1. Professor Wakefield gave evidence that the Council was a registered charity with a mission to reduce the impact of all cancers for Victorians. The Council is a research institute recognised by the National Health and Medical Research Council ('the NHMRC') and is reliant on grants, public donations, bequests and contracts for research funding.[20]
2. The Council has research policies and procedures consistent with its status as a recognised research institute including a HREC which reviews research projects using the national guidelines issued by the NHMRC.[21] The Council has a policy for the Responsible Conduct of Research, a Research Code of Practice, a Behaviour and Conduct Policy and other relevant policies concerning privacy and research misconduct.[22]
3. Professor Wakefield said that the Council's research programs underpin its work in cancer prevention and patient support. The Council's prevention initiatives, such as Quit and SunSmart, are grounded in behavioural science.[23] Over the past 30 years, the Council has undertaken ongoing monitoring and evaluation to guide the development and continuing improvement of these programs.

1. The Centre was established in 1986. It is one of the two major in-house research centres at the Council, dedicated to a science-based approach to the prevention and early detection of cancer, and the supportive care of people with cancer.[24] In essence, Professor Wakefield said, the Centre aims to find out why people behave the way they do, and why they behave in unhealthy ways.[25] It focuses on the behavioural aspects of cancer control and discovers how people can be encouraged and supported to change unhealthy behaviours.[26] The Centre's research is conducted in accordance with its ethics processes, privacy policy and policies relating to the responsible conduct of research and peer review.[27]
2. As the Director of the Centre, Professor Wakefield is responsible for supervising and conducting a range of behavioural research studies, which aim to assist with the development of cancer prevention, screening and support programs and policies.[28]
3. Professor Wakefield said that given that smoking is the leading preventable cause of cancer deaths in Australia, she considers that the Centre's research into tobacco control is central to the Council's mission.[29]
4. Under the National Statement on Ethical Conduct in Human Research issued by the NHMRC,[30] approval from a duly constituted ethics committee must be gained before research involving human subjects can begin.[31] Members of the Council's HREC are not employees of the Council, and their function is conducted independently of the Council. In approving research involving human subjects, the HREC is under an obligation to safeguard the interests of research participants.[32]
5. Professor Wakefield described the extreme difficulty associated with winning research grants - fewer than 15% of NHMRC research grant applications submitted in 2014 were funded.[33] Applications for funding are more likely to be successful if the researchers demonstrate that they have the experience to undertake the study, and are likely to produce valuable outputs (such as peer-reviewed journal papers that can influence health policy and practice).[34]

1. The Melbourne Collaborative Cohort Study is a long term study funded by the Council and VicHealth which investigates lifestyle and genetic factors that lead to the development of different types of cancers.[35] A Data Transfer Agreement ('the Agreement') has been made for this study with researchers at the American Cancer Society. The Agreement defines the circumstances in which data can be shared and collaborative research can be undertaken using data obtained by the Council.[36]
2. Professor Wakefield stated that the release of data without first securing a collaborative data sharing agreement, or prior to completion of peer-review processes, disadvantages the lead researchers, as this allows use of the data before the lead researchers have had the opportunity to complete analysis of the data and the preparation of research papers.[37] According to Professor Wakefield, such a practice is foreign to the research community as it undermines the ability of the lead researchers to whom the grant has been awarded to produce the full intended range of output for the study on behalf of their research team and the institution that supported the conduct of the study.[38]

1. Professor Wakefield described the nature of datasets produced in the process of undertaking empirical research as existing on a continuum:
   • 'working dataset': a dataset developed from the uncleaned and uncoded dataset, often containing the work of the researcher in cleaning the responses, re-coding responses into categories, and computing new variables from combinations of responses to individual questions;
   • 'master dataset': a dataset containing all data from different waves of the study which have been merged together for the first time;
   • 'non-final dataset': used to refer collectively to uncleaned and uncoded data, working datasets and master datasets; and
   • 'final dataset': a dataset which will not change, has been prepared for public sharing, and which contains cleaned and coded data. The responses contained in a final dataset are often displayed with some level of confidentiality, to protect the identity of the participants.[39]
2. Peer review is regarded as a method of self-governance, which promotes reliability and legitimacy of research.[40]
3. Professor Wakefield described the progression of research in accordance with a pre-determined research protocol, from the gathering, analysing and interpreting of data, leading to the writing up of data, analysis and conclusions, which is then submitted to a scientific journal for publication.[41] She said that:

(1) in general, draft or non-final versions of papers prior to journal submission are treated as preliminary and kept confidential within the research team;

(2) prior to acceptance by a journal, a paper is subjected to scientific peer review with the researchers expected to respond by making revisions identified by peer reviewers and the journal editor. More evidence may be provided to demonstrate why revisions may not be required;

(3) the revised paper and a letter itemising responses to reviewer comments is then further reviewed by the peer reviewers and the editor. Further revisions may result;

(4) once a manuscript is submitted to a journal for publication and is going through the peer review process, publicising a non-final form of the manuscript elsewhere would contravene agreements with the journal;

(5) while undergoing the peer-review process and until published, papers submitted to scientific journals are expected to remain confidential. Scientific journals publish the final form of the accepted paper; and

(6) some scientific journals link the final form of the accepted paper to the originally submitted version of the paper and the peer-reviewers' comments once the final accepted paper is published.[42]

1. Professor Wakefield detailed the restrictions that the Council imposes in making research materials public, namely when the research involves:

(1) sensitive data given in confidence by participants under strict ethics approval and consent conditions;

(2) preliminary research materials or internal documents (including non-final datasets) that are in draft form or have been superseded by revised versions and have not gone through the required scientific processes;

(3) data relating to incomplete studies that have not gone through the required scientific processes; and

(4) data relating to its own studies from which other analyses and papers are in progress or are still to be completed in order to fully exploit the investment in the studies.[43]

1. All of the disputed documents relate to studies undertaken by the Council as part of its evaluation of the plain packaging legislation.[44]
2. Under the World Health Organization's ('WHO') Framework Convention on Tobacco Control ('FCTC'),[45] signatory countries are required to implement controls on packaging and labelling to better inform consumers about health risks,[46] as well as comprehensive bans on the promotion of tobacco products.[47] Australia became the first FCTC signatory country to implement those requirements by way of the TPP Act, with all tobacco products sold in Australia from 1 December 2012 required to use the same drab dark brown coloured packaging, with brand and variant names in a standard font and position on the pack.[48]

1. Professor Wakefield said that documents 1, 3, 4, 5 and 6 are working datasets, which contain cleaned and coded data that underlie published papers, but also contain data intended to form the basis of future planned published papers, and therefore are not final datasets.
2. According to Professor Wakefield, Document 2 is an uncleaned and uncoded dataset, and not a final dataset.[49]
3. The disputed documents relate to the following research projects:
   • the ASSAD survey ('Document 1');
   • the National Monthly Tracking Survey of Smokers and Recent Quitters ('Document 2');
   • Silent Salesman Study ('Document 3' and 'Document 4'); and
   • Tobacco Retail Outlet Monitoring Study ('Document 5' and 'Document 6').[50]

1. Professor Wakefield explained that the disputed documents are data files with a file extension of ".dta".[51] They are electronic documents created and viewed through a data analysis and statistical program called Stata:
   • the disputed documents contain the data files of responses collected in the course of four different research studies.
   • the data is unable to be printed in a readable way, or exported into a single-dimensional format such as a ".pdf" or ".doc"; and
   • in each file the first level of data comprises the results of the relevant survey, which is displayed in coded form. The second level of data generally comprises a variable name, a description of the variable and value labels that explain what the coded values mean for each question.[52]
2. While some of the information is displayed in plain English, the majority of the questions and answers are assigned coded labels or numerical values, in order to reduce large quantities of information into a form that can be more easily handled and processed by the statistical software.[53] Each question contains its own range of codified answers, which may include additional coded values to reflect data cleaning undertaken to address discrepancies or errors in the answers given by participants.[54]
3. Datasets are cleaned following standard procedures which check for inconsistent responses, frivolous responding patterns and missing data:
   • responses are coded. Where possible, open-ended responses are sorted into categories;
   • working datasets underlying published papers contain computed variables constructed by recoding answers to a question in the survey into a different grouping of responses and variables;
   • in some of the datasets, two original variables measuring the day and precise time of the observation are combined into one variable indicating whether data collection occurred on a weekday before 4pm, on a weekday after 4pm, or on a weekend; and
   • datasets that involve a survey of members of the population are weighted to better reflect the population from which the survey sample is drawn.[55]

1. Document 1 embodies the ASSAD survey. Professor Wakefield said that the survey is a long-standing, core research endeavour of the Council and the Centre, which commenced in Australia in 1984.[56] It began as a survey of tobacco and alcohol behaviours; questions addressing illicit drug use were added in 1996.[57] It is one of the longest standing national data collections instituted anywhere in the world, using consistent methods and measures over time to monitor tobacco and alcohol use.[58]
2. Professor Wakefield described the ASSAD survey as a platform for investigating scientifically the effectiveness of policies and programs aiming to reduce student smoking prevalence and risky alcohol use.[59] The research based upon the survey was described as a critical component of the Council's mission to reduce the impact of cancer in the community.[60]

1. As to detriments that would be suffered if the dataset from this survey were released, Professor Wakefield said that:

(1) the release of the dataset from the ASSAD survey would contravene the research project proposal approved by the HREC that governs the collection of this data;

(2) release of the data would contravene approvals from Education Departments that allow schools to be approached about survey participation, as well as undermining the Council's assurances to students, parents and schools as to who has access to the data and how it will be utilised;

(3) in the process of conducting the research, the Council provided assurances to schools, parents and school children that their data would only be used for research purposes, that only aggregated data would be released, and that schools and students will not be individually identified;

(4) the public release of the dataset would be a breach of trust and would damage the Council's ability to obtain ethics approval to conduct future surveys, and obtain the consent of education offices, schools and parents;

(5) if the Council were compelled to provide the dataset, the Council would need to declare that this would be a possibility in future approaches to HRECs and education offices;

(6) the release of Document 1 jeopardises the likelihood that the study would be approved by the HREC or education authorities in the future;

(7) release of the data could impair the Council's ability to continue to conduct research critical to public health outcomes such as cancer prevention over the past 30 years;

(8) release of the dataset would undermine the Council's standing as a global leader in research on tobacco control, undermine research track records and make it more difficult to win competitive research grant funding; and

(9) by making the data public, the Council would substantially reduce the trust of its donors, who expect the Council to be a good custodian of sensitive data.[61]

1. Professor Wakefield described the ASSAD study as ongoing. She said that Document 1 contains results of ongoing and unpublished research, which should not be disclosed.[62]
2. In Professor Wakefield's view, Document 1 is a draft document, a working dataset, which has not been finalised for public release. If disclosed, she expressed concern about confusion or misrepresentation of preliminary data, and unfair or unreasonable criticism of data that has not been submitted for peer review. Document 1 has been kept confidential at all times, and it is the view of Professor Wakefield that it should not be disclosed.[63]

National Monthly Tracking Survey of Smokers and Recent Quitters

1. Professor Wakefield said that the National Tracking Survey of Smokers and Recent Quitters is a concluded body of research, conducted by the Council and funded by the Commonwealth Department of Health. The study involved a cross-sectional monthly tracking survey of 400 smokers, and smokers who had quit in the past year, for the purpose of assessing the short to mid-term effects of plain packaging of tobacco.[64]
2. The survey included a baseline survey of Australian adult cigarette smokers followed by a follow-up telephone survey within the first year of implementation of plain packaging laws in Australia.[65] The Council received data each month as the survey progressed.[66]
3. The research study was completed on 19 March 2015 when:

(1) final scientific manuscripts were provided to the Commonwealth Department of Health, including the electronic dataset; and

(2) the final scientific manuscripts and technical report were published.[67]

1. The Commonwealth Department of Health has made the final dataset available on its website by request. [68]
2. Professor Wakefield said that Document 2 records data gathered during the monthly tracking survey. The dataset contains uncleaned and uncoded responses from all respondents over all months of the survey. It is not the dataset underlying the published papers and technical report.[69]
3. The dataset was created from data provided by the Social Research Centre, which conducted the telephone surveys under contract to the Council.[70] Professor Wakefield said that:

(1) Council researchers led the design of the survey method and the construction of the survey questions;

(2) the Council was contracted to lead the study by the Department of Health;

(3) the survey design and questions proposed by the Council were scientifically reviewed by a committee which contained some of the world's most experienced tobacco packaging and labelling researchers; and

(4) the conduct, analysis and reporting of the survey results were a major scientific undertaking for the Centre between 2012 and early 2015.[71] The dataset comprises uncleaned uncoded data, representing over 2 years of research and the application of Council researchers' professional skill.[72] The document requires expert knowledge in operating Stata software in order to be understood. According to Professor Wakefield, the dataset as it stands would make little sense to a lay person or non-scientist. It would be little more than a mass of dots and numbers.[73]

1. Document 2 is an old dataset which contains the study data as it was in September 2014, when the original FOI request was submitted. While all variables are labelled, the data in Document 2 is unprocessed and uncleaned.

