Supplementary guidance on Chapter 7 of the Australian Code for the Responsible Conduct of Research (2007) Preamble In 2007 the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA) released The Australian Code for the Responsible Conduct of Research (the Code). Chapter 7 of the Code deals specifically with conflicts of interest and the responsibilities of institutions and of researchers in ensuring the responsible conduct of research. In the attached draft supplement we are seeking comment on a range of proposals for providing supplementary advice to the Code in order to respond to the mounting concern, both in Australia and globally, about the disclosure of interests and the challenges this poses to the research enterprise. Research is increasingly supported by a mix of public and private funds. Conflicts of interest are ever more likely to occur and must be identified and properly managed in order to maintain the integrity and reliability of the outcomes of research and to ensure public trust and the good reputations of individuals and organisations involved in research. Many commentators have also drawn attention to the growth and complexity of relationships between researchers and public and private organisations, and some have questioned the effectiveness of existing regulatory systems in tackling some of the problems arising from these relationships. Over the past few years there have been suggestions for improvements to the guidance provided by funding agencies in order to prevent an erosion of public confidence in the outcomes of research. This has been in response to many examples of the vulnerability of researchers and of their reputation when it comes to disclosing and acting upon the disclosure of competing interests. There is a strong and rising expectation that funding agencies will continue to take the lead in (a) ensuring that the conduct of research meets the highest ethical standards and (b) in supporting effective collaboration between researchers and public and private organisations. The attached draft supplement therefore takes into account the considerable efforts that have occurred on the national and international scene to provide new guidance on the responsible conduct of research, and to mitigate the risks associated with the growing and complex relationships between researchers and public and private organisations. Key Principles The following principles have been applied in this draft supplement: a) The promotion of ethical behaviour. b) Balancing the compliance burden with the institutions’ responsibility under the Code to manage the disclosure of relevant interests. c) A focus on financial aspects of conflicts of interest, noting that non-financial interests may also need to be disclosed and managed. d) The public right to information and increased transparency. Page 1 Draft Supplement to Chapter 7 of the Australian Code for the Responsible Conduct of Research (2007) 1. Framework for the new guidance 1.1 This new guidance is constructed within the framework of the Code, Chapter 7, and provides more detail on how the requirements of the Code are to be met by research institutions. 1.2 It should be used as a guide for researchers and institutions applying for or receiving public funding for research. 2. Responsibilities of Institutions 2.1 In accordance with Chapter 7 of the Code, institutions must maintain a policy for managing conflicts of interest. Such a policy should: a) Promote and support researcher compliance. b) Ensure that the identification of interests is facilitated. c) Encourage full disclosure. d) Guide the appropriate management of any conflicts. 2.2 The institution should make provision for and maintain a centralised record of interests in relation to publicly funded research grants, and a plan should be in place to deal with any conflicts of interest. 2.3 The institution’s policy should be given the widest possible distribution to its researchers and be available to the public from the web site of the institution. 2.4 Training on the policy should be made available to researchers. 2.5 An institutional policy should specify that all relevant financial interests must be disclosed. 1 The policy should also ensure disclosure of such interests to the public upon request. This applies to any interests that may affect, or be perceived to affect, the design, conduct, or reporting of funded research, or that might reasonably appear to be related to the researcher’s institutional responsibilities. 2.6 If a conflict of interest is identified, the institution must determine what measures are required to manage a conflict of interest appropriately and these measures should include the public disclosure of financial interests (for instance, when presenting or publishing the research). 2.7 In accord with the principles of transparency and the public right to information, we encourage institutions to maintain a register of their researchers interests’ in order to respond to reasonable requests about the sponsorship of research and any competing interests. 1 Disclosure is required of any payments, relevant to the research being undertaken, received by the researcher (or immediate family members, that is, a spouse or dependent children). This applies to payments from any publically or non-publically traded entity in the twelve months preceding the disclosure which amount, in total, to more than $5,000 (or equivalent in-kind, for example air fares). Disclosure is also required when the researcher (or the researcher’s spouse or dependent children) holds any equity interest (e.g. stock, stock option, or other ownership interest) amounting to more than $5,000. Page 2 3. Responsibilities of Researchers 3.1 It is the responsibility of the researcher to be familiar with the Code, the relevant institutional conflict of interest policy, and the conflict of interest policy of the organisation funding the research. 3.2 It is the responsibility of the researcher to disclose all relevant interests as soon as they become apparent. a) Financial interests – Relevant financial interests normally include those of the researcher (or an immediate family member, that is, a spouse or dependent children), that may affect the design, conduct, or reporting of funded research, or that might reasonably appear to be related to the researcher’s institutional responsibilities. The disclosure should include, but is not limited to: research or other funding from an entity with an interest in the project; equity interest in a publically or non-publically traded entity (e.g. stock, stock option, or other ownership interest); income from intellectual property rights (e.g. patents or copyrighted material); consultancies; gifts or gratuities, including travel, honoraria, meals and beverages, accommodation, entertainment, remuneration, educational event attendance (including registration fees). b) Public Disclosure – Researchers should comply with the relevant institutional policy on public disclosure. c) Disclosures should be updated as circumstances change, or at least annually during the period of the award. Page 3