Raven v The University of Sydney

NCAT Administrative and Equal Opportunity|2015-03-02

r of the Ethics Committee and the expert reviewers, and with the exception of the journal articles at Tab 3, 3. paragraphs 7, 8 and 10 and the first sentence of paragraph 9 in Exhibits R4(a) and (b), 4. Exhibit R7.

REASONS FOR DECISION

The applicant seeks access, under the Government Information (Public Access) Act 2009 (NSW) ("GIPA Act"), to information in documents held by the University of Sydney ("University"). This information is contained in an ethics application for research involving human participants and associated documents. The applicant, who is an academic, is seeking the information due to her concerns about a clinical trial which the University approved and, in particular, her concerns about the use of the antidepressant, sertraline, in the trial.

RELEVANT LEGISLATION

The object of the GIPA Act is to "is to open government information to the public" in stated ways "[i]n order to maintain and advance a system of responsible and representative democratic Government that is open, accountable, fair and effective" (GIPA Act, s 3(1)).
The GIPA Act establishes a presumption in favour of the disclosure of government information unless there is an overriding public interest against disclosure (s 5).
A person who makes an access application for government information has a legally enforceable right to be provided with access to the information unless there is an overriding public interest against disclosure of the information (GIPA Act, s 9(1)).
There is a general public interest in favour of the disclosure of government information (GIPA Act, s 12(1)). There is an overriding public interest against disclosure of government information if (and only if) there are public interest considerations against disclosure and, on balance, those considerations outweigh the public interest considerations in favour of disclosure (GIPA Act, s 13).
The public interest considerations listed in the table to s 14 are the only considerations, where Schedule 1 does not apply, that may be taken into account as public interest considerations against disclosure for the purpose of determining whether there is an overriding public interest against disclosure of government information (GIPA Act, s 14(2)).
The University relies on the following public interest considerations in the table referred to in s 14(2): "1 Responsible and effective government There is a public interest consideration against disclosure of information if disclosure of the information could reasonably be expected to have one or more of the following effects (whether in a particular case or generally): … (d) prejudice the supply to an agency of confidential information that facilitates the effective exercise of that agency's functions, (e) reveal a deliberation or consultation conducted, or an opinion, advice or recommendation given, in such a way as to prejudice a deliberative process of government or an agency, (f) prejudice the effective exercise by an agency of the agency's functions, (g) found an action against an agency for breach of confidence or otherwise result in the disclosure of information provided to an agency in confidence, … 4 Business interests of agencies and other persons There is a public interest consideration against disclosure of information if disclosure of the information could reasonably be expected to have one or more of the following effects: (a) undermine competitive neutrality in connection with any functions of an agency in respect of which it competes with any person or otherwise place an agency at a competitive advantage or disadvantage in any market, … (e) prejudice the conduct, effectiveness or integrity of any research by revealing its purpose, conduct or results (whether or not commenced and whether or not completed)."
Section 15 sets out the principles that are to be applied when determining whether there is an overriding public interest against disclosure. That section provides as follows: "15 Principles that apply to public interest determination A determination as to whether there is an overriding public interest against disclosure of government information is to be made in accordance with the following principles: (a) Agencies must exercise their functions so as to promote the object of this Act. (b) Agencies must have regard to any relevant guidelines issued by the Information Commissioner. (c) The fact that disclosure of information might cause embarrassment to, or a loss of confidence in, the Government is irrelevant and must not be taken into account. (d) The fact that disclosure of information might be misinterpreted or misunderstood by any person is irrelevant and must not be taken into account. (e) In the case of disclosure in response to an access application, it is relevant to consider that disclosure cannot be made subject to any conditions on the use or disclosure of information."
The GIPA Act also provides that "personal factors" of the application may be taken into account in some circumstances. Section 55 relevantly provides: "55 Consideration of personal factors of application (1) In determining whether there is an overriding public interest against disclosure of information in response to an access application, an agency is entitled to take the following factors (the personal factors of the application) into account as provided by this section: the applicant's identity and relationship with any other person, the applicant's motives for making the access application, any other factors particular to the applicant. (2) The personal factors of the application can also be taken into account as factors in favour of providing the applicant with access to the information. (3) The personal factors of the application can be taken into account as factors against providing access if (and only to the extent that) those factors are relevant to the agency's consideration of whether the disclosure of the information concerned could reasonably be expected to have any of the effects referred to in clauses 2-5 (but not clause 1, 6 or 7) of the Table to section 14."
In proceedings to review a decision made under the GIPA Act to refuse access to government information in response to an access application, the burden of establishing that the decision is justified lies on the agency (being, in this case, the University): GIPA Act, s 105(1).
The Tribunal's function on review under s 63 of the Administrative Decisions Review Act 1997 (NSW) is to decide what the correct and preferable decision is having regard to the material before it, including any relevant factual material and any applicable written or unwritten law.

