indicated that the laboratory of the Diabetes Transplant Unit will be inspected. It would be appreciated if this could be carried out before the Manager of the Unit departs for her 4 weeks annual leave. Her last date in the laboratory is Friday August 29. My understanding was that it was planned that the review would be completed by this time anyway. Your consideration of this issue would be appreciated." 55 Ms Malica responded promptly to the Plaintiff's letter by email on 21 August 2008 (Exhibit A, page 208): "Thank you for arranging Sarah Walke to deliver the documents relating to your study HREC Ref 05/151 to my office this afternoon as requested.

I note in your covering letter that you have requested the DTU inspection to be undertaken before the Unit Manager goes on 4 weeks leave from Friday 29 August.

In accordance with your request we do hope to have the inspection undertaken before 29 August.

I will contact you again tomorrow with more information.

When I spoke to Sarah this afternoon she indicated that there are many more documents, particularly relating to quality assurance and the preparation of the islets, retained at the DTU which you did not think were appropriate to provide to us at this stage, and it might be better to provide them to the inspector.

I have asked Sarah to email me a list of such documentation. Thank you for your cooperation in this matter." 56 The Review Committee met, for the first time, on 22 August 2008, with Professor Ward being present, in part, by invitation. The Review Committee considered the documents submitted by the Plaintiff on 21 August 2008. The minutes of the meeting contain the following (Exhibit A, page 335): "The Committee was so concerned about the state of this and other documentation (see below) that it decided during this meeting to recommend commissioning of a formal audit of all the trial-related paperwork, to be done by an external consultant with specific expertise in auditing clinical trials to GCP and TGA/FDA standards.

Action: Marie Malica to arrange GCP documentation audit to be undertaken as soon as possible." 57 Later on 22 August 2008, Ms Malica communicated with the Plaintiff and Ms Sarah Walke, Laboratory Manager in the DTU, by email for the purpose of attending the DTU to sight original documentation. At 6.05 pm on 22 August 2008, an email from Ms Malica to the Plaintiff included the following (Exhibit A, page 339): "Please find attached letter from Terry Campbell following the Review Committee's consideration of the documentation you provided.

I have not been able to confirm which day next week the DTU inspection will take place, but I hope to get back to you on Monday regarding this." 58 Attached to the email was a letter from Professor Campbell dated 22 August 2008 requesting certain additional information, with the letter identifying shortcomings in the information that had been provided by the Plaintiff the previous day and noting that the Plaintiff had not provided some information previously requested. The Plaintiff was requested to provide further information by 28 August 2008 (Exhibit A, pages 340-342). 59 For the purpose of conducting its investigations, the Review Committee determined on 22 August 2008 to appoint two external auditors, and in due course, the following persons were appointed for this purpose:

(a) Dr David Sarson, Director of Delpharm Consultants Pty Limited, who was to conduct a good clinical practice ("GCP") compliance audit in accordance with clause 5.1.6 of the terms of reference; and

(b) Dr Allison McLean, Director of Clinic Ready Pty Limited and Ms Kerryn Bouyer, Quality Manager of Q-Gen Pty Limited - to conduct a site inspection, review of procedures and facilities and quality assurance in accordance with clause 5.1.4 of the terms of reference. 60 In an exchange of emails between Ms Malica, Professor Campbell and Professor Ward on 25 August 2008, Professor Campbell said that it was "Robyn's call" whether Dr Sarson was engaged, and Professor Ward approved this step (Exhibit A, page 355). 61 By email dated 26 August 2008, Professor Campbell provided to Professor Ward a copy of the notes of the 22 August 2008 meeting described as "our first meeting" (Exhibit A, page 359). 62 By email dated 26 August 2008, the Review Committee informed the Plaintiff that Dr Sarson would visit the DTU at 9.30 am on 27 August 2008, and that Dr McLean and Ms Bouyer would undertake a site inspection and review of procedures, facilities and quality assurance on 28 and 29 August 2008 as part of the review process. 63 Later on 26 August 2008, the Plaintiff sought a delay of the two external formal reviews, until the week commencing 27 October 2008 for reasons explained in an email from the Plaintiff, to be mentioned shortly. 64 A number of emails sent on 26 August 2008, referred to in the following paragraphs, are of particular significance to the Plaintiff's claim for relief with respect to the Review Committee report based upon denial of procedural fairness. 65 At 1.14 pm on 26 August 2008, Ms Malica sent an email to the Plaintiff advising of the proposed site inspections by Dr Sarson on 27 August 2008 and Dr McLean on 28 and 29 August 2008. Ms Malica provided further information concerning the site inspections in the email, and requested that the Plaintiff and his staff make themselves available to Dr Sarson and Dr McLean to assist in their reviews. 66 At 4.18 pm on 26 August 2008, the Plaintiff replied by email to Ms Malica in the following terms (Exhibit A, pages 379-380): "Dear Marie

Your attempt to organize for the lab inspection as part of the review is appreciated. It is consistent with the decision by the CE Terry Clout (mentioned at a meeting involving him, Robyn Ward and me on 13.8.08) to reach a speedy conclusion as to the future of the clinical islet trial. My recollection of the meeting was that the internal review of the Human Islet trial and the Committee's report would be completed by the end of this week. This would allow a decision by Andrew Bernard as to the fate of the clinical trial to be made over the subsequent few days. The aim of this time line was to allow past matters to be dealt with speedily and allow a future path to be created.

However, the magnitude of what is being requested using external consultants indicates this time line will not be achieved. Turn around time for written reports from external consultants is at least 30 days. Certainly, this was the case when the GMP review on the Randwick campus was carried out by Allison McLean late last year.

Your advice of there being two external contractors to advise the Committee is new information; previously the correspondence indicated a single visit.

Last Friday you and Tali visited the laboratory of the Diabetes Transplant Unit and the Diabetes Centre and viewed much of the information being requested for review by David Sarson. Moreover, the Committee has asked a series of questions in relation to much of what Mr Sarson is to review. The answers to these questions have been requested by Thursday, the day after his proposed review.

In light of the above, the Committee's indulgence is now sought to delay the two external formal reviews until the week commencing October 27, with a preference for Tuesday October 28 and Friday October 31 (if two days are needed). The reason for the new times is as follows:

(a) the Manager of the Unit will be on annual leave (1.9.08 - 28.9.08) (b) I will be away for a number of days each week for the next 4 weeks (this is the time of the Jewish New Year and a series of religious festivals) [29.9.08 - 24.10.08]

Now, as regards the review by Allison McLean, can you please confirm that she has been advised the standard of the laboratory she is examining is not meant to be one that satisfies Good Manufacturing Practice (GMP) conditions. The Diabetes Transplant Unit categorically does not produce encapsulated human islets under such conditions; and, as previously argued, is not required to do so for the clinical trial (under existing TGA guidelines Schedule 7, Item 1 and Schedule 5, Item 7(q)). To the best of my knowledge, no laboratory on the Randwick campus operates under GMP conditions. Indeed, it was for this reason that the DTU had tried to upgrade its facilities last year to reach this standard. I am concerned that the Review Term of Reference 5.1.2 might lead Allison to believe otherwise.

To assist Allison in her future review, I will prepare a flow diagram as requested and hope to have it to you by COB today. The basis of the flow diagram is what is in the Protocols you have (the August 2008 version, which has yet to be submitted to the HREC for comment, is the same as the 2007 approved version with a small number of procedural changes). Could I suggest she be sent a Protocol together with the Flow Diagram.

Approval from the hREC [sic] was obtained previously for the isolation of human islets for non-clinical use, as part of mechanistic studies to guide the direction of the clinical program. Carrying out such studies is, after all, good scientific practice. Approval for carrying out such studies was originally given under approval number MP01/003, which is separate from the clinical study. Approval to continue these studies was given on August 23, 2006 (copy attached), and given the same HREC number as the clinical trial (05/151).

In view of the requested delay as to whether the clinical islet trial can continue, and if so under what conditions, can you confirm that it is appropriate to allow this mechanistic study to continue. The basis of Andrew's original letter advising to stop the clinical trial related to a belief that encapsulated islets for clinical use may not be produced under stringent enough conditions. The issue of non-clinical use of encapsulated islets to my knowledge has never been brought into question.

You should be aware that two PhD students, Vijay Ganapathy and Gayathri Sundaram use human islets as an integral part of their post-graduate degree. Preventing them gaining access to the islets will hinder their ability to complete their PhD within the time frame required by the University.

bernie." 67 At 5.06 pm on 26 August 2008, Professor Campbell sent an email to Ms Malica concerning the Plaintiff's request for a delay in the site inspections to be undertaken by Dr Sarson and Dr McLean. Professor Campbell copied the email to Ms Edwards, Mr Bernard and Mr Clout and also to Ms Walke. As will shortly become apparent, the email was copied inadvertently to Ms Walke. Ms Walke was a colleague of the Plaintiff working in the DTU. The earlier emails from Ms Malica and the Plaintiff had been copied to a number of persons, including Ms Walke. However, it is clear that the present email was copied to her unintentionally. Professor Campbell's email to Ms Malica was in the following terms (Exhibit A, pages 365-366) (emphasis added): "Hi all, This is an interesting development. I would suggest there are no reasons to agree to the request, on the grounds that all the documents and equipment, SOP's etc that are being reviewed should already be extant and readily available in the DTU and DTC.... and if this is not the case, then Bernie is, by definition, in breach of various relevant guidelines, unfortunately, while he cannot do much about the infrastructure of the DTU in terms of compliance with various guidelines between now and late October, he could certainly attempt to retrospectively generate some of the documents we are seeking in the CRO review, and this review should definitely not be delayed....we already have strong grounds to believe it will identify major deficiencies in GCP, to the extent that we would be likely (if these are confirmed) to recommend indefinite continuing of the suspension of the trial in any case .

It is Andrew's call of course, but I would suggest that he make it very clear to Bernie that regardless of what might have been suggested by Terry Clout, the Clinical Trial is NOT going to be recommenced until such time as the Cttee is satisfied that the conditions are appropriate to recommend this, and we cannot be satisfied of this until the reviews we requested are done. [We are expecting 'turnarounds' of at most a few days in any case] I would recommend that his request to delay the Review of documentation be denied and the Audit by David Sarson go ahead this week. I do not feel so strongly about the review by Alison McLean since as Bernie has conceded, the DTU facility is not GMP, and whether he is correct in saying that GMP standards were not specifically legally required for this study, I am confident the Cttee will be recommending that any recommencement should only occur in GMP Facilities .

As far as the request to continue isolation of human islets for non-human use, I do not feel strongly one way or the other and would be keen to hear views from the other members of the Cttee regards Terry Campbell"

Amongst other submissions concerning this email, the Plaintiff argued that it provided a further example of "overwhelming distrust and antagonism" between the Review Committee and the Plaintiff (T81). 68 I infer that Professor Campbell realised that his 5.06 pm email had been inadvertently copied to Ms Walke because, at 8.41 pm on 26 August 2008, he sent an email to the Plaintiff explaining the earlier email (Exhibit A, page 365): "Dear Bernie, As you may have already gathered from the email I inadvertently copied to Sarah this afternoon, the Review Committee has significant concerns from what it has seen so far, in a number of areas, related among other things to the documentation required by GCP in Clinical trials.

I apologise for sending an email, intended as an internal committee document, to Sarah. I have since had the opportunity of hearing from the membership of the Committee and had some discussions with some of them, and am now in a position to notify you formally that the Cttee have recommended and Andrew Bernard has agreed, that it is in the best interests of all concerned that both proposed reviews (ie the review of the DTU Facility and the CRO's Review of your trial Documentation), go ahead as planned this week.

I understand your reasons for seeking a delay but as the whole point of the reviews is to document what should already be firmly in place anyway, there can be no argument that time is required to prepare for such audits and there is no doubt the Research Office has the power and the right to audit any ongoing research under its supervision at short notice. This is one of the ways in which quality assurance can be maintained in Research Governance.

Accordingly, Andrew Bernard has been notified of this recommendation this evening and has agreed that the reviews should proceed as planned.

The processes should both be very quick, and the Review Committee should be in a position to provide at least a Preliminary report by next week-close to and possibly within the original deadline suggested to you by Terry Clout.

We have a meeting planned late this week and will discuss our response to your request to continue nonclinical islet cell collection at that time.

sincerely Terry Campbell" 69 At 11.38 am on 27 August 2008, Professor Campbell sent an email to Ms Walke, copied to the Plaintiff, concerning the email inadvertently copied to her the previous day (Exhibit A, page 389) (emphasis added): "I am writing to apologise for the email I inadvertently sent to you yesterday and to give some context to it.

Firstly, I am sorry it has caused you distress - this was certainly not my intent. It was intended as an internal committee document and as such I did not feel the need to couch any of the language in the way I would have done had I been communicating it directly to you or Bernie. It is the duty of any such Committee to look into whether the Ethical and Governance issues surrounding a complex trial such as this are being carried out appropriately and being kept current. We would be remiss in our duty to the Area Health service if we did not do this in a way that considers all possibilities, including the possibility of documents which are meant to be contemporaneously kept, being created after the fact. To act in a way that minimises this possibility is not for a moment to assume or ascribe wrongdoing on the part of anyone associated with the study, but simply to be carrying out our job. I was simply stating that the possibility of fraud must be considered in all such reviews; it is the committee's job to seek it out (and we sincerely hope, not to find it), and that was the context of my comments on that issue and one of the reasons for the decision to recommend going ahead with the audits .

It is true we found significant deficiencies in what was sent last week and that was the reason for the follow-up requests and for the formal audit of documents. That is a matter of fact which would normally have been formally conveyed to you at the end of the inquiry (hopefully with all issues resolved by then), and again I apologise for the cc to you. I do not however concede that I was stating any preconception or prejudice on the Committee's part . I was simply stating that we had significant concerns based on what we had so far before us, and taking appropriate actions to resolve them quickly (ie I was doing my job within the context of a review which is ongoing).

I also apologise for the inconvenience to you and Bernie in terms of timing, but the timing of this review is not of the Committee's making. We have been urged on all sides to move quickly, and given this, are moving as quickly as we can to resolve all outstanding matters and come to our Conclusions and recommendations. These will be conveyed to Andrew Bernard as soon as is possible and then it will be up to him to communicate to Bernie." 70 In an email sent at 11.48 am on 27 August 2008 to Professor Campbell and Ms Malica, Ms Walke objected to the notice given for the inspection and sought a delay. In an email sent to Ms Walke at 12.17 pm that day, Professor Campbell said (Exhibit A, page 384): "I am sorry Sarah,

But you have no grounds on which to object. The DTU is not your property but that of the AHS. Ethics Committees have an absolute right to request audits and at St Vincents for example (where I have long experience) the standard is to give no more than 24 hours notice.

The whole point is to take a snapshot of record-keeping, documentation etc, as it is, not as it might be after an opportunity to prepare. GCP demands that all this be up to date at all times.

Having said that, we will not place any unreasonable expectations on you and are very happy to see this as exactly that-a snapshot and where there are items of documentation etc that are not regarded as essential to be kept up to date, we will be very happy to allow you time subsequently to prepare these. The same will apply to questions (if any) to which you may not have immediate answers." 71 On 27 August 2008, Dr Sarson attended at the DTU to undertake an audit. 72 At 4.59 pm on 27 August 2008, the Plaintiff sent an email to Professor Campbell (copied to Ms Malica, Ms Edwards, Mr Bernard, Mr Clout and Ms Walke) under the heading "Procedural Unfairness". In the course of the email, the Plaintiff contended that Professor Campbell had made up his mind before the review was completed and that, as a matter of procedural fairness, he should disqualify himself from the process. The Plaintiff's email was in the following terms (Exhibit A, pages 377-378) (emphasis added): "Dear Terry,

As per the wishes of Andrew and the Committee, the Diabetes Transplant Unit (DTU) co-operated with David Sarson and providing everything he requested to review this morning. Can you ensure that the Unit receives a copy of his audit, regardless of the outcome of the review. I am advised this is standard practice for clinical audits, and provides guidance about how best to maintain the paperwork needed for clinical trials.

It was pleasing to see that the amount of time required by personnel of the DTU for today's audit was minimal. I see from the time schedule provided this afternoon by Allison that the audit for tomorrow and Friday will be much more labour intensive. This is of concern, as there are existing commitments that personnel in the Unit also need to meet. For example, the overview presentation that Allison has requested from me for 0930 tomorrow is not practical since I have a weekly clinic that starts then. Marie has kindly tried to ensure Allison arrives earlier so the overview can be given and the clinic conducted.

The other timing issue relates to the lab manager, Sarah Walke. She departs on annual leave after this Friday. The DTU has 15 personnel that need to be managed in her absence, and reasonably she needs time to set the structures in place to ensure the Unit continues to operate in as smooth a manner as possible in her absence. Originally, it had been requested that no review occur on the Friday to allow a reasonable amount of time for Sarah to carry out these necessary duties. That half a day has been left for this is helpful, but not what had been sought. The degree of pressure that arises as a result of this time pressure is already having negative health consequences.

Perusal of the agenda that Allison has provided suggests yet again that GMP standard are being sought. As stated previously, the DTU does not operate under GMP conditions. This raises an issue of a substantial nature.

As you are aware, the Unit inadvertently received an email from you as Chairman of the Committee, with copies to Andrew Bernard and Terry Clout. Towards the end of the email you said: I am confident the Cttee will be recommending that any recommencement (of the trial) should only occur in GMP Facilities .

From the above quote, it is clear that you have made up your mind, even before the review has been completed, that the islet trial should be conducted only under GMP conditions. Since there is no GMP facility on the Randwick Campus, the review seems rather meaningless. Since you have pre-judged the issue, the Trial could never be approved even if the Unit satisfied all other aspects of the manner that the trials are to be conducted .

Terry, I have always been prepared to co-operate with the review and am surprised that you hold the view reflected in the above quote, since it is not a TGA requirement that trials of this nature be held under GMP conditions.

I also note in passing that the DTU has been at the forefront in attempts to establish a GMP facility on the Randwick Campus.

Having regard to the above, as a matter of procedural fairness, I would respectfully submit that you have no alternative but to disqualify yourself from the process .

Further, having clearly indicated your view to the other members of the Committee, if the review is not only to be fair but seen to be fair, they too should be disqualified since there is a real risk that their view about the trials could have been influenced by you .

For Thursday and Friday, the Diabetes Transplant Unit will do its best to co-operate fully with the requirements of Allison and Kerryn over the next two days. However, there will need to be some flexibility over the timing of how things are examined. I will take this up separately with Marie who is co-ordinating the visit of Allison and Kerryn." 73 At 5.16 pm on 27 August 2008, Professor Campbell sought Professor Ward's views concerning the Plaintiff's email. Professor Campbell said (Exhibit A, page 421g) (emphasis added): "Can you call me after you've read the previous email from Bernie and we can discuss what to do before one of us talks to Andrew Bernard ?

My feeling is that the view I expressed was not a 'pre-judging' at all, but a considered decision already made by the full cttee at its first meeting and stupidly released earlier than planned . It does not relate at all to the issues of documentation etc which are being dealt with by audit and I note Bernie has not tried to stop the audits.

An alternative would be to accede to his request and disband the Committee. Sarson's and McLean's reviews would still go ahead and reports could then go direct to Andrew Bernard who could make his own calls without input from us. Either way the outcome is likely to be similar ." 74 At 5.43 pm on 27 August 2008, Ms Edwards sent an email to Professor Campbell (copied to Ms Malica, Mr Bernard and Mr Clout) concerning the Plaintiff's earlier email. Ms Edwards said (Exhibit A, page 416) (emphasis added): "Firstly, from my perspective as a member of the review committee I believe the Chair is entitled to express his opinion re one of the possible outcomes of the review. It is an opinion that may well be supported by the other members, based on the information reviewed to date about the conduct of the study. The committee members are adequately experienced and capable of making independent and informed judgements about the study. The recommendations put to the AHS will of course be made after due discussion and consideration of all the audit material by all committee members. I do not believe the committee members have been compromised in any way about the possible outcomes of the review .

On another issue raised by Bernie re the statement that since it is not a TGA requirement that trials of this nature be held under GMP conditions, I reiterate the following:

TGA requirements aside, it is the responsibility of the organisation (SESIAHS) to ensure:

• The facilities and resources required for the research to proceed at the site have been identified, are appropriate and available.

• The researchers involved in the project at the site have the necessary skills, experience, training and expertise to carry out their role in the research project.

• Whether the research should be conducted at its site.

To ensure appropriate governance of human research is in place, the Institution can impose more stringent requirements than the TGA, or any other legal requirements, on the researcher."

75 At 6.06 pm on 27 August 2008, Professor Campbell sent an email to Ms Edwards and Ms Malica in the following terms (Exhibit A, page 416) (emphasis added): "Firstly Marie I think it is quite reasonable to send your proposed email.

Regarding the request to disband the committee, I want to discuss with Robyn when I can get hold of her and then either she or I will talk to Andrew Bernard .

I certainly don't think I need to admit to pre-judging and am happy to say (as I believe is true) that in fact the Committee already decided after due discussion at its first meeting that we would recommend exactly what I said. The only thing I am guilty of there is pre-releasing a decision already taken by the Cttee .