1. As the dataset contains outdated or preliminary data, and has been superseded by a final version which is publicly available,[74] Professor Wakefield considered that it should not be disclosed. It is highly undesirable to have different versions, including a final version, of the same dataset disseminated. Document 2 has been kept confidential at all times.[75] Ill-informed publicity would undermine the public credibility of Council researchers, seriously threatening the organisation's ability to continue to attract donor income.[76]

1. Professor Wakefield said that the Silent Salesman Study is an investigator-driven research project, monitoring the prevalence and nature of personal tobacco pack display and smoking in outdoor areas of cafes, restaurants and bars in Melbourne and Adelaide, in order to evaluate whether such behaviours are more common under plain packaging than in a fully branded environment. The study is designed to monitor prevalence of pack display and active smoking before and after implementation of plain packaging. The study is an observational survey, where trained fieldworkers recorded observations from outdoor areas in selected street segments.[77]
2. The study is fully funded by the Council, Cancer Council South Australia, the South Australian Health and Medical Research Institute, and Quit Victoria.[78] The study was an unobtrusive observational study counting café patrons and cigarette packs, conducted in a public setting, and as such no ethics approval was required to conduct the study.[79]
3. Data was collected through fieldworkers sampling every venue in their assigned street segment, which had outdoor seating visible from the footpath, in the following phases:

(3) phase 3: mid-January 2014 to mid-April 2014; and

(4) phase 4: mid-January 2015 to mid-April 2015.[80]

1. Data collected during the study formed the basis of a final paper published by the international journal Addiction in 2014.[81] That study compared results from phases 1 and 2.[82] Data collected during that study also formed the basis of a final paper published by the British Medical Journal.[83] That study compared results from phases 1, 2 and 3.[84]

1. Professor Wakefield said that there are at least two further analyses and manuscripts underway or planned, using the data collected in the four phases. For this reason, the Silent Salesman study is considered incomplete.[85]
2. Documents 3 and 4 are Stata data files comprising the working datasets of the Silent Salesman Study. Document 3 comprises the merged and cleaned data representing the results of phases 1 and 2 of the Silent Salesman Study. Document 4 comprises cleaned data representing the results of phase 3 of the Silent Salesman Study, merged with the results of phases 1 and 2. Both documents contain observational questions and the responses to those questions of persons conducting the survey.[86]
3. These datasets contain additional data which have not formed the basis of any published papers. The studies relating to the survey questions and data are currently undergoing further research and analysis, and the data collected from the studies will form the basis of further papers to be released in the near future.[87] Professor Wakefield said that the datasets should not be disclosed prior to the completion of the study. Professor Wakefield considered she could not say more about the nature of the research questions and papers under contemplation without compromising the confidentiality that the Council retains about these matters.[88]
4. Professor Wakefield considered that the method used in the study is highly novel, as an unobtrusive way of determining the prevalence of smoking and pack display in public.
5. Given the intellectual and time investment made in conceptualising, designing, carrying out the study over a four year period, and then analysing the data, the Council is keen to ensure the study is able to contribute as much as possible to knowledge-building in tobacco control.[89]
6. Professor Wakefield said that disclosure of Documents 3 and 4 would permit other researchers who had nothing to do with and made no investment in the study, to analyse the Council's data and write papers that the Council should lead. That outcome would undermine the ability of the Council to build the track records of its own researchers and to add to its international profile as a leading research group in tobacco control.[90]
7. Professor Wakefield said that the datasets are considered working documents which contain the deliberations of Council researchers, which have not been finalised for public release.[91] She considered that these documents should not be disclosed, to protect against confusion or misrepresentation of preliminary data, and unfair or unreasonable criticism of data that has not been submitted to peer review. Documents 3 and 4 have been kept confidential at all times.[92]

1. The Tobacco Retail Outlet Monitoring Study is an observational study, monitoring the effects of plain packaging on the sale of tobacco products, including price, transaction time and the availability of counterfeit and contraband tobacco. Data was collected by a team of trained fieldworkers, who visited a panel of tobacco retailers monthly from May 2012 to August 2013 in Sydney, Melbourne, Adelaide and Perth.
2. The study was conceived, designed and led by Centre researchers and was funded by Quit Victoria, Cancer Council Australia, Cancer Council Victoria, Cancer Council South Australia, Action on Smoking and Health (UK), and its partner organisations Cancer Research UK, Smokefree SouthWest, and Fresh and Tobacco Free Futures.[93] It was a substantial, complex and expensive study for non-government organisations to fund, which yielded a wealth of information.
3. The study built substantially on methods established by the Council in the late 1990s to monitor the advertised price of tobacco in retail outlets, and more recently included monitoring of compliance with cigarette display bans and retail tobacco marketing strategies.[94]
4. Data collected as part of this study has formed the basis of four published papers.[95] These papers in peer-reviewed journals demonstrate how quickly retailers adapted to serving plain packs, how illicit tobacco is available for sale in most small tobacco retail outlets, and how advertised tobacco prices increased after plain packaging.
5. These papers are the first of a large number of papers that the Council wants to generate from this major data collection effort. Additional papers are proposed to be submitted for publication over the next 6 to 18 months.[96]
6. Professor Wakefield said that Documents 5 and 6 are Stata data files, comprising the working datasets of 16 months of data collection for the Tobacco Retail Outlet Monitoring Study. Document 5 has the monthly results of the retail store audits from May 2012 to August 2013.[97] Document 6 has three-monthly results of a subset of data collected every 3 months from May 2012 to July 2013.[98] Each dataset contains data that has not yet been included in the papers published to date.[99]

1. The studies are undergoing further research and analysis, and the data collected from these studies will be published in papers in the near future. Professor Wakefield is of the view that the datasets should not be disclosed prior to the completion of the study.
2. The datasets are draft datasets, containing the deliberations of Council researchers.[100] Some variables are yet to be fully re-coded, and the datasets still contain information that could reveal the identity of the stores which were the subject of the study. The datasets remain confidential within the Council.
3. Professor Wakefield said that the Council has worked collaboratively with other researchers, where arrangements to ensure satisfactory quality of the research have been agreed to.[101] The Council does not wish its original data files to be made available to researchers with whom it does not have such collaborative arrangements. If they are made publicly available, other researchers would be able to use Documents 5 and 6 to write papers using the data the Council has spent a good deal of money and intellectual capital collecting, before the Council has had the opportunity to do so itself. That would greatly reduce Council researchers' ability to compete for future funding, and erode the Council's ability to fund salaries for its research staff.[102]

1. Professor Wakefield said that part release of the disputed documents is not possible. The applicants seek the entirety of the content of the disputed documents.[103] She said that there is no other relevant information to which access could be granted.

1. Professor Wakefield gave evidence that the Council has undertaken some of the first evaluation studies of the early effects of plain packaging, publishing its results in scientific peer-reviewed journals. The Australian policy, and the scientific evaluation of it, are subject to intense local and international scrutiny given that Australia was the first country to introduce plain packaging legislation.
2. It is common ground that British American Tobacco disputes the efficacy of plain packaging legislation as a mechanism to reduce smoking, following the introduction of similar legislation in other countries.[104]
3. Professor Wakefield referred the Tribunal to the following publications regarding the tobacco industry:
   • The preamble of the Transparency in Tobacco Control resolution of the WHO:

Noting with great concern the findings of the Committee of Experts on Tobacco Industry Documents, namely, that the tobacco industry has operated for years with the express intention of subverting the role of governments and of WHO in implementing public health policies to combat the tobacco epidemic.[105]

In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law.[106]

• Principle 1 of the Guidelines for Implementation of Article 5.3 of the WHO Framework Convention on Tobacco Control,[107] which states:

There is a fundamental and irreconcilable conflict between the tobacco industry's interests and public health policy interests. 13. The tobacco industry produces and promotes a product that has been proven scientifically to be addictive, to cause disease and death and to give rise to a variety of social ills, including increased poverty. Therefore, Parties should protect the formulation and implementation of public health policies for tobacco control from the tobacco industry to the greatest extent possible.[108]

1. In early 2014 as a result of an FOI request, the applicant obtained data from a NSW Tracking Survey conducted by the Cancer Institute NSW. According to Professor Wakefield, the data from the research was incomplete.
2. In June 2014, the researchers from the Cancer Institute NSW submitted a manuscript to the British Medical Journal for peer-review and revision. In August 2014, prior to publication, British American Tobacco UK lodged a submission with the UK Department of Health,[109] by way of consultation on the proposed introduction of standardised packaging of tobacco products. The submission attached a report ('the Gibson report'), which contained data from the NSW Tracking Survey obtained by the applicant as a result of the FOI request. In November 2014, the paper submitted by the researchers was accepted for publication. In December 2014, the paper was published in final form.[110]
3. Professor Wakefield expressed the following concerns about the Gibson report:
   • the presentation of the survey findings by British American Tobacco UK lacked context, as it did not make clear that the survey was not intended to provide an indication of smoking prevalence;
   • the Gibson report contained graphs which were misleading. For example: aggregate statistics for 2013 were compared with those for 2012, despite the fact that plain packaging only commenced operation in October 2012. Other graphs contained axes that ran from 50% - 80%, rather than 0% - 100%, thereby exaggerating small increases and declines;
   • the data presented in the submission for 2014 only comprised 360 participants over a 2 month collection period, which was compared with about 2,500 participants in each of 2012 and 2013;
   • it was suggested in the Gibson report that the percentage of daily smokers increased from 2012 to 2013. It was not possible to draw this conclusion on the data available, which did not include information from those who had stopped smoking or were non-smokers, who were not eligible to participate in the survey;
   • the Gibson report failed to acknowledge a change in the conduct of the survey from mid-2013, at which time mobile phone participants were included, rather than just landline participants; and
   • the Gibson report did not undergo peer-review, and did not seek comment from the Cancer Institute of NSW. The Cancer Institute of NSW was not in a position to use its paper to correct any inaccuracies contained within the Gibson report, as its paper remained under embargo as a result of the peer review process for a period of five months after the British American Tobacco UK submission became public.[111]

1. In November 2014, the Australian Institute of Health and Welfare released the results of the 2013 National Drug Strategy Household Survey. Professor Wakefield stated that the results showed a record decline in smoking rates in Australia between 2010 and 2013. The figures on daily smoking were lower for 2013 for most age groups compared with 2010. Professor Wakefield suggested that the small number of respondents aged under 18 who participated in the survey made it difficult to detect change amongst that (youngest) age group. The figure for 12-to-17-year-olds was 0.9% higher in 2013 than in 2010; but Professor Wakefield suggested that this change between 2010 and 2013 was not statistically significant.[112]
2. Professor Wakefield stated that following the release of these results, British American Tobacco Australia published a media release with the headline 'Youth smoking rates soar two years post plain packs'.[113] This interpretation was refuted by the Australian Institute of Health and Welfare, which commented that the sample size of the survey was too small for such a conclusion to be drawn.[114] Nevertheless, three days later, British American Tobacco Australia published a further release to the same effect.[115]
3. According to Professor Wakefield, while researchers in her field are accustomed to refuting arguments from industry, scientific research cannot be defended until the peer-review process is complete. Premature release of data is likely to prejudice, not promote, the public interest in informed, accurate and fair debate.[116]

1. Associate Professor White is the leader of the ASSAD study, and has worked on every survey since 1987. The ASSAD survey is a triennial national survey designed to provide information about the current prevalence of tobacco, alcohol and illicit substance use among Australian secondary school students, and to examine trends in their substance use.[117] The ASSAD study has provided information over a long period of adolescents' tobacco and alcohol use in Australia. It provides information about substance use from the largest sample of secondary students.
2. From March 2006, all tobacco products made in Australia have featured one of seven new graphic health warnings.[118] Data from subsequent ASSAD surveys has been used to track and assess the effect of these warnings.
3. Following the introduction of plain packaging for tobacco products in Australia, the 2011 ASSAD survey was used to assess awareness and processing of health warnings and pack image.[119] The [2013] ASSAD survey continued the assessment of students' responses to cigarette packs after the introduction of plain packaging.
4. Associate Professor White gave evidence about the content of the ASSAD survey. Tobacco use questions relate to the recency of smoking, frequency of smoking in the previous seven days, method for accessing cigarettes, brand preferences, perceived ease of accessing cigarettes, intention to smoke in the next 12 months and self-description of smoking behaviours. Supplementary questions include smoking behaviours of parents and friends, attitudes to smoking, perceived health risks and perceptions of cigarette pack image.[120]

1. In November 2010, the Council submitted an application to the HREC for ethics approval to conduct the 2011 ASSAD survey. The application acknowledged that:
   • schools must provide written consent for their participation in the study;
   • parental consent must be given if required by the school; and
   • students' consent must be obtained.[121]

The application addressed ethical considerations such as the use of personal information and the Victorian Information Privacy Principles.[122]

9. Security procedures and access to information

All student questionnaires will be completed anonymously. Schools will be assigned an identification number and only this number will be stored with the student and school data.

All information identifying any one school in this project will be stored in a separate location to the de-identified questionnaires. Only the research team will have access to this information.

Analyses will be conducted at an aggregated level. No school or student will be identified in any reports from this study.[123]

1. The letters of invitation to schools were in a standard form submitted to the HREC as part of the application for ethics approval, and stated:

All information collected in the survey is treated in strict confidence and no student or school is identified in any report on the data collected through the survey. Data is only reported at an aggregated level and reports focus on reporting state or national prevalence estimates. Students complete the survey anonymously and are told specifically not to put their name on their survey. No information identifying the school is stored with the students' data and we do not provide school based data to any organisation or individual.[124]

1. The information brochure provided to schools stated:

Schools cannot be identified from the results and individual schools are not referred to. In addition, students' responses are completely anonymous and confidential. [125]

1. The letter sent to parents asking permission to include their child in the study stated:

[The Department of Education and Early Childhood Development or equivalent in each state] has approved the study, which is part of a national survey of secondary students. The results of the survey will be used to develop education programs aimed at reducing the use of drugs among young people.

Our school has agreed to participate in the study. Members of the research team will be coming to the school to conduct the survey in the next month. The survey is confidential and anonymous. Students are told NOT to write their names on the questionnaire.

I am writing to ask for your help by allowing your child to participate in the survey.

If you do not agree to your child being included in the survey, please complete the form below and return it to your child's teacher. If you do not return the form, we will assume that you are happy for your child to be included in the survey. If your child does not wish to participate she/he will be given the opportunity to withdraw from the study at the time of the survey.

Any information provided in the survey is completely confidential and will only be used for research purposes. No school or student will be identified in the data set or in any reports published from the study.

In view of the importance of this project as part of the continuing effort to improve the health of our young people, your assistance is greatly appreciated.[126]

1. Where schools or education authorities required active consent to be given by parents, the circular seeking this permission stated:

I am writing to ask for your help by allowing your child to participate in the survey.

For your child to participate in the study, your permission is needed. Please indicate on the form attached whether you agree or do not agree to your child participating in the study and return the completed form to your child's teacher. Your child will only be asked to participate in the study if you give your consent. If your child does not wish to participate she/he will be given the opportunity to withdraw from the study at the time of the survey.

Any information provided in the survey is completely confidential and will only be used for research purposes. No school or student will be identified in the data set or in any reports published from the study. [127]

1. Notice of final ethics approval was given by HREC in March 2011.[128]

1. In order to conduct the surveys in schools in Victoria, the Council required approval from the Department of Education and Early Childhood Development ('DEECD') for Victorian government schools, and from the Catholic Education Office Melbourne ('CEOM') for Catholic schools.
2. DEECD published guidelines for those who seek to conduct research in Victorian Government schools and early childhood settings.[129] The guidelines are a non-exhaustive list of applications that will not be approved:

To ensure that the duty-of-care to protect students is maintained, the Department will not approve the following applications. This list is not exhaustive but includes those that:

• have the potential for a high level of personal intrusion on participants, emotionally, psychologically and/or physically
• involve the administration of medications and/or drugs
  • potentially lead participants to unreasonably incriminate themselves, such as in illicit drug taking, stealing or carrying weapons
  • focus disproportionately or sensationally on negative behaviour, have the potential to stimulate stress or risk taking behaviour
  • have the potential to adversely affect the Department of Education and Early Childhood Development or the school
• are undertaken for commercial, marketing or journalistic purposes
• do not meet the standards of an applicant's HREC.[130]

1. In October 2010, the Council submitted an application signed by Professor Wakefield to DEECD for the 2011 ASSAD survey. The application provided detailed information concerning the 2011 ASSAD survey, and described how informed consent was to be obtained from parents and guardians, and participants:

Schools will follow their usual procedures for allowing students to participate. Schools will be asked to use a passive consent procedure. Parents receive letters through the mail describing the study and the survey contents, and if they do not want their child to participate in the study they must return the signed consent form. Non-responses imply approval for their child's participation. The contact teacher will keep a list of non-participating students.

Approval for passive consent procedures for the 2008 survey from the then DET Victoria is attached; the same procedure has been submitted to Cancer Council Victoria's Human Research Ethics Committee for approval for the 2011 survey.[131]

1. The strategies to maintain confidentiality are set out in the application in the following terms:

All students complete the survey anonymously and are told not to write their name on the questionnaire. Completed questionnaires are placed into an unmarked envelope and deposited into a box by students. Therefore, there is no way of tracing a particular survey back to an individual student. Schools will be assigned an identification number and only this number will be stored with the student and school data. All information identifying any one school in this project will be stored in a separate location to the de-identified questionnaires. Only the research team will have access to this information. All procedures meet with Victorian Information Privacy Principles.[132]

1. In November 2010, DEECD approved the conduct of the 2011 ASSAD survey, including the use of passive consent for the study in 2011.[133] Conduct of the survey was subject to additionally obtaining approval from the principal of each school asked to participate in the survey.[134]
2. A similar process was adopted by the Council to obtain approval from the CEOM. The approvals granted by the CEOM in March 2011 in relation to the 2011 ASSAD surveys required informed consent in writing by a parent/guardian before a student could participate in the research study, provided that the student was willing to do so.[135]

1. The 2011 ASSAD survey form as provided to students in Victoria stated:
   • Please do not write your name on this paper.
     • The information you give is private and will only be seen by the researchers.