CONFIDENTIALITY ORDERS

The University filed confidential evidence. A substantial amount of this evidence was the information sought by the applicant in these proceedings to which the University had refused access. In addition, the University redacted some material in the statement of one of its witnesses, Professor Sharon Naismith. It provided the redacted material to the Tribunal but not to the applicant.
Section 107(3) of the GIPA Act provides: "On an NCAT administrative review, NCAT must, on the application of the Minister administering this Act or the agency, receive evidence and hear argument in the absence of: (a) the public and the applicant, and (b) the applicant's representative if NCAT is of the opinion that it is necessary to do so to prevent the disclosure of information for which there is, or for which there could be or is claimed to be, an overriding public interest against disclosure."
The University applied to the Tribunal for an order that it receive some evidence and hear some of the University's argument in the absence of the public and the applicant. I formed the opinion that it was necessary to do this to prevent the disclosure of information for which there is, or for which there could be or is claimed to be, an overriding public interest against disclosure. Accordingly, the Tribunal conducted part of the hearing in the absence of the public and the applicant, pursuant to s 107(3) of the GIPA Act.
I was also satisfied that it was desirable to make an order, by reason of the confidential nature of the evidence and other material, prohibiting or restricting the disclosure to the applicant of some of the evidence given before the Tribunal, and of the contents of some documents lodged with the Tribunal or received in evidence by the Tribunal. I ordered, pursuant to s 64(1)(d) of the Civil and Administrative Tribunal Act, that the disclosure to the applicant of the following be prohibited: 1. evidence and other material in the confidential session, 2. Exhibit R5 (comprising most of the information sought by the applicant) with the exception of tabs 9, 12 and 13, other than the names of the chair of the Ethics Committee and the expert reviewers (that is, those names are to be redacted), 3. paragraphs 7,8 and 10 and the first sentence of paragraph 9 in Exhibits R4(a) and (b) (being the statement of Professor Naismith), 4. Exhibits R6 and R7 (being, respectively, the "Preliminary Response to Beyond Ageing Complaint" and minutes of HREC meetings).
I also made an order at the hearing prohibiting publication of the transcript of confidential sessions pursuant to s 64(1)(c) of the Civil and Administrative Tribunal Act.
Following the hearing, the respondent reconsidered, at the Tribunal's direction, whether to disclose Exhibit R6 and the journal articles at Tab 3 of Exhibit R5 to the applicant, and decided to do so. Accordingly, I vary the orders above so that they do not apply to Exhibit R6 and the journal articles at Tab 3 of Exhibit R5. I also make an order pursuant to s 64(1)(c) of the Civil and Administrative Tribunal Act prohibiting publication of the material which is now subject to a non-disclosure order under s 64(1)(d).

PUBLIC INTEREST CONSIDERATIONS IN FAVOUR OF DISCLOSURE

The applicant relied upon the general public interest in favour of disclosure referred to in s 12(1) of the GIPA Act, and on two of the examples of public interest considerations in favour of disclosure following s 12(2). Those examples are: "(a) Disclosure of the information could reasonably be expected to promote open discussion of public affairs, enhance Government accountability or contribute to positive and informed debate on issues of public importance. … (e) Disclosure of the information could reasonably be expected to reveal or substantiate that an agency (or a member of an agency) has engaged in misconduct or negligent, improper or unlawful conduct."
In relation to the example in (a), the applicant submitted that the information she sought could reasonably be expected to enhance the University's accountability in relation to clinical trials and research more broadly, firstly by requiring researchers to provide detailed evidence-based justifications of their research involving human participants, and secondly by requiring the HREC to provide detailed justifications of its decisions regarding the complaint made by the applicant and her colleagues, including disclosure of the evidence used by reviewers. She also submitted that disclosure of the information requested could reasonably be expected to contribute to positive and informed debate about research and about the use of antidepressants.
The University acknowledged that there is a public interest in disclosing information that facilitates public scrutiny of research proposals and promotes transparency in University decision making. It submitted, however, that researchers are already required to provide detailed evidence-based justifications of their research to the HREC and that the appropriate time for debate about research is following the publication of peer-reviewed research results, not at the clinical trial phase.
I accept that there is a public interest in the disclosure of the information the applicant has sought concerning the clinical trial, because it could reasonably be expected to promote open discussion of public affairs, enhance Government accountability and contribute to positive and informed debate on issues of public importance. Such issues include the use of anti-depressants in a clinical trial. Disclosure of the information sought would not necessarily require researchers to provide evidence-based justifications of their research, or require the HREC to provide justifications of its decisions regarding the applicant's complaint. However, disclosure of the information could reasonably be expected to enhance the accountability of the HREC and the University (being, in this context, the Government: see GIPA Act, Sch 4, cl 7).
In relation to the example in (e), the applicant contended that the Beyond Ageing trial was not compliant with the National Statement and that it should not have been approved by the HREC. She said that she had formed this view because the University had revised the participant information sheet and follow up protocol after her complaint, implying that these were not initially ethically adequate, and also because the University refused to disclose the evidence on which its decisions were based, suggesting that that evidence would not stand up to scrutiny.
The applicant submitted that there were two matters in which the University, through the HREC, may have been negligent: first, in approving a clinical trial that did not meet the National Statement and secondly in allowing the trial to continue without an appropriate evidence base, particularly regarding the potential harms of sertraline use and abrupt cessation.
The applicant expressed concern that there was inadequate monitoring of trial participants once they stopped taking sertraline, saying that the nature and scope of adverse withdrawal effects documented in the medical literature indicated that more was needed. She reported that a letter she had received from the Manager of Human Ethics said that the reviewers considered abrupt cessation to be "common practice." The applicant also said she had not had a response to her query, made to the University, about whether the reviewers had cited any evidence-based academic references to support their claim about the safety of abrupt cessation.
As the University submitted, it is not the Tribunal's role to determine the merits of the clinical trial or to determine whether the HREC's approval of the clinical trial constituted a breach of the National Statement. In any event, the applicant has not provided evidence which would establish that the University has been negligent or which would allow the Tribunal to conclude that the information could reasonably be expected to reveal or substantiate her allegations. Nor is there evidence from which the Tribunal could conclude that the HREC's approval of the trial constituted a breach of the National Statement. This is not to suggest that expert evidence on this issue would have been helpful or desirable; proceedings under the GIPA Act, like those under the former Freedom of Information Act 1989 (NSW), should not be used "as a vehicle for the collateral review of the merits or validity of official action" (Crewdson v Central Sydney Area Health Service [2002] NSWCA 345 at [24]).
The applicant's allegations, and those she and four of her colleagues made in their complaint to the University, are relevant insofar as they indicate that academics with collective expertise in ethics, psychiatry, medicine, psychology and epidemiology, all of whom have doctoral qualifications, have concerns about ethical and methodological aspects of the trial. One of those concerns is the abrupt and potentially harmful cessation of sertraline. This in itself indicates that there is a public interest in favour of disclosure of information relating to the trial, as this would allow the safety or otherwise of the trial to be subject to greater academic and possibly public scrutiny, and would also facilitate public debate about ethical and methodological aspects of the trial.
It is not, of course, necessary to frame a public interest consideration in favour of disclosure in terms of the examples in s 12 of the GIPA Act. These examples do not form part of the Act and are guides only: Interpretation Act 1987 (NSW), s 35(2); GIPA Act, Sch 4, cl 14. It is in the public interest that any risks and deficiencies associated with the trial be exposed, and that the ethics application and associated documents be accessible to potential critics and others, so that informed debate about the trial may occur, and so that the HREC's conduct is subject to scrutiny. Without considering whether disclosure of the information sought could reasonably be expected to reveal that the University has engaged in negligent or improper conduct, the Tribunal may nevertheless recognise the public interest in facilitating debate about the nature of the University's conduct and the safety of the trials it approves.