Andrew may wish to play the 'safer' option and just disband us, the two Audits can still report to him and he can either decide based on their reports or get another bunch of experts together. " 76 On 27 August 2008, Dr Sarson conducted an inspection of the DTU laboratory. 77 At 8.15 am on 28 August 2008, Professor Campbell responded to the Plaintiff's email (at [72] above) in the following terms (Exhibit A, pages 376-377) (emphasis added): "Dear Bernie, Can I first thank you for your cooperation in the processes that have been arranged for this week. I realise as you point out, that Allison's review today and tomorrow in particular, will be time consuming for you and Sarah and a particular burden for Sarah given her imminent departure on leave. I think it was important to move quickly and you have been most accommodating. I am more than happy for a copy of David Sarson's report to go to DTU, but a final decision on that would rest with Andrew Bernard who is formally the client to whom it will be addressed.

In terms of your view that I have pre-judged the recommendations of the Review Committee, I must strongly disagree with your interpretation of the statement you have quoted from the email I inadvertently copied to Sarah. The question of whether Studies such as the Islet Cell transplant trial should be carried out in SESIAHS in future, under non-GMP conditions was discussed by the committee at it first meeting on Friday August 22, and the view I expressed in the email was simply reflecting where I believed we had got to during that discussion-no final decision was recorded as there was no need at the time to do so, and we will discuss it and other matters further at future meetings. We felt (and I agree) that whether or not it is required under TGA guidelines, it is best practice, and should be recommended as standard practice to the General Manager .

This was not a pre-judgement of mine which I was seeking to impose on the others, but a considered judgement of all the committee, taken a few days earlier and simply being fed back to them in my email was never meant to be conveyed to anyone outside the Committee, although of course, if it remains our view at the conclusion of our Review, it will then be conveyed to Andrew Bernard as one of our recommendations .

In regards to your comment that if that is our view then why persist with the rest of the Review (including the external audits), I can see the logic of your query, but would make two comments:

i) If that view is eventually formed into a recommendation to the GM, it will only be a recommendation; there is no obligation on the GM's part to accept it

ii) Quite apart from that, we were asked by Andrew Bernard not only to make recommendations about any future Transplant trials, but also to review the conduct of the current (suspended) Trial. We had serious concerns about several aspects of the responses we received from you last week, which we also reviewed and discussed at our Aug 22 meeting, and on that basis, requested the Audits to clarify these further in as expeditious and expert a manner as possible.

Accordingly Bernie, I see no reason to withdraw from the Committee, and certainly no reason for any other member of the Committee to withdraw. [The Committee was appointed by Andrew and it remains of course, his prerogative to dismiss us .] I expect very quick turnarounds from David Sarson and from Allison McLean, and hope to be able to get at least a preliminary report to Andrew Bernard within the time window promised by Terry Clout. This would certainly not have been possible were the Audits not to have been held this week, and also would not have been possible without your and Sarah's cooperation for which I am grateful. sincerely Terry" 78 At 5.52 pm on 28 August 2008, the Plaintiff replied to Professor Campbell's email in the following terms (Exhibit A, page 376) (emphasis added): "Dear Terry

Firstly, let me say the Product audit is underway at present and appears to be running smoothly. Allison and Kerry have been accommodating to our logistical requests that I raised yesterday with Marie.

Secondly, the preliminary conclusion reached by the Committee (as stated in your email) that best transplantation practice requires GMP conditions be met on the Randwick campus is one that the Diabetes Transplant Unit would support. Indeed, as you know, the Unit has been trying to have such a facility created on campus for some time now.

If this is the final recommendation of the Committee and it is adopted by Andrew, it will have implications for every transplant unit on campus, not just the encapsulated human islet trial which your committee is reviewing. It will effectively stop bone marrow transplants, for example, until a GMP Facility is created and the cells are prepared in this Facility.

Of course, Andrew might be prepared to have a period of grace for those transplanting cells, whilst GMP facilities are being developed, if indeed this pathway is chosen to proceed with.

Should that be so, would your Committee be prepared to consider recommending allowing the Encapsulated Human Islet Program to continue in the interim, and if so, on what basis. As you know, the Terms of Reference do provide for this option.

On the procedural matter I raised in my last email, you have confirmed the accuracy of my contention that not only you have prejudged the matter but that the whole Committee may well have done so even before the review was complete. We disagree on the actions that should arise from this .

As to your two reasons as to why the review should continue:

The conclusions of reviews by a Committee of this type are always merely recommendations to the GM. If the process is flawed then there is no point to the review.

Serious concerns about several aspects of the responses received last week. I trust these concerns were covered by your letter of August 22, in which you raised a number of issues, and asked for further information? [Marie has received my response to these today]. If there are further concerns, could you please advise what they are to allow for the opportunity to respond to them." 79 On 28 August 2008, the Plaintiff provided further information to the Review Committee in response to Professor Campbell's letter of 22 August 2008 (Exhibit A, page 422). The Plaintiff also took the opportunity in his letter to advance arguments on a number of issues. 80 On 28 and 29 August 2008, Dr McLean and Ms Bouyer conducted an inspection of the DTU laboratory. 81 In an email at 7.48 pm on 28 August 2008, Dr McLean informed Ms Malica of the key findings of her audit (Exhibit A, page 443): "The following points summarise the key findings of the audit today:

We consider there is considerable risk to the safety of patients due to the lack of quality oversight and systems of control

Inadequate sterility assurance systems coupled with unvalidated Sterility testing methods

Non existant [sic] control over raw materials used in production eg use of collagenase that is not suitable for human use

Critical data is not recorded and production records are inappropriate

Traceability is compromised through inadequate record keeping

There is no independent Quality Function or formal review against specifications where they exist

While there has been considerable effort to write procedures and protocols it is clear that they have not been implemented successfully. Further in our opinion there are inadequate resources to successfully fix it on the short term.

We regret that we have to report these findings. The group are passionate about the science but clearly need outside support to help with the quality aspect of the clinical production.

We will complete a detailed report by next Friday for your review. I hope that this summary is adequate for your meeting tomorrow and again thank you for this opportunity." 82 On 29 August 2008, Dr Sarson provided a draft report to Ms Malica (Exhibit A, pages 448-455; page 463). In the draft report, Dr Sarson noted that the audit had been arranged at short notice, thereby precluding a thorough examination of all the documentation held by the Research Governance Office. It was noted that the auditor was reliant on the documentation provided, and acknowledged that some other relevant documentation may be held at DTU which may alter the conclusions drawn (Exhibit A, page 448). The draft report of Dr Sarson expressed the following conclusions (Exhibit A, page 455): "The audit of the documentation provided, revealed significant non-compliance with GCP Guidelines. As a result of this, the data gathered thus far is unacceptable for review by regulatory authorities unless significant remedial action is taken.

The onus for this non-compliance must be shared by the investigator and by the approving HREC. In the auditor's opinion, this is an important research activity (islet transplantation) which could lead to greatly improved quality of life to brittle diabetic patients. For this reason it is a pity that the data in its current form is not usable in a regulatory dossier.

However, patient safety and ethical practice are the cornerstones of good research and should be pre-eminent in any venture of this type.

The auditor recommends that the study not be continued until the relevant GCP elements have been incorporated into the research plans and remedial action taken to improve the quality of existing data." 83 The Review Committee met, for the second time, on the morning of 29 August 2008 to consider the preliminary comments of Dr Sarson and Dr McLean, and the documents which had been submitted by the Plaintiff on 28 August 2008. Dr McLean's preliminary comments raised significant concerns for patient safety. The Review Committee resolved that the findings in relation to patient safety warranted immediate action. The Review Committee invited Mr Bernard to attend part of the meeting in order to provide an update. The minutes also record that Professor Ward was present, in part, by invitation. The Review Committee recommended to Mr Bernard that the suspension of the trial be confirmed. The Review Committee also recommended that, as a matter of urgency, the Plaintiff should be required that day to produce to Mr Bernard original trial-related documents, and that urgent consideration ought be given to notifying the patients of the Clinical Trial suspension and how their conditions would be monitored. 84 The minutes of the Review Committee meeting recorded that consideration had been given to the Plaintiff's request of 27 August 2008 that the committee members stand down on the basis of prejudgment on the part of the Chair, with all members rejecting any claim of bias or prejudgment and confirming that they would continue their deliberations as a committee (Exhibit A, page 457). 85 On 29 August 2008, Ms Malica requested Dr Sarson to make a number of amendments to his draft report (referred to at [82] above). With respect to the conclusions expressed, Ms Malica stated (Exhibit A, page 463): "Page 8 conclusions, whilst we recognise you do have content knowledge in this area, for the purposes of this report it might be best to remove the following statement "In the auditor's opinion, this is an important research activity (islet transplantation) which could lead to greatly improved quality to life to brittle diabetic patients. For this reason it is a pity that the data in its current form is not suitable in a regulatory dossier'. If you agree, please amend and return the report."

Competing submissions were made concerning this email. The Plaintiff contended that this pointed to a desire on the part of a Review Committee member to cause Dr Sarson to delete material in his draft report which was broadly favourable or helpful to the Plaintiff. The Defendant submitted that the material went beyond governance issues, and into scientific merit, and was irrelevant to the terms of reference of the Review Committee. 86 Following the Review Committee meeting on 29 August 2008, Ms Malica sent an email to Mr Bernard in the following terms (Exhibit A, pages 465-466) (emphasis added): "Following this morning's meeting of the Review Committee established under your auspices to review the abovementioned trial I am writing to advise the following. Our initial finding is that :

a) your directive of 27 March 2008 to cease the above-mentioned clinical trial was justified

The Review Committee commissioned two expert reviews which were undertaken this week. Attached is the preliminary report from David Sarson regarding GCP documentation compliance, and a brief email from Allison McLean summarising the key findings from day one of a two day site inspection which will be completed today. These draft reports will be incorporated into the Committee's final report.

The following must occur TODAY as a matter of urgency .

Professor Tuch must be requested to submit to you by close of business today:

The complete & original Trial Master File All original documents provided to the Review Committee and to David Sarson for the GCP documentation compliance audit undertaken on 27 August Any other trial related documents in their original form A cover letter stating that the trial documentation provided is complete You may advise Prof Tuch that copies of all documents will be made & returned to him for his record.

Also TODAY consideration must be given to the following as a matter of urgency. The 4 patients transplanted must be notified as soon as possible :

Of the Hospital Executive's decision to suspend the trial & on what basis

How will the patients be notified? (ie should they first receive a letter asking they call to make an appointment for a consultation, or should they just be called)

Who should be present during the initial consultation (ie medical & counsellor)

What tests should be done for possible infections & how often?

The Hospital Executive may need to seek expert medical advice on a number of the issues listed above.

Terry Campbell will have a preliminary report to you by Monday 1 or Tuesday 2 September 2008, and a more comprehensive report by approximately 15 September .

Please note, due to the urgency of relaying this information to you today I have sent this email without first having it approved by Terry Campbell or Carmel Edwards .

I hope they will respond to advise if I have misinterpreted anything from our discussions today .

Lastly, could you please confirm that members of the Review Committee are legally covered by the AHS ?

Please do not hesitate to contact Tali Leizer or myself if we can assist with anything further." 87 Later on 29 August 2008, Professor Campbell emailed Mr Bernard, attaching "a preliminary report with some draft recommendations from the DTU Review Committee". Professor Campbell advised that he would be away for a week, and then the Review Committee was to meet again on 12 September 2008 and that, by then, he should be in a position to write a full report which would include the two external reviewers' reports as appendices, but that "I thought you should have this document as soon as possible" (Exhibit A, page 467). An eight-page preliminary report accompanied the email with 10 draft recommendations (Exhibit A, pages 468-475). 88 On 29 August 2008, a teleconference took place between Mr Bernard and Mr Clout concerning the Review Committee preliminary report and draft recommendations (Exhibit A, page 476). 89 On 31 August 2008, Mr Bernard reviewed the preliminary report of the Review Committee (Exhibit A, pages 481-489). On 1 September 2008, Mr Bernard emailed Ms Malica proposing a "skeleton of an Action plan for responding this week to the draft Audit Report" (Exhibit A, page 490). The Plaintiff contends that this email points to Mr Bernard dictating an outcome to the Review Committee. In these circumstances, it is appropriate to set out in full Mr Bernard's email to Ms Malica (copied to Professor Ward and Dr Mackie) (Exhibit A, pages 492a-492b): "All, I've put the following together as the skeleton of an Action plan for responding this week to the draft Audit Report.

In my review of the documentation, particularly the recommendations of Terry's draft Report the issues are

2. in light of the totally inadequate governance, conduct documentation and supervision of the individual project at DTU under Review, the adequacy of these aspects in relation to other research being conducted in DTU is also now under a cloud. These other projects require a similar review

a meeting needs to be held with Prof Tuch to discuss the recommendations in the Report, and obtain his response to the recommendations and findings. I suggest the Jim [sic] and I would meet with Bernie and possibly others (please let me know who) also attend.

We particularly need Prof Tuch's response to the risks identified by the Review in terms of the safety of the 4 transplant recipients and how he has managed the infection and contamination risk during the project. Depending on his response, we should recommend a way forward consistent with recommendations #4 and #5 in the draft Report and the independent expert advice separately sought and provided

Major concerns have been reached regarding the adequacy of Research governance and the functioning of the HREC prior to December 2007. The implications are that a review of all relevant other projects on the Randwick campus be undertaken and a risk register established.

The Research office requires further resourcing to undertake the necessary reviews above, to provide education for staff as recommended in #9

EAP or alternative be discussed for counselling of DTU staff and PhD students.

• Report to BT and make time for him to meet to discuss with AB, JM et. al. this week to discuss response to recommendations #1,2, 3, 4, 5, 6

• AB, RW and JM to discuss who should provide expert advice under Recommendation#2 and get that advice to feed back to BT

• Research office identify extent of additional resources necessary to implement Recommendations #6, 7,8,9

• AB to complete Brief to DCO and CE this week on the draft Report and the outcomes of the above, including BT's response to both the Report and our intended actions.

Your comments please. I will get Deidre to find a time for us to meet and discuss tomorrow." 90 On 2 September 2008, Professor Ward sent an email to Mr Bernard and Ms Malica in response to Mr Bernard's email of 1 September 2008. The Plaintiff submits that this email evidences Professor Ward dictating the outcome to the Review Committee, with this happening before the Plaintiff had been given an opportunity to respond to the preliminary report. In this respect, the Plaintiff submits that Professor Ward appears to have an underlying animosity towards the Plaintiff. Given the submissions made concerning this email, it is appropriate to set it out in full (Exhibit A, page 493) (emphasis added): "Hi Andrew and All,

I agree with the items in the skeleton Action plan but I think the next step is to identify the issues which need to be discussed with Bernie this week. The final GCP audit report will not be available until probably Friday and the lab report is due Friday or maybe Monday next week. Terry Campbell's document is still in draft form. It would not be appropriate for Bernie to view any of the documents until such time as they are complete. I am not even sure if you were planning on giving Bernie a copy of Terry's report .

Having said all this Bernie is shooting off emails and making all sorts of assumptions so I definitely agree that we need a meeting with Bernie this week .

In my mind the messages which need to be conveyed to him at this weeks meeting are ;

1. His study cannot proceed and it will not be allowed to proceed in the foreseeable future

2. He must not have contact with the four patients he has injected in the trial - we need to determine if they are under his medical care or someone else looks after them

3. He should not make contact with the GCP or the laboratory reviewer.

4. His other studies are likely to be reviewed and it is possible that they too will be stopped

5. No more grant applications will be supported at this point in time - he is currently trying to develop a complicated arrangement with India (the email to Jim and me last night) .

I think it would be helpful if Jim, you, I and Marie met to discuss. Both Jim and I are away next week." 91 On the evening of 2 September 2008, Professor Ward sent an email to Professor Campbell, copied to Ms Malica. The Plaintiff submits that this email again points to dictation of the Review Committee process by Professor Ward, rendering all that followed to be "high farce". Once again, given the significance attached to the email in the Plaintiff's submissions, it is appropriate to set it out in full (Exhibit A, page 496) (emphasis added): "Hi Terry,

AB has asked that the report is a little more explicit about stating why it is a COI [conflict of interest] for BT to be a manufacturer, investigator, doctor etc etc. He understands it is obvious but feels Terry Clout may not .

Tonight Andrew Bernard prepared a brief to Terry Clout informing him of his intention to write to Bernie tomorrow to let him know that the study will not be proceeding . He is also going to let Bernie know that he will have copies of the final report from you and the two auditors on 22nd Sept (I hope this is okay). I assume you are okay with your report going to Bernie. AB will also tell Bernie that he is not to make direct contact with the auditors, Marie, me, you or anyone else involved.

Re the medicare billings, PBS scripts, subsidy related to injections of islet cells (not all were done in Southern path, Jim tells me at least the first one was done by Greg Keogh in the angio suite at POW) - if you recommend that this needs to be followed up AB will do this after the report has been given to Bernie.

Re the patients: Jim and I are going to speak to them once AB gets all the names from Bernie and after 22nd Sept. We figured it was better that these people were cared for by physicians who did not work at POW. We are going to see if Leslie Campbell and Deb Marriott from SVH would be prepared to do this.

Once the final report from Alison is through I will get advice on the potential harms to the patients re infection and also from the contaminants.

Andrew Bernard asked if you could join him on a visit to Deb Picone. The purpose of this visit is to provide her with a frank appraisal of the situation regarding BT .

RE Bernie's latest proposal re India: Andrew Bernard has made it very clear that Jim Mackie should tell Bernie that this proposal will not be supported by the hospital - so if UNSW decide to proceed with this application they will also need to find the space etc for BT ." 92 On 4 September 2008, Professor Campbell sent an email to Professor Ward in the following terms (Exhibit A, page 503a) (emphasis added): "I had assumed Andrew was going to go through the preliminary report with Bernie - I thought that's what you were saying the other day. I guess this way is 'safer' but it does delay things . If you'd [sic] like to discuss using teh [sic] prelim report as a starting point, I think it may have some merit but also some hazard . Certainly, Bernie should have a chance to comment on a draft of at least the 'final' report, before we sign off on it ." 93 Professor Ward responded later on 4 September 2008 to the email from Professor Campbell (Exhibit A, page 503a) (emphasis added): " We initially thought we would show him the preliminary report but our concern was that any errors/omissions etc would be used by Bernie. It seemed cleaner to deal with one document ." 94 The Plaintiff submits that these emails demonstrate the close involvement by Professor Ward in the processes of the Review Committee in a way which reinforces a reasonable apprehension of bias. 95 Mr Bernard wrote to the Plaintiff on 3 September 2008, noting that he had received a preliminary report from the Review Committee recommending that the suspension of the Clinical Trial was justified. He advised that there would be further consideration of the suspension following receipt of the final report. He said "It is my intention that a copy of the final report will be promptly provided to you for your consideration and the provision to me of a response" (Exhibit A, page 500). The Chief Executive Issues Register also noted that action would be taken to "provide a copy of the final report to Professor Tuch as soon as possible following its submission, and invite Professor Tuch to respond to the recommendations therein" (Exhibit A, page 502). 96 The Review Committee held its third meeting on 12 September 2008. 97 By letter dated 12 September 2008, Ms Malica informed the TGA that the Clinical Trial had been suspended pending the outcome of the review (Exhibit A, page 520). 98 On 14 September 2008, Dr Sarson provided his final report to the Review Committee (Exhibit A, pages 522-529). Dr Sarson had deleted the material from his draft report in accordance with Ms Malica's suggestion (at [85] above). 99 On 14 September 2008, a number of emails passed between Professor Campbell, Ms Malica and Professor Ward concerning the review. The Plaintiff submits that these emails demonstrate, once again, the direct involvement of Professor Ward in the considerations of the Review Committee, and the ready acceptance by Ms Malica of Professor Ward's proposal. In an email of 14 September 2008 to the Review Committee members, Professor Ward said (Exhibit A, page 590) (emphasis added): " I haven't looked at the document yet but I did speak to Andrew Bernard re how to deal with the financial issues - his preference was that you simply listed all the things which needed to [be] chased up and he will do this through the POEM business manager after the review is complete. 100 On 15 September 2008, an email was sent to Professor Ward and the other Review Committee members, in which Ms Malica said (Exhibit A, page 590) (emphasis added): "I think the text generally is excellent.

i) I think Robyn has answered the question about financial aspects (& yes I probably will be the one following up most things for the GM).

Section 2.1.7 patient consent forms - you mention 'Ms Malica was asked to seek further information on that from Prof Tuch, and failing that, from the Red Cross.' I don't recall being asked to clarify that with Bernie so maybe we should remove that, but will follow up with the Red Cross again today. If we get something useful we can include it.

ii) ICH GCP is quite a lengthy doc (~50 pages), so it should probably be an appendix of its own.

iii) ICH GCP also covers off on the responsibilities of the institution

iv) yes I'm more than happy to do the contents pages etc (I love formatting!). I have a few typographical suggestions to make the doc consistent but will leave them until we're ready for me to make it pretty." 101 By 17 September 2008, in circumstances that are not explained by the evidence, a copy of the draft report had been provided to Ms Carol Kirby, University Solicitor for the University of New South Wales. By email dated 17 September 2008, directed to Professor Campbell, Ms Kirby made "some suggestions and comments" concerning the draft report and expressed concern that the Plaintiff should be given an opportunity to respond, noting that she did "not know what procedure has been followed" (Exhibit A, page 608r). 102 On 19 September 2008, the Review Committee held its fourth meeting. On that day, Professor Campbell emailed a draft covering letter to the other Review Committee members and Professor Ward for comment (Exhibit A, pages 609-610). 103 Later on 19 September 2008, Professor Campbell sent an email to Mr Bernard in the following terms (Exhibit A, page 611) (emphasis added): "The DTU Review Committee met this morning to finalise its report and I am emailing now to let you know we plan to deliver it to you on Monday Sept 22.