• You may withdraw from the survey at any time.[136]

1. Questions asked of students included questions such as:

28. (a) What brand of cigarettes do you usually smoke?

28. (b) Do the cigarettes you usually smoke come from packets of ...?

29. (a) Where, or from whom, did you get the last cigarette that you smoked?

[Different alternatives were identified including parents, family members or friends, or purchase from various retail outlets].

29. (b) If someone else bought cigarettes for you, who was this person?

[Various alternatives including friends over or under 18 years, brothers or sisters over or under 18 years, strangers or others are listed].[137]

1. There were also questions specifically about family smoking habits:
   1. Here are some questions about your family and friends. [Questions are then asked about whether either parent, or brothers or sisters or 5 closest friends smoked].
   2. What are the rules or restrictions on smoking cigarettes in your house?

1. What are the rules or restrictions, if any, on cigarette smoking when you are in the family car?

[Various alternatives are provided].[138]

1. Questions directed as to whether smoking at school is permitted, and as to tobacco packaging included:
   1. Are students allowed to smoke at your school?

1. Please think about the pictures below and answer the questions next to them.

[Packs of various brands of cigarettes are then depicted showing cigarette packets prior to plain packaging, and asking questions about the student's reaction to branding and to people who smoke the identified brand].

1. Here are some things people have said about different brands of cigarettes. How much do you agree or disagree with each of the following statements?

[Questions are then put as to the relative ease of smoking, addiction, quitting, extent of harmful substances in them, and whether packs of cigarettes are better looking than others].[139]

1. A similar application for ethics approval with undertakings as to the confidentiality of the survey and the use of data was submitted in December 2012 for the 2013 survey. Approval for this study was ultimately received in February 2013.[140]
2. The 2013 ASSAD survey form contained a different range of questions, but made similar enquiries to the 2011 ASSAD survey form.[141]
3. The Council submitted an application to DEECD for the 2013 ASSAD survey in February 2013. The procedure by which student and parental consent was to be obtained was described in similar terms to that provided in 2011. Strategies to maintain confidentiality were set out in the application.[142] The documentation provided to DEECD was similar to that provided in 2011.[143]
4. In April 2013, DEECD gave conditional approval for the 2013 ASSAD survey to be administered in Victorian government schools.[144]
5. A similar process was adopted by the Council to obtain approval from the CEOM. The approval granted by the CEOM in March 2013 in relation to the 2013 ASSAD survey required the informed consent in writing by a parent or guardian before a student could participate in the research study, provided that the student was willing to do so.[145]

Concerns about future access to schools to conduct ASSAD surveys

1. Associate Professor White said access to schools is essential for the conduct of the ASSAD study. It is crucial to the reliability of the study and its results that a sufficient sample size of both schools and students is obtained. She expressed a number of concerns about securing schools to participate in the study:
   • the Council has been refused permission by some education authorities;
   • once education authorities consent, individual schools needed to consent to participation in the study. It was increasingly difficult to obtain consent of individual schools to participate in the study. Consent is given to the Council partly in recognition of its long established history of operating the ASSAD survey, its record in conducting the survey ethically with strict compliance to the guidelines specified by Education Departments, and the value education authorities place upon the Council's approach to gaining a clearer understanding of the patterns and determinants of adolescent substance use;
   • the approval for the Council to access schools is given under strict conditions, including relating to data control and use of data; and
   • if the Council cannot assure schools that the data will be kept confidential, this may provide a reason for a school not to participate in the study.[146]

1. As to the possible release of Document 1, Associate Professor White expressed a number of concerns:

(1) it would disclose individual's answers to questions, relating to tobacco use, along with their age, gender, academic achievement and available pocket money;

(2) the data could be useful to commercial entities which are currently not able to collect that information from adolescents because education authorities do not permit the conduct of commercial surveys in schools;

(3) Document 1 could be used by commercial interests such as tobacco companies to adapt their marketing strategies to suit and attract school children more effectively. This could lead to significant adverse public health outcomes;

(4) price discounting may be used to attract adolescents to different brands, with different levels of discounting used in different areas; and

(5) such a result would go directly against ethics approvals which are granted on the premise that ASSAD research is of benefit to the community.[147]

1. If Document 1 is released, the Council will be obliged to inform the participating education authorities, along with the HREC of the release. Associate Professor White suggested that it is likely that this would create significant obstacles in obtaining future ethics approvals for the ASSAD survey, could jeopardise the likelihood of education authorities approving the conduct of the study in their schools and may reduce the likelihood of schools, parents and students participating in the study.[148] This could affect the viability of the 2017 ASSAD study. A threat to the viability of the 2017 ASSAD study could threaten the conduct of the survey into the future, and in turn the long term study of the impact of plain packaging.[149]
2. Associate Professor White described Document 1 as a working data file, consisting of data from the 2011 and 2013 ASSAD surveys, plus variables developed from existing variables for data analysis purposes.[150] Computed variables are made either by recoding the answers to one question in the survey into different groupings, or by combining responses from several items to compute an overall scale score.[151] The data is analysed to determine patterns, from which to draw conclusions and/or build models. Much of the data would be unintelligible without understanding the different analyses that have been undertaken, including how new variables are computed and whether specific groups of students are included or excluded from analyses.[152]
3. The digital nature of the dataset can lead to inappropriate analysis of the data by those who are not appropriately skilled in analytic practices used in the behavioural sciences.[153] The different interpretation of results can lead to confusion and doubt as to the accuracy of reported findings.
4. In analysing the data sets for patterns, researchers are required to use their experience in data. The Council has a long history of research into smoking behaviours in the Australian population, commencing in the mid-1970s, and brings this expertise to the design and analysis of the ASSAD datasets. The approach adopted by the staff of the Council in analysing the ASSAD survey is stringently critiqued in a peer-review process and is often subjected to further assessment and review. This leads to further revisions, and corrections.[154] As is usual during the peer review process, revisions undertaken in response to reviewers' comments often lead to further analyses, sometimes the creation of new variables, or modifications that are applied to the dataset and reported in a revised paper.[155]
5. Associate Professor White was of the view that Document 1 is a working dataset, which is not suitable for general release. It has never been intended for public release. As was the case for Professor Wakefield, Associate Professor White was concerned about the ability of the community to assess the validity of alternate results the outcome of analysis methods which have not been subjected to traditional peer review processes.[156]

1. Document 1 contains responses to questions from the 2011 and 2013 ASSAD surveys. Analysis of some of the questions posed in the surveys have been the subject of several published research papers.[157] Two articles in particular[158] describe and discuss the methods of the ASSAD survey, survey measures, the statistical analyses employed, results of the survey and conclusions drawn, as well as the limitations of the study.[159] They were both externally peer reviewed prior to publication, and both constitute final deliverables provided to the Commonwealth Department of Health under the funding agreement.[160]

1. The Council is continuing to conduct analysis on the data obtained in the 2011 and 2013 ASSAD surveys, including data not yet published or considered by the two research papers. That analysis will produce further manuscripts to be published in late 2016. The Council also intends to publish papers incorporating the 2017 ASSAD data.
2. Publication of research results in peer reviewed journals is extremely important both to the Council and the individual researcher. The Council must show value for the money it contributes to research. It is accepted that this can be done through a number of peer-reviewed publications produced from research and the impact of its research in the broader field. As Australia was the first country in the world to introduce plain packaging legislation, peer reviewed research conducted on the short- and long-term impact of TPP legislation on the smoking behaviours of adolescents is of great interest.
3. Peer-reviewed publications are also very important to a researcher's career, as they demonstrate the researcher's academic track record. This is considered when applying for research funding. Any reduction in the ability of a researcher to publish peer reviewed research has a negative impact on the researcher's track record, and future ability to secure grant funding.[161]
4. In Associate Professor White's view, Document 1 contains data from a study that is not yet complete.[162] It is undesirable for such data to be made public.

1. Mr Harper has held the position of CEO of the Council since April 2011. The Council convenes a number of scientific and medical advisory committees, made up of professionals providing cancer services, representatives of universities, hospitals, medical colleges, associations and specialist research institutions, and individual specialist oncologists, radiologists and surgeons.[163] Mr Harper was of the view that the Council's ability to attract the highest calibre of professionals to its advisory committees, and therefore to advise government policy and professional practice, was critical to its ability to achieve its objects.[164]
2. Mr Harper referred to a number of statistics about smoking, including the fact that almost two in every three smokers will die early as a result of their smoking,[165] and that tobacco is a causal factor in about 30% of cancer deaths.[166] Smoking tobacco is addictive, and many smokers try to quit on a number of occasions but fail. Mr Harper was of the view that it is common for smokers who have struggled to quit to find reasons to avoid health messages.[167]
3. In the last 5 years, over half of the Council's total income has been derived from bequests, donors, fundraising and related activities. The Council received funding from Vic Health and the Department of Health and Human Services ('DHHS') to run the Victorian Cancer Registry and other high profile cancer prevention programs such as Quit and SunSmart.[168] The Council is one of the most trusted 'brands' in Victoria, and is known as one of the older, more established, not-for-profit organisations. The willingness of members of the public to donate to the organisation depends on the public's perception of Council's trustworthiness and effectiveness.[169]
4. The Council is ranked from third to fifth among Australian research institutions, and 60th to 67th among international research institutions.[170]

Loss of access to schools for research and cancer prevention education

1. Ongoing behavioural research surveys of school children provide critical information for the Council to plan cancer prevention programs and policies, and to monitor the outcomes of these programs and policies.[171] The Council's longstanding reputation with the public as a responsible custodian of data would be severely damaged by the release of the disputed documents. Mr Harper stated that the Council's HREC, the education authorities, individual schools, and parents would not have permitted school children to participate in the ASSAD surveys if they thought that the dataset was able to be accessed by tobacco companies.[172]
2. The Council would likely face loss of reputation with funding partners, including the State Governments and State Cancer Councils, which fund the ASSAD survey. They entrust the Council to undertake the survey in a responsible manner and keep the data secure.[173]
3. Loss of reputation on the part of funders and public could well result in an inability to continue other research, such as that relating to sun protection, diet and physical activity.
4. Mr Harper expressed concern that damage to the Council's reputation as a credible, trusted source of information could result in Victorians being less likely to adopt the Council's recommendations regarding prevention, detection and treatment of cancer, and being less likely to use the Council's services. This could result in loss of life.[174]

Reduced willingness of the public, including cancer patients, to participate in other research projects

1. The loss of trust resulting from the release of data to tobacco companies may affect other areas of research that the Council undertakes. In particular, Mr Harper was concerned about the willingness of physicians to recruit patients to participate in studies to assess the cancer treatment experience.[175]

Loss of competitive edge for attracting high calibre staff and securing funding

1. The work of the Council's internal research units depends on its continuing ability to attract and retain high calibre staff. There is increasing competition to win grant funding from the NHMRC and other funding agencies, with less than 15% of submitted project grant applications receiving funding in 2014.[176] The Council seeks to preserve its cutting edge in terms of forging new research knowledge. The Council's donors expect it to lead new discoveries through cancer research. The loss of reputation which would result from the disclosure of the ASSAD survey data would undermine the Council's position as coordinator of this important national survey. It is likely that this would substantially erode its research reputation, and undermine its ability to create and sustain research partnerships.[177] Mr Harper was of the view that this would compromise the Council's ability to attract additional NHMRC funding and contracts that rely on survey data collection.[178]

1. Many of the Council's donors and supporters do so following the loss of relatives and friends to tobacco-caused cancers. Mr Harper stated that these donors and supporters expect the Council to advocate effective tobacco control policies, regardless of any resistance encountered from tobacco companies.[179]
2. Allowing tobacco companies access to data that could help them in their marketing strategies could undermine donor trust and volunteer work.[180] This may lead donors and volunteers to decline in future to support the Council through donations and participation in fundraising events.

1. Mr Harper is concerned that the release of the disputed documents to tobacco companies has the potential to lead to misuse of the information. The Council accepted that its policies may be inconvenient for tobacco companies, and is therefore prepared to vigorously defend its research.[181] Mr Harper suggested that the Council welcomed rigorous scientific scrutiny.[182]
2. Mr Harper expressed concern that the data provided to the applicant could be shared with anyone, and used in ways that are misleading or mischievous.[183] Statements to the public based on an erroneous interpretation of the data contained in the disputed documents could easily confuse the public, jeopardise the Council's credibility, and undermine the future effectiveness of the Council's fundraising activities and prevention campaigns.[184]

1. Professor Fox has held the position of chair of the Council's HREC since December 2013. He described the process by which consent was obtained from students participating in the ASSAD survey as the key to the conduct of the research.[185] Without a clear process of gaining informed consent by or on behalf of the students, the HREC cannot approve the conduct of the study.[186]
2. Confidentiality over the data collected as part of the ASSAD study must be maintained and guaranteed, so that the HREC can give permission for the study to commence and continue.[187] HREC approval of the ASSAD survey is predicated on the publication of the results in an aggregated format, which does not contain individual or identifiable data.[188]

1. Professor Fox expressed a number of serious concerns about the release of Document 1. They include:
   • release of Document 1 would breach the privacy principles upon which HREC approval of the ASSAD survey is based. In future, Professor Fox stated that the Council would need to declare in the Participant Information Sheets that there was a possibility of the release of confidential, identifiable individual data. The Council's HREC, in accordance with NHMRC guidelines, could not approve a study that carried such a risk; and
   • release of Document 1 could destroy the Council's research reputation at both a scientific and ethical level.[189] There would be national and international consequences, as a result of the Council's international reputation in its conduct of such behavioural studies as the ASSAD survey. At stake would be the Council's reputation relating to both the scientific value of the research, but also the integrity of the research project.[190] Release of Document 1 would degrade the Council's reputation relating to the handling of confidential information.
2. Professor Fox provided a copy of the National Statement.[191] As to ethical considerations affecting research involving children and young people, the National Statement says:

Research involving children and young people raises particular ethical concerns about:

• their capacity to understand what the research entails, and therefore whether their consent to participate is sufficient for their participation;
• their possible coercion by parents, peers, researchers or others to participate in research; and
• conflicting values and interests of parents and children.[192]

1. Significantly, the National Statement permits a review body to approve research concerning children or young people only if the research aims to benefit the category of children or young people to which the participant belongs.[193] The National Statement addresses 'the best interests of the child':

4.2.13 Before including a child or young person in research, researchers must establish that there is no reason to believe that such participation is contrary to that child's or young person's best interest.[194]

1. Dr Timms has held the position of Executive Director of the Performance and Evaluation Division in the DET.[195] Dr Timms described in detail the rigorous review process undertaken by DET for the approval of research in Victorian Government schools.[196]
2. Dr Timms said that all research applications that are deemed more than 'low risk' (as defined by NHMRC), or which pose any level of risk to the site or to DET, which is the case for the ASSAD survey, receive a higher degree of scrutiny and review by DET.[197]
3. Dr Timms stated that generally speaking, DET will not approve research applications that:

(a) are undertaken for commercial or material gain, including those involving primarily marketing activities or market research;

(b) have the potential to adversely affect DET, schools, early childhood setting or participants; or

(c) do not meet the standards of an applicant's [HREC].[198]

1. DET provides approval in principle for research projects, subject to compliance with specified conditions. Failure to comply with DET's conditions would be taken extremely seriously by DET, and may result in withdrawal of approval and/or support for the project.[199]

1. As to the release of Document 1, Dr Timms expressed a number of concerns:
   • if the ASSAD data were unconditionally released, this may result in DET withdrawing its ongoing support for the project. The Council is under an obligation to ensure that the data is used responsibly, and in the manner set out in its application for approval.[200] The Council must safeguard the privacy and confidentiality of participants at all times. The researchers and custodians of the data are obliged to take every precaution to prevent the data becoming available for uses to which participants did not consent.; and
   • future applications by the Council may be jeopardised, and future ASSAD surveys may not be approved. Schools may also be reluctant to participate in future ASSAD surveys, and other surveys of this kind, if they are aware their answers may be released under the FOI legislation.[201]
2. Dr Timms stated that DET had provided approval for the ASSAD survey under the assurance that:

(a) all data is treated in the strictest confidence;

(b) no student or school will be identified in any reports or publications;

(c) data is only reported at an aggregate level; and

(d) data will not be provided to any third party organisations or individuals.[202]

1. Professor Carapetis is a qualified paediatrician, infectious diseases physician and public health physician with a PhD in clinical, epidemiological and public health research. He received instructions to provide an expert report in these proceedings.[203]
2. He described the ASSAD survey as a state of the art, 3-yearly survey conducted since 1984. It is one of the longest such surveys of its kind in the world. The methodology is tried and proven. The data from this survey are relied on by all governments in Australia to monitor trends in tobacco, alcohol and illicit drug use, and as key indicators of progress in achievement of Australia's national drug strategy. The research has resulted in multiple, important, peer-reviewed publications. Taken together the policies of graphic health warnings and subsequently plain packaging are having important impacts on reducing the attractiveness of tobacco product packaging to adolescents.[204]
3. Professor Carapetis described the release of working datasets as 'unheard of, in my experience'. A working dataset is incomplete, in that further review may be done of variables including more recoding or creation of new variables. He could not think of a circumstance in which a working dataset released to someone who was not a core collaborator, someone in whom the researcher had confidence, and with whom the researcher had a formal agreement regarding analysis, interpretation and reporting on the data. Releasing a working dataset to the public would not be a good way of ensuring research integrity and reliability because it would be too open to misinterpretation.[205] Release of a working dataset was not a typical check and balance in scientific practice and procedure. In the absence of a full understanding of the data, analysis of a working dataset can lead a researcher to misinterpret the data and produce spurious conclusions from it.[206]

1. As to the release of datasets, Professor Carapetis expressed a number of concerns. They are summarised below.

1. The researchers have gone to great lengths to ensure the data from the ASSAD survey is held confidentially. Any risk to confidentiality might affect student responses to the sensitive subjects of the survey in the future, and invalidate the study methodology.[207]

1. If Document 1 is released, containing data collected from individual participants, even if cleared and recoded, there were concerns about the appropriateness of analysis by others of the dataset. If the data are analysed out of context, without an understanding of the study itself and the details of each variable, erroneous conclusions could be drawn.[208]

1. The ethical approval process and the subsequent procedures for gaining informed consent presume that collected data will be used for the purpose for which it is collected. Use for other purposes needs to be approved by the HREC, and may require consent from the participants. A failure to ensure privacy of research data renders the study unethical.[209]

1. Handing over a dataset before researchers have completed their analysis of the data and subsequent publication of peer reviewed works potentially detracts from research productivity.[210] Sharing of data between researchers is normally only done as part of an established collaboration, accompanied by a written collaboration agreement. Such a written agreement would include a clear explanation of the research, establish a protocol for any publishing by the researchers (which would normally include co-authorship for the primary researcher), and make arrangements for the return or destruction of the data at the end of the analysis.[211] Any potential commercial use of the data would be addressed in the agreement.

1. Professor Carapetis considered an opponent to be someone who is known to object to the research itself, or hold an opinion about the research findings that contradicts that reported by the researcher.[212] An opponent can be contrasted with a competitor, or a person with an academic interest in the subject who holds a certain amount of doubt or remains to be convinced. Professor Carapetis could identify no reason to share data with opponents, as their objective is likely to be to discredit the findings of the research. It is unlikely that an opponent could be trusted to analyse and interpret the data correctly in an open, honest and vigorous way.[213]

1. An individual research project eventually reaches a stage where the data have been analysed and reported to the fullest extent. At this stage, the project is considered complete. When a research team decides that a project is complete, it is usual for it to notify the HREC and provide a summary of the research findings and any outputs.[214] This process is usually repeated in favour of any stakeholders who provided funding.[215] Such notifications are an indication that the research team considers the project complete.

1. If data from a research study is misused, this reflects poorly on the researchers themselves, as any misconstrued findings arise from data obtained during their research. Moreover, any such release and reporting, if not planned in advance and included in the protocol approved by a HREC and provided to participants, may be in contravention of the ethics approval.[216] This could expose the researcher to accusations of academic misconduct. Professor Carapetis was of the view that this would undoubtedly damage the researcher's reputation amongst scientific peers or with the relevant organisations (such as schools or education authorities) whose cooperation may be required for similar research in the future.[217]

1. The applicant relied on evidence from Dr Neil McKeganey, a sociologist specialising in research relating to substance use and misuse based in Glasgow, Scotland; Professor W. Kip Viscusi, Professor of Law, Economics and Management at Vanderbilt University in Nashville, Tennessee in the United States of America, and Mr Stephen Leslie Gibson a director of an economic consultancy based in London. The applicant also relied on affidavit material from his solicitor.[218]

1. In his expert report,[219] Dr McKeganey contended that the disputed documents should be released.
2. The main points advanced by Dr McKeganey in favour of release were in summary:

(a) reducing the time taken to generate research findings;

(b) ensuring more widespread analysis of the data from research studies;

(c) reducing unnecessary duplication of research studies;

(d) strengthening the authority of research findings;

(f) increasing the public health benefit of research; and

(g) increasing the public engagement with research;

(2) leading world funders of public health research are committed to making the data obtained through the studies they fund publicly available;

(3) researchers are not the sole owners of the information provided to them by their research participants. In reality, research participants provide details about their lives to researchers in the belief that the information given will be used for the public benefit;

(4) datasets can be made publicly available in a format that preserves confidentiality;

(5) the datasets to which access is sought have already generated publications in peer-reviewed journals;

(6) the reputation of the Council and its researchers would be greatly enhanced within the scientific community if the raw datasets were made publicly available;

(7) to refuse access to data from past studies on the basis that the tobacco industry might use the information for commercial purposes is unjustified;

(8) none of the information requested contains data that would allow for the identification of any individual or school;

(9) the research participants have not been assured that the data would only be analysed by researchers from the Council.[220] A decision to open up the datasets to wider analysis does not violate any promise made to participants as part of the informed consent process;

(10) there is no reason to assume that public access to the research data would be perceived by research participants or the public as negative. Such access could be seen as a means of strengthening support for the research;

(11) the Council has chosen to engage in public policy debate by arguing for the adoption of plain packaging legislation. It is disingenuous that the data acquired by the Centre can subsequently be withheld;

(12) scrutiny by a greater range of researchers and research institutions of the data relating to the plain packaging legislation might provide important confirmation of the Council's conclusions about the impact of the legislation. Science is about discovering truths, not proving people right;

(13) peer reviewers do not normally have, or seek, data access. They consider whether researchers have employed appropriate statistical techniques, whether the findings are worthy of sufficient interest to be published in a peer reviewed journal, or whether the authors have made claims that go beyond the data reported in the manuscript; and

(14) open access to data has nothing to do with the quality of the research staff.[221]

1. Professor Viscusi provided an expert report,[222] which stated in summary:

(1) the absence of open access to the data impedes efforts by other researchers to examine the implications of the data, and to make conclusions that might assist in the development of effective and soundly grounded public policies;

(2) public health and the prevention of cancer deaths in Australia will be enhanced by release of the data;

(3) the published studies do not analyse all of the questions asked in the surveys, many of which are quite important to an assessment of the performance of plain packaging policies;

(4) release of the data does not undermine the conduct of high quality research;

(5) the greatest gains to the public are derived from making information public and sharing the information;

(6) allowing other researchers access to the data does not prevent Council researchers from analysing the data as well;

(7) if the Council's research is sound, research, policy and advocacy of the Council can continue unimpeded;

(8) the release of the data can be structured to preserve the confidentiality of the survey respondents by eliminating identifying information;

(9) research participants will be treated ethically if the data is released in a manner that does not directly identify them or their institution;

(10) if external critiques of the Council research are unreasonable, unjustified or invalid, the scientific community will recognise these shortcomings;

(11) there is nothing misleading about early versions of datasets;

(12) there is no risk from the release of 'partial, incomplete or draft versions of documents', since the request is for the data, not for draft articles in progress;

(14) Council researchers may be using data to make invalid claims, that would not withstand scrutiny once the data becomes available; and

(15) release of policy relevant data is the best approach to ensure a balanced assessment of the data.[223]

1. Professor Viscusi considered that the availability of the data as Stata files was the norm in economic research, and in many other disciplines.[224] All of his statistical analyses for his own research conducted over two decades has been performed using Stata.[225]
2. Professor Viscusi expanded at some length on his opinions as to published articles and studies concerning plain packaging. In general, he considered that the conclusions drawn in published studies that plain packaging was effective were misplaced or misconceived, and were not supported by his own studies.[226]
3. Finally, as to access to the study data, Professor Viscusi considered that the available articles provide only a partial overview of some of the implications available to be drawn from the data. Reliance on the data presented in the articles is not sufficient. It is essential to have the data files.[227]

1. As to the ASSAD survey, which gave rise to Document 1, Professor Viscusi opined that the study provided no consistent support for plain packaging.[228] He referred to two published studies,[229] and said that neither considered the smoking behaviour questions included in the survey, the significance of peer effects, or whether smoking was permitted in the student's household.[230]

1. As for the National Tobacco Plain Packs Tracking Survey ('NTPPTS'), which gave rise to Document 2, Professor Viscusi considered that the published articles did not demonstrate consistent evidence of a positive effect of plain packaging. In his view, beliefs in the harmfulness of cigarettes are insignificantly lower after plain packaging, whether focusing on the overall differences, or those that have been adjusted for age, gender, education and other factors.[231] In his view, the data did not provide consistent support for plain packaging, even taking into account non-behavioural variables.[232]

1. As to the Silent Salesman Study, which gave rise to Documents 3 and 4, Professor Viscusi considered that the observation by field workers of people smoking at selected outdoor venues in Australia, and the display of cigarette packs pre and post plain packaging, was not a meaningful measure of the effects of plain packaging.[233] The Silent Salesman data provides no evidence that any person reduced smoking after the introduction of plain packaging.[234] Professor Viscusi surmised from the data that plain packaging was already subject to some wear-out effect one year after the implementation of the measure.[235]
2. While the published articles present overviews of the Silent Salesman data, Professor Viscusi stated that the data did not permit a detailed examination of how changes in the locations being observed, and changes in the clientele at the locations being observed, could have influenced the results.[236] He also observed that it is important to examine smoking-related behaviour in conjunction with demographic information.[237]

1. As for the Tobacco Retail Outlet Monitoring Study, which gave rise to Documents 5 and 6, Professor Viscusi considered that the researchers had not pooled the data for the periods from June 2012, September 2012, December 2012 and February 2013 to see if there was an overall shift in retrieval times, after adjusting for any existing trend in retrieval times.[238] There is no adjustment made for store-specific differences. If the data from this study was publically available, it would be feasible for other researchers to test more thoroughly for the effect of plain packaging on retrieval time.[239] Studies of the sales of illicit tobacco and of cigarette prices relied on data from a very small sample of outlets, for which the composition of the sample was not identical over time.[240] In addition, the published results for pricing only related to the most prominently advertised single packs. As a result, the effects on the distribution of all cigarettes cannot be ascertained purely based on the published results.[241] Access to the data may assist in assessing the broader applicability of the findings.[242]

1. Mr Gibson provided an expert report,[243] in which he made a number of general observations in relation to the public interest considerations in providing access to information:
   • it is important to have as much information as possible in the public domain;
   • where information is only available to one side of the debate, regulatory powers would often be used to require regulated companies to provide or publish relevant information;
   • public interest considerations against disclosure are generally narrow and limited, and typically imply specific redactions, rather than a broad refusal to grant access. Public interest considerations might include confidentiality, price-sensitive information, issues relating to national security, or information that might impact on the prevention or detection of crime;
   • following consultation, it is for the decision-making body to consider the evidence provided by all stakeholders, and decide what weight to place upon each submission in reaching a decision on the policy question; and
   • where specific facts are in dispute (such as whether plain packaging has been effective in reducing tobacco use), the widest possible analysis and discussion of the evidence is desirable in forming the final policy decision.[244]
2. As to the public interest in disclosure of the Council's data, Mr Gibson said:
   • the evidence-base in relation to plain packaging is strengthened by having multiple researchers analyse the underlying data;
   • the evidence presented by the Council in at least one peer reviewed paper[245] was not incontestable, and in his view, misrepresented the results of the survey on which it was based; and
   • it is in the public interest that the data is available under an FOI request, so that the discussion on plain packaging in Australia, the United Kingdom, and other jurisdictions can fully encompass the policy implications of the evidence base.