PUBLIC INTEREST CONSIDERATIONS AGAINST DISCLOSURE

The considerations on which the University relies in the present case require a determination about whether disclosure "could reasonably be expected" to have the effects prescribed in one or more of the paragraphs in the various clauses in the table to s 14. These words are to be given their ordinary meaning. They "require a judgment to be made by the decision-maker as to whether it is reasonable, as distinct from something that is irrational, absurd or ridiculous, to expect that" disclosure would have the relevant effect: Attorney-General's Department v Cockcroft (1986) 10 FCR 180; Nature Conservation Council of NSW v Department of Trade and Investment Regional Infrastructure and Services [2012] NSWADT 195 at [146]; Salmon v Department of Justice (Corrective Services New South Wales) [2014] NSWCATAD 160 at [45].

Prejudice the supply of confidential information (clause 1(d))

The University claims that there is a public interest consideration against disclosure of the information sought in that its disclosure could reasonably be expected to prejudice the supply to the University of confidential information that facilitates the effective exercise of its functions (GIPA Act, s 14, table, clause 1(d)).
In Commissioner of Police NSW Police Force v Camilleri [2012] NSWADTAP 19 ("Camilleri") at [27] and [29], the Appeal Panel of the ADT observed that the approach to be taken to clause 1(d) to the table to s 14 in the GIPA Act is similar to that taken to a similarly-worded provision in cl 13(b)(ii) of Sch 1 to the (repealed) Freedom of Information Act. It quoted (at [28]) from an earlier decision of the ADT Appeal Panel in Director General, Department of Education & Training v Mullett [2002] NSWADTAP 13 at [58] which considered that clause: "58 In our view cl 13(b)(ii) requires the Tribunal to engage in a relatively abstract analysis. It must ask whether material of the kind sought to be protected on the present occasion would, if released, prejudice the supply of similar material to government in the future, as a matter of reasonable expectation. That requires the Tribunal to characterise the nature of the material sought to be protected on the present occasion; to identify the extent to which material of that kind can only be obtained, or can only reasonably be obtained, by confidential communication; the extent to which guarantees of confidentiality may be necessary."
Similar comments were made by the ADT Appeal Panel in Macquarie University v Howell (No 2) [2009] NSWADTAP 19 at [10].
The respondent relied upon the Appeal Panel's comments concerning the analysis the Tribunal must undertake as being "abstract". The "relatively abstract" nature of the Tribunal's analysis does not mean that the Tribunal may proceed upon mere speculation. There must be some evidentiary basis from which the Tribunal may infer that disclosure of the information sought could reasonably be expected to prejudice the supply to an agency of confidential information. It is not sufficient for the respondent to make an assertion that this is the case: cf Hynes v General Manager, Hawkesbury City Council [2004] NSWADT 135, at [123].
In Manly v Ministry of Premier and Cabinet (1995) 14 WAR 550, Owen J of the Western Australian Supreme Court considered that the decision maker, under Western Australian freedom of information legislation, was required to have probative material to support a view, required under that statute, that disclosure of matter could reasonably be expected to prejudice the future supply of confidential information. His Honour remarked: "How can the Commissioner, charged with the statutory responsibility to decide on the correctness or otherwise of a claim to exemption, decide the matter in the absence of some probative material against which to assess the conclusion of the original decision maker that he or she had 'real and substantial grounds for thinking that the production of the document could prejudice that supply' or that disclosure could have an adverse effect on business or financial affairs? In my opinion it is not sufficient for the original decision-maker to proffer the view. It must be supported in some way. The support does not have to amount to proof on the balance of probabilities. Nonetheless, it must be persuasive in the sense that it is based on real and substantial grounds and must commend itself as the opinion of a reasonable decision-maker."
The same reasoning applies, in my view, to a determination under the GIPA Act that disclosure of certain information could reasonably be expected to prejudice the supply to an agency of confidential information that facilitates the effective exercise of its functions.
The Appeal Panel in Camilleri observed, at [33], that "the question of whether the information supplied is 'confidential information' must be examined, primarily at least, by reference to the agency's evidence as to the conditions under which it conducts the service within which the information was received". In a similar way, the question of whether it can reasonably be expected that the supply of confidential information will be prejudiced by disclosure of particular information is to be examined primarily by reference to the agency's evidence from which such a conclusion may be inferred.

Is the relevant information "confidential information"?