We consider that, in the interests of natural justice, the next step is that it should go as a Draft to Professor Tuch giving him say one week to have the opportunity to respond to any issues of factual accuracy and then we should make any changes we agree to, and submit the Final Report to you as soon as that has happened ." 104 Mr Bernard responded later that day as follows (Exhibit A, page 611): "I have advised Bernie in writing that I would provide a copy of the report for his consideration of a response and then I would meet with him to discuss. I am happy to send him as a draft, invite a response as you propose below." 105 Soon after on 19 September 2008, Professor Campbell sent the following email to Mr Bernard (Exhibit A, page 612) (emphasis added): "Thanks Andrew. I think you could play it by ear in terms of what happens next but that it would probably be best if the word 'draft' appears on what he is sent first .

If he has some information of which we are unaware which changes our views on anything substantial, then we have a chance to make such changes before the final report is made more generally available (to whomever you choose to share it with) and before you have your formal meeting with him . I think it will be important that he not be allowed to prolong this part of the process however...an extra week, if he requests it, may be reasonable - we certainly do not wish to be painted as unreasonable - but much more than this should not be needed as we are only seeking errors of fact at this stage, he has every opportunity to argue about Conclusions/Implications after the final report is handed down .

If he has no such feedback to the Review Committee, then you could move even more quickly to your proposal that he meet with you to discuss the implications of the Report." 106 The Review Committee made a draft final report available to Mr Bernard by letter dated 22 September 2008. The covering letter from Professor Campbell to Mr Bernard was in the following terms (Exhibit A, page 613) (emphasis added): "I enclose the draft final report of the Diabetes Transplant Unit Review Committee.

The Committee considers that the appropriate next step would be for this report to [be] made available to Professor Bernie Tuch who should be asked to provide a written response (as to matters of fact only), within a brief period, say one week. At the end of that time, I propose that the Review Committee reconvene for a final meeting make any changes it considers appropriate and submit the final report to you .

It is important that the Human Research Ethics Committee be informed of the outcome of our Review and you may wish to consider how best to do this .

May I take this opportunity of thanking you and your staff for facilitating this process." 107 A copy of the draft report was sent to the Plaintiff for his comment on 23 September 2008, requesting a response from him by 1 October 2008 (Exhibit A, page 648) (emphasis added): "I write to advise you that the Final Draft Report of the Diabetes Transplant Unit Review Committee has been received.

As I outlined in my letter to you of 3 September 2008, I now provide you with a copy of this Report seeking your written response as to matters of fact contained within the report , so that any changes can be made and the Final Report issued. I request that your response be submitted to my office by Wednesday 1 October 2008.

You will note from the content of the Report and its recommendations that there are significant implications for both the hospital and the DTU. I have requested that a meeting between us be organised, after the Final Report is presented, to discuss how the recommendations can be taken forward.

I look forward to your response." 108 On 29 September 2008, the Plaintiff sent an email to Mr Bernard in the following terms (Exhibit A, page 652): "Today I received a copy of the draft report from the Audit Committee, with your cover letter dated September 23. To be able to give you a meaningful response to the matters of fact in the report, will take a little while, as I am sure you will appreciate. The report is after all more than 100 pages in length.

A working week should be sufficient time, as Professor Campbell has indicated.

As advised over a month ago, however, I will be absent for several days in the next fortnight, on annual leave.

Accordingly I propose to give you the written response requested by Monday October 13, and trust this will be acceptable. I am happy to meet with you thereafter to discuss a way of moving forward in a constructive manner.

I did try and ring you and discuss this matter, as I will be in clinic this afternoon and absent tomorrow and Wednesday (annual leave).

I will be contactable on [telephone number] at clinic this afternoon to discuss the matter if you wish to. However, I will not have access to email, and will not be able to view these until Thursday afternoon, after clinic on that day." 109 Later on 29 September 2008, Mr Bernard sent an email to Professor Campbell and Ms Malica (Exhibit A, page 652): "I have spoken to Bernie this afternoon and granted an extension of deadline for his comments to come back on Factual accuracy to 8th October. There was no reason for extension beyond that. I will pass on the response." 110 The Plaintiff submitted that, in the circumstances of the case, this period was an "exceedingly restricted window" to respond to the draft report. 111 On 8 October 2008, the Plaintiff provided a written submission in response to the draft report (Exhibit A, pages 653ff). With respect to the issue of patient safety, the Plaintiff referred to Transmissible Spongiform Encephalopathy ("TSE") (colloquially known as Mad Cow Disease) safety issues and mentioned advice from the manufacturer, Serva Electrophoresis GmbH ("Serva") (Exhibit A, page 657). Together with his letter of 8 October 2008, the Plaintiff provided a number of documents including technical notes issued by Serva (Exhibit A, page 661u-661v). 112 On 9 October 2008, Ms Malica sent an email to Dr McLean seeking comments concerning a number of issues, including TSE risk and the Serva material (Exhibit A, page 661). 113 On 10 October 2008, the Review Committee met to consider the Plaintiff's response to the draft report. 114 On 14 October 2008, Ms Bouyer, on behalf of Dr McLean, responded to Ms Malica's request for information concerning TSE risk and the Serva material. Ms Bouyer provided information concerning Collagenase NB 1 Premium Grade in an email which included the following (Exhibit A, page 671): "Allison forwarded on your email regarding the TSE information to me and I have done some research for you. Please see my response below.

After reviewing the documentation provided it appears that the product will meet the TSE guidelines and the risk to DTU patients would be minimal. In order to verify this completely though, it would be best to contact Serva directly and request a copy of their certification and also to verify that the premium grade materials comply to the TSE guidelines. I have been able to verify that Serva have been certified by EDQM (European Dictorate for Quality of Medicines) but EDQM does not tell you which products specifically was certified. This would have to come from Serva providing the certification themselves.

Something I also would note is that the Premium grade does indicate that this product is not for human use and GMP grade should be used for this purpose (see below from Serva website and link to product information). This is not necessarily due to TSE risk but it would be pertinent to confirm with Serva why this is the case." 115 A copy of the draft Review Committee response to the Plaintiff's submission was sent to Professor Ward. On 14 October 2008, Professor Ward sent an email to Professor Campbell attaching the amended draft with the email stating (Exhibit A, page 673b): "Have made a few minor edits. Please note the tracking will be visible so probably worth cutting and pasting into your document if you wish to accept the changes." 116 On 14 October 2008, Professor Ward sent an email to Serva seeking information about the use of Collagenase NB 1 Premium Grade for the preparation of islet cells for transplantation into humans (Exhibit A, pages 675-676). 117 On 15 October 2008, Ms Johanna Moench of Serva replied to Professor Ward's email (Exhibit A, page 675). The Plaintiff submits that Professor Ward was making an enquiry of a third party for the purpose of the Review Committee's report. The Plaintiff submits that this is significant to the claim of apprehended bias arising from the involvement of Professor Ward in the process of the Review Committee, and further as a denial of procedural fairness in that the information provided from Serva on 15 October 2008 was not communicated to the Plaintiff until the final report. 118 On 16 October 2008, Ms Edwards sent an email to Professor Ward and the Review Committee members saying (Exhibit A, page 677): "So it does appear that there may be some risk, however small, to the participants in the study because premium Grade rather than GMP Grade collagenase has been used in the CT." 119 On 17 October 2008, Professor Ward sent an email to Professor Campbell suggesting the wording for part of the final report dealing with the TSE risk issue (Exhibit A, page 679ak). It appears that the wording contained in Professor Ward's email was utilised in the final report (Exhibit A, page 694). 120 On 20 October 2008, the Review Committee released its final report, together with a letter dated 20 October 2008, which responded to the Plaintiff's submissions of 8 October 2008 (Exhibit A, pages 680ff). The final report found (Exhibit A, page 693): "… multiple instances of major non-compliance with accepted research practice both in terms of manufacture of a potential new therapeutic agent for administration to humans and in terms of the conduct of the associated clinical trial." 121 Other findings included (Exhibit A):

(a) "major concerns regarding patient safety related to the total inadequacy of the manufacturing standards and quality control" (page 693);

(b) non-compliance issues which provided "evidence of lack of competence of the investigation team led by Professor Tuch to carry out either the manufacture, or the administration to humans under trial conditions of encapsulated pancreatic islet cells" (page 694);

(c) "significant ethical issues, in the view of the Review Committee, which should have precluded approval for the study as outlined in the current protocol" (page 694) - these included the Plaintiff's two conflicts of interests - first, he was the inventor of the therapy and was thus in a position to gain financially, and yet he was the "investigator" conducting the trial to test it in humans so that the Clinical Trial was not at arm's length - secondly, the Plaintiff was using his own patients in the Clinical Trial (pages 694-695);

(d) the current state of affairs was as "a result of a combination of multiple failings on the part of both the Principal Investigator and the institution in which he worked" and that the Clinical Trial should not have been approved by the NHN HREC - this showed a "substantial breakdown, both in terms of Human Research Ethics and in terms of the Institutional Governance of Human Research" (page 695);

(e) the Review Committee accepted that the events in issue "took place in an environment which was not conducive to the conduct of good clinical research practice" but this did not diminish the "responsibility of the Principal Investigator for his multiple breaches of nationally and internationally accepted guidelines" (page 695). 122 The Review Committee relied heavily on the findings of Dr Sarson and Dr McLean in their audit reports. Each report comprised an appendix to the final report of the Review Committee. The report of Dr McLean concluded that: (a) there was insufficient control over the production process;

(b) there was inadequate formalised specification for testing and that the review of test results was not being conducted in a rigorous manner;

(c) there was inadequate control over the raw materials, consumables and equipment being used in the production and testing;

(d) the personnel involved in the production and testing were not adequately trained in good production and testing practices;

(e) there was inadequate reviewing and/or poorly documented reviewing of all of the above for the approval for release of the materials into the clinic. 123 The report of Dr McLean also found (page 4): "There was considerable evidence that patients could have been put at risk through the introduction of raw materials that were not appropriate for human use … The severity of this risk could not be determined since the calculation of the extent of risk is multifactorial. In addition the poor record keeping and lack of in-process specifications and testing, if continued, could invalidate the scientific merit of the study." 124 The final report of the Review Committee made 13 recommendations (Exhibit A, pages 696-697): "1. The Review Committee finds that the original decision by Mr Andrew Bernard General Manager, Northern Hospital Network, on 27 March 2008 to suspend the encapsulated pancreatic islet cell transplant trial was appropriate.

On the basis of the facts and circumstances set out in this report, and in the reports of two expert reviewers, the Review Committee finds that this Clinical Trial has not been carried out in accordance with accepted national and International standards for the conduct of human research. This study spans the full spectrum from invention to animal studies to manufacture for transplant into man and then to the actual transplant processes themselves. The serious breaches to accepted human research practice which have been identified demonstrate that neither Professor Tuch, nor the other personnel related to the trial as a group, have the competencies required to carry out such a complex first-in-man clinical trial. The Committee therefore recommends that the suspension of the study be continued indefinitely.

The study should not be recommenced unless it has greatly enhanced resourcing, both in terms of research personnel and in terms of the facilities available. It would require a complete overhaul of the design of the study including the establishment of an arms-length Steering Committee, as well as an Independent Data Safety Monitoring Board and Quality Control in the manufacturing facility. Professor Tuch should not be directly Involved in the conduct of the study, as he is both the inventor and the manufacturer of the therapy being trialled . A completely new submission to the HREC would be necessary. In addition, the NHN Executive would need to accept the role of 'sponsor' of the Clinical Trial and ensure its significant responsibilities in relation to this role are upheld. It would also need to set in place processes and procedures in the Facility in which 'manufacturing' processes are to be carried out mat ensure compliance with accepted standards. The Committee accepts that at the present time, full compliance with GMP standards is not mandated in a trial such as this, but believes the Area Health Service should give consideration to ensuring adherence with Internationally acceptable practice at the least.

The patients involved in the trial, both those transplanted and those listed as enrolled or 'pre-enrolled', should be notified of the suspension of the trial and told of the reasons behind this. This needs to be done urgently and it is recommended that it be done in two stages. In the first instance a senior medical officer other man Professor Tuch, (such as the Professor of Medicine), possibly with the assistance of an experienced and trained counsellor, should contact each of the patients and talk to them individually, explaining the circumstances in so far as we are aware at this stage.

Expert advice should be sought urgently, preferably from an Infectious Diseases consultant and an Endocrinologist, as to the appropriate immediate, medium and long-term follow up of the patients who have already been transplanted to ensure that their lack of complications thus far continues, and to detect any problems immediately and deal with them. This process will need to be established by the NHN Executive. It needs to be separated from Professor Tuch. When the details of this follow-up process are clear, the patients should again be called in, given this information and encouraged to take part in the planned program. It will likely need to be very long-term and should, of course, be at no cost to the patients.

The Research Support Office should review, as a matter of urgency, all of the other studies involving Professor Tuch which involve interventions or procedures on humans, including human fetal [sic] tissue usage. These should be identified and suspended pending review.

An Educational Program for researchers and potential researchers on the campus, including a functioning web page for the Research Support Office, should be a priority.

Due consideration should be given to the needs of the staff in the DTU. They should be counselled on an individual basis according to their situation.

The Review Committee understands from a brochure publicly available in the Diabetes Centre, that Professor Tuch has been offering his 'encapsulation' services to other (presumably external) investigators, wishing to use pancreatic (or possibly other) cells for experimental transplantation. The Committee assumes this work involves only animal experimentation, but would request that the Executive seek assurances from Professor Tuch that no human studies are being provided with cells from this source.

The General Manager, NHN should investigate the possibility of financial irregularities with respect to this study in terms of inappropriate charging of research-related expenses either to patients or to Medicare or to Private Health Insurers.

Given the lack of effective Research Governance on the part of the previous Research Support Office and NHN Executive uncovered by this Review, the General Manager should give consideration to reviewing all ongoing hospital-sponsored clinical trials within the NHN, with a view to establishing a risk register. As part of this process, it may well be necessary to audit and/or request resubmissions from some of these studies. This process will almost certainly require employing an external contractor to carry out this work as the Research Support Office does not have the capacity to do so in a reasonable timeframe.

The resources of the Research Support Office should be expanded as soon as possible to allow proper Governance of future clinical trials on the campus.

The NHN Executive should give consideration to how best to deal in future with its responsibilities, as defined by Good Clinical Practice and mandated under the CTN Scheme, as Sponsor of Clinical trials initiated by its employees and contractors, assuming the Institution reviews the potential risk versus benefit of the Clinical Trial and agrees to sponsor it. This may include requesting assistance from the Research Support Office in drafting criteria/guidelines for the future." 125 The final report of the Review Committee included nine appendices, one of which was a full copy of the Plaintiff's submission of 8 October 2008 concerning the draft report (Appendix 9). 126 The covering letter dated 20 October 2008, which accompanied the final report, referred to enquiries made of Serva by the Review Committee and the response (Exhibit A, page 683). 127 On 20 November 2008, Mr Bernard sent to Mr Clout a brief containing a submission that he accept the recommendations contained in the final report, and that he take certain action to implement those recommendations (Exhibit A, pages 711-715). On 21 November 2008, Mr Clout accepted the recommendations in the final report and the action plan proposed by Mr Bernard to implement those recommendations (Exhibit A, page 712). 128 On 21 November 2008, Mr Bernard sent an email to Professor Les Field and Professor Richard Henry of the University of New South Wales, enclosing the action plan arising from the final report of the Review Committee (Exhibit A, page 709) (emphasis added): " I have previously provided copies to the University of the final Report of the Diabetes Transplant Review Committee . The Report has been considered by the Area Health Service Chief Executive, who has authorised that I now commence action in response to the recommendations contained in the Report.

I attach for your information, my Brief to the Chief Executive, which includes as an attachment an outline of the Actions that I will now commence. I will keep the University informed of progress with these actions through Professor Ward's office." 129 On 21 November 2008, Mr Bernard wrote to the Plaintiff in the following terms (Exhibit A, page 710): "You have received a copy of the Final Report of the Review Committee, which was submitted to me by the Committee Chairman after consideration of your response dated 8 October 2008 to the final draft Report.

I have submitted a copy of the final report to the Area Health Service Chief Executive, together with my intended actions to be taken in response to the recommendations contained in that Report. I am now in receipt of his authorisation to proceed with a series of actions in response to the 13 recommendations detailed in the Final Report.

A copy is attached of the Brief to the Chief Executive together with the actions with which I will now be proceeding.

I have instructed Professor Ward and Dr Mackie to proceed with contacting patients involved in the Trial. Infectious diseases expert advice has been obtained on the potential infectious risks associated with the quality of reagents used in the preparation of transplanted islets.

The Human Resources Department and Dr Mackie will organise a meeting with your staff within the next week to address their concerns and to offer support during this difficult time for all.

Please contact my office [telephone number] to arrange a time for us to meet should you wish to discuss the actions as outlined above.

I thank you for your patience and cooperation during this extended period of Review and look forward to working through the actions as outlined above in the best interests of your patients, your staff, yourself and the Health Service." 130 The letter to the Plaintiff attached the "Brief to the Chief Executive", which had been accepted by Mr Clout on 21 November 2008. Amongst the recommendations were the following (Exhibit A, page 712): "It is recommended that the Chief Executive authorises the GM-NHN to immediately communicate the findings and actions to: * Professor Bernie Tuch, and advise him of the actions of the GM-NHN will put into place

• Staff of the DTU, informing them of the outcomes of the Review and the support that will be made available to them by the Health Service

• Professor Robyn Ward and Dr James Mackie, instructing that they commence arrangements consistent with the actions outlined in Attachment A

• Other bodies and authorities that need to be informed of the findings of this Review, and the actions to be taken by the Areal health Service." 131 The Plaintiff was not given an opportunity to be heard before Mr Clout decided that the final report ought be distributed to, amongst others, the University of New South Wales and "other bodies and authorities that need to be informed". 132 On 28 November 2008, Mr Clout forwarded the final report to the New South Wales Medical Board, accompanied by a letter in the following terms (Exhibit A, page 716) (emphasis added): "I wish to advise that a review has recently been conducted of the Diabetes Transplant Unit at the Prince of Wales Hospital concerning matters relating to the Transplantation of Pancreatic islet Cells by the staff of that Unit under the supervision and involvement of Professor Bernard Tuch.

The review has now been completed and the final report, together with a number of Appendices, is attached for your information.

The Reviewers noted in their report a number of concerns which relate to the medical and research practice of Professor Tuch which are considered to be of sufficient gravity that the matter should be reported to the Medical Board . The Reviewers noted, inter-alia, the following matters of concern:

• Multiple incidences of major non-compliance with accepted research practice - both in terms of manufacture of a potential new therapeutic agent for administration to humans, and in terms of the conduct of the associated clinical trial (Section 3 - Summary and Discussion).

• Very real conflicts of interest with the Principal Investigator (Section 3.3).

• Multiple breaches of nationally and internationally accepted guidelines (by the Principal Investigator- Professor Tuch) (Section 3.4).

• Use of material not approved for human use thereby placing patients at potential risk of transmissible spongiform encephalopathy (Section 3.1).

• The Reviewers' report relating to the findings of Professor Tuch's clinical and research practice, together with the use of a substance not approved for use In humans raised sufficient concerns that it is felt the Medical Board should be advised of the issues.

Should you require any further information regarding this matter please contact Associate Professor Ian Rewell, Area Director Medical Services on telephone …" 133 On 1 December 2008, Professor Field, the Deputy Vice-Chancellor (Research) at the University of New South Wales, wrote to the Plaintiff, noting that he had received a copy of the final report from the Defendant, and that the findings may constitute a breach of the "UNSW Code of Conduct for the responsible practice of research". Professor Field stated that he was considering "whether these findings and the material in the report, constituted prima facie case of research misconduct" and the possible consequences which may follow. Professor Field concluded the letter in the following way (Exhibit A, page 718): "I take this opportunity to inform you that I am referring the Report to the Chair of the UNSW Human Research Ethics Committee to consider what, if any, action is required by the Ethics Committee. I am also informing relevant grant bodies that if I am considering allegations of research misconduct involving you.

The Code of Conduct for the Responsible Practice of Research requires me to make a determination as to whether there is a prima facie case of research misconduct. If you wish to put any material before me regarding the Report or matters relating to the Report, please provide it to me within 7 days of the date of this letter. It is my practice to deal with these matters expeditiously, however, if you require further time to respond, I will consider a request for a limited extension." 134 On 9 December 2008, Mr Clout wrote to the Plaintiff indicating, that the report had been provided to the New South Wales Medical Board (Exhibit A, page 719) (emphasis added): "I refer to the report of the Review Committee for the Islet Transplantation Clinical Trial and note that the findings of the reviewers contain a number of matters of concern which include, multiple incidents of major non-compliance with accepted research practice; conflicts of interest in your role as principal investigator; multiple breaches of nationally and internationally accepted guidelines; and the use of material not approved for human use thereby placing patients at potential risk of transmissible spongiform encephalopathy. As these matters could be construed as indicating unprofessional conduct or professional misconduct as a medical practitioner, I have referred the reviewers report to the NSW Medical Board for their consideration " 135 I infer that the New South Wales Medical Board referred Mr Clout's letter of 28 November 2008 to the Health Care Complaints Commission. On 5 January 2009, an officer of the Health Care Complaints Commission wrote to the Plaintiff in the following terms (Exhibit A, page 720): "I am writing to advise you that the Health Care Complaints Commission has received a complaint from South Eastern Sydney & Illawarra Area Health Service regarding your supervision of the Diabetes Transplant Unit at the Prince of Wales Hospital concerning matters relating to the Transplantation of Pancreatic Islet Cells. A copy of the complaint is enclosed.