1. In response to criticisms that the Council is running an advocacy campaign in favour of plain packaging legislation, Professor Wakefield said:
   • the Council works across the spectrum of cancer control, and as an organisation is strongly committed to reducing cancer incidence and mortality;
   • the Council regards advocacy of evidence-based policy as a crucial part of its role in preventing cancer;
   • the Council has a long-term commitment to the exploration and evaluation of program and policy interventions, which aim to reduce tobacco use; and
   • the Council implements a model, as recommended by leading academics, whereby researchers and end-user policy practitioners consult with each other throughout a research project. Professor Wakefield explained why, in her view, this did not result in conscious or unconscious bias on the part of the researcher, and described how this was achieved.[246]
2. Regarding the parallels that were drawn between the Council and the Cancer Institute of NSW, Professor Wakefield noted that the Council is an NHMRC approved administering institution for research - the Cancer Institute of NSW is not.[247] The Cancer Institute of NSW does not receive investigator-led NHMRC research grants, although it can participate in grants awarded to an administering institution. Council researchers are subject to research performance outputs, including the award of investigator-led research grants.[248] Unlike the Cancer Institute of NSW , the Council is heavily reliant on competitive research grants and donor income.[249]
3. As to Professor Viscusi's opinion on the limitations in the analysis and findings set out in the published papers, Professor Wakefield said:
   • an empirical paper published in a peer-reviewed journal essentially needs to be a complete record of the data relied on and the conclusions drawn from the data;
   • journals have tight word limits for published papers;
   • any single journal paper could not possibly present an exhaustive overview of all survey questions and all analyses;
   • the peer-reviewed journal papers published by the Council on plain packaging were focussed largely on the first full year of implementation; and
   • the peer-reviewed papers published by the Council did not seek to definitively examine the level of achievement of the overall objects of the TPP Act.[250]
4. Significantly, Professor Wakefield said that many more years of post-implementation data would be required to reliably quantify any impacts on smoking behaviour. Analyses which seek to do that too early after a policy is introduced are likely to underestimate policy effects. In the case of the ASSAD survey, this can only be ascertained with the passage of sufficient years for children to pass through their entire adolescence without taking up smoking.[251]

1. In her reply witness statement,[252] Associate Professor White said that data from the 2011 and 2013 ASSAD surveys comprising Document 1 are stored at a unit record level.[253] This means that data from each student participating in the study is represented as a single line of data, containing his or her postcode, the type of school he or she attends (Government, Catholic or independent), the postcode of the school attended and the State the student resides in.[254] While the names of students or the name of the school surveyed are not displayed, the data set does contain an indicator of the school type and the postcode of the school. Using this information, it could be possible to determine what school the data relates to.[255]
2. The Council tells the HREC, education authorities approving the conduct of the study in their schools, the schools, parents and students that data will only be reported at an aggregated level, and that no school or student will be identifiable.[256]
3. Other observations made by Associate Professor White were:
   • the published papers arising from Document 1 classify students into a number of different smoker groups depending on their responses to questions on cigarette use, eg 'experimenters'; 'past month smokers'.[257] This is reported in the published papers;
   • the TPP Act does not have as one of its aims a reduction in the number of cigarettes smoked per day; and
   • the research papers state why the researchers do not examine changes in adolescent prevalence, or smoking uptake.[258]

1. Mr Harper provided a statement in reply.[259] He focussed on the legal, organisational, and operational differences between the Council and the Cancer Institute of NSW. This included differences in purposes, funding, council membership, strategic direction, deductible gift recipient status, and research capacity.[260]

1. Professor Carapetis also provided a statement in reply.[261] He highlighted that the individuals from whom data was collected were not informed at the time they gave consent that the data might be made available to other parties.[262] He stated that it is naïve to suggest that the release of such data was ethically acceptable, because the consent process did not specify exactly which researchers would be given access to the data, or as long as individuals and schools cannot be identified. In his view, the tobacco industry had a track record of misuse and misrepresentation of research data without subjecting it to peer review or scientific scrutiny.[263]
2. Other observations of Professor Carapetis included:
   • in the move towards greater data sharing, there is a difference between depositing research data into a publicly-available repository, and giving it to third parties who have not made it clear how they intend to use the data, and what commitment they have to scientifically-rigorous analysis and appropriate peer comment;
   • there are issues to be clarified regarding incomplete datasets, and the rights of researchers to maximise the benefits of their research;
   • the datasets found in the disputed documents were not collected on the basis that they would be made available to any individual to do with what they please; and
   • the Council has clear procedures in place for data sharing, allowing third parties to obtain data but also ensure that such data will not be misused.[264]

1. Dr McKeganey provided a supplementary expert report.[265] He did not wish to revise his previous report.[266]

1. Professor Viscusi provided a supplementary expert report.[267] He considered that the evidence and additional information put to him did not affect his earlier opinions.[268]

1. Mr Gibson provided a supplementary expert report.[269] He considered that the revised assumptions and additional information put to him had no, or an insignificant, impact on the opinions previously expressed in his report.[270]

Objections to evidence and witness criticisms

1. The applicant filed written objections to the admissibility of some of the evidence of the Council.[271] The objections were mainly on the basis of relevance, hearsay or expertise. The Council filed a response to the applicant's objections.[272] In turn, the applicant provided a note on the Council's response to the applicant's objections.[273] In general, the passages of evidence under objection are not germane to the main issues in the proceeding, or are marginally relevant at best.
2. Section 98 of the Victorian Civil and Administrative Tribunal Act 1998 (Vic) ('VCAT Act') provides:

(b) is not bound by the rules of evidence or any practices or procedures applicable to courts of record, except to the extent that it adopts those rules, practices or procedures;

(d) must conduct each proceeding with as little formality and technicality, and determine each proceeding with as much speed, as the requirements of this Act and the enabling enactment and a proper consideration of the matters before it permit.

1. Nonetheless, the Tribunal acts on the basis of rationally probative evidence.[274] As a result, irrelevant evidence provided by the parties has no bearing on the ultimate outcome. Relevant hearsay evidence may be received whether expert or non-expert. It is given such weight as is appropriate, after taking into account the source from which it was derived, and the general reliability of the material. Hearsay material from unnamed sources is entitled to little, if any weight, unless uncontroversial. Speculative material is almost always given no, or very little, weight.[275]
2. In the circumstances of this case, it is appropriate to take the applicant's objections to the admissibility of parts of the Council's evidence, and its note in reply, as submissions that the parts of the evidence referred to should be given no weight by the Tribunal. Equally, the submissions made by the Council in support of the passages of evidence objected to will stand as submissions to the effect that the evidence referred to is entitled to be given weight, apart from the instances where the passages objected to are not pressed. All submissions have been read and considered by the Tribunal in making its final decision.

1. The Council provided extensive written submissions by way of commentary and criticism of the witness statements of the applicant's expert witnesses.[276] In turn, the applicant responded to each written submission made by the Council, with further written submissions.[277]
2. Prior to the hearing, the parties agreed that witnesses would not be cross-examined. No witness had the opportunity to answer criticisms or challenges to his or her evidence. As a result, the Tribunal does not consider that the evidence of any witness can be dismissed or disregarded. The witnesses are largely expert witnesses with outstanding qualifications and international eminence in their respective areas of scientific research and in their academic and professional appointments. It would be unfair and inappropriate to dismiss or disregard the evidence of a witness without that witness having had any opportunity to respond. The evidence of all witnesses has been taken into account and given such weight as the Tribunal has deemed appropriate.

1. The Council claims that Documents 1-6 are exempt under s 30(1) of the FOI Act. The exemption is made out only if the Council satisfies the Tribunal that:

(1) disclosure of the document would disclose matters in the nature of consultation or deliberation that has taken place between officers in the course of, or for the purpose of, the deliberative processes involved in the functions of the Council;

(2) disclosure of the document would be contrary to the public interest; and

(3) the document contains material not being purely factual material.

1. The Council and the applicant referred to a number of decided cases, which highlighted the application of the exemption The decisions also provide guidance as to the scope and interpretation of s 30(1).
2. In Penhalluriack v Department of Labour and Industry.[278] Judge Lazarus described the purpose of s 30(1):

... to protect the deliberative processes of government and to ensure that measure of confidentiality which will enable policy and the like decisions to be taken after the frankest possible interchange of views and ideas between officers of the public service and between them and their Minister, as well as between members of the ministry ...[279]

His Honour then referred to the 'public interest' requirement as 'placed there to cut down the breadth of application of the exemption so that it extends to protect the public interest, but no further'.[280] His Honour described the exemption as 'very wide indeed'.[281]

1. In Halliday v The Office of Fair Trading,[282] consideration was given to whether handwritten notes taken by a legal officer while instructing counsel during a Magistrates' Court hearing were exempt under s 30(1). The Administrative Appeals Tribunal ('AAT') held that the notes attempted to record what was said in court, and did not meet the description of 'opinion advice or recommendation'.[283] These words conveyed a meaning of matters in the nature of 'a personal view', 'an opinion recommended or offered' or 'a presentation worthy of acceptance'.[284]
2. By contrast, in Baker v Department of Education and Training,[285] a report prepared by an independent investigator into a complaint concerning a primary school was part of the deliberative processes of the school.[286]
3. In Re Waterford and Department of the Treasurer (No 2),[287] the AAT held that the expression 'deliberative processes' is wide enough to include any of the processes of deliberation or consideration involved in the functions of an agency.[288] The act of deliberating involves the weighing up or evaluation of competing considerations that may have contributed to the course of action:

In short, the deliberative processes involved in the functions of an agency are its thinking processes - the processes of reflection, for example, upon the wisdom and expediency of a proposal, a particular decision or a course of action. Deliberations on policy matters undoubtedly come within this broad description. Only to the extent that a document may disclose matter in the nature of or relating to deliberative processes does [the internal working documents exemption] come into play.[289]

1. The Full Court of the Federal Court considered the equivalent Commonwealth provision[290] in Harris v Australian Broadcasting Corporation.[291] The Court distinguished between purely factual, and deliberative material. In order to qualify for the exemption, material had to be an opinion, advice, or recommendation for the purpose of the deliberative processes.[292]
2. In Re Thwaites and Department of Health and Community Services,[293] the AAT considered a summary of analyses of re-admissions undertaken by branches of the Department, including various versions of the data. The AAT considered this material to be 'factual'.[294] This conclusion was unaffected by the fact that there existed a debate as to the correctness of the factual assertions contained in the document.[295]
3. In Doyle v Department of Human Services,[296] the Tribunal considered documents called 'Hospital Highlights Reports'. They contained financial, treatment and graphical information. The Tribunal held that what it described as the 'throughput information' was purely factual. However, the financial information contained matter in the nature of opinion or advice, because it was based on estimates and assumptions.[297]
4. Finally, in Department of Health and Human Services v Herald and Weekly Times Pty Ltd,[298] the Tribunal considered a document containing data on the number of patients removed from Victorian elective surgery waiting lists, year by year, and by categories such as sex, age range, urgency, surgical specialty and health service.[299] The Tribunal held that the release of the document would simply disclose purely factual information. Release would not disclose the Department's deliberations.[300]

(1) Would disclosure of the document disclose matters in the nature of consultation of deliberation that has taken place between Council officers in the course of or for the purpose of the deliberative processes involved in the functions of the Council?

1. The Council submitted to the Tribunal that the datasets represented 'consultation or deliberation' between officers in the course, or for the purpose of, its deliberative processes involved in its functions. It submitted that the reference to deliberative processes involved in its functions in s 30(1) of the FOI Act was a reference to the context in which the consultation or deliberation took place.
2. The applicant submitted that the disputed documents were not in the nature of opinion, advice, recommendation, consultation or deliberation as might be protected by s 30(1)(a), and did not include 'deliberative processes involved in the functions of an agency'.
3. The disputed documents variously include the information in the form of data collected by surveys of adolescent school children, monthly tracking of smokers and recent quitters, observational studies relating to the prevalence and nature of cigarette pack display and smoking in the outdoor areas of cafes, restaurants and bars, and tobacco retail outlet monitoring studies which monitors the effect of plain packaging on the sale of tobacco products.

1. For the reasons which follow, it is my view that the disputed documents do contain material in the nature of consultation or deliberation, and were prepared in the course of the deliberative processes involved in the scientific research functions of the Council.
2. First, the different surveys contain questions selected and formulated by officers of the Council to address the aims and requirements of the various studies. The selection and formulation of questions, their sequencing and presentation to respondents in questionnaires, and the instructions given to observers require significant scientific and statistical learning and expertise. I accept, as described by Professor Wakefield, the progression of a research project, commencing with the gathering, analysis and interpretation of data in accordance with a pre-determined research protocol. Collection and analysis of data in a dataset forms a fundamental and vital component of behavioural scientific research.
3. Secondly, it is plain that the development and use of the datasets requires the application of considerable creativity, skill and experience in statistics. It includes analysis in identifying from answers potential new variables that can be used for the purpose of further analysis and investigation. The process of analysis entails the assessment of relativities and probabilities between outcomes and possible causes. The transfer of information from questionnaires to the datasets is also a process that requires considerable skill and judgment on the part of experienced researchers. I accept that all these processes and functions constitute 'deliberation' on the part of researchers and officers of the Council.
4. Thirdly, use of the datasets permits outcomes to be linked with different variable inputs. If a change in behaviour over a period is observed, the cause of the change in behaviour can be identified using expert analysis of the data, and by excluding other factors that might potentially be causal. Thus, to identify whether plain packaging has led to a reduction in consumption of tobacco products by a particular group of the population, it is necessary to exclude other factors that might have been operating simultaneously, such as television anti-smoking campaigns, fiscal policies or increased prices.
5. Fourthly, it is clear that the variables recorded within each dataset include those constructed by the research team. The variables do not correspond directly with questions asked in the survey, but include computed variables created by combining responses from several questions to make a new variable. It is up to the research team to use its knowledge and expertise to identify research questions, and then compute variables to allow it to undertake analysis and consider what conclusions can be drawn from the analysis. The Stata software also identifies missing data, e.g. if a question is irrelevant to the circumstances of the respondent, or if a response is removed due to its frivolous character, or if there has been a data error.
6. Finally, the Stata software is able to apply weighting to aggregate figures, to adjust for over or under sampling of the type of people (e.g. gender, age, socio-economic status) in the sample, to better ensure that the data reflects the actual population distribution of key demographic characteristics. When the results are adjusted for weighting, aggregated figures change, giving figures more indicative of the actual population distribution.

(2) Would disclosure of the document be contrary to the public interest?

1. Both the applicant and the Council filed statements of public interest grounds.[301] The public interest grounds relied on by the applicant were:
   1. The public benefit, including to public health, of public access to research data, recognised by the world's leading health research funders and scientific literature.
   2. The need to ensure that public interest decision-making by policy-makers, in relation to the public health effects of plain packaging legislation, is based on the broadest possible analysis of the available data.
   3. The importance of the data sets in dispute in reaching conclusions about the effectiveness of plain packaging legislation.
   4. The fact that the [Council] has long been a vocal advocate in support of plain packaging legislation, has published papers based on the data, and has used those papers and data in its advocacy campaign in support of plain packaging legislation.
   5. The need for access to those data sets to be given in order to properly evaluate the claims that have been made by the [Council] about them, and the implications of the data for the assessment of public health effects associated with plain packaging legislation both in Australia (in the context of, and beyond, the ongoing Post Implementation Review) and abroad where plain packaging legislation is being actively considered.
   6. The fact that the peer review process that applied to the [Council's] papers is not a substitute for public access to the underlying data.
   7. The fact that the quality of the [Council's] research staff is not a substitute for public access to the data.
   8. The fact that previous analyses of published papers by the [Council] and others on the effectiveness of plain packaging legislation, against the underlying data where it has been made available, has revealed that:
      1. different interpretations and conclusions can be reached, based on the data, from those set out in the published papers; and
      2. the published papers have adopted a selective and incomplete approach to the data.
   9. In relation to [Document 1], the fact that published papers by the [Council] have not analysed a significant issue investigated by the relevant part of the ASSAD study, namely the effect of plain packaging legislation on prevalence.
   10. The fact that disclosure of the documents will not have the negative consequences claimed by the [Council] and its witnesses and, in fact, will have the positive consequences identified by the [applicant] and its witnesses.[302]
2. The public interest grounds relied on by the Council were:
   1. Smoking is the leading cause of preventable death by cancer in Australia.
   2. The [Council] is a highly ranked and [NHMRC]-recognised research institute that undertakes research into the factors that influence the uptake and cessation of smoking. Its research informs public debate and government policy on matters of public health, including tobacco control.
   3. The application before the Tribunal concerns 6 documents containing data obtained in the conduct of research into the efficacy of tobacco plain packaging legislation. The data sets are in draft form and have never been made public. Public release of research data, such as that constituting the documents in dispute, is foreign to orthodox scientific practice and procedure and outside the parameters of typical data sharing and collaboration. Document 1 contains data obtained from Australian school children concerning their use of, and attitudes towards, licit and illicit substances, with a major focus on tobacco and responses on tobacco product beliefs and preferences.
   4. ...
   5. The [Council] relies on the public interest in:
      • 5.1. promoting public health and reducing the incidence of preventable cancer deaths in Australia;
      • 5.2. protecting processes that permit the conduct of high quality research into the forces that shape the use of tobacco and the factors that influence the uptake and cessation of smoking, in order that such research continues to be available to government policy makers and to inform government policy;
      • 5.3. promoting future investment in public health research;
      • 5.4. protecting the continuation of research directed at evaluating the efficacy of tobacco control policy and legislation in Australia, to promote high quality decision-making and policy by government;
      • 5.5. the continuation of the research, policy and advocacy operations of the [Council] - a body corporate and registered charity that exists to support cancer sufferers, prevent or reduce the prevalence of cancer and undertake cancer research - at their current level;
      • 5.6. respecting and furthering the wishes of research participants as to the maintenance of confidentiality and the use made of information they provide;
      • 5.7. promoting the ethical conduct of research by ensuring the conditions on which research participation occurs are respected;
      • 5.8. maintaining the [Council's] ability to attract high calibre research staff, volunteers and national and international funding for its work by avoiding unreasonable, unjustified or invalid comment and claims directed at undermining research concerning tobacco control;
      • 5.9. protecting individual researchers, research teams and research institute's resources by ensuring they are deployed to the furtherance of research and not toward defending against baseless or unfair criticisms based on comparing early versions of datasets with the qualitative results of final studies;