Both parties proceeded at least partly on the basis that the relevant question was whether the information the subject of the applicant's access application was confidential. The information to which the public interest consideration in cl 1(d) is directed is that which may (or may not) be supplied to the University in the future, being information which is generally of a similar kind to that sought by the applicant. In this case it includes information provided in ethics applications made to the HREC by researchers, information in expert reviewers' reports, researchers' communications with the HREC and contributions to discussions by HREC members in meetings which may be recorded in HREC minutes.
Evidence concerning the confidentiality of information handled by the HREC was given by a senior member of the University's academic staff, Professor Jill Trewhella, the Deputy Vice-Chancellor (Research). Professor Trewhella stated that the HREC operates under the National Statement, a copy of which the University provided to the Tribunal. Clause 5.1.37(t) of the National Statement provides: "An institution that establishes an HREC should ensure that the HREC establishes, implements and documents working procedures to promote good ethical review, including procedures for: ... (t) appropriate confidentiality of the content of applications and the deliberations of review bodies."
Clause 5.2.19 of the National Statement provides: "A review body may seek advice from experts to help in considering a research proposal (eg, as in paragraph 5.1.33). Such experts should be bound by the same confidentiality requirements as the review body members. Any conflicts of interest they may have should be disclosed and managed…"
The terms of reference for the HREC are annexed to Professor Trewhella's statement. They provide: 1. for its objectives, which include to facilitate ethical research in accordance with the National Statement; 2. that persons who are appointed as members of the HREC are required to sign a statement undertaking that all matters of which the person becomes aware during the course of his or her work on the HREC will be kept confidential; 3. that the HREC may seek advice from experts to assist in the review of a research proposal subject to the same undertaking of confidentiality as required from HREC members; and 4. that files for ethics applications will be kept securely and confidentially.
Professor Trewhella gave evidence, which was not directly challenged, that applications for ethics approval are treated confidentially, that the HREC discussions are confidential, that communications between the HREC and experts are confidential and that expert reports are received in confidence.
The applicant accepted that the HREC's proceedings are conducted in confidence and that members are required to sign a statement undertaking to keep confidential all matters they become aware of during the course of their work on the HREC. However, the applicant pointed out that cl 5.1.37(t) of the National Statement referred to "appropriate confidentiality" and that the National Statement could not mandate absolute confidentiality, as there may be a need to disclose the content of applications made to the HREC and/or the deliberations of review bodies, in circumstances involving fraud or crime, or in response to freedom of information applications.
The applicant's submission appears to assume that absolute confidentiality is required before information is properly considered to be "confidential". The term "confidential information" in cl 1(d) of the table in s 14 of the GIPA Act does not connote information which may not be disclosed in any circumstances. The term captures information which is not to be disclosed in ordinary circumstances. The circumstance that the National Statement qualifies the level of confidentiality as being that which is appropriate, and the circumstance that the information may need to be disclosed for legal reasons, does not detract from it being "confidential information" within cl 1(d).
The University did not specifically address the question of whether oral participation by HREC members in debates and discussions in HREC committee meetings constitutes the "supply" to the University of "information" within cl 1(d) of the table in s 14 of the GIPA Act. Whilst the word "information" is not defined in the GIPA Act, the term "government information" is defined in s 4 to mean "information contained in a record held by an agency". I am satisfied that the views and ideas of members are properly described as information and that the expression of their views orally is the supply to the University of information within the meaning of cl 1(d), at least in circumstances where those views are subsequently recorded in minutes or other records.
Accordingly, the University has established that the relevant information is "confidential information" within cl 1(d).