The Commission is legislatively required to assess complaints within 60 days of their receipt. The Commission invites you to provide a written response to this complaint to the Commission within 28 days from the date of this letter. Your response will assist the Commission in making an informed assessment decision regarding the management of the complaint. Please be aware that your response will be provided to the complainant unless you indicate that your response is to be used only for Commission assessment purposes. You will be contacted again when the assessment is completed." 136 On 8 January 2009, the linkage grant from the Australian Research Council to the DTU was suspended. 137 On 21 January 2009, the Plaintiff's solicitor wrote to Mr Clout inviting him to declare the final report void, and setting out the grounds upon which it was alleged that the report was void (Exhibit A, pages 722-735). 138 On 29 January 2009, the Plaintiff replied to the letter from the Health Care Complaints Commission (Exhibit A, pages 736-740). 139 On 13 February 2009, the Plaintiff commenced the present proceedings by filing a Summons seeking relief in this Court. 140 At the hearing on 27 April 2009, it was acknowledged by the Plaintiff that he had resigned his appointment at the University of New South Wales and that the disciplinary process that had been set in motion by the University had come to an end (T8).

Some General Observations Concerning the Nature and Functions of the Review Committee and the Requirements of Procedural Fairness 141 It was common ground before me that the Review Committee owed the Plaintiff a duty to afford him procedural fairness. However, the Defendant denied that there were any matters that would give rise to a reasonable apprehension of bias, and also denied that the Review Committee had failed to afford the Plaintiff a reasonable opportunity to be heard. 142 At the outset, it is appropriate to characterise the nature of the functions being exercised by the Review Committee and the requirements of procedural fairness which existed in this case. 143 The Review Committee was established by Mr Clout under s.29B HS Act to assist the Defendant in the exercise of its functions under s.10 of the Act, and Mr Clout in his management and control of the affairs of the Defendant under s.24 HS Act. The statute does not provide any further guidance concerning the nature of the task being undertaken by the Review Committee, nor the scope of the duty to afford procedural fairness in the circumstances of this case. 144 The terms of reference of the Review Committee (at [51] above) point to a range of governance and systems issues. Nevertheless, the evidence indicates that, from the outset, the conduct of the Plaintiff himself with respect to the Clinical Trial was a central feature. The various emails to which reference has been made support this conclusion. He was named in the terms of reference. There was the prospect that findings critical of the Plaintiff would be made, and that these findings were capable of damaging his reputation and standing in the medical profession and the scientific community. Depending upon the findings which might be made, there was the prospect of communication of findings to other persons and agencies which might give rise to further action detrimental to the interests of the Plaintiff. 145 The evidence supports a conclusion that there was a disciplinary flavour to the process from its early stages, and an approach taken whereby the Plaintiff was the prime focus of attention in this respect. As the review continued, the disciplinary flavour of the process strengthened. What commenced notionally as an investigatory process to inform the Chief Executive of the Defendant on governance and systems issues became an investigation of the conduct of the Plaintiff, with the expectation that strong and damaging findings would be made about him. This became entirely overt in the Review Committee's final report, with Mr Bernard and Mr Clout immediately treating the report as containing findings of misconduct on the Plaintiff's part, which ought be disclosed to the University of New South Wales and the New South Wales Medical Board. 146 The rules of procedural fairness are not immutable and are influenced by the circumstances in which they are invoked. The requirements of procedural fairness depend upon the circumstances of the case, the nature of the inquiry, the rules under which the decision maker is acting and the subject matter that is being dealt with: Stollery v Greyhound Racing Control Board (1972) 128 CLR 509 ("Stollery") at 526; Hall v New South Wales Trotting Club Limited (1977) 1 NSWLR 378 at 386. The basic tenet that justice should not only be done, but be seen to be done, does not warrant fanciful and extravagant assertions and demands: Stollery at 519. Fairness is not an abstract concept - it is essentially practical, and the concern of the law is to avoid practical injustice: Re Minister for Immigration and Multicultural and Indigenous Affairs; Ex parte Lam (2003) 214 CLR 1 at 13-14 [37]; Musumeci v Attorney General of NSW (2003) 57 NSWLR 193 at 200 [40]. 147 Given the nature of the issues being considered by the Review Committee, it was to be expected that its members would have some familiarity with the topic under consideration, with facts relevant to it and with one or more of the parties involved. A degree of familiarity may be an advantage rather than a disqualifying factor. Mere past association will not generally be held to give rise to a reasonable apprehension of bias, although it is a question of degree: Commissioner of Corrective Services v Government & Related Employees Appeal Tribunal [2004] NSWCA 291 at [23]-[25]. 148 The obligations of procedural fairness must be assessed against the practical realities, in particular circumstances: Greyhound Racing NSW v Cessnock & District Agricultural Association [2006] NSWCA 333 at [75]. The general law principles expounded in cases involving courts or quasi-judicial tribunals should not be translated, without adaptation, to the circumstances of statutory administrative decision makers. A particular decision maker may bring to the task a great deal of information and ideas which have accumulated or formed in the course of deciding other applications: Greyhound Racing NSW v Cessnock & District Agricultural Association at [118]. An evaluation of the realities and not the legalities of the situation is required when dealing with the question of what fairness demands in the circumstances: White v Ryde Municipal Council [1977] 2 NSWLR 909 at 925. 149 The test for apprehension of bias is whether a fair-minded lay observer might reasonably apprehend that the decision maker might not bring an impartial and unprejudiced mind to the resolution of the question at hand: Webb v The Queen (1994) 181 CLR 41 at 47, 57, 67-68; Johnson v Johnson (2000) 201 CLR 488 at 492; Ebner v Official Trustee (2000) 205 CLR 337 at 344. The hypothetical observer is both objective and reasonable, gives the issues some consideration rather than forming a snap judgment, and is attributed with knowledge of the actual circumstances of the case, being a broad knowledge of the material objective facts, as distinct from a detailed knowledge of the law or knowledge of the character or abilities of the decision maker, with the hypothetical observer then fairly assessing the decision-maker's conduct in the context of the whole of the process. 150 It is for the Plaintiff to prove the factual foundation establishing the failure to afford procedural fairness, and a reasonable apprehension of bias must be firmly established. It is not sufficient if the reasonable bystander "has a vague sense of unease or disquiet": Re JRL; Ex parte CJL (1986) 161 CLR 342 at 362. 151 The test for reasonable apprehension of bias by prejudgment is whether an independent observer might reasonably apprehend that the decision maker might not be open to persuasion: McGovern v Ku-Ring-Gai Council [2008] NSWCA 209; 251 ALR 558 at 561-563 [14]-[30]. A conflict of interest case is to be distinguished from a prejudgment case. In a prejudgment case, it is necessary to consider the degree of closure of the allegedly closed mind, but where a relevant conflict of interest is established the reasonable apprehension follows almost as of course: McGovern v Ku-Ring-Gai Council at 562 [26]. 152 Where it is claimed that denial of procedural fairness arises from a failure to give adequate opportunity to prepare a case, or time to prepare it, the test is whether a person has been informed of the case against him with a reasonable opportunity being given to prepare the case before hearing: Kioa v West (1985) 159 CLR 550 at 582. It is appropriate to consider whether the time allowed was manifestly unreasonable: Balmain Association Inc v Planning Administrator for the Leichhardt Council (1991) 25 NSWLR 615 at 632-633.

The Plaintiff's Complaint that Individuals Were Acting as Accusers and in the Position of Decision Maker

The Plaintiff's Submissions 153 The Plaintiff submitted that a central aspect of the bias rule is the principle that a person who is in the position of accuser or prosecutor ought not to participate in the making of the decision which is reached in relation to the charge which has been made: Stollery; Rendell v Release On Licence Board (1987) 10 NSWLR 499 at 507; Re Macquarie University; Ex parte Ong (1989) 17 NSWLR 113 ("Ong"). It was submitted that this of itself gives an appearance of prejudgment, and hence an appearance of bias. It was submitted that a person is in the position of accuser when he or she is, in substance, a complainant regarding the conduct of the person subject to inquiry and charge. 154 The Plaintiff submitted that Professor Ward, Professor Campbell and Ms Malica were in the position of accusers, and also participated in making the findings and recommendations and in the drafting of the Review Committee report. 155 The Plaintiff submitted that Professor Ward made the original complaint against the Plaintiff which resulted in the establishment of the Review Committee. Amongst other things, it was submitted that Professor Ward suggested to Mr Bernard the form of words he should use in his letter to the Plaintiff advising him that the trial was suspended and that he had requested the HREC to review the protocol. Reliance was placed upon a number of comments made by Professor Ward in emails as indicating a degree of influence upon the process. By way of example, reference was made to the email dated 28 April 2008 from Professor Ward to Mr Bernard (at [37] above). 156 The Plaintiff submitted that Professor Ward had input into the selection of members of the Review Committee and supported the appointment of Professor Campbell and Ms Malica. 157 The Plaintiff emphasised that Professor Ward recognised the difficulty with respect to impartiality if she were a member of the Review Committee. Reference was made to Professor Ward's email of 2 June 2008 (see [43] above). 158 Despite Professor Ward's stated intention to "stay away from this ad hoc committee", the Plaintiff submitted that Professor Ward did not stay away from the Review Committee. Rather, the Plaintiff submitted that she monitored its decision making by being copied emails, by adding to the allegations, by reviewing and obtaining evidence and attending its meetings and advising its members on the issues before them. 159 The Plaintiff submitted that Professor Ward suggested to Mr Bernard that she should invite Professor Campbell to chair the Review Committee. Thereafter, Professor Ward met with Professor Campbell who agreed to chair the Review Committee. Reference was made to Professor Ward's email of 7 June 2008 (at [44] above) noting Professor Campbell's comment concerning the correctness of the decision to stop the trial - "You don't need a committee to tell you - you have no other choice". 160 The Plaintiff submitted that Professor Ward played a part in the selection of Professor Campbell knowing that he would support a suspension decision. 161 The Plaintiff submitted that Professor Ward, with the assistance of Ms Malica, drafted the terms of reference of the Review Committee, and deleted from Ms Malica's draft a term of reference seeking a recommendation as to whether the suspension of the trial should be lifted, and conditions on which it could continue. 162 The Plaintiff pointed to an email from Professor Ward dated 26 June 2008 suggesting to the Review Committee the names of people who could undertake external audits of the DTU, including Dr McLean (at [45] above). The Plaintiff submitted that an email from Professor Campbell dated 25 August 2008 reveals that it was Professor Ward who decided whether Dr Sarson was to be commissioned to carry out the GCP compliance audit (at [60] above). 163 The Plaintiff submitted that, soon after initiating the suspension of the trial and the referral to HREC, Professor Ward indicated in an email to Mr Bernard dated 12 April 2008, her desire that issues she had raised about the trial should impact on other studies of the Plaintiff (Exhibit A, page 73): "Andrew - This is only the first of Bernie's studies and I think this issue may impact in a significant way on his other 'plans' with new grants etc." 164 The Plaintiff observed that, thereafter, Professor Ward forwarded to Mr Bernard an email on 27 April 2008 including a warning given by Professor Campbell to the Plaintiff that the University of New South Wales would not give institutional support to the Plaintiff's next project and that the Plaintiff would need to obtain this from the Defendant. 165 The Plaintiff submits that Professor Ward was present at the first meeting of the Review Committee on 22 August 2008 and at the subsequent meeting on 29 August 2008. In an email dated 26 August 2008, she reported to Mr Bernard, sending him "notes from our first meeting" in order to give him "the feel of what is going on" (Exhibit A, page 359). 166 The Plaintiff submits that Professor Ward determined the detail as to implementation of the draft report as early as 2 September 2008, seeking a discussion on implementation between herself, Mr Bernard and Ms Malica (see [90] above). 167 The Plaintiff noted that when Professor Campbell circulated the draft report to Ms Malica and Ms Edwards, it was also forwarded to Professor Ward. She responded to Professor Campbell's questions as to inclusion in the report of material relating to tissue donors and financial aspects by instructing Professor Campbell in an email dated 14 September 2008 that Mr Bernard would deal with the financial aspects after the review was complete (see [99] above). 168 The Plaintiff relied upon the email from Professor Ward to Mr Bernard dated 10 April 2008 concerning a planned visit by a Member of Parliament to the DTU and the PoW Hospital, referred to at [35] above, as providing additional insight into Professor Ward's view of the Plaintiff. 169 The Plaintiff pointed to an email dated 3 May 2008 from Professor Ward to Mr Bernard and Mr Clout concerning an intellectual property dispute between the DTU and the University of New South Wales, which included the following comment (Exhibit A, page 100): "… As you can no doubt imagine the normal strategies have been pursued - endless emails, meetings, mediation etc but this is coming to naught with Bernie in loop. Being reasonable or realistic is not really part of his make up." 170 The Plaintiff relied upon the fact that the Review Committee meetings on 22 and 29 August 2008 and 10 October 2008 were held in Professor Ward's office, with the meeting of 22 August 2008 being moved to an earlier time in order to enable her to be present (Exhibit A, page 358a). On 26 August 2008, Professor Campbell sought Professor Ward's "input" on the draft minutes of the Review Committee's meeting, along with other members of the Review Committee and she responded that she was happy to leave the document as it was, for the discussion the next Friday (Exhibit A, page 358a). 171 The Plaintiff submitted that Professor Ward's participation in the decision making of the Review Committee was so consistent, constant and maintained at the smallest level of detail that she was effectively a member of the Review Committee. The Plaintiff submitted that Professor Ward controlled the deliberations of the Review Committee and its outcomes. 172 The decision to notify to the TGA of the suspension of the Clinical Trial, without the knowledge of the Plaintiff was conveyed to Professor Ward, who responded to members of the Review Committee with the information that Mr Bernard knew that "we" (the Review Committee) would notify the TGA (Exhibit A, page 332b). Professor Ward requested Ms Malica to copy Mr Bernard in when she sent the notification to the TGA and Ms Malica assured Professor Ward that she would run the correspondence by her before sending it to the TGA (Exhibit A, page 358b). 173 The Plaintiff relied upon the fact that Professor Campbell sought Professor Ward's comments on Mr Bernard's action plan. Professor Ward corrected Professor Campbell's assumption, and opposed a course of action whereby the Plaintiff would be given the preliminary report, referring to their concern that "any errors/omissions etc could be used by Bernie" and "it seemed cleaner" to only give him the draft of the final Review Committee report (see [93] above). 174 After exchanging emails with Serva, Professor Ward advocated proceeding with the Review Committee report, without attempting to obtain further information about the risk of TSE, asserting that the DTU should have used "human grade" (Exhibit A, page 673a). Further, it was Professor Ward who finalised the paragraph dealing with this matter in the Review Committee report (Exhibit A, page 679ak). 175 On 14 and 17 October 2008, Professor Ward made amendments to the response letter to accompany the final Review Committee report and warned that the tracking in the document she had sent should be removed (see [115], [119] above). 176 The Plaintiff submitted that the evidence demonstrated clearly that Professor Ward had been the original complainant against the Plaintiff in a process that saw the establishment of the Review Committee, that she recognised that it was inappropriate that she be a member of the Review Committee, but that thereafter she played an active part in the selection of the Review Committee, its processes and deliberations in such a way as to demonstrate that she was an accuser, but nevertheless participated in the decision-making process so as to constitute a breach of the bias rule. 177 The Plaintiff submitted that Professor Campbell had an appearance of bias by reason of his existing relationship with the Plaintiff, which included Professor Campbell being in the position of accuser against the Plaintiff in a dispute concerning authorship, institutional attribution of publications and access to embryonic stem cells. This dispute is said to have arisen when Associate Professor Sidhu resigned in order to take an appointment as director of a newly established stem cell laboratory within the Neuropsychiatric Institute at the University of New South Wales. The Plaintiff submitted that when Associate Professor Sidhu claimed rights to work undertaken within the DTU, Professor Campbell represented him in negotiations with the Plaintiff as director of the DTU. 178 The Plaintiff also contended that, during the period whilst the Review Committee was on foot, Professor Campbell had made unrelated complaints about the Plaintiff concerning research projects other than the Clinical Trial. Reliance was placed upon email communications between Professor Campbell and Professor Ward in September 2008 in which Professor Campbell complained about the Plaintiff's applications for research grants. Professor Campbell suggested that the review offered an opportunity to prevent the Plaintiff from obtaining any further research grants (Exhibit A, page 492a): "On reflection, this would also be an opportunity to tell him not [to] apy [sic] for any more funding from India or anywhere else!" 179 The Plaintiff submitted that this placed Professor Campbell in the position of accuser, alleging that the Plaintiff was a person who ought not hold any research grants. In her next email to Professor Campbell, Professor Ward confirmed that Mr Bernard had decided that PoW Hospital would not give institutional support to the Plaintiff in an application for that grant (Exhibit A, page 496b). 180 The Plaintiff submits that, following Professor Ward's meeting with Mr Bernard on 2 September 2008 to discuss the action plan, Professor Campbell took instructions from Professor Ward concerning the drafting of the report (Exhibit A, page 496a). 181 The Plaintiff submitted that Ms Malica took on the mantle of accuser of the Plaintiff as well. Reliance was placed upon an exchange of emails between Professor Ward, Ms Malica and Professor Campbell on 22 August 2008 following receipt of documents produced to the Review Committee by the Plaintiff. Professor Ward immediately asked for a report. Ms Malica responded (Exhibit A, page 332c): "He hasn't got anything of note. I think we uncovered evidence of at least one forged consent form." 182 Professor Ward immediately relayed this message to Professor Campbell. It is said that Ms Malica and Professor Ward were in the position of accusers, raising new allegations against the Plaintiff, in this instance, the alleged commission of a criminal offence. The Plaintiff submitted that Ms Malica gave no explanation for her opinion that the signature was forged. In a separate email sent later the same day to members of the Review Committee, Ms Malica stated that one consent form was mainly written in blue and the date was printed in black. She also stated that there were inconsistencies between the copies provided to the Review Committee and the original copied consent forms in the file at the DTU. Ms Malica expressed her view that the Plaintiff had dishonestly created documents or forged signatures and, at that time, was continuing to do so (Exhibit A, page 332c): "… notably the copy on one patient file has a different 'witness' signature to the one provided to us & held in Bernie's Site Regulatory File (which he is obviously busily compiling now). Consent for patients enrolled but not transplanted - these do not exist. I decided not to press Bernie for more info about what CRFs should be included for screening & enrolment because I didn't want to give him any hints for documents he could manufacture now." 183 The Plaintiff submitted that Ms Malica did not indicate on what basis she formed the view, impliedly conveyed, that the consent forms were not authentic. It was submitted that, as in the case of her email to Professor Ward, Ms Malica alleged to other members of the Review Committee that the Plaintiff was dishonest with regard to documentation. However, she did not pursue the allegation further by seeking to test the authenticity of the document, nor did she withdraw the allegation. It was submitted that Ms Malica later appeared to retreat from her original allegation (Exhibit A, page 670a). The Review Committee contented itself with the comment that there must be written delegation of authority to co-investigators to obtain consent and such delegations were not found in the audit (Exhibit A, page 670a).