(b) to avoid reduced participation by schools and students; and

(c) to ensure survey responses are honest and accurate; and

6.3. ensuring that data, revealing how school children feel about tobacco products and other substances and respond to tobacco product marketing, is not made public - so as to avoid its commercial exploitation in Australia and abroad.[303]

1. In oral submissions, the applicant emphasised a number of specific arguments to support his contention that the public interest favoured disclosure of the datasets. They include:

(1) the datasets are critically important in evaluating and understanding the public health effects of plain packaging legislation;

(2) the Council has used the datasets to publish numerous peer-reviewed papers and propound its view that the legislation is working;

(3) it is widely recognised that the provision of public access to research data is of public benefit;

(4) there is a need to ensure that public interest decision-making by policy-makers in relation to the public health effects of plain packaging legislation is based on the broadest possible analysis of the available data. This is particularly the case given the Council's involvement in advocating the adoption of plain packaging legislation;

(5) in the case of each dataset, research papers have been published which use that data to draw conclusions about the effect of the TPP legislation;

(6) the testing of the opinions expressed in those papers requires that the data be made available;

(7) the peer group review process is not a substitute for public access;

(8) the quality of the Council's research staff is not a substitute for public access; and

(9) public access will increase public engagement in policy and research.

1. As to the public interest considerations relied on by the Council, the applicant contended:

(1) promoting public health and reducing the incidence of preventable cancer deaths in Australia will be enhanced by releasing the requested data;

(2) release of the data will not undermine efforts directed at protecting processes that permit the conduct of high quality research;

(3) opening access to the requested data will not affect future investment in public health research;

(4) release of the requested data will not frustrate the continuation of research;

(5) the Council's ability to continue research will not be impacted;

(6) the confidentiality of survey respondents is already protected;

(7) research participants are treated ethically if the data is not released in a manner that identifies them or their institution;

(8) active debate on issues relating to tobacco control will not hinder the Council's ability to attract staff or funding;

(9) it is reasonable for individual researchers, research teams and research institutes to spend some time and resources answering criticisms;

(10) the capacity to achieve future funding and value to society are enhanced where information is made publicly available;

(11) there need not be any confusion or unnecessary debate resulting from the release of partial, incomplete or draft versions of documents;

(12) it is in the public interest to promote debate regarding tobacco control measures and to allow decision-makers in Australia and other countries to have access to multiple interpretations of evidence; and

(13) Australia's reputation will be better served by allowing global engagement with the Australian data.

1. In relation to the public interest considerations advanced by the Council in respect of Document 1, the applicant contended:

(1) there is nothing in the sharing of Document 1 that is incongruous with research ethics or that would impact on the continuation of the ASSAD survey;

(2) Document 1 is in a form that preserves the confidentiality and anonymity of the survey respondents; and

(3) the Council has already released data through journal publications.

1. The applicant deployed the evidence of Dr McKeganey, Professor Viscusi and Mr Gibson in support of his submissions as to the public interest.

1. In Graze v Commissioner of State Revenue,[304] Judge Macnamara AP said:

As I have in frequently observed Freedom of Information determinations over the years, the possibility of public scrutiny may improve the quality of advice that is given to administrative decision-makers. The provision of advice that is superficial or the result of insufficient analysis or might be thought to be slanted to a particular political view would be deterred by the prospect that such advice might come to light under the Freedom of Information system. The fact that Parliament has left the public interest issues relative to internal working documents at large indicates, to my mind, that it contemplates that the public interest may cut both ways.

One might multiply instances of public interest analyses in particular Tribunal determinations. In my respectful view, what is required in each case is a consideration of where the public interest lies relative to the particular document or documents in dispute. There is no universal answer as to where the public interest lies with respect to internal working documents.[305]

1. I agree with his Honour that there is no universal answer as to where the public interest lies with respect to internal working documents. The public interest must be determined in the circumstances of the individual case.
2. The considerations advanced in this proceeding as to where the public interest lies are wide ranging. There is a high level of public debate and commercial interest in the efficacy of plain packaging on tobacco consumption in Australia and across the world. There is a high level of international scientific interest in the work of the Council, and the results that it has published. The objectives of the FOI Act provide for information held by agencies to be made available to the public, and for there to be a general right of access to documents in the possession of agencies, subject to specified exemptions.[306]
3. On the other hand, the disputed documents in this proceeding are datasets integral to the scientific research activities of the Council. The Council is a leading body with world ranking in the field of cancer research and programs. The Council's deliberative processes extend to its work as a recognised research institution with two research centres.
4. In my view, the public interest concerning the disclosure of research documents of a scientific research institute is informed and guided by s 34(4)(b)(iii) of the FOI Act, by way of analogy. If a document comprising partly completed scientific or technical research, which is also an internal working document of a scientific research institute such as the Council, were to be disclosed, in circumstances where the institute or the researchers might be unreasonably exposed to disadvantage, the public interest would, I consider, on balance favour the non-disclosure of the document embodying the partly completed scientific or technical research. However, on completion of the research, the balance of public interest swings in favour of disclosure of the documents prepared during the research process, including datasets.
5. There are important reasons of public interest why partly completed scientific research undertaken by scientific and technical research institutes should not be required to be disclosed. I accept the evidence of Professor Wakefield, Professor Fox and Professor Carapetis as to why it is undesirable, and not in the public interest, to release internal working documents prior to completion of a scientific research project. They include:

(1) it is in the public interest to uphold the system of ethical scientific research undertaken following approval from HRECs - if the release of documents by a scientific research institute would breach ethical research standards as determined by a properly constituted, expert ethics committee, the public benefit in releasing documents must be seriously questioned;

(2) it is in the public interest to uphold and protect ethical scientific research, and not permit documents containing information about people to be released where that information might cause the release of in confidence information provided by research participants;

(3) recognition must be given to the position and rights of researchers who invest significant time and hard won research funding into research projects - it is fair and reasonable that they should have the opportunity of publishing their results before other researchers take advantage of their work and findings;

(4) the premature release of internal documents of a scientific research institute may prejudice or adversely affect the scientific research project itself, or the researchers whose reputation may be dependent on the quality of research and information released;

(5) drafts and internal working documents are ordinarily superseded by final manuscripts. It is reasonable to deny public access to incomplete drafts and internal working documents ; and

(6) drafts and internal working documents are of their very nature likely to contain omissions or errors. They may need further refinement. Data may need cleaning or weighting to be meaningful and representative. They may not embody full justification of the reasoning process ultimately preferred in final form. Their release should be approached with some caution, lest misleading information or messages be released into the public domain.

1. For these reasons, I find that disclosure of Documents 1, 3-6 inclusive would be contrary to the public interest.
2. However, in my view, public interest favours the release of Document 2. The National Tracking Survey of Smokers and Recent Quitters was completed in March 2015. Final manuscripts were provided to the Commonwealth Department of Health. Final scientific manuscripts and technical reports were published online. The Commonwealth Department of Health has made the final dataset available online by request.
3. While Document 2 comprises uncleaned and uncoded data, and requires the professional skills of a trained researcher to access, there is little (if any) reason for the dataset not to be released. The final dataset is available, and research papers representing the conclusion of the project have been published.
4. I acknowledge, as Professor Wakefield deposes, that Document 2 is an old dataset containing baseline and cohort study data in a single master file as it was in September 2014.[307] It has been superseded by the final dataset available by request from the Commonwealth Department of Health. However, this does not seem to me to be a sufficient reason for denying access, in the public interest, and in the present circumstances.
5. Professor Wakefield also said that Document 2 should not be released as it contained outdated or preliminary data, and might inadvertently or intentionally cause confusion, mischief or ill-informed publicity.[308] Again these considerations do not, in my view, outweigh the desirability of public access, particularly as the final dataset has been released. It would seem relatively straight forward to highlight the inaccuracies associated with reliance on an outdated dataset that has been superseded, and to point to the final and complete electronic data set held by the Commonwealth Department of Health as supporting the final published research manuscripts. In my view, there is no sufficient reason in the public interest why access should be refused to Document 2.
6. For the reasons given, I find that the disclosure of Documents 1, 3-6 is contrary to the public interest. However, I find that the public interest favours the release of Document 2.

(3) Does the document contain information that is not purely factual material?

1. All of the datasets represent and contain much more than 'purely factual information'. They are the result of professional skill and judgment in following a scientific process supported by analysis and informed debate within the research team to determine how best to capture the data that enables the topic of interest to be assessed. As I have described, the information recorded in the datasets goes much further than recording answers to factual questions.[309]

1. I find that the disclosure of each of Documents 1, 3-6 (inclusive) would disclose matters in the nature of consultation or deliberation that has taken place between officers in the course of, or for the purpose of, the deliberative processes involved in the functions of the Council, and would be contrary to the public interest. I also find that each of the documents contains material not being purely factual material. Documents 1, 3-6 (inclusive) are therefore exempt from disclosure under s 30(1) of the FOI Act.
2. I also find that Document 2 is not exempt from access by the applicant.

1. The Council claims that Documents 1-6 are exempt under s 34(4)(b)(iii) of the FOI Act. The exemption is made out only if the Council satisfies the Tribunal that:

(1) a document contains the results of scientific or technical research undertaken by an officer of an agency; and

(2) the disclosure of the results before the completion of the research would be reasonably likely to expose the agency or an officer of the agency unreasonably to disadvantage.

1. In Mildenhall and Department of Premier and Cabinet (No 1),[310] the Tribunal decided that while studies such as physics and chemistry were the paradigms of scientific method, the word 'scientific' was wide enough to extend to the social sciences.[311] The expression 'technical' extended to things belonging to, appropriate or peculiar to, or characteristic of, art science, profession or occupation, including the technical arts and applied sciences generally.[312]
2. The duration of research was considered by the Queensland Information Commissioner in Re Coultbart and Princess Alexandra Hospital and District Health Service,[313] in these terms:

A research project may extend over months or years, with many stages, and with interim or preliminary results being achieved at those various stages. I consider that s 45(3) was intended to protect such interim or preliminary results from disclosure before the whole project is completed, and before final results are reviewed, analysed and assessed, and findings are made, based on those overall results. Accordingly, I am not persuaded to depart from the view I expressed in Re Spilsbury that s 45(3) does not apply to the results of research, if the research in question has been finalised, as in this case.[314]

1. The issue whether the disclosure of results would be reasonably likely to expose the agency or an officer of the agency unreasonably to disadvantage was considered in Hopper v Department of Agriculture and Rural Affairs.[315] Exemption was claimed for a document summarising the results of a feedlot evaluation trial. The Tribunal accepted submissions that if the results of the project were released in an incomplete state, misleading conclusions would be reasonably likely to be drawn as to the outcome of the project. As a result, competitiveness in overseas markets would be reasonably likely to be affected, so as to expose the business unreasonably to disadvantage.[316] In addition, the Tribunal held that premature disclosure of information would be reasonably likely to lead to a misleading conclusion as to the likely results of the project. This would be reasonably likely to unreasonably disadvantage the researcher carrying out the project.[317]

(1) Does the document contain the results of scientific or technical research undertaken by an officer of an agency?

1. The parties agreed, and I find, that the disputed documents contain the results of scientific or technical research undertaken on behalf of the Council. It was not contended that the datasets which make up the disputed documents were not prepared for scientific purposes. I accept the evidence of Professor Wakefield, Associate Professor White, Professor Fox and Professor Carapetis in this respect. Each of the disputed documents are datasets prepared in the course of scientific research projects carried out by the Council.

(2) Would the disclosure of the results before the completion of the research be reasonably likely to expose the Council or an officer of the Council unreasonably to disadvantage?

1. Professor Wakefield described the ASSAD project as an ongoing, long-standing, core research endeavour of the Council which commenced in 1984. According to Professor Wakefield, Document 1 is a draft document, as a working dataset, which has not been finalised for public release.[318]
2. Associate Professor White described the continuing analysis of the data obtained in the 2011 and 2013 phases of the ASSAD survey, including data not published or considered in the two papers published to date.[319] That analysis could produce further manuscripts, which will include data published in previous articles and data from the 2013 ASSAD survey. The Council will publish these papers in late 2016.[320] For this reason, Associate Professor White said Document 1 contained data from a study that is not complete.[321]

1. The National Tracking Survey and underlying research underpinning Document 2 is complete.[322] Accordingly, Document 2 is not eligible for exemption under s 34(4)(b)(iii).

1. While data collected during the Silent Salesman Study has already formed the basis of two published articles,[323] Professor Wakefield said that there are at least two further analyses and manuscripts underway or planned, using the data collected throughout the study.[324] She said that the datasets comprising Documents 3 and 4 contain additional data which did not form the basis of the published papers.[325] The Council is undertaking further analysis of this additional data, and has particular research questions and papers in train.[326]

1. Professor Wakefield said that each dataset contains data that has not been included in the papers published to date. The data collected from these studies will form the basis of papers to be released in the near future.[327] She said that additional papers will be submitted for publication over the next 6 to 18 months.[328]

1. I accept the evidence of the Council's witnesses, and find that each of Documents 1, 3-6 (inclusive) represent scientific research undertaken by or on behalf of the Council, which is incomplete at this time.
2. The datasets comprising Documents 1, 3-6 (inclusive) contain data intended by the Council and its officers to be the subject of additional research papers, to be published in the future.
3. Document 2 contains data relating to completed research, and is therefore not exempt under s 34(4)(b)(iii).