Prejudice to the supply of information

In order for the public interest consideration against disclosure in cl 1(d) to apply, the University must also establish that the disclosure of the information sought by the applicant could reasonably be expected to prejudice the supply to it of confidential information. The word "prejudice" is to be given its ordinary meaning, namely: "to cause detriment or disadvantage": Hurst v Wagga Wagga City Council [2011] NSWADT 307 at [60], Australians for Sustainable Development Inc v Barangaroo Delivery Authority [2013] NSWADT 252 at [65]. In this context, it refers to a situation in which it could be expected that the disclosure of information the applicant seeks would impede the provision of confidential information to the University in the future.
The University submitted that disclosure of the information sought by the applicant would prejudice the supply to it of information about researchers' research and would result in fewer applications for ethics approval being submitted to the HREC. It said that, in the context of contracted research with private entities, the research would not proceed without an assurance of confidentiality to protect the patented intellectual property arising from the research. It also submitted that disclosure of expert reports, HREC minutes and communications between experts and the HREC would prejudice the supply to it of reports from experts and would inhibit the free debate between committee members, and the exchange of information between committee members and experts.
The applicant relied upon publications from two other Australian universities which indicated that information about applications for ethics approval may be subject to release under freedom of information legislation, and noted that the NHRMC warned researchers that the NHRMC was subject to such legislation. She provided evidence that Charles Darwin University included in its list of essential reading for HREC applicants the Northern Territory Information Act 2002, which she said suggested that HREC functioning is not unduly compromised by researchers' awareness of the potential application of freedom of information legislation.
The applicant also relied upon Re Whitely and Curtin University of Technology [2008] WAICmr 24, a case in which Curtin University of Technology refused Mr Whitely access to documents involved in an individual's submission to that university's ethics committee, under the Western Australian freedom of information legislation. In that case, Mr Whitely agreed to accept access to edited copies of the requested documents, with the names of the relevant HREC members deleted. The documents captured by Mr Whitely's application included an application for ethical approval of research involving humans, reviewer reply forms and recommendations and submissions from the researcher to the HREC.
One of the exemptions Curtin University relied upon in the Re Whitely proceedings was that disclosure could reasonably be expected to prejudice the future supply of information to the Government or to an agency. The Acting Information Commissioner observed (at [50]) that no probative information to the relevant standard had been put before him by the agency to establish how or why the disclosure of the relevant pages of the documents in question could reasonably be expected to prejudice the future supply of information of a certain kind to Government or to the agency. It was also relevant that much of the information about the project was already in the public domain (at [93]). Finding that the agency had not established to the required standard that the exemption applied, he commented (at [96]): "96 I acknowledge that there is a public interest in ensuring that the community has confidence that universities have integrity and ethical standards in relation to their research and that the HREC must be free to act in a full and frank manner when considering research proposals. I accept the agency's advice that it has stringent internal and external reporting requirements and that research processes are closely monitored and sub-standard research practices are not tolerated. In my view, stringent internal and external reporting requirements as described by the agency are both necessary and appropriate but I would expect that to be the case in any event. However, the fact that such processes exist at the agency does not mean that individuals such as the complainant should be denied access to the same documents, in an effort to satisfy themselves that such internal and external reporting requirements are appropriate and being adhered to. An assertion that the complainant and the public at large should 'take the agency's word for it' that all the necessary checks and balances are being adhered to is not sufficient to persuade me that the public interest is best served by non-disclosure."
The University sought to distinguish Re Whitely on the basis that the University had provided probative material supporting its claim that disclosure would prejudice the supply of information.
The University's evidence concerning the potential prejudice to the supply of information to it was given by Professor Trewhella, Professor Naismith and Dr Rebecca Halligan, the Director of Research Integrity and Ethics Administration.
Professor Trewhella expressed the view that confidentiality is essential to the functioning of the HREC. She said that the University relies upon the expertise and candour of HREC members and experts to determine whether research proposals are ethically acceptable and worthy of approval, and they must feel free to speak with candour. In her opinion, the disclosure of HREC documents would adversely affect the free flow of debate and damage the ability of the HREC to comprehensively analyse and assess applications for ethics approval.
Professor Trewhella was of the opinion that confidentiality was required to protect researchers and third parties who have invested money in research. In order to encourage their full and frank participation in the ethics approval process, it was Professor Trewhella's view that researchers had to be confident that they were not at risk of having their research ideas copied or taken by others. Further, she stated that if researchers knew that their applications and communications could be disclosed to other parties, they would be likely to feel inhibited in their ability to comprehensively describe the nature of their research and potential risks associated with it.
Professor Trewhella gave oral evidence that members and prospective members of ethics committees had expressed concerns about the confidentiality of the process to her. She said that they had asked her whether their comments, made in meetings, would be confidential. She also said she had had conversations with researchers about protecting their intellectual property, and she observed that there was a general concern about confidentiality in so far as it related to this issue.
Dr Halligan told the Tribunal that, if ethics applications, HREC minutes, expert reviewers' reports and associated documents could be accessed under legislation, the University would need to advise the relevant people (its employees and affiliates, HREC members and experts) that these documents could be disclosed. This would, in her view, raise concerns for researchers about the protection of their ideas and their intellectual property. She said that it would also impede the effective functioning of the research ethics review process, as public release of the HREC members' names could expose them to lobbying or criticism, and this would compromise their ability to make frank, independent and impartial contributions to HREC deliberations. Dr Halligan anticipated that public release of the expert reviewers' names could expose them to criticism, and this would compromise their ability to perform their role of providing a robust, independent and impartial assessment of the proposed research, and make it difficult for the University to find experts willing to undertake this task.
Dr Halligan said that confidentiality was essential to contracted research (joint research projects undertaken with third parties), because it protected the intellectual property and financial investment of third parties. She expressed the opinion that third party investors would look to other institutions if they believed that applications to and communications with the HREC could be disclosed to other parties. The University would then suffer a disadvantage when competing with private sector bodies for third party investors in the research market.
Dr Halligan gave evidence that, before joining the University, she worked in a pharmaceutical company which sponsored a number of projects through the University. She said that, on one occasion, that company paid the University to do work relating to the development of a new vaccine prior to its release on the Australian market, research approved by an animal research ethics committee. In her view, had the company's competitors become aware of the research, they would have sought to impair the launch of the vaccine and the company's financial investment would have been lost.
Dr Halligan said that, when she joined the University, it had been the University's practice to include minutes of ethics committee meetings in letters written to researchers. According to Dr Halligan, this led to complaints, delays and the breakdown of relationships. She said that members of ethics committees did not feel safe and felt that they had to justify themselves. Since the University had ceased providing ethics committee meeting minutes to researchers, Dr Halligan found that it was easier to recruit ethics committee members. She acknowledged that other factors may have contributed to this, such as better support being provided to those members.
Dr Halligan addressed the applicant's proposal that the information be released to her with the names of researchers, experts and HREC members redacted. She gave evidence that ethics committee members with research expertise often know the investigators listed on the research proposals and, conversely, investigators and other researchers often know members of the committees. As a consequence, in Dr Halligan's view, it is possible that even de-identified information released about ethics committee deliberations, such as meeting minutes, may be attributed to individual committee members. She said that it was difficult to find independent research academics to investigate allegations of research misconduct or review external complaints. Because such academics needed to have expertise in a relevant research field, according to Dr Halligan, even de-identified information about reviews released publicly could allow the reviewer to be identified by the investigators or others.
Professor Sharon Naismith, a clinical neuropsychologist at the University and a chief investigator on the NHMRC Project Grant for the Beyond Ageing Project II, also gave evidence for the University. She expressed the view that, if confidential information from the HREC were released, researchers like herself, when expressing views about research proposals, would feel inhibited in their ability to speak freely about the credibility of the science they were evaluating. Professor Naismith said that the release of confidential information from the HREC processes would be damaging to scientific research and to the ethics review process, because it would inhibit robust dialogue between ethics committees and researchers.
Professor Naismith also said that, if she was an ethics committee member and knew that information from ethics committee meetings could routinely be released, she would be disinclined to raise concerns about individual research proposals, because her comments could be attributed to her personally. She was of the opinion that, as the scientific research community is small, that could later cause prejudice for her own work.
In written submissions filed before Professor Naismith's statement was filed, the applicant submitted that neither Professor Trewhella nor Dr Halligan provided any evidence in support of their claims about the negative impacts of disclosure. She said they did not provide findings on any material questions of fact, as required by s 61 of the GIPA Act. Instead, in the applicant's submission, they speculated about likely effects without referring to any evidence of such effects at any university. There was no evidence, in the applicant's view, to support the opinions of Professor Trewhella and Dr Halligan about the predicted negative effects from disclosure. The applicant submitted, both orally and in writing, that the University's witnesses had a conflict of interest, in that they were employed by the University, and said that this diminished the weight the Tribunal should give their evidence.
As the respondent submitted, the allegation that the respondent's witnesses have a conflict of interest was not put to them, and they have not had an opportunity to respond to it. The applicant's contention that the respondent's witnesses have a conflict of interest is perhaps better understood as an allegation that they are partisan, and therefore likely to give evidence which supports the University's case. Whilst I take into account their association with the University, each of the University's witnesses presented as truthful, and each was prepared to make concessions where appropriate.
The applicant's position that the respondent's evidence is speculative has some basis insofar as that evidence involves Dr Halligan and Professor Trewhella providing an opinion as to what other people (researchers, experts and HREC members) would be likely to do if the requested information were to be released. However, the University's evidence goes further than mere statements of opinion as to the likely effect of disclosure. There is evidence before the Tribunal that Dr Halligan and Professor Trewhella have had experience dealing with prospective or current HREC members who have had concerns about confidentiality; that the intellectual property of commercial sponsors of research and others may be impacted by disclosure; and evidence from Professor Naismith that, as a researcher, she would feel inhibited about expressing views about research proposals if confidential information were released. There is a proper basis in the evidence of Dr Halligan, Professor Trewhella and Professor Naismith from which it may be inferred that, if the information sought were to be disclosed: 1. some commercial sponsors would be deterred from sponsoring research or from applying to the HREC for ethics approval, due to the perceived need to protect their commercial interests; 2. some researchers would not be as candid in their ethics applications, knowing others may gain access to them; 3. some prospective HREC members would be deterred from participating as members due to concerns about confidentiality; 4. HREC members would, in some cases, be more inhibited in expressing their views about research proposals than otherwise; and 5. experts would be less likely to agree to conduct a review for the HREC and would also be, in some cases, more guarded in their comments where they did conduct a review.
I accept the respondent's submission that these proceedings can be distinguished from Re Whitely and Curtin University of Technology [2008] WAICmr 24, because the University has provided probative evidence to the relevant standard from which it may be inferred that the disclosure of information to the applicant could reasonably be expected to prejudice the future supply of information to the University.
I accept evidence given by the applicant, Professor Naismith and Dr Halligan that there is a trend towards greater transparency in the research arena, including the use of open peer reviews of academic research (that is, reviews in which the name of the reviewer is disclosed). However, contrary to the applicant's submission, the existence of this trend does not establish that researchers, HREC committee members and others would not be inhibited in the provision of information to the University if they were not assured of confidentiality. The context is different and the existence of a trend does not mean that all or most academics or HREC members are comfortable with being named. The evidence is to the contrary.
As indicated earlier, the applicant sought information with the names of the authors and HREC members removed. Disclosure of anonymised information is likely to have a less prejudicial effect on the supply of information that full disclosure. However, this does not eliminate the potential prejudice to the supply of information. Both Professor Trewhella and Dr Halligan gave evidence that academics and others often thought they knew the identity of an anonymous reviewer and both indicated that, in specialised areas, there may a small number of experts, making it easier to deduce the identity of the writer. Even the possibility of others correctly guessing the identity of the author of a review or a comment in an HREC meeting may be sufficient to deter people from participating in the process, or to affect their degree of candour.
The applicant's evidence that the ethics committees of other universities warn researchers that freedom of information legislation may apply indicates, potentially, that researchers continue to make ethics applications notwithstanding such a warning. However, the Tribunal does not have any evidence before it of the number of ethics applications made to such universities, or evidence of whether that number increased or decreased following the warning, and whether the change (if any) can be attributed to the warning. Even if the Tribunal did have such evidence, there is a distinction between providing researchers with a statement that freedom of information legislation may apply, and the effect of a disclosure which evidences that freedom of information legislation may require the disclosure of, for example, an ethics application.
The respondent has established that it is reasonable, as distinct from irrational, absurd or ridiculous, to expect that disclosure of the information sought by the applicant would prejudice the supply of other confidential information to the University.