The Defendant's Submissions 184 With respect to the Plaintiff's complaint that individuals were acting as accusers and in the position of decision maker, Ms Sharp submitted that cases such Stollery and Ong did not assist the Plaintiff. It was submitted that, in these cases, the person characterised as the accuser stood in a very special position with respect to the person under investigation. Reliance was placed upon Hall v New South Wales Trotting Club Limited at 387-388 in this respect, emphasising the need for direct and personal involvement by the "accuser" in the matters under consideration. 185 It was submitted that the evidence does not support a finding that Professor Ward was an "accuser" of the Plaintiff. It was submitted that Professor Ward was the professor of medicine at the PoW Hospital clinical school and, from October 2007, was the Director of Research at the NHN. From March 2008, when the RSO was restructured, the senior manager of that office reported to Professor Ward and, amongst other things, the RSO supported the NHN HREC. 186 The Defendant submitted that at no time did Professor Ward make an accusation against the Plaintiff in which she was personally concerned, or which involved consideration of dealings between the Plaintiff and herself. Rather, she passed on to Mr Bernard the fact that an external reviewer had raised a serious concern in relation to patient safety in the Clinical Trial. She recommended that the Clinical Trial be suspended and that the matter be referred to the NHN HREC. The Defendant submitted that it was necessary for Professor Ward to pass on this information, both in the interest of research governance and in her role as a clinician where a serious question of patient safety had been raised. 187 The Defendant submitted that a review of the correspondence involving Professor Ward contained in the folders (Exhibit A) showed that she stood in a position of somebody assisting with investigation, rather than in the role of an accuser. Before the Review Committee was formed, she investigated certain matters concerning the Clinical Trial. She provided advice to Mr Bernard about the membership of the Review Committee and about its terms of reference. Once the Review Committee was formed, she assisted in gathering information for the Review Committee. The Defendant submitted that there was nothing improper about such assistance. The terms of reference expressly stated at clause 3.3 that the Review Committee was to be supported by a secretariat within the RSO and that the secretariat would provide ongoing support to the Review Committee as necessary. Clause 4.5 of the terms of reference provided that if expert advice be provided to the Review Committee, that the expert would have no voting rights. Clause 4.6 permitted the Review Committee to seek assistance from individuals in the review of study documentation. 188 The Defendant submitted that the Review Committee clearly had investigative responsibilities and that it was appropriate to have input from those who had investigated. 189 The Defendant submitted that the terms of reference did not require the Review Committee to be independent (T106). The investigatory nature of the Review Committee reinforced that independence was not required. 190 With respect to Professor Campbell, the Defendant submitted that the evidence concerning Professor's Campbell's role in relation to Associate Professor Sidhu and the Plaintiff could not support a finding that Professor Campbell was an "accuser". The Defendant submitted that the role of Professor Campbell in this dispute did not rise above that of mediator, and did not establish that he was an "accuser" of the Plaintiff in relation to the matters to be considered by the Review Committee. 191 It was submitted that the evidence did not otherwise demonstrate personal animosity as between the two men, or that Professor Campbell had any interest in the way in which the disputes were resolved between the two of them. 192 Further, even if a reasonable apprehension of bias could arise from the matters relied upon by the Plaintiff, including the role of Professor Campbell in the Associate Professor Sidhu matter, the Plaintiff had waived any objection to Professor Campbell being a member of the Review Committee in that he raised no concern on that issue from the time the Review Committee was established. The Plaintiff's later request that Professor Campbell disqualify himself from the process arose from alleged prejudgment disclosed in the email of 26 August 2008 and this had nothing to do with the Associate Professor Sidhu matter. 193 The Defendant submitted that the evidence did not establish that Ms Malica was an "accuser" so as to give rise to a reasonable apprehension of bias. Decision Concerning Plaintiff's Complaint that Individuals Were Acting as Accusers and Also in the Position of Decision Maker 194 I accept the Plaintiff's submission that the "accuser" principle, emerging from cases such as Stollery and Ong, is not confined only to circumstances where the alleged "accuser" is a witness against the person. It applies to a person who in substance made the complaint leading to the establishment of an inquiry, in particular, where the person has formed the view that the complaint was made out: Ong at 134-135. 195 Whether a plaintiff is able to demonstrate a factual foundation for a finding that the relevant apprehension of bias arises from a person who is an "accuser" participating in the decision-making process is a factual issue to be determined in the circumstances of each case. There is no basis in principle for confining this class of apprehended bias to witness-type cases. The approach which I take is supported by the obiter comments in Rendell v Release on Licence Board at 507F-G. In the present context, the principle may be engaged where the evidence reveals that a person instigated or set in train the relevant process, and made a decision to suspend the Clinical Trial, where the correctness of the suspension decision itself falls to be decided by the Review Committee. 196 It has been held that a person who was a member of a professional governing body, or its relevant committee, which instituted disciplinary proceedings to be dealt with by a tribunal, ought be disqualified from sitting on that tribunal on the grounds of apprehended bias, even where the person had no recollection of earlier involvement in the relevant process: Carver v Law Society of NSW (1998) 43 NSWLR 71. As the issue was one of apprehended and not actual bias, no question was raised concerning the probity or integrity of the person involved: Carver v Law Society of New South Wales at 102. A fair-minded and reasonable observer who became aware that a person who had been involved in the investigation and the decision to bring proceedings was to be involved in determining the charge, might reasonably apprehend that the person might not bring an impartial mind to the resolution of the matter: Carver v Law Society of New South Wales at 87. It has been observed that a person whose ability to earn a living is jeopardised by an adjudication is entitled to have that adjudication performed by "an independent group of people": Hedges v Australasian Conference Association Limited [2003] NSWSC 1107 at [100]; Graham v Baptist Union of New South Wales [2006] NSWSC 818 at [56]. 197 A realistic and practical assessment must be made of the evidence to determine whether apprehended bias, in the Stollery and Ong sense, has been demonstrated in this case.

Professor Ward as an "Accuser" 198 In approaching the Plaintiff's claim on this issue, it is necessary to bear in mind the position held by Professor Ward, at relevant times in 2007 and 2008, which shed light upon her involvement in the process. It was Professor Ward who brought to the attention of Mr Clout and Mr Bernard the report in 2007 which raised questions concerning the Clinical Trial. Professor Ward strongly recommended suspension of the Clinical Trial and Mr Clout acted upon this recommendation. The Clinical Trial was suspended pending the review to be undertaken by the Review Committee. The Review Committee was to decide, amongst other things, the correctness of the suspension decision. Professor Ward determined to stand back from the activities of the Review Committee so that she could be involved in the implementation process. 199 I accept that Professor Ward played a very significant role in the selection of the Review Committee members, and in the setting of the terms of reference. It was necessary for Mr Clout and Mr Bernard to keep in mind, at this point of the process, that it was Professor Ward who had recommended the suspension of the Clinical Trial. A decision concerning the future of the Clinical Trial was a critical issue for investigation and report by the Review Committee. 200 Although some input from Professor Ward might have been desirable in the selection of the Review Committee membership and the setting of the terms of reference, it was important that Mr Clout and Mr Bernard ensured that an ad hoc committee was selected that was independent, and could reasonably be seen to be independent. I do not accept the Defendant's submission that the Review Committee was not required to be independent - clause 4.1 of the terms of reference required members to declare any potential conflicts of interest. Further, the subject matter of the review, as it commenced and progressed, was such that independence was required to ensure procedural fairness.

201 Although it was probably inevitable that members of the Review Committee would have some knowledge of the subject matter under consideration and the persons involved, it was important that persons be selected who could be reasonably considered as an independent group of persons. 202 The evidence indicates that Professor Ward had communications with Professor Campbell before his appointment to chair the Review Committee, and that these communications involved an effective acceptance by the two persons that the decision to suspend had been inevitable (see [44] above). 203 A reasonable observer may readily form the view that Professor Ward had an interest in the Review Committee vindicating the decision to suspend the Clinical Trial. In this context, the concept of "accuser" should be understood as Professor Ward having initiated action adverse to the Plaintiff, with the correctness of that action to be subject to assessment by the Review Committee. In these circumstances, it seems to me that Professor Ward may be accurately characterised as an "accuser" for the purpose of application of the Stollery and Ong principle. In the words of the Court in Hall v NSW Trotting Club Limited at 387E-F, Professor Ward was "so directly and personally involved in the matters under consideration that the only reasonable inference is that [she] must have an interest in the outcome of the proceedings". 204 It is necessary to consider what the evidence reveals was the involvement by Professor Ward in the process of the Review Committee thereafter. The emails referred to in some detail earlier in this judgment point to regular communications between Professor Ward and Review Committee members on issues critical to their functions. A consistent approach seems to have been adopted of copying emails to Professor Ward, when members of the Review Committee were communicating with each other with respect to their deliberative processes. Professor Ward responded from time to time, with suggestions for action, including amendment of draft documents. 205 The minutes of the Review Committee meetings disclose that Professor Ward and Mr Bernard were present "in part, by invitation". This notation appears to acknowledge that Professor Ward was an invitee only, who (by implication) was not expected to play a part in the deliberative processes of the Review Committee. However, the emails suggest a different role. 206 I accept the following submissions of Mr Simpkins SC, in his closing address, with respect to the role of Professor Ward (T92-93):

(b) she made recommendations as to the composition of the Review Committee to review the suspension decision that she had caused to be made;

(c) she promoted the appointment of Professor Campbell as the chair of that Committee, knowing that Professor Campbell regarded the suspension as a justified act;

(d) she recognised that she was in a position of conflict, at least to the extent of declining to be an official member of the Review Committee;

(e) she assisted in the settling of the terms of reference that would review the decision that she had caused to be made;

(f) she nominated the consultants who were to be engaged to undertake investigations for the Review Committee;

(g) she approved the retainers of those consultants;

(h) she participated in the meetings of the Review Committee;

(i) the language used by Professor Ward in emails indicates that she regarded herself as an unofficial member of the Review Committee;

(j) she engaged in communications with the Review Committee about the draft report;

(k) she assisted in settling the terms of the draft report;

(l) she made enquiries of a third party (Serva) for the purposes of the Review Committee being informed, and she assisted in settling the Review Committee's letter which dealt with the Plaintiff's submissions made on 8 October 2008. 207 I accept the Plaintiff's submission that Professor Ward could not have been an official member of the Review Committee, a principal objective of which was to review the decision that she had effectively made. I accept the Plaintiff's submission that, although Professor Ward refrained from appointing herself or accepting an appointment to the Review Committee, she otherwise acted in a dominant role in the whole process of inquiry. 208 In all the circumstances, I am satisfied that the Plaintiff has made good his ground of apprehended bias with respect to the involvement of Professor Ward, by application of the Stollery and Ong principle. Dissatisfaction engendered in the mind of a reasonable observer, aware of the facts, by the constant involvement of Professor Ward in the decision-making process of the Review Committee, having regard to her personal connection with the matter in hand, would not be extravagant or farfetched: Stollery at 519. Indeed, it would, in my view, be very fairly based. 209 This finding is one of apprehended bias. There is no finding of impropriety against Professor Ward, who did not give evidence in the proceedings. The Plaintiff's success upon this ground is based upon the requirement that the process be undertaken in compliance with the rules of procedural fairness. The Plaintiff has demonstrated that the rules were not complied with in this respect. 210 I uphold the Plaintiff's submission with respect to Professor Ward.

Professor Campbell as an "Accuser" 211 The Plaintiff's claim that Professor Campbell was an "accuser" is based upon his involvement in the Associate Professor Sidhu matter and what is said to be a type of conflict of interest with the Plaintiff concerning research grants. 212 I am not satisfied that the evidence demonstrates that the role of Professor Campbell with respect to the dispute between the Plaintiff and Associate Professor Sidhu rose above that of a mediator. Any finding adverse to Professor Campbell on this issue must be based upon something more than the bare assertion or belief of the Plaintiff (T12). I am not satisfied on the balance of probabilities that Professor Campbell can be appropriately characterised as an "accuser" so to activate the Stollery and Ong principle. 213 In any event, the Plaintiff did not object to the appointment of Professor Campbell to the Review Committee, based upon his prior involvement in the Associate Professor Sidhu matter. Even if the Plaintiff had been able to demonstrate reasonable apprehension of bias under this heading, he waived his right to object upon that basis. 214 With respect to the other argument under this heading, the Plaintiff relies upon comments made by Professor Campbell in certain emails sent in September 2008. I do not consider that Professor Campbell's past involvement with research grants rendered him an "accuser" of the Plaintiff so as to attract the Stollery and Ong principle. 215 I reject the Plaintiff's claim for relief under this heading.

Ms Malica as an "Accuser" 216 The Plaintiff's submission with respect to Ms Malica focuses upon emails in August 2008 in which Ms Malica raised the prospect that the Plaintiff had forged a document or documents. The evidence indicates that this possibility was the subject of a number of email communications. The final report of the Review Committee did not contain any such suggestion or finding. 217 I do not consider that this evidence gives rise to a finding that Ms Malica was an "accuser" of the Plaintiff so as to attract the Stollery and Ong principle. That principle involves consideration of events leading up to the establishment of a review or inquiry, which could give rise to a finding that a person who was an "accuser" should not have played any part in the decision-making process. In Ms Malica's case, the Plaintiff's argument arises from a concern raised by Ms Malica during the review process. It might be expected that issues will arise for consideration during such a process, some of which may lead nowhere and be put aside. No finding was made adverse to the Plaintiff in the final report of the Review Committee in this respect. 218 I am not satisfied that the Plaintiff has made good his claim for relief on this basis.

The Plaintiff's Submissions 219 The Plaintiff submitted that the terms of reference of the Review Committee themselves (at [51] above) contained assumptions which prejudged the conduct of the Plaintiff and the issue of whether the Clinical Trial met regulatory requirements. It was noted that clause 7.1 of the terms of reference identified the Plaintiff by name, and that he was the only individual named therein as a person whose conduct was subject to review. 220 The Plaintiff submitted that, on reading the terms of reference, a fair-minded observer might reasonably apprehend that the draftsperson had already formed the view, and that the Review Committee might proceed on the same view, that there would be difficulties in obtaining documents from the Plaintiff and that the Clinical Trial did not meet regulatory requirements. 221 The Plaintiff submitted that there was a reasonable apprehension of bias by reason of prejudgment by Professor Campbell. Reference was made to the email of 7 June 2008 (see [44] above) to the effect that Professor Campbell had said of the decision to stop the trial "You don't need a committee to tell you this - you have no other choice". 222 The Plaintiff relied upon Professor Campbell's advice to Ms Malica not to include in the terms of reference any provision for an appeal. 223 On 25 August 2008, Professor Campbell expressed his view to Professor Ward that she should give the Plaintiff notice of Dr Sarson's review not on the day of the review, but on the day before "much as it is tempting to do so". 224 The Plaintiff relied upon Professor Campbell's email on 26 August 2008 (see [67] above) which was copied inadvertently to Ms Walke and came to the attention of the Plaintiff. The Plaintiff submitted that Professor Campbell stated his views in this email on three factual issues which were before the Review Committee:

(a) statement on Good Manufacturing Process ("GMP") issue where Professor Campbell expressed confidence that the Review Committee "will be recommending that any recommencement should only occur in GMP facilities" ;

(b) statement on breach of guidelines based on the expected report of Dr Sarson whereby Professor Campbell observed that "all the documents and equipment, SOP's etc that are being reviewed should already be extant and readily available in the DTU and DTC … and if this is not the case, then Bernie is, by definition, in breach of various relevant guidelines" ;

(c) statement on compliance with GCP whereby Professor Campbell said "… we already have strong grounds to believe it will identify major deficiencies in GCP, to the extent that we would be likely (if these are confirmed) to recommend indefinite continuing of the suspension of the trial in any case" . 225 The Plaintiff also relied upon Professor Campbell's statement in this email expressing an opinion as to the likely conduct of the Plaintiff if an extension of time were granted - "Unfortunately, while he cannot do much about the infrastructure of the DTU in terms of compliance of various guidelines between now and late October, he could certainly attempt to retrospectively generate some of the documents we are seeking in the CRO review, and this review should definitely not be delayed". 226 The Plaintiff referred to his email application on 27 August 2008 for Professor Campbell and other Review Committee members to disqualify themselves, a request declined by Professor Campbell in an email of 28 August 2008 (see [72] above). 227 The Plaintiff submitted that the three statements referred to at [224] above, communicated a concluded view of Professor Campbell on three central issues before the Review Committee. These views were expressed to other members of the Review Committee and to Mr Clout, at a time only 12 days after the terms of reference had been sent to the Plaintiff. The Plaintiff submitted that the further statement complained of (at [225] above) contained a serious allegation that the Plaintiff would be dishonest with regard to documentation in the DTU if he had the opportunity. Accordingly, the Plaintiff submitted that Professor Campbell embarked upon the review with an adverse view of the Plaintiff's credit. 228 Whilst acknowledging Professor Campbell's email to the Plaintiff (at [68] above), and to Ms Walke (at [69] above) attempting to dispel impressions given by the inadvertently transmitted email, the Plaintiff pointed to Professor Campbell's email to other Review Committee members and Professor Ward (at [73], [75] above) which took a very different position. The Plaintiff submitted that this email stated that Professor Campbell did not need to admit to prejudgment, even though he and the other Review Committee members knew that they had already made their decision. 229 The Plaintiff submitted that, whilst Professor Campbell, as a matter of form, offered the Plaintiff an opportunity to make submissions by letter dated 23 September 2008 (at [107] above), Professor Campbell considered that nothing the Plaintiff could say could result in any change to the Review Committee's conclusions or recommendations. 230 It was submitted that it was within Professor Campbell's contemplation that some factual statement might be adjusted in response to the Plaintiff's submission, but that he was firmly of the view that any such adjustment could not alter the conclusions and recommendations. 231 The Plaintiff pointed as well to Professor Campbell's email to Professor Ward on 27 August 2008 seeking the latter's view concerning the Plaintiff's request that Professor Campbell disqualify himself (see [73] above). Emphasis was placed on Professor Campbell's comment that it "was not a prejudging at all, but a considered decision already made by the full cttee at its first meeting and stupidly released earlier than planned". 232 The Plaintiff submitted that this email discloses that Professor Campbell's prejudgment of the issue was evident to him, and that he had made a mistake in disclosing too early the decision the Review Committee made at its first meeting. His opinion that the outcome of the review would be similar, even if the Review Committee had no further role, reflected his expectation that the position would not change. It was submitted that the proper conclusion was that Mr Bernard would make the same decision as that reached by the Review Committee at its first meeting, and that these judgments were made before the Plaintiff had had an opportunity to make a submission. 233 The Plaintiff sought to contrast the content of Professor Campbell's email to Professor Ward with Professor Campbell's email to the Plaintiff expressing a very different view, namely that no final decision has been reached (see [77] above). 234 The Plaintiff submitted that Professor Campbell's statement to the Plaintiff that the decision reached by the Review Committee at its first meeting "was never meant to be conveyed to anyone outside the committee" was not true. Professor Campbell had communicated to Professor Ward every decision made by the Review Committee, and had involved Professor Ward in the processes of the Review Committee at all stages. The Plaintiff noted that, whilst Professor Campbell confined the copying of the email to the Plaintiff to members of the Review Committee, Mr Bernard and Mr Clout, he immediately forwarded it separately to Professor Ward for her approval, which was forthcoming with the reply "Well said Terry" (Exhibit A, page 447a). 235 When the Plaintiff responded by pointing out the implications of stopping all transplants unless a GMP facility was created for the NHN, and that this would include bone marrow transplants, Professor Campbell decided that he would not respond, an approach which was considered "sensible" by Professor Ward (Exhibit A, page 447g). 236 The Plaintiff submitted that, taken as a whole, the evidence clearly indicated that Professor Campbell was committed to a consistent concluded view, incapable of alteration, from start to finish, as to the conclusions the Review Committee should reach, and that this amounted to prejudgment by Professor Campbell. 237 The Plaintiff submitted that prejudgment had been demonstrated on the part of Ms Malica. It was submitted that Ms Malica was quick to reach findings on factual issues adverse to the Plaintiff and to convey them to other members of the Review Committee before the evidence relevant to that issue had been fully and fairly evaluated. 238 The Plaintiff relied upon Ms Malica's request to Dr Sarson to amend his report to remove a paragraph relating to HREC's compliance with governance requirements and to delete a paragraph (see [85] above). 239 The Plaintiff relied upon Ms Malica's swift transmission to other Review Committee members that Dr Sarson's verbal comments were adverse to the Plaintiff (Exhibit A, page 402). 240 The Plaintiff submitted that prejudgment on the part of Ms Edwards was also established. It was submitted that Ms Edwards was quick to reach final conclusions prior to completion of the review and to convey those opinions to persons who were not members of the Review Committee, including reports to Professor Ward and Mr Bernard. 241 When informed by Ms Malica that Dr Sarson took only three hours to complete the audit of the DTU and that "basically it doesn't look very good", Ms Edwards immediately responded "It does not surprise me that it only took three hours, nor his comments" (Exhibit A, page 421c). 242 The Plaintiff submitted that Ms Edwards had a view prior to the audit that the DTU would not meet regulatory requirements.