Reasonably likely to expose the Council or an officer of the Council to disadvantage

1. The applicant's witnesses all contended that the disclosure of the disputed documents would not expose the Council or its researchers unreasonably to disadvantage.
2. I have carefully reviewed the submissions made by the applicant, and the substantial body of evidence provided on his behalf.[329] Notwithstanding this evidence, I must reject the opinions and conclusions expressed by the witnesses for the applicant concerning the absence of disadvantage to the Council or council officers. Instead, I accept the opinions and conclusions on this subject expressed by the witnesses for the Council.
3. I find that the disclosure of the datasets contained in Documents 1, 3-6 (inclusive) before the completion of the research which the respective datasets represent would be reasonably likely to expose the Council and the researchers acting on behalf of the Council unreasonably to disadvantage. I accept the evidence of the Council's witnesses as to these matters, unchallenged as it was by cross-examination.
4. In coming to this conclusion, I accept Professor Wakefield's evidence to the effect that:

(1) deliberation is an integral part of the scientific method. Researchers expect that privacy will be maintained to promote open and frank exchange of ideas within the research teams and mentoring from supervisors;

(2) premature release of data will disadvantage the Council's researchers who are conducting the project, by permitting others who have nothing to do with the study to analyse and make use of the data before the Council's researchers have the opportunity to complete their analyse of the data and prepare papers;

(3) the research process is undertaken on the understanding that the work is in draft form, so that there is opportunity to detect and correct errors, and identify alternative interpretations of findings prior to the research being scrutinised by independent scientific reviewers when the paper is submitted for publication;

(4) the research process involves researchers challenging each other and their work, analysing data from different perspectives, expressing sceptical views, identifying weaknesses, reaching dead-ends, re-examining hypotheses, and methods and revising data upon receiving new information. Premature publication of data would cause disadvantage;

(5) in empirical studies, researchers are judged on their final manuscript and published description and summary of the results of analysis - not on draft or non-final datasets;

(6) draft documents are unlikely to contain the full justifications or the complete methodology which would be set out in full manuscripts;

(7) draft documents do not present data in a format suitable for public dissemination and may contain data errors or unclear responses;

(8) draft documents contain non-final datasets that are later revised, and conclusions that are later refined, honed or omitted as a result of scientific peer review;

(9) release of internal or draft research documents may result in confusion or misrepresentation of the research in public particularly if draft documents differ from published data;

(10) there may be unfair or unreasonable criticism of the research or researcher if preliminary or uncorrected research material is subjected to public scrutiny before it is subject to correction and peer review processes;

(11) the risk of these consequences may divert the researcher from completing the research to respond to comments or criticisms;

(12) opponents of research may take advantage of the release of draft or incomplete documents to make allegations of scientific dishonesty or bias which may adversely affect the reputation of a researcher, even if ultimately unfounded or unsubstantiated;

(13) given the complexity of the issues, any confusion or misrepresentation may linger in the public domain and policy fields; and

(14) inappropriate scrutiny of draft documents may damage the effectiveness of the final published reports.[330]

1. I also accept Mr Harper's evidence of other disadvantages that the Council or its researchers might suffer in the event of the release of the disputed documents, including:

(1) loss of access to schools for research and cancer prevention education;

(2) reduced willingness of the public, including cancer patients, to participate in other research projects;

(3) loss of competitive edge for attracting high calibre staff and securing funding;

(5) potential for misuse of information.[331]

1. Professor Carapetis expressed significant concerns about the release of the working datasets, and could not think of a circumstance where a working dataset would be released to someone who was not a core collaborator, or under a formal agreement regarding analysis, interpretation and reporting on the data.[332]
2. I accept that the concerns expressed by Professor Carapetis would be likely to expose the Council or its researchers unreasonably to disadvantage, including:

(3) risk to scientific process within the Council by the need to address issues arising from premature publication;

(4) adverse impact on researcher rights, and on a researcher's reputation;

(6) failure to have in place proper data showing agreement;

(7) absence of reason to share data with an opponent; and

(8) risk of research remaining incomplete or being misunderstood.[333]

1. For these reasons, I conclude that each of Documents 1, 3-6 (inclusive) are documents containing the results of scientific or technical research undertaken by an officer of the Council, and that the disclosure of the results before the completion of the research would be reasonably likely to expose the Council or an officer of the Council unreasonably to disadvantage. Documents 1, 3-6 (inclusive) are therefore exempt from disclosure under s 34(4)(b)(iii) of the FOI Act.
2. I also conclude that Document 2 is not exempt from access by the applicant.

1. The Council claims that Document 1 is exempt under s 35(1)(b) of the FOI Act. The exemption is made out only if the Council satisfies the Tribunal that:

(1) the disclosure of the document would divulge any information or matter communicated in confidence by or on behalf of a person to an agency ('the confidentiality requirement'); and

(2) the disclosure of the information would be contrary to the public interest by reason that the disclosure would be reasonably likely to impair the ability of an agency to obtain similar information in the future ('the impairment requirement').

1. The application of s 35(1)(b) was considered in Ryder v Booth.[334] The Court held that whether information is communicated in confidence is a question of fact,[335] and that the phrase 'communicated in confidence' is to be given its ordinary meaning.[336] It is unnecessary to consider whether legal obligations of confidence are set up by such communications.[337]
2. In Re Shulver and Victoria Police Force,[338] the Tribunal held that no formal confidentiality agreement was required to establish that information was communicated in confidence, nor was it necessary to establish a 'meeting of the minds'.[339] The fact that a letter is headed 'private and confidential' is also not sufficient in itself to establish that the communication was made in confidence.[340]

1. In Ryder v Booth,[341] the Court also held that the question of impairment is a question of fact decided on the balance of probabilities.[342] The word 'impair' is to be given its ordinary meaning; 'to damage, injure'.[343] Whether impairment is 'reasonably likely' must be considered having regard to the interests of an agency and the public interest in transparency.[344]
2. In the expression 'reasonably likely', 'reasonably' requires the word 'likely' to be given a meaning less definite than probable.[345] The expression speaks of a chance of an event occurring or not occurring, which is real, not fanciful or remote.[346] It does not refer to a chance which is more likely than not to occur.[347]

(1) Would the disclosure of Document 1 divulge any information or matter communicated in confidence by or on behalf of a person to the Council?

1. I am satisfied that Document 1 contains information communicated by students in confidence to researchers conducting the ASSAD survey on behalf of the Council. I accept the evidence of Professor Wakefield, Associate Professor White, Dr Timms and Professor Fox as to the confidential basis on which the ASSAD surveys are conducted.
2. I accept that schools were informed that all information collected in the survey is treated 'in strict confidence', and that no student or school would be identifiable in any report containing the data collected through the survey.[348] Schools were advised that data would only be reported at an aggregated level,[349] that they could not be identified from the results, and that individual schools would not be referred to. Schools were further informed that student's responses were 'completely anonymous and confidential'.[350]
3. I accept that when permission was sought from parents for their child to participate in the survey, parents were informed that the survey was 'confidential and anonymous', and that students would be instructed not to write their name on the survey.[351] Parents were advised that the responses given to the survey would only be used for research purposes, and that no school or student would be able to be identified in any datasets or any publications resulting from the survey.[352]
4. I accept that the 2011 and 2013 ASSAD survey forms instruct students not to write their names on the paper, and that all responses will be kept private and only viewed by the research team.[353] The survey asked a range of personal questions. It is unlikely that the students would feel comfortable giving frank answers to these questions without the assurance of confidentiality which was provided.
5. I accept that the DEECD approved the conduct of the ASSAD survey on the basis that the data collected would be treated confidentially, and that any publications would report data only at an aggregate level. DEECD was assured that neither students not schools would be identifiable.[354]
6. I accept the evidence of Professor Fox, in his capacity as Chair of the Council's HREC, that research involving children raises particular ethical concerns about the sufficiency of consent. The essential basis of research involving children is that it would benefit the category of children or young people to which the participant belonged, and that the research was in the child's best interests.[355]
7. I am satisfied on the evidence that the disclosure of Document 1 would divulge information communicated in confidence to Council researchers by students undertaking the ASSAD survey in 2011 and 2013. Despite all of the measures that were taken to ensure confidentiality of the ASSAD surveys, disclosure of Document 1 would release information that was always intended to be kept confidential.
8. Associate Professor White said that the information sought extends to individual answers to questions relating to tobacco use, along with their age, gender, academic achievement and available pocket money.[356] As the data from the 2011 and 2013 surveys is stored at a unit record level, the data from each student participant is represented as a single line of data.[357] This line of data contains each student's postcode, the type of school attended, the postcode of the school, and the State the student resides in, which would make it possible to determine what school the data relates to.[358] It would then be feasible, using the school type indicator and postcode, to assemble a profile of the participating students from each school. The release of this information contained in Document 1 clearly contravenes the undertakings given by the Council as to anonymity for the student and school.
9. Professor Fox expressed serious concerns that the release of Document 1 would contravene the privacy principles on which HREC approval for the study was granted.[359]
10. Dr Timms considered the release of Document 1 would contravene the research proposal, and be in breach of the assurances given by the researchers.[360]
11. I find that Document 1 contains information communicated in confidence to officers of the Council by student participants in the 2011 and 2013 ASSAD surveys.

(2) Would the disclosure of the information be contrary to the public interest by reason that the disclosure would be reasonably likely to impair the ability of the Council to obtain similar information in the future?

1. Professor Wakefield considered that the public release of Document 1 would be a breach of trust, and would damage the Council's ability to obtain approval to conduct future surveys, as well as the consent of educational authorities, schools and parents. The release of the data would jeopardise the likelihood that the study would be approved in the future by the HREC.
2. If Document 1 is released, Associate Professor White considered that the Council would be obliged to inform the participating educational authorities, as well as the HREC, of the release. This could jeopardise the viability of the 2017 ASSAD survey.[361]
3. Mr Harper referred to loss of access to schools for research and cancer prevention education.[362] He referred to the loss of reputation by the Council as a responsible custodian of data.[363] He said that the HREC, schools and parents would not have permitted school children to participate in the ASSAD surveys if they thought that the dataset was able to be accessed by the tobacco industry. The Council's loss of reputation could well extend to other research sought to be undertaken in schools relating to cancer prevention.[364]
4. Professor Fox said the HREC could not approve a study that carried a risk of release of confidential identifiable individual data.[365] This supports the evidence of Associate Professor White that the future of the ASSAD survey would be jeopardised by the release of Document 1. Professor Fox said the reliability of HRECs in Australia to protect data, individual privacy and research hypotheses would be brought into question.[366] There could be catastrophic results for medical research in Australia.
5. Dr Timms expressed concern that educational authorities would withdraw support for the ASSAD survey if Document 1 were released.[367] The consequences of the release of Document 1, as described by Dr Timms,[368] may result in the rejection of future applications to run ASSAD surveys in schools.
6. I accept the evidence of Professor Wakefield, Associate Professor White, Mr Harper, Professor Fox and Dr Timms that the disclosure of Document 1 is likely to impair the ability of the Council to obtain similar information in the future. The release of the confidential information contained in Document 1 is virtually certain to attract protest and expression of strong concern on the part of educational authorities, schools, parents and school children alike. There are likely to be complaints of unethical behaviour, that participating schools and students were misled, that the HREC approval was seriously breached, and that the undertakings given to educational authorities and schools have not been honoured. It is reasonable to expect serious complaint and public concern that information permitted by schools and parents to be obtained from schools students to inform research, curtail cigarette smoking and to restrain the consumption of cigarettes and other drugs could now be used for the reverse purpose, to assist in the promotion and sale of cigarettes.
7. In my view, if the information contained in Document 1 is released, it is highly likely that the credibility of the ASSAD survey will be very seriously undermined. It is also highly likely that approvals would not be forthcoming from many schools and educational authorities which have given their approval in the past. If the reputation of the ASSAD survey is impugned, future survey approval and support will be very difficult to obtain. It is likely that authorities, schools, and in many cases, parents and students, would be taken aback, if not aghast, at the possible use of the information to promote smoking, or market cigarettes to school students.
8. For the reasons given, I am satisfied that the disclosure of the information contained in Document 1 would be contrary to the public interest, by reason that the disclosure would be reasonably likely to impair the ability of the Council to obtain similar information in the future.

1. I have previously rejected the applicant's argument as to the effect of commencement of ss 23 and 25 of the ICO Act on the right of the Council to claim exemption under s 35(1)(b) of the FOI.[369]
2. For the reasons given, I find that the disclosure of Document 1 would divulge information communicated in confidence by or on behalf of a person to the Council, and the disclosure of the information would be contrary to the public interest by reason that the disclosure would be reasonably likely to impair the ability of the Council to obtain similar information in the future. Document 1 is therefore exempt from disclosure under s 35(1)(b) of the FOI Act.

1. Under s 50(4) of the FOI Act, the Tribunal has the power to grant access to an exempt document where the public interest requires access to the document.
2. In Osland v Secretary to the Department of Justice,[370] French CJ, Gummow and Bell JJ reviewed the conditions that must be satisfied before the power in s 50(4) can be exercised by the Tribunal. The Court noted:

... the FOI Act neither defines nor expressly limits the range of matters relevant to the 'public interest' which may require that access should be granted.[371]

It was recognised in the joint reasons on the earlier appeal to this Court that 'there are obvious difficulties in giving the phrase "public interest" as it appears in s 50(4) a fixed and precise content' ...

The power to grant access on public interest grounds is not, in terms, vested in the relevant Minister or agency ... Rather, it is a power included in the powers conferred on the Tribunal ... It has been called a "significant and exceptional" power and "a most extraordinary provision" ... the word "requires" which appears in s 50(4) directs the decision-maker to identify a high-threshold public interest before the power can be exercised. It is not enough that access to the documents could be justified in the public interest. The terminology of the sub-section does not define a rule so much as an evaluative standard requiring restraint in the exercise of the power.[372]

1. The applicant contended for the exercise of the power in s 50(4) on the basis of the contentions set out in the applicant's statement of public interest grounds.[373] The Council contended that the public interest was in favour of exemption of the disputed documents, also relying on its statement of public interest grounds,[374] and the evidence of its witnesses.
2. I adopt my conclusions as to the public interest, as previously set out.[375]

1. I find that the public interest does not require the grant of access under s 50(4) to Documents 1, 3-6.
2. Document 2 is not an exempt document.

Can exempt matter be deleted from the disputed documents?

1. The applicant relies on a letter dated 19 April 2016 sent by the applicant to the Council's solicitors, which states:

To be clear, the Request does not extend and has never extended to any survey data about alcohol, marijuana/cannabis or any other subject matter that is not related to the implementation of the TPP Act.

In response to the Request, CCV initially identified 7,128 documents as being relevant to the Request and denied access in full to each of the 7,128 documents. In its decision, CCV did not provide any information about what documents (or broad categories of documents) were encompassed in the 7,128 items that were said to be caught within the request.

The Applicant wrote to CCV on 25 November 2014 noting that although 7,128 documents had been identified as being caught by the Request, the Applicant anticipated that the vast majority of these documents were not relevant to the Request. In the 25 November 2014 letter, the Applicant clarified the limited nature of the Request:

"...I do not wish to obtain every document referring to the survey or survey results. Rather, I am seeking a single document (or, if no such document exists, the core series of documents) recording the questions and consolidated data for each relevant survey - i.e. the results of the survey to date."

This communication assisted in narrowing the ambit of the documents to the 6 documents in dispute between the Applicant and CCV.

2 No personal or identifying information sought

To the extent that any clarification is needed, no data or information is being sought that would or could disclose the identity of any respondent to any survey conducted by CCV.