Does confidential information facilitate the exercise of the University's functions?

The respondent submitted that the confidential information supplied to it facilitated the exercise of its functions as set out in the University of Sydney Act 1989 (NSW). That Act provides, in s 6, that the University's functions include the provision of facilities for education and research of university standard, the encouragement of the dissemination, advancement, development and application of knowledge informed by free inquiry, and the carrying out of research, to meet the needs of the community. The University submitted that the receipt of ethics applications and associated documents such as expert reports and correspondence facilitates its functions of providing facilities for research, encouraging the dissemination, advancement, development and application of knowledge informed by free inquiry and carrying out research. Similarly, in the University's submission, the free exchange of views in HREC meetings facilitates the exercise of those functions.
The applicant submitted, in effect, that the HREC would function effectively even if the information provided to it were not confidential. She said that there were no grounds for believing that the external reviewers would not have provided a candid review absent the assurance of confidentiality, particularly if they were guaranteed anonymity. The applicant also said that researchers expect to have their views tested in the court of peer review, making it implausible that the researchers would not be willing to stand publicly by their rebuttals of evidence-based concerns about the safety of the trial.
The applicant appeared to assume that cl 1(d) requires the University to show that confidential information facilitates the exercise of the University's functions in circumstances where non-confidential information would not do so. I do not need to decide whether this position is correct, as I am satisfied that the exercise of the University's functions is facilitated by the circumstance that the information supplied to the HREC is confidential.
The evidence of Professor Trewhella and Dr Halligan, discussed above, establishes that the confidential circumstances in which information is supplied to the University's HREC make HREC members more willing to share their views frankly in meetings (facilitating the encouragement of the dissemination of knowledge informed by free inquiry), make commercial parties more likely to sponsor research at the University (facilitating the carrying out of research at the University) and make researchers more likely to be candid in their ethics applications and less likely to take them elsewhere (facilitating the carrying out of research at the University and encouraging the dissemination of knowledge). Their evidence also establishes that prospective reviewers are more likely to accept an appointment as such in these circumstances.
For these reasons, the University has discharged its onus of establishing that disclosure of the information sought by the applicant could reasonably be expected to prejudice the supply to the University of confidential information that facilitates the effective exercise of the University's functions within cl 1(d) of the table in s 14 of the GIPA Act.

Prejudice the effective exercise of an agency's functions (clause 1(f))

In order to establish this public interest consideration against disclosure the University must establish that a disclosure of the information in issue could reasonably be expected to prejudice the effective exercise of its functions.
The University's relied upon its submissions in relation to clause 1(d) of the table in s 14 of the GIPA Act. Although cl 1(f) does not refer to confidential information, the respondent submitted, effectively, that the reason the effective exercise of the University's functions would be prejudiced by the disclosure of the information sought is that those functions depended upon certain information remaining confidential. In these circumstances, this public interest consideration does not add anything, or adds very little, to the consideration in clause 1(d). Nevertheless, I am satisfied, for the reasons given in relation to clause 1(d), that this public interest consideration applies in the circumstances of this case.