The Defendant's Submissions 243 The Defendant submitted that the construction which the Plaintiff seeks to put on clause 7.1 of the terms of reference is not open, on a fair reading of that clause. It was submitted that the clause does not support a conclusion that the Review Committee had prejudged the issues because of any assumption concerning the Plaintiff's conduct and whether the Clinical Trial met regulatory requirements. 244 The Defendant submitted that the argument that there was prejudgment by Professor Campbell ought be rejected. The Defendant responded to the four issues upon which the Plaintiff relied, emerging from the inadvertent email of 27 August 2008 (see [224]-[225] above). 245 In assessing this email (and others), the Defendant submitted that it is important to have regard to matters of context, including the fact that the Review Committee met over a number of sessions and, in between those meetings, shared thoughts via email. It was submitted that the sharing of tentative views between Review Committee members in this way was to be expected so that those views might be tested, refined or refuted. It was submitted that caution must be exercised in assessing a claim of prejudgment, by references to communications between Review Committee members over the course of the inquiry, where ideas may be exchanged and tested as part of the deliberative process. These communications should ordinarily remain confidential to ensure frank exchange of ideas: Roylance v General Medical Council (No. 2) [2000] 1 AC 311 at 323-324. The Defendant submitted that this was a very different thing from prejudgment, whereby a person has a closed mind which cannot be changed. 246 The Defendant pointed to Professor Campbell's emails to the Plaintiff and Ms Walke which demonstrated that any expression of view in the inadvertent email was tentative only, accompanied by an express denial by Professor Campbell of prejudgment. Reliance was placed upon a statement in Johnson v Johnson at 494 [16] that the effect of a statement that might indicate prejudgment, can be removed by a later statement which withdraws or qualifies it. 247 With respect to the GMP issue (at [224(a)] above), the Defendant noted that the Review Committee did not ultimately make a recommendation that any recommencement of the Clinical Trial should only occur in GMP facilities. Rather, Recommendation 3 of the final report (see [124] above) expressed the Review Committee's acceptance "that at the present time, full compliance with the GMP standards is not mandated in a trial such as this". Accordingly, the Defendant submitted that this constituted a categorical indication that Professor Campbell had not brought a closed mind to that matter. 248 With respect to the statement on breach of guidelines based on the expected report of Dr Sarson (see [224(b)] above), the Defendant submitted that this cannot be seen as prejudgment. A statement that, if the documents were not extant and readily available, then the Plaintiff was "by definition, in breach of various relevant guidelines" was a simple statement of fact and, importantly, the Defendant submitted that the statement did not suggest that the documents would be found "not to exist". 249 With respect to the statement on compliance with GCP (see [224(c)] above), the Defendant pointed to the words of qualification contained in the email ("We would be likely (if these are confirmed)") as indicating that the view was based upon the material reviewed to date and was subject to amendment if further information was received. 250 With respect to the possibility of retrospective preparation of documents (see [225] above), the Defendant submitted that this statement cannot be fairly construed as a comment by Professor Campbell as to what he expected the Plaintiff was likely to do. Rather, it was clear that Professor Campbell was merely stating a possibility that was prudent to take into account when considering whether to delay the audit inspections by two months. 251 The Defendant submitted that the expression of provisional views does not amount to prejudgment, and does not automatically indicate that the decision-maker's mind is closed. It was stressed that, when suspected prejudgment of an issue is relied upon to ground the disqualification of a decision maker, what must be firmly established is a reasonable fear that the decision-maker's mind is so prejudiced in favour of a conclusion already formed, that he or she will not alter that conclusion irrespective of the evidence or arguments presented to him or her: Laws v Australian Broadcasting Tribunal (1990) 170 CLR 70 at 100. The expression of tentative views which reflect a certain tendency of mind are not, on that account alone, to be taken to indicate prejudgment: Johnson v Johnson at 493 [13]. 252 The Defendant submitted that the email of 26 August 2008 stood in no different position to a comment of a judge midway through a trial that he was yet to be persuaded by a point that a party was making. Such a comment did not establish prejudgment: R v Lusink; Ex parte Shaw (1980) 2 ALR 47 at 51. 253 The Defendant submitted that the evidence relied upon by the Plaintiff in support of the claim of prejudgment by Ms Malica and Ms Edwards did not support such a conclusion. It was submitted that a multi-member decision maker, engaged in an investigative exercise, will express tentative views along the way for discussion with other committee members and that, for the Plaintiff to succeed on this point, it is necessary to prove that Ms Malica and Ms Edwards had a closed mind on the matters before them. The Defendant submitted that the Plaintiff had not discharged that burden.

Decision on Prejudgment Ground 254 In approaching the claim for relief by reference to alleged prejudgment by Professor Campbell, I have regard to the totality of evidence which bears upon that issue. The test is whether an independent observer might reasonably apprehend that Professor Campbell might not be open to persuasion (see [151] above). 255 Taken alone, I do not think that clause 7.1 of the terms of reference takes the matter very far. However, it must be borne in mind that Professor Campbell had made a comment to Professor Ward with respect to the inevitability (and thus correctness) of the decision to suspend the Clinical Trial (see [44] above). Taken with this, the terms of reference point to a significant focus upon the conduct of the Plaintiff as part of the review. 256 Both the Plaintiff and the Defendant have advanced competing arguments concerning the email of 26 August 2008, which was inadvertently sent to Ms Walke, and the subsequent emails which serve to explain and qualify this email. I make due allowance for some informality in lines of communication between members of the Review Committee during the deliberative processes. That said, there was a somewhat unusual pattern of copying email communications between Review Committee members to third parties, including Professor Ward and Mr Bernard. These were not email communications confined to the Review Committee members. 257 I readily accept that allowance must be made for the raising of tentative views which may, or may not, end up as part of the conclusions reached. The analogy with judicial expressions of tentative views in the course of argument is apt. That said, it is necessary to consider the particular circumstances of the case at hand. 258 At various points along the way, statements are made by Professor Campbell which suggest a firm view adverse to the Plaintiff. The process whereby the draft report was provided to the Plaintiff, leading to the settling of the final report, has the flavour of the inevitable about it. 259 The Defendant correctly observes that the Review Committee did not recommend in its final report that the Clinical Trial could only recommence in GMP facilities. This reflects a changed position from Professor Campbell's email of 26 August 2008. However, the contemporaneous communications revealed in the emails, and surrounding documentation, would cause an independent observer to have real concern as to whether Professor Campbell's mind was open to persuasion on issues adverse to the Plaintiff concerning resumption of the Clinical Trial. 260 I emphasise that the present issue is not one of impropriety or actual bias or any element of malice on the part of Professor Campbell towards the Plaintiff. As mentioned earlier, the test for reasonable apprehension of bias by prejudgment involves the reasonable apprehension of an independent observer. 261 Making all due allowance for that independent observer having a complete picture of the processes of the Review Committee and the issues under consideration, I am satisfied on the balance of probabilities, that an independent observer might reasonably apprehend that Professor Campbell might not be open to persuasion on issues under consideration by the Review Committee with respect to the Plaintiff and the suspension or possible resumption of the Clinical Trial. Accordingly, I am satisfied that the test for reasonable apprehension of bias by prejudgment on the part of Professor Campbell has been established in this case. 262 The principal element of the claim for prejudgment on the part of Ms Malica is her request, acceded to by Dr Sarson, to remove from his report aspects which might be regarded as being favourable to the Plaintiff. No explanation has been offered for this approach by Ms Malica. I have referred to the competing submissions of the parties on this point (see [85] above). I do not think that this aspect of the evidence greatly assists the Plaintiff on the prejudgment ground. 263 It may be said that certain statements of Ms Malica and Ms Edwards revealed in the emails pointed to a ready acceptance of features adverse to the Plaintiff. In the result, however, I am not satisfied on the balance of probabilities that an independent observer might reasonably apprehend that Ms Malica or Ms Edwards might not be open to persuasion on matters concerning the Plaintiff and the suspension or possible resumption of the Clinical Trial. 264 Accordingly, the Plaintiff has succeeded in his claim for relief based upon reasonable apprehension of bias by prejudgment with respect to Professor Campbell, but not Ms Malica or Ms Edwards.

The Plaintiff's Complaint Based Upon Interest in Outcome of Review

The Plaintiff's Submissions 265 The Plaintiff submitted that Professor Ward, Ms Malica and Ms Edwards had an interest in protecting their own positions as persons responsible for governance of research at PoW Hospital or in the Defendant. Where a decision maker has an interest in a decision-making process, which need not be a financial interest, there is a reasonable apprehension of prejudice, partiality or prejudgment: Ebner v Official Trustee in Bankruptcy. 266 The Plaintiff referred to Chapter 3.3 of the National Health and Medical Research Council ("NHMRC") "National Statement of Ethical Conduct in Human Research" dealing with responsibilities of individuals and institutions in the carrying out of clinical trials. Reference was also made to Chapter 1 of NHMRC "Australian Code for the Responsible Conduct of Research" concerning the responsibility of institutions. The Plaintiff noted that the Department of Health requires all staff of area health services to comply with the NHMRC "National Statement of Ethical Conduct in Human Research" and the Department required human research ethics committees to undertake scientific review of clinical trials. 267 Reference was also made to the TGA's "Note for Guidance on Good Clinical Practice" issued in July 2000. 268 With respect to Professor Ward, the Plaintiff submitted that, prior to sending her complaint which initiated the review, she and Ms Edwards had searched HREC records for the Plaintiff's ethics proposals. Professor Ward acknowledged that, since 17 November 2007 when the Defendant's existing ethics committee ceased to exist, they had been "in crisis mode". Professor Ward acknowledged that the PoW Hospital was the sponsor for the Clinical Trial, that the Defendant may not have realised this and she doubted whether the Defendant had obtained appropriate indemnity (Exhibit A, page 73). In the context of an email to Mr Bernard as to whether the PoW Hospital should support a research-funding proposal by the Plaintiff, Professor Ward admitted that the Hospital, and not the Plaintiff, was responsible for the lack of governance (Exhibit A, page 87): "Bernie, perhaps through no fault of his own has been working in a largely unregulated research environment here on the POW campus. On a positive note, things are improving; …" 269 On learning that the RSO had not received approval from the TGA in 2005, the Plaintiff suggested notifying the TGA. However, Professor Ward agreed with Professor Campbell and Ms Malica not to tell the TGA that there was no approval for the 2005 Clinical Trial Notification ("CTN") (Exhibit A, page 193). 270 The Plaintiff submitted that Ms Malica had an interest in the outcome of the review. Its findings potentially could damage her employment position and reputation. Yet, the Plaintiff submitted, Ms Malica accepted the appointment to the Review Committee and did not disclose any conflict of interest pursuant to clause 4.1 of the terms of reference. 271 It was submitted that Ms Malica's interest in avoiding responsibility for the shortcomings of the RSO was evident when the Plaintiff offered to contact the TGA about the non-receipt of approval of 2005 CTN, subject to the reviews of HREC and RSO on this course. Ms Malica said that "It appears he is trying to put this back onto the Research Support Office" (Exhibit A, page 193). The Plaintiff submitted that this evidenced a concern on Ms Malica's part that responsibility for failing to ensure that the 2005 CTN was received by the TGA might be sheeted home to the RSO, of which she was manager, rather than to the Plaintiff. 272 It was submitted that Ms Malica had an interest in the outcome of the review with regard to future funding of her office. The Plaintiff submitted that the presence of Ms Malica on the Review Committee generated an appearance of bias - a fair-minded observer might reasonably apprehend that she might have an interest in avoiding criticism of her own performance in research governance and in improving the resources of the RSO. 273 The Plaintiff submitted that Ms Edwards was research advisor in the RSO and had been responsible for governance during the period after the disbanding of the ethics committee in November 2007, when all three staff in its secretariat simultaneously resigned. She was then responsible for the executive support for the new HREC. 274 The Plaintiff noted that Ms Edwards attended the HREC meeting on 21 April 2008. It was noted at that meeting that the Clinical Trial had been halted by Mr Bernard, that this was a research governance issue and that it should first be dealt with by the PoW Hospital Executive. Ms Edwards was responsible under the supervision of Professor Ward, for drafting the official letter from HREC to Mr Bernard, to request him to set up a review committee. The Plaintiff submitted that this step relieved the HREC from dealing with the governance issue itself. However, Ms Edwards, with her continuing interest as the officer responsible for the HREC and compliance with NHMRC and departmental requirements with regard to HREC, remained a participant in the decision-making process under the auspices of the Review Committee. 275 The Plaintiff submitted that Ms Malica and Ms Edwards had a duty to comply with the various NHMRC requirements and Departmental policies, and to ensure that others within NHN did so. It was submitted that part of the Review Committee's terms of reference included determination whether there had been breaches of those duties, and that Ms Malica and Ms Edwards had an interest in deflecting criticism as to their own performance. The Plaintiff submitted that both Ms Malica and Ms Edwards were responsible for governance at times covered by the review, and that they were at the centre of any inquiry into institutional failure. 276 The Plaintiff submitted that the final report of the Review Committee made no findings at all about whether officers in the institution discharged their responsibilities. An appendix to the report set out a simple very general summary of various governance policies, but did not identify the responsibilities of the institution as sponsor. No adverse findings were made as to whether the HREC, the RSO, the Director of Research (Professor Ward) or the Director of Research Governance (Professor Rose) failed to meet the standards set by the NHMRC. 277 The Plaintiff submitted that clauses 5.1.5, 5.1.6, 5.2 and, in particular, clauses 6 and 6.2 of the terms of reference required the Review Committee to consider institutional responsibilities and any non-compliance with relevant standards of governance. This would have included the responsibility of the sponsor to engage a contract research organisation to monitor the Clinical Trial, documentation of the cost of treatment and financial aspects and submission of required applications (such as the 2005 CTN) to the appropriate authorities for review or acceptance. 278 The Plaintiff noted that paragraph 3.4 of the response letter accompanying the final report was entitled "Institutional Versus Researcher Responsibilities", but contained no more than a terse statement that research which is "inherently unethical" should not be carried out and that the Review Committee wished to "make this message extremely clear, as it does not appear at present to be clear to Professor Tuch" (Exhibit A, page 679t). 279 The Plaintiff submitted that, had the Review Committee properly addressed its terms of reference, it would have made findings as to whether on the evidence the HREC, the RSO, Director of Research and Director of Research Governance manifestly failed to perform their obligations.

The Defendant's Submission 280 The Defendant submitted that the Plaintiff's contentions with respect to Ms Malica's interests were purely speculative and that there was no evidentiary foundation from which a reasonable apprehension of bias could be firmly established. The Defendant submitted that it was difficult to see how the findings of the Review Committee could have damaged Ms Malica's reputation given that she did not take up the position of Manager, Research Governance within the RSO until 7 May 2008, after the events under investigation by the Review Committee. 281 The Defendant makes similar submissions with respect to Ms Edwards. It was submitted that there was no evidence that she was still employed by the Defendant at the time of the review and that she had been temporarily appointed to the position of research advisor to the RSO in the period of around February to May 2008.

Decision Concerning Interest in Outcome of Review 282 The focus of this ground for relief must be Ms Malica and Ms Edwards, who were members of the Review Committee. The role of Professor Ward is only relevant insofar as any light is shed upon the position of Ms Malica and Ms Edwards under this ground. 283 If a conflict of interest was demonstrated on the part of Ms Malica or Ms Edwards, a reasonable apprehension of bias would arise almost as of course as a result of membership of the Review Committee: McGovern v Ku-Ring-Gai Council at 562 [26]. 284 It is necessary to focus attention upon the interests of Ms Malica and Ms Edwards which are said to have been affected by the subject matter of the review. In circumstances where the evidence does not demonstrate that Ms Malica or Ms Edwards were occupying relevant positions of responsibility within the Defendant at the time of events surrounding the Clinical Trial, it is difficult to see how either of them had an interest which could rise to a conflict of interest in their membership of the Review Committee. 285 This is not to say that a more cautious approach may have been appropriate involving appointment of members to the Review Committee who were completely external to the Defendant. It might be thought that persons with relevant training and experience in governance issues could have been found elsewhere. 286 That said, it remains for the Plaintiff to demonstrate, on the balance of probabilities, a proper factual foundation for a reasonable apprehension of bias by reference to interest of Ms Malica and Ms Edwards. The Plaintiff has not discharged this burden. 287 I reject this claim for relief of the Plaintiff.

Claim by Plaintiff that Review Committee Failed to Afford Him a Fair Hearing 288 The Plaintiff contended that the Review Committee failed to afford him an adequate hearing, and hence denied him procedural fairness because:

(a) the Review Committee failed to give the Plaintiff notice of all the allegations it considered;

(b) the Review Committee failed to disclose to the Plaintiff the McLean and Sarson reports in a timely way, or at all; and

(c) the Review Committee refused to allow the Plaintiff reasonable time to prepare a response.

Plaintiff's Submissions Concerning Alleged Failure to Disclose Allegations 289 The Plaintiff submitted that failure to give notice of an allegation, which is the subject of determination and findings, constitutes a very clear denial of procedural fairness. Even where a person is given notice of hearing, a failure to provide notice of one of the charges to be considered at the hearing generally constitutes a denial of procedural fairness. 290 The Plaintiff submitted that the final report of the Review Committee made findings and expressed opinions on matters which were not topics for findings or recommendations according to the terms of reference. The Plaintiff submitted that these were:

(a) whether the decision of Mr Bernard to suspend the trial was appropriate - Recommendation 1 found that it was;

(b) whether the Plaintiff was competent to carry out a complex first-in-man clinical trial - Recommendation 2 found that he was not;

(c) whether other personnel in the DTU involved in the Clinical Trial were competent to carry out a complex first-in-man clinical trial - Recommendation 2 found that they were not;

(d) whether the Plaintiff should be excluded from the conduct of a future study similar to the Clinical Trial - Recommendation 3 found that he should be so excluded;

(e) whether the Plaintiff had offered his encapsulation services to other investigators, and whether these other investigators were conducting studies or procedures on humans - Recommendation 9 found that the Plaintiff had made such offers and recommended that the Defendant should seek assurances from him in that regard;

(f) the nature of the financial and billing arrangements for the Clinical Trial - the terms of reference did not give the Review Committee a function of investigating matters relating to billing of patients and use of Medicare - however, the Review Committee in paragraph 2.1.2 made adverse findings with respect to these matters.

291 The Plaintiff submitted that these topics were considered by the Review Committee and adverse findings were made. No notice of the topics, or of any allegations in connection with them, was given to the Plaintiff in the terms of reference provided to him or in the letter from Professor Campbell dated 14 August 2008 or subsequently. It was submitted that the Plaintiff had no opportunity to comment on the findings, other than the inadequate period in which he was allowed to respond to the draft report. 292 The Plaintiff submitted that procedural fairness required that the allegations be identified and disclosed in advance of any draft report. It was submitted that, even in the draft report, which was almost identical with the final report, the allegations were not articulated precisely, rather adverse findings were simply made. 293 The Plaintiff submitted that the serious allegation made by Ms Malica that the Plaintiff had forged a patient consent form was never put to the Plaintiff to enable him to answer it, yet it was communicated to Professor Ward and Professor Campbell. 294 The Plaintiff referred as well to the failure on the part of the Review Committee to bring to the attention of the Plaintiff, Dr Sarson's comments made on the day he conducted the audit and Professor Campbell's observations that "On reflection, this would also be an opportunity to tell him not [to] apy [sic] for any more funding from India or anywhere else!" (see [178] above). The Plaintiff submitted that the allegations about his research grants were not put to him. 295 Insofar as the Defendant sought to rely upon a suggested relationship between the terms of reference and findings and recommendations made by the Review Committee, the Plaintiff submitted that the expressions relied upon were vague and that, in an inquiry akin to disciplinary proceedings, this did not meet the standards of procedural fairness. It was submitted that allegations must be precisely disclosed and that this is not done merely by terms of reference. 296 In response to the Defendant's submission that provision of the draft report satisfied the relevant requirement, the Plaintiff submitted that disclosure of allegations in a draft report did not comply with the requirements of procedural fairness. It was emphasised that the draft report did not contain allegations, but bare findings and recommendations only were made.

Defendant's Submissions Concerning Alleged Failure to Disclose Allegations 297 The Defendant submitted that the terms of reference raised for consideration the matters challenged by the Plaintiff under this heading. Not only were the matters caught by the terms of reference, the Defendant submitted that the allegations were disclosed in full when the Plaintiff received the draft report and was invited to comment.

Decision Concerning Alleged Failure to Disclose Allegations 298 The terms of reference identified a number of topics which were to be addressed by the Review Committee in its investigation, and no doubt reported upon in its final report. I do not think that the terms of reference themselves constituted a disclosure of allegations made against the Plaintiff. Nevertheless, the terms of reference constituted the framework within which the Review Committee was expected to proceed. 299 The draft report was made available to the Plaintiff (together with the Sarson and McLean Reports) with an opportunity to raise any factual matters concerning its content. Although complaint is made by the Plaintiff concerning the period of time allowed for him to respond to the draft report, he proceeded to do so and made submissions concerning matters raised in the draft report. 300 I am not satisfied that the findings complained of (at [224]-[225] above) lay outside the terms of reference so as to warrant a finding that the Review Committee was acting ultra vires. The topics were not entirely extraneous to the Review Committee's task. The Plaintiff responded to the draft report in his letter of 8 October 2008. He did not assert in that letter that there was inadequate disclosure of matters raised in the draft report.

301 The concern raised by Ms Malica about the possible forgery or alteration of documents went nowhere, and was not the subject of any adverse finding against the Plaintiff. Properly understood, it fell into the category of a matter raised during the course of the Review Committee's considerations, but then put to one side. It was not necessary to disclose this to the Plaintiff as it was not an allegation upon which the Review Committee proposed to rely. 302 It has not been demonstrated, in the circumstances of this case, that the requirements of procedural fairness mandated revelation of the material concerning other research grants. 303 The Plaintiff has not demonstrated, in the circumstances of this case, that the process failed to reveal to him the allegations of fact about which he was being called upon to comment. This ground does not succeed.

Plaintiff's Submissions Concerning Alleged Failure to Disclose Reports 304 The Plaintiff submitted that procedural fairness required disclosure of significant, relevant and credible evidence on which the decision maker relies, and that failure to disclose this material constituted a failure to disclose the case against the person whose interests are affected, denying the person an opportunity to present his case: Kioa v West at 629; Applicant VEAL of 2002 v Minister for Immigration and Multicultural and Indigenous Affairs (2005) 225 CLR 88 at 95-96. 305 It was submitted that the Plaintiff requested a copy of the McLean Report from Professor Campbell who responded that he had no objection, but that the McLean Report was not then provided to the Plaintiff. The Plaintiff submitted that he did not see the Sarson Report until he received it as an appendix to the draft report. 306 The Plaintiff referred to Professor Ward's email of 14 October 2008 to Serva and the response of Ms Moench. The Plaintiff submitted that the information from Serva was significant, relevant and credible and was not provided to the Plaintiff. Rather, the Plaintiff submitted, Professor Ward pursued the issue by asking the wrong questions of the wrong person, without seeking further information from the Plaintiff or disclosing to him Serva's response to her enquiry. Had this information been disclosed to the Plaintiff, it is submitted that he could have answered it in the terms later set out in his letter dated 29 January 2009 to the Health Care Complaints Commission. 307 The Plaintiff submitted that the Serva material was only disclosed to him in Professor Campbell's letter of 20 October 2008 which accompanied the final report. It was submitted that the Review Committee left the Plaintiff in the dark as to the adverse material in the McLean and Sarson Reports and in the Serva email, until it was too late for him to respond.