3.3 Data and information not required in respect of Document 1

Data or information in respect of Document 1 that identifies the following is not sought:

• the name of the respondent who supplied data - which we understand from the evidence (see paragraph 79.1 of the affidavit of Melanie Wakefield dated 28 August 2015) is not included in the document in any event;
• the type of school the respondent attends (government, Catholic or independent) and the post code of the school attended;
• any of the other data from the "office use only" box on page 1;
• the suburb or town in which the respondent lives (question 1(a));
• the post code for the respondent's address (question 1 (b));
• the respondent's year level at school (question 2);
• the respondent's date of birth (question 5);
• answers to questions 6, 8, 18, 19 (a) and (b), and 43; and
• answers to questions 22-31, 35 (ii) and (iii), 38, 39 and 40(d)-40(o), which does not relate to tobacco products.

If CCV considers that there are additional survey questions that would provide material which would enable the personal details of a survey respondent to be identified or are not relevant to assessing whether the TPP is meeting its objects, please identify the relevant survey questions so that we can confirm if the data in relation to those questions is required.[376]

1. Section 25 of the FOI Act requires the Council to give access to a redacted document, provided that three conditions are satisfied:

(1) a decision is made not to grant a request for access to a document on the ground that the document is an exempt document;

(2) it is practicable for the Council to grant access to a copy of the document with such deletions as to make the copy not an exempt document; and

(3) it appears from the request, or the applicant subsequently indicates, that the applicant would wish to have access to such a copy.

1. The Council does not dispute that the applicant has satisfied requirements (1) and (3) above in relation to the disputed documents. However, the Council submits that it is not practicable to grant access to a copy of the disputed documents with the deletions that would be necessary to make them not exempt documents.[377]
2. Professor Wakefield said that the part release of the disputed documents is not possible as the information sought - the consolidated questions and answers of the study - are the entirety of the content of the disputed documents.[378]
3. In a letter sent in October 2014 to the applicant, Mr Harper advised that he had considered, in accordance with s 25 of the FOI Act, whether it would be practicable for the Council to grant access to copies of the documents with such deletions as to make the copies not exempt documents. He advised that he was satisfied that it was not practicable to produce a document containing non-exempt information, given that the factual information in the documents could not be separated from opinions, or the results of scientific or technical research.
4. Neither Professor Wakefield nor Mr Harper were cross-examined about these statements. No evidence was led controverting their statements and their evidence that it is not practicable to redact any of the disputed documents to produce a document containing non-exempt information.
5. I accept the statements and evidence of Professor Wakefield and Mr Harper as to s 25 of the FOI Act, and hold that requirement (2) above is not made out. I am satisfied that it is not practicable for the Council to grant access to a copy of any of Documents 1, 3-6 (inclusive) with such deletions as to make the copy not an exempt document.

1. I am satisfied that the Council has established the exemptions claimed for Documents 1, 3-6 (inclusive). I am not satisfied that any claim for the exemption of Document 2 has been proven.

1. I am not satisfied, for the purpose of s 50(4) of the FOI Act, that the public interest requires the grant of access to Documents 1, 3-6 inclusive.

1. I am satisfied that it is not practicable to redact Documents 1, 3-6 (inclusive) so as to make a non-exempt document.

1. The claims for exemption by the Council under ss 30(1), 34(4)(b)(iii), and 35(1)(b) of the FOI Act are upheld in relation to Documents 1, 3-6.
2. The claims for exemption fail in relation to Document 2.

[1] Letter from the applicant to the Council dated 11 September 2014.

[2] Letter from the Council to the applicant dated 29 October 2014.

[3] Application for review of FOI decision dated 25 November 2014.

[4] Letter from the Council to the applicant dated 4 December 2014.

[5] Letter from the applicant to the Council dated 5 December 2014.

[6] Respondent's further revised schedule of documents in dispute dated 8 September 2015.

[8] Signed by the Commonwealth of Australia acting through the Department of Health and Ageing on 18 December 2012 and signed by the Anti-Cancer Council of Victoria trading as the Cancer Council Victoria on 7 December 2012.

[9] Order of Justice Garde dated 16 May 2016 ('interim suppression order').

[10] Order of Justice Garde dated 26 September 2016 ('permanent suppression order').

[11] Statement of Todd Harper dated 29 September 2015 [7] ('Mr Harper's statement').

[12] Anti-Cancer Council Act 1936 (Vic) s 4(1).

[14] Referring to Purcell v Ombudsman [2002] VCAT 842 [27]-[32].

[15] See: D.C. Pearce and R.S. Geddes, Statutory Interpretation in Australia (Lexis Nexis Butterworths, 8th ed, 2014) [6.10]-[6.12].

[16] Tobacco Plain Packaging Act 2011 (Cth).

[17] Standardised Packaging of Tobacco Products Regulations 2015 (UK).

[18] Applicant's Statement of Legal Contentions dated 23 November 2015 [1]-[3].

[19] Victoria Police v Marke [2008] VSCA 218 [29], [66].

[20] Statement of Professor Melanie Wakefield dated 28 August 2015 [7]-[8] ('Professor Wakefield's statement').

[30] National Health and Medical Research Council, National Statement on Ethical Conduct in Human Research (2007, updated May 2015) National Statement on Ethical Conduct in Human Research ('National Statement').

[32] Professor Wakefield's statement [25].

[45] World Health Organization, WHO Framework Convention on Tobacco Control (2003, updated 2005, 2005) World Health Organisation ('FCTC').

[48] Professor Wakefield's statement [67].

[81] M Zacher et al, 'Personal tobacco pack display before and after the introduction of plain packaging with larger pictorial health warnings in Australia: an observational study of outdoor café strips.' (2014) 109(4) Addiction 653.

[82] Professor Wakefield's statement [104].

[83] M Zacher et al, 'Personal pack display and active smoking at outdoor café strips: assessing the impact of plain packaging 1 year postimplementation' (2015) 24 Tobacco Control ii94.

[84] Professor Wakefield's statement [105].

[95] See: Melanie Wakefield, Megan Bayly and Michelle Scollo, 'Product retrieval time in small tobacco retail outlets before and after the Australian plain packaging policy: real-world study' (2014) 21 Tobacco Control 70; Megan Bayly, Michelle Scollo and Melanie Wakefield 'No lasting effects of plain packaging on cigarette pack retrieval time in small tobacco retail outlets' (2015) 24(e1) Tobacco Control e108; Michelle Scollo, Megan Bayly and Melanie Wakefield 'Availability of illicit tobacco in small retail outlets before and after the implementation of Australian plain packaging legislation' (2015) 24(e1) Tobacco Control e45; Michelle Scollo, Megan Bayly and Melanie Wakefield, 'The advertised price of cigarette packs in retail outlets across Australia before and after the implementation of plain packaging: a repeated measures observational study' (2015) 24(e1) Tobacco Control e82.

[96] Professor Wakefield's statement [116].

[105] World Health Organization, WHA54.18 Transparency in tobacco control (22 May 2001) Tobacco Free initiative (TFI) .

[107] World Health Organization, Guidelines for implementation of Article 5.3 of the Who Framework Convention on Tobacco Control (November 2008) Guidelines for implementation of Article 5.3 .

[109] British American Tobacco, Our response to the UK Government's 2014 plain packaging consultation (August 2014) Plain packaging .

[110] Sally M Dunlop et al, 'Impact of Australia's introduction of tobacco plain packs on adult smokers' pack-related perceptions and responses: results from a continuous tracking survey' (2014) 4(12) BMJ Open e005836.

[111] Professor Wakefield's statement [129].

1. [113] British American Tobacco Australia, Youth smoking rates soar two years post plain packs (27 November 2014) 2014 media releases .

[114] Mark Hawthorne and Vanessa Desloires, 'Big Tobacco distributes report bullying plain packaging laws' The Age (online), 27 November 2014 .

[115] British American Tobacco Australia, Industry consultation a must during plain pack review (1 December 2014) 2014 media releases .

[116] Professor Wakefield's statement [133].

[117] Statement of Associate Professor White dated 28 August 2015 ('Associate Professor White's statement') [7].

[128] Associate Professor White's statement [37].

[141] Ibid exhibit VW-4. Above [123]-[125].

[157] Victoria White, Tahlia Williams and Melanie Wakefield, 'Has the introduction of plain packaging with larger graphic warnings changed adolescents' perceptions of cigarette packs and brands?' (2015) 24 Tobacco Control ii42; Victoria White et al. 'Do larger graphic health warnings on standardised cigarette packs increase adolescents' cognitive processing of consumer health information and beliefs about smoking-related harms?' (2015) 24 Tobacco Control ii50.

[159] Associate Professor White's statement [59].

[165] Emily Banks et al. 'Tobacco smoking and all-cause mortality in a large Australian cohort study: findings from a mature epidemic with current low smoking prevalence' (2015) 13(1) BMC Medicine 38.

[166] Centers for Disease Control and Prevention, 'Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses - United States, 2000 - 2004', (2008) 57(45) Morbidity and Mortality Weekly Report 1226.

[185] Statement of Professor Richard Fox dated 27 September 2015 ('Professor Fox's statement') [13].

[191] Above n 30.

[192] Professor Fox's statement exhibit RF-2, 50.

[195] Statement of Dr Wendy Jean Timms dated 9 September 2015.

[203] Affidavit of Professor Jonathan Rhys Carapetis dated 2 October 2015 exhibit JRC-4.

[218] Affidavit of Damian Finn affirmed 23 November 2016.

[219] Expert report of Dr Neil McKeganey dated 18 November 2015 ('Dr McKeganey's report').

[220] Cf above [65](2), [132]-[134].

[222] Expert report of Professor W. Kip Viscusi dated 18 November 2015 ('Professor Viscusi's report').

[229] Above n 157.

[230] Professor Viscusi's report 30-31.

[243] Expert report of Mr Stephen Leslie Gibson dated 19 November 2015 ('Mr Gibson's report').

[245] Above n 110.

[246] Mr Gibson's report [8]-[17].

[252] Statement of Associate Professor Victoria White in reply dated 7 December 2015 ('Associate Professor White's reply statement').

[255] Ibid. Cf above [181].

[256] Associate Professor White's reply statement [7].

[259] Statement of Todd Harper in reply dated 7 December 2015 ('Mr Harper's reply statement').

[261] Affidavit of Jacob Ari Coppel dated 18 January 2016 exhibit JAC2.

[265] Supplementary expert report of Dr Neil McKeganey dated 9 May 2016 ('Dr McKeganey's reply report').

[267] Supplementary expert report of Professor W. Kip Viscusi dated 9 May 2016 ('Professor Viscusi's reply report').

[269] Supplementary Expert Report of Stephen Leslie Gibson dated 8 May 2016 ('Mr Gibson's reply report')

[271] Applicant's objections to admissibility of respondent's evidence dated 25 January 2016.

[272] Response to applicant's objections to admissibility of respondent's evidence dated 9 May 2016.

[273] Applicant's note on respondent's response to applicant's objections dated 17 May 2016.

[274] Worldwide Enterprises Pty Ltd v Silberman [2008] VCAT 836 [46]; Secretary to the Department of Infrastructure v Williamstown Bay and River Cruises Pty Ltd [2011] VSC 191 [59].

[275] Jason Pizer and Emrys Nekvapil, Pizer's Annotated VCAT Act (Thomson Reuters, 5th ed, 2015) 500-501 [VCAT.98.160].

[276] Schedule 1: Respondent's submissions in response to Dr Neil McKeganey's witness report and supplementary statement dated 17 May 2016; Schedule 2: Respondent's submissions in response to Professor Kip Viscusi's witness report dated 17 May 2016; and Schedule 3: Respondent's submissions in response to Mr Stephen Leslie Gibson's expert report and supplementary statement dated 17 May 2016.

[277] Schedule 1: Applicant's response to respondent's submissions in response to Dr Neil McKeganey's witness report and supplementary statement dated 19 May 2016; Schedule 2: Applicant's response to respondent's submission in response to Professor Kip Viscusi's witness report and supplementary statement, dated 19 May 2016; and Schedule 3: Applicant's response to respondent's submissions in response to Mr Stephen Leslie Gibson's expert report and supplementary statement dated 19 May 2016.

[278] (Unreported, County Court of Victoria, Lazarus J, 19 December 1983).

[282] (Unreported, Administrative Appeals Tribunal of Victoria, Coghlan, 20 July 1995).

[285] [2005] VCAT 2263.

[287] [1984] AATA 67; (1984) 5 ALD 588.

[290] Freedom of Information Act 1982 (Cth) s 36.

[291] [1984] FCA 8; (1984) 1 FCR 150.

[293] (1995) 8 VAR 361.

[296] [2002] VCAT 1768.

[298] [2015] VCAT 291.

[301] Applicant's statement of public interest grounds dated 23 November 2015 ('applicant's public interest grounds'); Respondent's statement of public interest grounds dated 5 October 2015 ('respondent's public interest grounds').

[302] Applicant's public interest grounds [1]-[10] (citations omitted).

[303] Respondent's public interest grounds [1]-[6] (citations omitted).

[304] Graze v Commissioner of State Revenue (Review and Regulation) [2013] VCAT 869.

[306] Above [14].

[307] Above [73].

[308] Above [74].

[309] Above [227]-[231].

[310] (1995) 8 VAR 284

[313] (2001) 6 QAR 94.

[314] Ibid [91]. Referring to Re Spilsbury and Brisbane City Council (1999) 5 QAR 335. Section 45(3) of the Freedom of Information Act 1992 (Qld) was the equivalent provision to s 34(4)(b)(iii) of the FOI Act.

[315] (Unreported, Administrative Appeals Tribunal of Victoria, Harding, 20 December 1990).

[318] Above [67].

[319] Above [140].

[321] Above [143].

[322] Above [70].

[323] Above [79].

[324] Above [80].

[325] Above [82].

[327] Above [90].

[328] Above [91].

[329] Above [182], [183], [192].

[333] Above [172]-[179].

[334] [1985] VicRp 86; [1985] VR 869.

[338] (1995) 9 VAR 71.

[339] Ibid 84, referring to Re Pepperell and Ministry of Housing (1989) 3 VAR 191.

[340] Ibid, referring to Re Barnes and Commissioner for Corporate Affairs (1985) 1 VAR 16.

[341] [1985] VicRp 86; [1985] VR 869.

[344] Medical Practitioners Board of Victoria v Sifredi [2000] VSC 33 [20].

[345] Department of Agriculture and Rural Affairs v Binnie [1989] VicRp 73; [1989] VR 836, 837.

[348] Above [112].

[349] Above [113].

[351] Above [114].

[353] Above [123].

[354] Above [117]-[122], [127]-[131].

[355] Above [161].

[356] Above [133].

[357] Above [198].

[359] Above [160].

[360] Above [167].

[361] Above [134].

[362] Above [148].

[364] Above [151].

[365] Above [159].

[367] Above [167].

[369] Above [35].

[370] [2010] HCA 24; (2010) 241 CLR 320 ('Osland').

[372] Ibid [13]-[14] (citations omitted), referring to Osland v Secretary, Department of Justice (2008) 234 CLR 275, 300 [57].

[373] Above [232].

[374] Above [233].

[375] Above [238]-[249].

[376] Letter from Graeme Johnson to Michele Rowland and Jacob Coppel dated 19 April 2016.

[377] Document 2 is not an exempt document, and is therefore not discussed further in this section.

[378] Above [96].