Reveal a deliberation or opinion so as to prejudice a deliberative process of an agency (clause 1(e))

The respondent raised the application of the public interest considerations against disclosure in cl 1(e) and cl 4(e) in the table in s 14 of the GIPA Act, at the hearing. In its notice of decision of 13 July 2013, the University relied upon both these considerations in the schedule of documents appended to it, but only referred in its reasons to cl 1(e). In its reconsideration of that decision on 9 October 2013, following an Information Commissioner review, the University claimed that cl 4(e) applied, but did not mention cl 1(e). The respondent filed and served written submissions and submissions in reply in January and March 2014, neither of which raised the application of cl 1(e) or cl 4(e). Prior to the hearing, the applicant was entitled to assume the respondent was no longer relying upon them. The introduction of new public interest considerations at the hearing is unsatisfactory, particularly in circumstances where the applicant is unrepresented.
The respondent referred only very briefly to the application of the public interest consideration in cl 1(e) in oral submissions. This consideration is that disclosure of the information sought could reasonably be expected to reveal a deliberation or consultation conducted, or an opinion, advice or recommendation given, in such a way as to prejudice a deliberative process of government or an agency. It relied upon Cameron v Commissioner of Police, New South Wales Police Force [2014] NSWCATAD 13 at [66] and [71] and Fire Brigade Employees' Union v Fire and Rescue NSW [2014] NSWCATAD 113 at [57]-[58]. I accept that those cases describe the correct approach to be taken to this public interest consideration against disclosure.
The respondent has not provided sufficient material, in the way of submissions, for me to properly consider the application of this public interest consideration against disclosure. As a result of this and of the late notice that the respondent is relying upon cl 1(e), the applicant has not been given an adequate opportunity to make submissions about whether, assuming that disclosure of the information sought revealed a deliberation, consultation, opinion or advice, this would prejudice a deliberative process of the University.
In these circumstances, the respondent has not discharged its onus of establishing that this public interest consideration against disclosure applies. If I am wrong about this, I doubt whether I could make a finding that this consideration applied, consistently with the rules of procedural fairness (Civil and Administrative Tribunal Act, s 38(2)).

Disclose information provided in confidence (clause 1(g))

The University submitted that disclosure of the information sought by the applicant could reasonably be expected to result in the disclosure of information provided to it in confidence. It again relied upon its submissions in relation to cl 1(d).
The applicant submitted that, given that she had requested anonymised information, it was difficult to accept the claim that the provision of that information could reasonably be expected to result in the disclosure of information provided in confidence.
The evidence of Dr Halligan and Professor Trewhella establishes that the information which the applicant seeks was provided to the University in confidence. Whilst the GIPA Act contemplates that information may be provided to an applicant in a redacted form (GIPA ACT, s 74), doing so does not change the character of the information which was provided to the University. The information remains information provided in confidence, whether or not it is disclosed with the names of individuals deleted.
I am therefore satisfied that disclosure of the information the applicant seeks could reasonably be expected to result in the disclosure of information provided to the University in confidence within cl 1(g).

Undermine competitive neutrality in connection with agency functions (clause 4(a))

The respondent submitted that disclosure of the information sought could reasonably be expected to undermine competitive neutrality in connection with functions of the University in respect of which it competed with other persons, or otherwise place the university at a competitive disadvantage in a market. It said that if Australian universities, including the University, were unable to guarantee confidentiality in their review of ethics applications and complaints, they would become less attractive for domestic and international research and research funding. The University also said that it would have a competitive disadvantage when competing with private sector bodies for third party investors in the domestic and international research market.
The applicant submitted that the University's claim that Australia would become less attractive for international research, should the information she seeks be released, was unfounded and speculative. She said that it was likely that international research funders were aware of the limits of confidentiality that could be guaranteed in this respect. The applicant did not provide any evidence for her own factual claim and I have not given it any weight.
Professor Trewhella's evidence was that, if the University and other publicly funded institutions were unable to guarantee confidentiality in their processes, there was a risk that Australia would become less attractive for international research and research funding. There was also a risk, in Professor Trewhella's view, that private companies would establish their own ethics committees to ensure that their research remained confidential.
Dr Halligan confirmed, in cross examination, that there was at least one privately-owned, not for profit ethics committee which was accredited and which could provide competition for the University. She could not think of any other privately-owned ethics committees. There was very little evidence provided about this not for profit ethics committee, how many applications it was capable of handling or how it functioned.
The University has not discharged its onus of establishing that this public interest consideration against disclosure applies in the present circumstances. I accept the applicant's submission that the University's evidence about the risks of disclosing the information sought is largely speculative. Whilst the evidence of Professor Trewhella indicates that it is possible that the disclosure of the information would have the effect set out in cl 4(a) of the table to s 14 of the GIPA Act, the University has not established that it is reasonable to expect that this would occur.
Prejudice the conduct, effectiveness or integrity of any research by revealing its purpose, conduct or results (cl 4(e))
As indicated above, the respondent raised the application of this public interest consideration against disclosure at the hearing. Some of the confidential evidence led by the respondent was directed to its application.
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[Not for publication] The applicant's own evidence about this was that, whilst a colleague had considered providing information about the trial to a journalist, she had no plans to do so. The question of whether disclosure of the reviewers' comments is properly characterised as a disclosure of the purpose, conduct or results of the research was not explored, and was not put to the applicant.
I note also that s 15(d) of the GIPA Act provides that the fact that disclosure of information might be misinterpreted or misunderstood by any person is irrelevant and must not be taken into account when determining whether there is an overriding public interest against disclosure of government information. Ms Tronson submitted orally, in a different context, that this did not mean that evidence concerning the potential misinterpretation of information could not be used in relation to establishing that the supply of information would be prejudiced. The logical extension of this argument is that such evidence may also be used in relation to cl 4(e). On the basis of the arguments presented, I am not persuaded that this is the case, and the circumstance that this argument was not made until the hearing means that the applicant has not had an adequate opportunity to address it.
In these circumstances, I am not satisfied that the respondent has established that this public interest consideration against disclosure applies.