Defendant's Submissions Concerning Alleged Failure to Disclose Reports 308 The Defendant submitted that the Plaintiff received the Sarson and McLean Reports at the time of service of the draft report. It was submitted that the Plaintiff indicated that he needed a working week to respond to the draft report, including the Sarson and McLean Reports, and that he was given more time than this to do so. The Defendant observes that the Plaintiff made no complaint in his 8 October 2008 submission that he did not have adequate time to prepare his response. 309 With respect to the Serva material, the Defendant submitted that the evidence reveals contact by the Review Committee with Serva after it had received the Plaintiff's 8 October 2008 written submission concerning the draft report. The Review Committee followed up the Plaintiff's claims in this respect. Ms Malica consulted with Dr McLean and Ms Bouyer and was told that Premium Grade was not suitable for human use. Professor Ward followed up with a representative of Serva. The Defendant submitted that, as the Plaintiff advised in his 8 October 2008 submission that he only used Premium Grade, assurances about the GMP Grade were not relevant to the Review Committee's deliberations.

Decision Concerning Alleged Failure to Disclose Reports 310 I am not persuaded that any denial of procedural fairness has been demonstrated arising from the provision of the Sarson and McLean Reports. Each report was provided as an appendix to the draft report. The fact that Professor Campbell may have indicated an intention at an earlier time to provide the McLean Report does not, of itself, give rise to a denial of procedural fairness if the provision of that report did not take place until the draft report was furnished. 311 There are some unsatisfactory features emerging with respect to the Serva material. It was the Plaintiff who referred to Serva in his response of 8 October 2008 to the draft report. Thereafter, the Review Committee caused enquiries to be made of Serva. There is a live issue as to whether the Review Committee understood correctly the Serva material, and its suggested relevance to the inquiry. The appropriate course would have been to furnish to the Plaintiff the Serva material obtained by the Review Committee between 8 and 20 October 2008, for any further comment which the Plaintiff wished to make with respect to it. The Review Committee did not take this course. 312 The requirements of procedural fairness do not demand a potentially open-ended process of disclosure by the decision maker to an interested person of material which may bear upon the decision-making process, so that comment and counter-comment can be made and considered. A practical and realistic assessment is required as to what is required to avoid practical injustice to the Plaintiff. 313 In the circumstances of this case, I am satisfied that the Review Committee ought to have disclosed the additional material which had come from Serva, for the purpose of any comment which the Plaintiff wished to make. After all, the Review Committee had considered the issue sufficiently important to make its own overseas enquires with Serva after 8 October 2008. The issue was not without its technical complexities, and fairness required a clear, accurate and complete understanding of what the Plaintiff said on the topic. This would have been a relatively limited and concise step, with the Review Committee being entitled to allow a short period for any further comment from the Plaintiff. 314 In the circumstances of this case, I am persuaded that the failure of the Review Committee to take this course with respect to the Serva material gave rise to a denial of procedural fairness in this respect.

The Plaintiff's Submissions Concerning Alleged Failure to Allow Him an Adequate Opportunity to Prepare his Case 315 As a minimum content of procedural fairness, the Plaintiff submitted that a reasonable opportunity to present a case not only requires notice that a decision will be made, but also a reasonable opportunity to prepare a case before the hearing is held. 316 The Plaintiff submitted that the entire process of the review was conducted with haste and, given that the Clinical Trial had been suspended, that haste was not justified. The Review Committee was not required by its terms of reference to report by a specified date. 317 Complaint was made by the Plaintiff concerning a number of aspects of the review, including Professor Campbell's refusal of the Plaintiff's request for the audit to be delayed to 27 October 2008. It was submitted that the period of seven to 10 days for the Plaintiff to respond to the draft report was inadequate in the circumstances of the case, in particular, given his other commitments. It was submitted that Dr Sarson's review of documentation in the DTU was carried out at short notice, so that it was of limited use to the Review Committee. 318 It was submitted that Ms Malica informed the Plaintiff for the first time in the early afternoon on 26 August 2008 that there would be two audits, with Dr Sarson to visit on 27 August 2008 and Dr McLean to visit on 28 and 29 August 2008. The Plaintiff requested more time, as did Ms Walke, but these requests were refused. 319 Complaint is made that the draft report was sent under cover of a letter dated 23 September 2008, not received by the Plaintiff until 29 September 2008, and that the letter limited the Plaintiff to the making of submissions concerning "matters of fact contained within the report". The Plaintiff requested an extension of time until 13 October 2008 for the making of a submission, but Mr Bernard allowed him until 8 October 2008. 320 The Plaintiff submitted that he does not have a special burden to discharge in relation to the question of time to prepare his case, and that he is not required to adduce particular evidence to prove that the time was inadequate. It was submitted that the Court assesses the reasonableness of the time allowed in the light of the circumstances and that, in the context of the present case, the time allowed was not reasonable.

Defendant's Submissions Concerning Alleged Failure to Allow Plaintiff an Adequate Opportunity to Prepare his Case 321 The Defendant submitted that the Plaintiff's assertion that he was not given sufficient time to prepare and present his case to the Review Committee, or the external auditors, must be evaluated against the fact that the Plaintiff, himself, had urged the Review Committee to proceed quickly. 322 The Defendant submitted that the evidence disclosed that the Plaintiff was given numerous and ample opportunities to prepare and present his case to the Review Committee from late July 2008, when he was placed on notice of the proposed terms of reference. There were requests by the Review Committee for documents on 14 and 22 August 2008, with no request for further time by the Plaintiff in this respect. A letter dated 28 August 2008 from the Plaintiff made detailed submissions on some of the classes of documents requested. The draft report of the Review Committee was provided under cover of a letter dated 23 September 2008 from Mr Bernard, and the Plaintiff made a detailed written response in a letter dated 8 October 2008. Although the Plaintiff had sought more time to respond, his letter did not claim that he had insufficient time to prepare his response. 323 The Defendant noted that the Review Committee had tried to progress the matter because the Plaintiff wished the matter to be resolved quickly. The Plaintiff's letter of 21 August 2008 to Ms Malica requested that the two external audits be conducted before 29 August 2008, and Ms Malica took steps to comply with this request. Thereafter, the Plaintiff sought a delay of the audits until late October 2008, a request refused by the Review Committee. 324 The Defendant submitted that the Plaintiff's claim that he was not given enough time to prepare for the audits must be evaluated against the fact that the purpose of the audits were to take a "snapshot" of the documents which existed at the time. The purpose of the audits was to confirm that the documents which should have been in the DTU were, in fact, there. As such, the Defendant submitted that it should not have been necessary to give the DTU lengthy time to prepare for the audits. 325 The Defendant submitted that the Plaintiff was afforded ample opportunity to prepare his case.

Decision Concerning Alleged Failure to Give Adequate Opportunity to Prepare Case 326 The onus lies upon the Plaintiff to establish that he was denied procedural fairness in the manner complained of. 327 The question is whether the Plaintiff has established that practical injustice resulted from the time frames imposed by the Review Committee. Relevant to this assessment is the Plaintiff's own request that the external audits take place before 29 August 2008. The Plaintiff altered his position in this respect, requesting a deferral until late October 2008, with the Review Committee declining this request. The Plaintiff provided documents as requested, without any application for an extension of time. There is force in the Defendant's submission that the purpose of the request for documents was the provision of a "snapshot" of documents at the relevant time. 328 It is not clear on the Plaintiff's evidence why Mr Bernard's letter enclosing the draft report sent on 23 September 2008 was not received by the Plaintiff until 29 September 2008 (T33-36, 39-40). The Plaintiff requested a period until 13 October 2008 to respond and was granted an extension until 8 October 2008. He provided a submission on 8 October 2008, without any complaint concerning the strictures of time allowed nor any request for further time to deal with any particular issue. 329 To demonstrate denial of procedural fairness of this type, more is required than a complaint that more time was sought, and should have been allowed by the decision maker, for the provision of a submission. The Plaintiff has not demonstrated how practical injustice was caused to him as a result of the times permitted, at various points between July and October 2008, for the provision of documents, material and submissions to the Review Committee. 330 I am conscious that the Serva material arising from the Review Committee's own enquiries on and after 14 October 2008 did not come to the attention of the Plaintiff until he received the final report on 20 October 2008. The non-provision of this material to the Plaintiff has given rise to an earlier finding in his favour with respect to denial of procedural fairness. However, I am not persuaded that the present ground for relief has been made good. 331 It is has not been demonstrated that the period or periods allowed by the Review Committee for the Plaintiff to take steps during the course of the review were manifestly unreasonable, or otherwise such as to constitute a denial of procedural fairness to the Plaintiff.

The Plaintiff's Complaint that the Review Committee Exceeded its Power

The Plaintiff's Submissions 332 The Plaintiff contends that the Review Committee acted in excess of its power so that its report is invalid on three bases:

(a) the Review Committee exceeded its terms of reference in that the matters on which it made findings and recommendations were beyond the terms of reference;

(b) the Review Committee failed to have regard to relevant considerations;

(c) the Review Committee had regard to irrelevant considerations. 333 The Plaintiff repeated the submissions made (at [224]-[225] above) with respect to the claim that the Review Committee exceeded its terms of reference. 334 With respect to the second and third grounds of challenge under this heading, the Plaintiff acknowledged that these must be relevant considerations which the decision maker is bound to take into account (or not to take into account) in the exercise of power and that, in order to determine which factors the decision maker is bound to take into account, it is necessary to consider the subject matter, scope and purpose of the statute: Minister for Aboriginal Affairs v Peko-Wallsend Limited (1986) 162 CLR 24 at 39-40. To determine the relevant considerations for the Review Committee, consideration should be given to the objects of the HS Act and the terms of reference. 335 The Plaintiff submitted that relevant considerations which the Review Committee was bound to take into account, but failed to take into account in this case, were that:

(a) the Premium Enzyme was used as a catalyst in the Clinical Trial to detach islet cells, but was washed out before the transplantation of the microcapsules into the participants;

(b) the GMP Enzyme was not available at the commencement of the Clinical Trial in 2005, and only became available in 2007;

(c) the GMP Enzyme, like the Premium Enzyme, is labelled "Not for Human Use" ;

(d) the GMP Enzyme and the Premium Enzyme are produced by the same company from the same non-TSE animals, and only differ in that the GMP Enzyme comes with certified traceability to those non-TSE animals;

(e) the Premium Enzyme is used by other clinical researchers preparing islets for human transplants in Europe and the United States, and is accepted for this purpose by the Federal Drug Administration in the United States; and

(f) the DTU did have informed consent of the participants about the general risk of infectious diseases contracted from the islet cells and media used to extract them in the Clinical Trial, and specified AIDS and other serious diseases as possible risks. 336 The Plaintiff submitted that irrelevant considerations which the Review Committee was bound not to take into account, but did take into account, were that:

(a) there was a risk that participants would contract TSE through the Clinical Trial, when the risk was miniscule; and

(b) there was no disclosure of the risk of TSE to the participants in the Clinical Trial, when the risk was not material, and therefore disclosure was not warranted.

The Defendant's Submissions 337 In response to this submission, the Defendant referred to the manner in which the Serva issue emerged from the Plaintiff's submission of 8 October 2008. The Defendant submitted that, to the extent that the Plaintiff now asserts that the DTU was in fact using the GMP Grade, this was contrary to what he told the Review Committee and was not a matter he had made known to the Review Committee. Each of the factors which the Plaintiff alleges the Review Committee failed to take into account, were matters he did not make known to the Review Committee at the time of the report. They are new contentions that the Plaintiff has developed subsequently, in his correspondence with the Health Care Complaints Commission. The Defendant submitted that the Court should not take account of matters which were not known to the decision maker at the relevant time. 338 The Defendant submitted that the Plaintiff had made no attempt to articulate why, as a matter of statutory construction, the Review Committee, which was concerned with issues of patient safety, was bound, in the Peko-Wallsend sense, not to consider the alleged irrelevant matters. It was submitted that the Review Committee (which had been asked to consider matters of patient safety) would be expected to take account of a risk to safety, even if it was only a slight risk. The Defendant observed, in any event, that the final report expressly acknowledged that the risk was "very small".

Decision Concerning Alleged Excess of Power by Review Committee 339 In a different context, I have already considered the Plaintiff's submission that findings and recommendations were made by the Review Committee which went beyond the terms of reference. For reasons expressed at that point in the judgment (at [300] above), I am not persuaded that the findings and recommendations of the Review Committee went beyond the terms of reference. Accordingly, I reject the first ground for relief under the present heading. 340 With respect to the second and third grounds asserting the failure to have regard to relevant factors and the taking into account of irrelevant factors, I keep in mind the limits of the test posed in Peko-Wallsend. 341 The factors that are, or are not, relevant to a decision-maker's task are to be identified primarily, perhaps entirely, by reference to the statute rather than the particular facts of the case that the decision maker is called upon to consider: Minister for Immigration and Multicultural Affairs v Yusuf [2001] 206 CLR 323 at 347-348 [73]. To invoke error of law based upon a failure to take account of relevant considerations, it is necessary to identify matters, the consideration of which is mandated by law: Saville v Health Care Complaints Commission [2006] NSWCA 298 at [55]. This ground is not to be used as a type of appeal against a finding of fact which is said to be erroneous. The essence of this ground is that the decision maker was required, in the exercise of the relevant statutory function, to have regard to certain factors, or to disregard other factors. 342 I am not satisfied that the Plaintiff has made good these grounds for relief. In my view, the Plaintiff's legitimate grievance with respect to the Serva material arises from the non-disclosure by the Review Committee, prior to provision of the final report on 20 October 2008, that communications had taken place with Serva and that certain information had been provided by Serva since 8 October 2008 which the Review Committee proposed to have regard to in its findings and recommendations. 343 I reject the Plaintiff's claim for relief based upon alleged excess of power by the Review Committee.

Plaintiff's Claim for Relief with Respect to the Acceptance Decision of Mr Clout on 21 November 2008

The Plaintiff's Submissions Concerning Claim of Apprehended Bias 344 The Plaintiff submitted that, in making the recommendation on 20 November 2008 to Mr Clout to accept the Review Committee report and recommendations, Mr Bernard did not exercise a discretion independent of Professor Ward. It was submitted that this lack of independence characterised his decision to establish the Review Committee and infected the decision to accept and implement the findings and recommendations of the Review Committee. 345 The Plaintiff submitted that, in implementing decisions already made by Professor Ward, Mr Bernard placed himself in the position of "accuser" and that, in accepting her opinions, he prejudged the matter before him. It was submitted that Mr Bernard had a personal interest in the outcome of the review because he may be seen to have failed to discharge his responsibilities for governance at PoW Hospital. 346 The Plaintiff submitted that:

(a) Professor Ward gave Mr Bernard the form of words to be used in his letter to the Plaintiff suspending the trial;

(b) Mr Bernard deferred to Professor Ward's advice as to what he should do after suspension of the Clinical Trial;

(c) Mr Bernard simply accepted Professor Ward's suggestion that Professor Campbell chair the Review Committee;

(d) in recommending acceptance by Mr Clout of the Review Committee's findings and recommendations, Mr Bernard followed a path which was predetermined by his acceptance of Professor Ward's complaint and the manner in which it should be pursued. 347 The Plaintiff relied upon the comments of Mr Bernard on the preliminary report dated 29 August 2008, which included findings of non-compliance by the Plaintiff with procedures of the HREC and Departmental policy, including the statement "It is the responsibility of researchers to know and comply with policy and legislative requirements". It was submitted that Mr Bernard sought to emphasise the role of the Plaintiff, rather than any other person in the Defendant. 348 Reliance was placed upon Mr Bernard's request for an amendment to be made to the draft report so that it be made more explicit "Why it is a COI [conflict of interest] for BT to be a manufacturer, investigator, doctor etc etc. He understands it is obvious but feels Terry Clout may not". 349 The Plaintiff submitted that, in recommending the acceptance decision to Mr Clout on 20 November 2008, Mr Bernard had a closed mind. He had taken steps already to implement the preliminary report provided to him on 29 August 2008. He had provided an action plan to Professor Ward and others, containing seven matters which matched those in the preliminary report, and had already proposed a meeting with the Plaintiff to discuss those recommendations (Exhibit A, page 493). 350 The Plaintiff submitted that, as early as 2 September 2008, Professor Ward reported that Mr Bernard had prepared a brief to Mr Clout on various matters relating to implementing the recommendations in the preliminary report, although the final report would not be delivered for some weeks. Mr Bernard had sent Mr Clout a preliminary report dated 31 August 2008 with recommendations to continue suspension of the Clinical Trial and listing other recommendations. The Plaintiff submitted that Professor Ward continued to retain control over the implementation plan, advising Mr Bernard as to its content, and that it was to be given to the Plaintiff in an interview. The Plaintiff submitted that the steps which followed after 30 August 2008 were made on a predetermined path, which also had the approval of Mr Clout. 351 The Plaintiff submitted that Mr Bernard was the key advisor to Mr Clout, so that an appearance of bias on his part would amount to an appearance of bias in Mr Clout's decision.

The Defendant's Submissions Concerning Claim of Apprehended Bias 352 The Defendant submitted that Mr Bernard cannot be regarded as an "accuser", with reliance being placed upon the narrower construction of Stollery and Ong proposed by the Defendant. 353 Further, the Defendant submitted that Mr Bernard was not the decision maker for the purpose of the acceptance decision. It was Mr Clout who made the decision to accept the findings and recommendations of the Review Committee.

Decision Concerning Claim of Apprehended Bias 354 It is the case that Mr Clout, the Chief Executive of the Defendant, made the decision on 21 November 2008 to accept the Review Committee report and to implement its recommendations. It is also the case that Mr Bernard, in the circumstances of this decision, was a key advisor to Mr Clout. It was Mr Bernard who had liaised between the Review Committee and Mr Clout with respect to this issue. 355 For reasons already expressed (at [194ff] above), I do not accept the Defendant's narrow submission with respect to the "accuser" principle in Stollery and Ong. Rather, it remains a matter for assessment, on the facts of the particular case, to determine whether a person, may be characterised appropriately as an "accuser", and whether that person has become involved in the decision-making process in a manner which gives rise to a reasonable apprehension of bias.

356 I am not persuaded that Mr Bernard acted in the role of an "accuser" with respect to the Plaintiff. Mr Bernard had an understandable role to play in the establishment of the Review Committee as a result of Professor Ward's referral of the matter to Mr Clout.

357 A more troubling feature is the process undertaken by Mr Bernard, in late August and September 2008, which had the flavour of moving towards implementation of recommendations before any submission had been received from the Plaintiff with respect to the draft report, nor any final decision made by the Review Committee, let alone by Mr Clout. At the very least, there was a significant blurring of the line which ought to have existed between the Review Committee and Mr Bernard. 358 However, I am not persuaded that this establishes prejudgment on the part of Mr Bernard, let alone an approach which, in some way, can be sheeted home to Mr Clout so as to infect his decision on 21 November 2008 to accept the Review Committee report and recommendations. 359 I reject the Plaintiff's claim for relief under this ground.

Plaintiff's Submissions Concerning Failure to Afford Hearing Before Acceptance Decision of 21 November 2008 360 The Plaintiff submitted that Mr Clout's decision of 21 November 2008 was an exercise of power under s.24 HS Act, which was subject to the principles of procedural fairness, so that he had a duty to give a hearing to the Plaintiff. 361 It was submitted that Mr Bernard's recommendation and Mr Clout's acceptance, made on 20 and 21 November 2008 respectively, were made without offering the Plaintiff a hearing. Indeed, the Plaintiff submitted these decisions had already been made. It was submitted that any reference which Mr Bernard made to communication with the Plaintiff, was for the purpose of informing him of the process of implementation of the recommendations made by the Review Committee in its preliminary report. 362 The Plaintiff submitted that the attachment of the Plaintiff's submission dated 8 October 2008, as an appendix to the final report of the Review Committee, did not provide the Plaintiff with an opportunity for a hearing before Mr Bernard and Mr Clout. The Plaintiff was not provided by Mr Bernard and Mr Clout with an opportunity to respond to the matters contained in the covering letter dated 20 October 2008 which accompanied the final report. 363 The Plaintiff submitted that the decision of the High Court of Australia in State of South Australia v O'Shea [1987] 163 CLR 378 did not assist the Defendant. The present case was not a two-stage statutory decision-making scheme. Further, the Plaintiff submitted that the decision to be made by Mr Bernard and Mr Clout was not necessarily governed by the terms of reference of the Review Committee. It was a different exercise of power, rather than a final exercise of power in one process. 364 In any event, the Plaintiff submitted that fresh material was taken into account in the form of the Serva material which had been obtained by the Review Committee between 8 and 20 October 2008. Mr Bernard and Mr Clout did not seek a response from the Plaintiff to the letter of 20 October 2008, which referred to the Serva material. 365 The Plaintiff submitted that the entire process was not fair. The Review Committee denied the Plaintiff procedural fairness.

Defendant's Submission Concerning Failure to Afford Hearing Before Acceptance Decision of 21 November 2008 366 The Defendant submitted that the Plaintiff had been given a proper opportunity to be heard before Mr Clout's decision of 21 November 2008 by the opportunity provided to him to comment on the draft report of the Review Committee. The Plaintiff's submission of 8 October 2008 was annexed to the final report of the Review Committee, and was before Mr Clout for the purpose of his decision of 21 November 2008. 367 The Defendant submitted that this was a multi-stage process, not uncommon in administrative decision making. It was submitted that the investigation process was split from the decision-making process, with the Review Committee undertaking the former function by means of a fact-finding exercise and the issue of a report with findings and recommendations. It was the subsequent decision of Mr Clout to adopt and implement the report and recommendations which was the operative decision. The Defendant submitted that it was necessary to consider the decision-making process in its entirety: Ainsworth v Criminal Justice Commission (1992) 175 CLR 564 at 578. 368 The Defendant relied upon State of South Australia v O'Shea and submitted that the decision-making process as a whole had afforded the Plaintiff procedural fairness, so that it was not necessary for Mr Bernard and Mr Clout to provide him with a further opportunity to be heard. The hearing before the Review Committee had provided a sufficient opportunity for the Plaintiff to present his case so that the decision-making process, viewed in its entirety entailed procedural fairness: State of South Australia v O'Shea at 389.

Decision Concerning Failure to Afford Hearing Before Acceptance Decision of 21 November 2008 369 I accept that the principles explained in State of South Australia v O'Shea may extend to a multi-stage decision-making process, even where that process is not part of a statutory scheme. A sequential approach to administrative decision making may be a practical and sensible approach in a given case. 370 What remains necessary, however, is that a fair hearing is afforded to a person as part of such a decision-making process. In the present case, the Review Committee had obtained the Serva material between 8 and 20 October 2008 and had relied upon this material in a manner adverse to the Plaintiff in the final report. The Review Committee did not provide this material to the Plaintiff before 20 October 2008. 371 In State of South Australia v O'Shea, it was made plain that, in a two-stage decision-making process, where the second and final stage involves some new matter which a party has not had an opportunity to deal with, or where additional material had been gathered or new facts had emerged after the first hearing, then procedural fairness required that the final decision maker give a hearing: State of South Australia v O'Shea at 389, 403, 410, 412. 372 In circumstances where the Serva material had not been provided to the Plaintiff by the Review Committee, the requirements of procedural fairness called for Mr Bernard and Mr Clout to ensure that the Plaintiff had an opportunity to respond to the Serva material, before a decision was made whether or not to accept the report and recommendations of the Review Committee. 373 It was the case that the Plaintiff had knowledge that material had been obtained from Serva, given the reference to this in the letter of 20 October 2008 which was furnished to him. However, Mr Bernard and Mr Clout did not provide him with the primary material (including the email communications with Serva), nor extend to him at all an opportunity to respond by reference to the material that had been in the hands of the Review Committee as at 20 October 2008. 374 In the circumstances of this case, I am satisfied that the Plaintiff was denied procedural fairness in this respect, so that this ground of challenge has been made good.

Plaintiff's Claim Based Upon Failure to Afford a Hearing Before the Review Committee Report and Recommendations and the Acceptance Decision Were Notified to the University of New South Wales and the New South Wales Medical Board

The Plaintiff's Submissions 375 The Plaintiff submitted that procedural fairness required that, before a decision maker released to another agency material which was adverse to the interests of an individual, including by exposing that individual to a new hazard or prejudice, the individual ought be afforded a hearing on that proposed course: Ainsworth v Criminal Justice Commission; Johns v Australian Securities Commission (1993) 178 CLR 408; Consolidated Press Holdings Limited v Federal Commissioner of Taxation (1995) 57 FCR 348. 376 It was submitted that the Defendant had a duty to give the Plaintiff a hearing before it disclosed the Review Committee report to other persons or agencies. If disclosure by the Defendant was made to the New South Wales Medical Board under s.117A HS Act, the Plaintiff submitted that this provision did not exclude procedural fairness in the performance of that duty. It was submitted that the Plaintiff had a legitimate expectation that he would be informed, prior to the commencement of the review of the potential outcomes, including that if the report contained any adverse findings, the Defendant would send it to other agencies. 377 The Plaintiff submitted that Mr Clout's letter of 28 November 2008 to the New South Wales Medical Board, which enclosed a copy of the Review Committee report, seriously misstated the findings of the Review Committee. Not unexpectedly, the Plaintiff submitted, the New South Wales Medical Board referred Mr Clout's letter to the Health Care Complaints Commission, which in turn wrote to the Plaintiff on 5 January 2009 requesting a response to issues raised by the report. 378 Further, Mr Clout wrote to the University of New South Wales on 21 November 2008. The Plaintiff only became aware of this action when he received a letter dated 1 December 2008 from Professor Field, advising that the matters in the Review Committee report could form the basis for a finding of a prima facie case of research misconduct. 379 The Plaintiff noted that Mr Clout did not inform the Plaintiff of these actions until a letter was sent on 9 December 2008, well after the notifications had been given to third parties. 380 The Plaintiff submitted that the Defendant had denied the Plaintiff procedural fairness by sending the report to the University of New South Wales and to the New South Wales Medical Board, and indirectly to the Health Care Complaints Commission, without first giving him a hearing as to that proposed course. 381 The Plaintiff also emphasised that emails which had come to light, in preparation for the hearing in this Court, revealed that Professor Campbell had already sent successive drafts of the Review Committee report to Ms Kirby seeking her comments, which were provided. On 17 September 2008, Ms Kirby conveyed to Professor Campbell her concern that the Review Committee did not appear to be giving the Plaintiff a fair hearing and gave advice on how that might be done (see [101] above). 382 The Plaintiff also noted that, on 25 October 2008, Professor Ward pressed Mr Bernard to send the final report to Professor Field, Professor Henry and Professor Peter Smith at the University of New South Wales (Exhibit A, pages 702a-702b). Mr Bernard said he was happy to do so once Mr Clout had agreed to the action plan (Exhibit A, page 702a). Professor Campbell protested that this placed him in an awkward position (Exhibit A, page 702a). Mr Bernard relented and agreed to the Review Committee report being provided to the three individuals at the University of New South Wales (Exhibit A, page 702a). Mr Bernard himself provided a copy to the three University persons on 21 November 2008, the day upon which Mr Clout signed the action plan, noting that he had himself previously sent copies to the University of New South Wales (Exhibit A, page 715a). 383 The Plaintiff submitted that the decision to release the report affected the Plaintiff's reputation, and there was an implied entitlement to be heard before this step was taken: Johns v Australian Securities Commission at 470-472.

The Defendant's Submissions 384 The Defendant observed that Mr Clout's letter of 28 November 2008, forwarding a copy of the final report to the New South Wales Medical Board, involved him being merely a conduit of information, and that no new finding had been added to the final report. It was submitted that Mr Clout was bound to so act under s.117A HS Act. 385 In addition, the Defendant pointed to Mr Bernard's letter of 21 November 2008 (at [129]-[130] above) which enclosed an action plan foreshadowing disclosure to the University of New South Wales and other agencies. 386 The Defendant submitted that the Plaintiff had been afforded a fair hearing before the Review Committee, and that a further hearing was not required before the report was further disseminated by the Defendant. It was submitted that no guarantee had been provided to the Plaintiff that the final report would not be made known to others, and that he could not have a legitimate expectation that he would be consulted before the final report was circulated. 387 The Defendant sought to distinguish Consolidated Press Holdings Limited v Federal Commissioner of Taxation upon the basis that there were statutory guarantees of secrecy, which bore upon the question whether a person had a legitimate expectation that he would be consulted, before papers he had submitted to the Australian Taxation Office would be provided to an external expert for comment. Likewise, the Defendant submitted Johns v Australian Securities Commission ought be distinguished, as the case involved disclosure of a transcript of evidence before the Australian Securities Commission, with a statutory secrecy provision having some application.

Decision 388 The appropriate starting point is clause 2.1.3 of the terms of reference (see [51] above), which expressly required advice from the Review Committee as to who should be informed of the findings of the review. The draft report and final report did not address this question. Although the prospect of dissemination of the report to a third party was envisaged in the terms of reference, it was not referred to by the Review Committee. The draft report which was furnished to the Plaintiff did not contain any recommended course in this respect, to which the Plaintiff would have had an opportunity to respond. 389 In these circumstances, it seems to me that the Plaintiff had a legitimate expectation that he would be given an opportunity to be heard, before the final report and recommendations of the Review Committee was provided to any third party. 390 Mr Bernard's letter of 21 November 2008 to the Plaintiff revealed that disclosure of the report was to occur. However, Mr Clout had already decided this should happen, without hearing the Plaintiff on the issue. Mr Clout took this decision even though the Review Committee had not addressed clause 2.1.3 of the terms of reference. By the time the Plaintiff received Mr Bernard's letter, the University of New South Wales had been provided with the report. 391 Mr Bernard's letter of 21 November 2008 did not foreshadow provision of the report to the New South Wales Medical Board. The Plaintiff was informed that this had happened after it had occurred. 392 The evidence reveals that the final report and recommendations were furnished to the New South Wales Medical Board and the University of New South Wales without prior notice to the Plaintiff. 393 That the final report and recommendations of the Review Committee had a capacity to cause significant harm to the reputation and professional standing of the Plaintiff was borne out by the prompt response of both external agencies to whom disclosure had occurred. The New South Wales Medical Board referred the matter to the Health Care Complaints Commission for investigation of the Plaintiff's conduct for professional disciplinary purposes. The University of New South Wales raised the question as to whether the Plaintiff had engaged in research misconduct. 394 I accept that s.117A HS Act required the Defendant to provide the report and recommendations to the New South Wales Medical Board. This is a clear demonstration that what might have started as an investigation into governance issues had become, along the way, a process that made findings and recommendations suggesting professional misconduct or unsatisfactory professional conduct on the Plaintiff's part. 395 I accept the Plaintiff's submission that s.117A does not exclude the requirement to afford procedural fairness to the Plaintiff in the circumstances of this case, where he had a legitimate expectation that he would have an opportunity to make submissions before the report and recommendations were disclosed to any third party. There may, of course, be cases where s.117A disclosure may be appropriate without notice to the affected person to protect the integrity of any investigatory process. However, that is not this case. The Plaintiff had a clear and legitimate expectation that he would be heard before disclosure of the report to a body such as the New South Wales Medical Board, and he was not afforded that opportunity. 396 Although there was no statutory guarantee of secrecy applicable here, the principles considered by Lockhart J in Consolidated Press Holdings Limited v Commissioner of Taxation at 355 assist the Plaintiff. A legitimate and reasonable expectation arose in the present case from the features to which I have referred. 397 A decision to release the report and recommendations of the Review Committee had the potential (at the very least) to prejudice the Plaintiff's interests, in that it was likely to affect perceptions of his integrity and injure his reputation: Johns v Australian Securities Commission at 470-471. 398 Practical injustice has resulted in this case from the failure of the Defendant to afford the Plaintiff an opportunity to be heard before disclosing the Review Committee report and recommendations to third parties. 399 In my view, this was a clear case, arising from the terms of reference and the circumstances of the matter generally, where the Plaintiff was entitled to be heard before disclosure of the report and recommendation occurred. This did not occur, and a denial of procedural fairness has resulted. 400 The Plaintiff has made good this ground for relief. 401 Before leaving this ground, I observe that the fact that the draft report was provided to Ms Kirby, who provided advice to Professor Campbell on 17 September 2008 concerning the need for the Plaintiff to be given a chance to respond, is somewhat puzzling. The Review Committee was functioning under the statutory umbrella of the HS Act, on behalf of Mr Clout, as Chief Executive of the Defendant. The provision of the draft report to the University solicitor appears to have been irregular. It might be expected that any legal advice ought to have been provided by the Defendant, or its legal advisor.

Relief 402 The Plaintiff seeks relief in the nature of certiorari quashing the report and recommendations of the Review Committee and the acceptance decision of Mr Clout of 21 November 2008. In addition, the Plaintiff seeks declarations that the Review Committee denied the Plaintiff procedural fairness, and that the Defendant denied the Plaintiff procedural fairness by Mr Clout's acceptance decision of 21 November 2008, and the notification to the New South Wales Medical Board and the University of New South Wales of the Review Committee report and recommendations.

Submissions of Parties 403 In the event that the Plaintiff established a basis for relief, the Defendant submitted that an order in the nature of certiorari was not available to quash the report and recommendations of the Review Committee, as that report had no legal effect in and of itself. Reliance was placed upon Ainsworth v Criminal Justice Commission at 580-581 and 595; R v Collins; Ex parte ACTU Solo Enterprises Pty Limited (1976) 8 ALR 691 at 699; Greiner v Independent Commission Against Corruption (1992) 28 NSWLR 125 at 148; Hot Holdings Pty Limited v Creasy (1996) 185 CLR 149 at 159, 165, 174; Police Integrity Commission v Shaw (2006) 66 NSWLR 446 at 462 [65] and [67] and Cox v Corruption and Crime Commission [2008] WASC 199 at [85]. 404 The Defendant submitted that, insofar as the decision in Hot Holdings Pty Limited v Creasy may support the availability of relief in the nature of certiorari, that case may be distinguished in the circumstances of this case. The Defendant submitted that Mr Clout was not bound to take account of the Review Committee's final report. Whilst Mr Bernard had constituted the Review Committee in order to make findings of fact and recommendations which could be taken into account by the Executive in determining its approach, there was nothing, as a matter of statute or common law, which obliged Mr Clout to take those findings or recommendations into account. Accordingly, the Defendant submitted, the Review Committee's final report was not a precondition to the Chief Executive's exercise of power, and thus relief in the nature of certiorari was not available to quash the report. 405 The Defendant accepted that declaratory relief would be available in these circumstances, in accordance with the principles in Ainsworth v Criminal Justice Commission. 406 The Plaintiff submitted that relief in the nature of certiorari was available in this case, in addition to declaratory relief. 407 It was submitted that the Executive of HREC referred the matter to Mr Bernard, with the recommendation that it ought be dealt with by a small committee established to review it. Mr Bernard agreed to do so. The Review Committee was established pursuant to Mr Clout's power under s.29B HS Act. Mr Clout delegated power to the Review Committee to making findings and recommendations to Mr Bernard, on the basis of which he would give advice to Mr Clout. The Plaintiff submitted that, impliedly, the Review Committee had power to determine the matters contained in its terms of reference, and was confined by those terms of reference. 408 The Plaintiff submitted that Hot Holdings Pty Limited v Creasy supported the availability of relief in the nature of certiorari in this case. It was submitted that other decisions to which the Defendant referred did not assist on this point, and that the question fell to be determined by reference to the principles in Hot Holdings Pty Limited v Creasy.

Decision 409 I have found that the Plaintiff was denied procedural fairness in a number of respects, in the processes under consideration in these proceedings. 410 It has been observed that a decision made contrary to procedural fairness is void, although it may have some effect or existence in law until declared void by a competent body or court: Calvin v Carr [1979] 1 NSWLR 1 at 8; Ong at 118, 140. 411 I consider that Hot Holdings Pty Limited v Creasy supports the Plaintiff's submissions in this case. The Court must ask whether the report or recommendations operate as a precondition, or as a bar to a course of action, or as a step in a process capable of altering rights, interests or liabilities: Hot Holdings Pty Limited v Creasy at 162. The critical question is whether the ultimate decision maker may lawfully ignore the recommendations, or whether he is obliged to take them into account. A preliminary decision or recommendation, if it is one to which regard must be paid by the final decision maker, will have the requisite legal effect upon rights to attract certiorari: Hot Holdings Pty Limited v Creasy at 165. 412 I accept the Plaintiff's submission that Mr Clout, as the Chief Executive of the Defendant, had a legal obligation to take into account the report and recommendations made by the Review Committee. The Review Committee was not analogous to a corruption investigation tribunal or royal commission, whose recommendations could be ignored by the Executive Branch. Rather, the Review Committee had been established by Mr Clout in the exercise of his power under s.29B HS Act. Having established a Review Committee, and provided it with its terms of reference, Mr Clout was bound to take into account its report and recommendations, as a relevant consideration in the sense described in Peko-Wallsend and the authorities referred to at [341] above. If he ignored the report and recommendations of the Review Committee, Mr Clout would fail to take into account a relevant consideration which he was bound to take into account. I accept the Plaintiff's submission that this kind of legal obligation, derived from Peko-Wallsend and construction of the HS Act, is precisely the kind of legal obligation which the majority had in mind in Hot Holdings Pty Limited v Creasy at 173-175. 413 I do not consider that the other authorities relied upon by the Defendant assist the resolution of this question, in the factual circumstances of this case and the statutory scheme arising under the HS Act. 414 Accordingly, I am satisfied that relief in the nature of certiorari is available in the circumstances of this case. The Review Committee report had the requisite legal effect upon the Plaintiff's rights to attract certiorari. The decision of Mr Clout on 21 November 2008 to accept the Review Committee's report and to implement its recommendations was the ultimate and operative decision which affected the Plaintiff's rights directly. It had the requisite legal effect upon the Plaintiff's rights so as to attract certiorari. 415 Relief in the nature of certiorari and declaratory relief are discretionary remedies. It is neither possible nor desirable to fetter the power to grant declaratory relief by laying down rules as to the manner of its exercise: Ainsworth v Criminal Justice Commission at 581-582. 416 The Plaintiff has established a foundation for the grant of relief in the nature of certiorari and declaratory relief. I do not consider that there is any proper discretionary basis for declining to grant the Plaintiff such relief.

Conclusions and Orders 417 The Plaintiff sought relief in this Court upon a variety of grounds arising from the Defendant's processes, by which he was affected between April and December 2008. He has succeeded in his claim for relief on some grounds, but not others. 418 Put shortly, the Plaintiff has demonstrated an entitlement to relief upon the grounds that:

(a) there was a reasonable apprehension of bias arising from the involvement of Professor Robyn Ward in the establishment and decision-making process of the Review Committee, in circumstances where she was the instigator of that process and an "accuser" of the Plaintiff;

(b) there was a reasonable apprehension of bias by prejudgment, in that an independent observer might reasonably apprehend that Professor Terry Campbell might not be open to persuasion on the issues for decision by the Review Committee;

(c) there was a denial of procedural fairness by the Review Committee, as a result of its failure to disclose to the Plaintiff, before issuing its final report and recommendations, the Serva material which had been obtained by the Review Committee between 8 and 20 October 2008;

(d) there was a denial of procedural fairness by Mr Bernard and Mr Clout, in failing to provide the Plaintiff with the Serva material, and an opportunity to respond to it, before a decision was made on 21 November 2008 to accept the findings and recommendations of the Review Committee;

(e) there was a denial of procedural fairness by Mr Bernard and Mr Clout, as a result of the failure to give the Plaintiff a hearing before deciding to disclose to the New South Wales Medical Board and the University of New South Wales, the final report and recommendations of the Review Committee and Mr Clout's decision to accept those findings and recommendations. 419 At the beginning of this judgment (at [2]), I said that it is important to observe what is, and what is not, determined in these proceedings. The issues raised in this case concern administrative processes undertaken with respect to the Plaintiff, and determination of his complaint that these processes did not comply with the requirements of the law. These proceedings do not address the medical and scientific merits of the Plaintiff's research concerning diabetes, nor the efficacy of that research. 420 I have determined, however, that there were significant shortcomings in the processes adopted by the Defendant with respect to the Plaintiff in 2008, with a consequence that practical injustice has resulted. The Plaintiff contended that reasonable apprehension of bias had been demonstrated at several points in the process, and I have upheld that submission in various respects. None of those involved in the Review Committee, in its establishment and in the decision to accept its report and recommendations and to disseminate its findings, gave evidence in the proceedings before me. For the purpose of determining the Plaintiff's claim for relief, I was not required to make a finding, nor have I made a finding, that any person acted with malice or impropriety directed towards the Plaintiff. The findings which I have made arise from application of the principles of administrative law and, in particular, the reasonable observer test, to the processes affecting the Plaintiff in 2008. 421 I am satisfied that it is open to the Court to grant relief in the nature of certiorari together with declaratory relief, in the circumstances of this case. 422 With respect to costs, the Plaintiff has succeeded substantially in his claim for relief upon a number of grounds. However, many grounds were pressed and several were rejected. In all the circumstances, I have in mind ordering the Defendant to pay 80% of the Plaintiff's costs of the proceedings. However, as the question of costs was not the subject of argument at the hearing, if either party wishes to make application for a different costs order on application to my Associate within seven days, I will vacate the order for costs and make such orders as I consider appropriate, after considering such submissions as the parties wish to make on the question of costs. 423 I make the following orders and declarations:

(a) I declare that in making the report and recommendations made on 20 October 2008 ("the Review Committee Report") by the Diabetes Transplant Unit Review Committee appointed by the Defendant pursuant to ss.24 and 29B Health Services Act 1997 ("the Review Committee"), the Review Committee of the Defendant denied the Plaintiff procedural fairness;

(b) I make an order in the nature of certiorari quashing the Review Committee Report;

(c) I declare that the decision of Mr Terry Clout, the Chief Executive of the Defendant on 21 November 2008 to accept the Review Committee Report and to implement its recommendations ("the Acceptance Decision") denied the Plaintiff procedural fairness;

(d) I make an order in the nature of certiorari quashing the Acceptance Decision;

(e) I declare that, in notifying in November and December 2008 the University of New South Wales and the New South Wales Medical Board of the Review Committee Report and the Acceptance Decision, the Defendant denied the Plaintiff procedural fairness;

(f) the Defendant is to pay 80% of the Plaintiff's costs of the proceedings;

(g) the order for costs may be vacated on application made by either party to my Associate within seven days, in the event of which I will determine the appropriate procedure for taking submissions from the parties on the question of costs.

08/12/2009 - Incorrect case name. - Paragraph(s) 387

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