PERSONAL FACTORS OF APPLICATION

The respondent relied upon the applicant's identity and relationships with other persons and her motives for making the access application as factors which could be taken into account in determining whether there is an overriding public interest against disclosure of the information she sought (GIPA Act, s 55(1)(a)). Those factors may only be taken into account as factors against providing access in relation to cl 2-5 of the table to s 14 of the GIPA Act (GIPA Act, s 55(3)). As I have found that these clauses do not apply, the personal factors of the application may not be taken into account as factors against providing access.
The applicant submitted that the personal factors of the application favoured disclosure (GIPA Act, s 55(2)).
The respondent accepted that the applicant's motives for making the access application appeared to be a genuine concern about the use of the antidepressant, sertraline, in the clinical trial for the research project. The applicant agreed that she was motivated by genuine concerns about the use of sertraline in the clinical trial, in terms of the potential harms to trial participants and the possibility that the trial may be used to justify prescribing sertraline more broadly to people who are not depressed. The applicant described her "key concern" as abrupt withdrawal from sertraline by trial participants, and said she was also concerned about inadequate monitoring of trial participants once they cease taking sertraline.
The respondent submitted that the applicant's motives had appropriately been served by the effective handling of her complaint and appeal to the HREC, and the subsequent modification of the participant information sheets and follow-up procedure. The applicant disputed this. She said that several of her concerns, particularly the abrupt and potentially harmful cessation of sertraline, has not been appropriately addressed.
The applicant's genuine concern about the use of sertraline and the health of trial participants is a factor in favour of providing her with access to the information she seeks (GIPA Act, s 55(2)). Whether or not the applicant's motives have been "appropriately served" by the way her complaint is handled, or whether other researchers share the applicant's concerns, is not relevant to what those motives are.
Section 55(2)(c) ("any other factors particular to the applicant") is also relevant, in my view, to some of the information sought. Insofar as the applicant seeks information responding to her complaint, this is information in which she has a particular interest. It is a factor particular to the applicant that she made a complaint to which that material responds. This was not, however, the subject of submissions by either party, and I have not given it significant weight.

BALANCING PUBLIC INTEREST CONSIDERATIONS

In addition to the general public interest in favour of disclosure (GIPA Act, s 12(1)), there are significant public interest considerations in favour of disclosure of the information sought by the applicant. The public interest in enhancing the HREC's accountability is to be given a reasonable amount of weight: if the minutes of its deliberations and the content of the ethics applications which it approves are not accessible by the public under the GIPA Act or otherwise, it is likely to avoid public scrutiny in relation to its decision-making at the time it makes its decisions. This is undesirable, given that it is exercising the important function of reviewing research proposals involving human participants. It also means that, if there are any problematic issues regarding a trial which has been approved, they are less likely to become public until the trial is concluded.
There is also a strong public interest in contributing to positive and informed debate on issues of public importance, including, broadly, the issue of the approval of trials involving human participants and, more specifically, trials involving the use of anti-depressants by human participants. The applicant has raised some serious concerns about the safety of certain aspects of the trial. Whilst the Tribunal is not in a position to evaluate the substance of those concerns, the circumstance that they are shared by four other academics with a wide range of expertise indicates that they should not be lightly dismissed. It may be that, if the applicant were provided with the information she seeks, her concerns would be allayed. On the other hand, it may be that she would still have concerns, and the expression of those concerns in the context of having more knowledge about the trial could contribute to a positive and informed debate about the safety and methodology of the trial.
There are also the personal factors of the application which favour disclosure: the applicant's motives in seeking the information and, in respect of the information responding to her complaint, the circumstances that it directly concerns that complaint and that she has a particular interest in knowing how her complaint has been dealt with.
I have found that the applicable public interest considerations against disclosure are that disclosure could reasonably be expected to: prejudice the supply to the University of confidential information that facilitates the effective exercise of its functions; prejudice the effective exercise by the University of its functions; and result in the disclosure of information provided to an agency in confidence (GIPA Act, s 14, table, cl 1(d), (f) and (g)).
The most significant public interest consideration against disclosure is that, if the information is disclosed, there is a real danger that the effective exercise of the HREC's functions will be prejudiced (GIPA Act, s 14, table cl 1(d) and (f)). Disclosure could reasonably be expected to inhibit the supply of confidential information to the HREC in a variety of significant ways. The evidence establishes that fewer people would be prepared to serve on the HREC or provide expert reviews to the HREC if they thought the minutes of HREC meetings or their reviews could be disclosed. The University has also established that it could reasonably be expected that researchers and HREC members would be more circumspect in the information they provide to the University, and more reluctant to criticise research proposals if they thought their views could be identified (even in circumstances where the information was disclosed anonymously). It is also reasonable to expect that commercial sponsors of research, would, at least in some circumstances, decide not to sponsor research subject to HREC approval and/or seek ethics approval elsewhere such as interstate universities or private institutions.
Determining where the balance lies between the competing interests is "a question of fact and degree, requiring the weighing of competing matters, and is a task that is not amenable to mathematical calculation": Hurst v Wagga Wagga City Council [2011] NSWADT 307 at [94]; Salmon v Department of Justice (Corrective Services New South Wales) [2014] NSWCATAD 160 at [46].
Part of the value of the transparency which would flow from disclosure of the information sought by the applicant is that it would allow scrutiny of the information contained in the ethics application and the associated documents the subject of her application, and would open up the possibility of scrutiny of similar information in the future. This opportunity for greater public scrutiny would come, however, at the cost of what could reasonably be expected to be less effective scrutiny at the agency level. The confidentiality of HREC processes encourages full disclosure of the content of proposed research by researchers, robust debate about ethics applications within HREC meetings and impartial and uninhibited criticism of proposals by reviewers. It thus contributes to ensuring that the ethical aspects of research involving human participants are properly considered and subject to rigorous assessment. It is relevant that there is likely to be an opportunity for public discussion of the outcome of the research to which the ethics application relates when the results of that research are published. Such publication is likely to facilitate positive and informed debate, and to contribute to the accountability of the HREC, albeit some years after it granted ethics approval.
On balance, the public interest considerations against disclosure outweigh those in favour of disclosure, including the personal factors of the application, even though the considerations in favour of disclosure are not insubstantial. There is a strong public interest in preserving the confidentiality of ethics applications and of the University's processes for considering such applications, so as to ensure that researchers continue to provide full and frank information when seeking ethics approval, that they continue to seek such approval at public institutions, that reviewers are prepared to conduct reviews and do so candidly and that HREC members are not inhibited in what they say about ethics applications in meetings. The prejudice to the supply of confidential information, and the effective exercise of the functions the University exercises through the HREC, could reasonably be expected to be significant.
For these reasons, the correct and preferable decision is to affirm the respondent's decision to refuse access to the information sought by the applicant. I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 21 May 2015

Freedom of Information Act 1989(NSW)

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