Reform of the regulatory framework for human genetic research

13.24 The Inquiry received a wide range of views and comments about the adequacy of the regulatory framework for human genetic research. Views ranged from those that were highly supportive of the existing framework through to those suggesting a broad agenda for change. In many cases the changes proposed were broadly applicable to all human research and not limited to addressing issues raised by human genetic research specifically.^[31]

13.25 A common theme in consultations with individuals and organisations involved in human genetic research was concern about the present and possible future costs of compliance with regulatory requirements. It was noted that research funding rarely includes any allocation for compliance costs—such as the cost of operating HRECs, obtaining ethics approval for research proposals, complying with ethical requirements for the de-identification of samples, and satisfying monitoring and reporting obligations.^[32]

13.26 The same groups, and HREC members, frequently observed that the National Statement has only been in operation since 1999 and that there may not have been enough time to evaluate whether its guidance is effective in protecting privacy and ensuring ethical conduct in human genetic research. Particular concerns were expressed about the need to avoid any retrospective reforms that might have adverse practical implications for existing long-term research projects.^[33]

13.27 The NHMRC’s Research Committee emphasised that the Inquiry, when considering the introduction of new regulatory mechanisms, should assess

whether there is evidence that abuses have occurred in association with Australian data collections in the area under investigation. This is particularly necessary where the regulations envisaged are likely to act as a barrier to research. It should be born in mind that in genetic research, in particular, primary beneficiaries of the results of the research are likely to be the subjects (including their families) from whom data is collected. Barriers which delay study commencement or progress in this highly competitive setting—often involving at least some commercial funding—may prevent the studies being conducted on Australian population samples, with a resulting loss to the individuals as well as to Australian research.^[34]

13.28 Several other submissions identified the commercialisation of human genetic research as an important background development.^[35] For example, the Centre for Law and Genetics noted that

it is a feature of human genetic research that commercial arrangements include the hand over of tissue or blood samples. In this respect the samples and information they contain have become commercial commodities.^[36]

13.29 Many submissions suggested significant changes to the regulatory framework for protecting privacy and ensuring ethical conduct in human genetic research. For example, Privacy NSW suggested a range of reforms to improve the ‘transparency and accountability of ethics review in respect of genetic research involving humans’. These included the establishment of an independent, national ethics review committee; enhancing the obligations of HRECs to report their decisions; a single, independent and transparent complaints mechanism to deal with decisions made by any HREC; strong civil and criminal sanctions where privacy is breached; and effective audit of an HREC’s activities, including monitoring throughout the research period.^[37]

13.30 Professor Nick Saunders and Associate Professor Paul Komesaroff highlighted several issues of particular interest to the research and ethics communities. These included concerns relating to the question of waiver of consent, the monitoring of research by HRECs, de-identification of genetic samples, withdrawal of participants from research projects, provision of advice to participants and the storage of data.^[38]

13.31 Specific reforms suggested in submissions and consultations are discussed in the following chapters. The National Statement is scheduled for formal review by the NHMRC during the 2003–2005 triennium, consistently with NHMRC policy of revising guidelines that have been in place for five years. A number of recommendations made in this Report are directed to the NHMRC, for implementation as part of its review of the National Statement.

Enforcing compliance with the National Statement (Chapter 14)

13.32 The enduring value of the National Statement was highlighted in a number of submissions—even those that suggested changes to its scope or content. For example, the Office of the Federal Privacy Commissioner observed that, like the Declaration of Helsinki and other international ethical guidelines, the National Statement has persuasive authority, has been reviewed at appropriate intervals, and has proven responsive to past challenges in medical research.^[39] Saunders and Komesaroff observed that the National Statement ‘commands profound moral authority in the community’.^[40]

13.33 However, the application of the requirements for institutions and their HRECs to be registered with the NHMRC and to follow the processes set down in the National Statement is incomplete. As emphasised in many submissions, there is currently no obligation on private research bodies to adhere to the provisions of the National Statement.^[41] Submissions and consultations suggested that, in view of the increasing commercialisation of human genetic research, the mechanisms by which compliance with the National Statement is enforced should be strengthened.

13.34 Chapter 14 examines this issue and recommends that the NHMRC review the mechanisms for achieving compliance with the National Statement, with particular regard to human research conducted wholly within the private sector.

Human genetic research and consent (Chapter 15)

13.35 The concept of consent is fundamental to the legal and ethical regulation of human research. The National Statement generally requires consent to the use of human tissue samples, genetic material and genetic information in medical research, other than in limited and defined circumstances.

13.36 Submissions and consultations raised concerns about various aspects of consent and, in particular, whether adequate privacy protection is afforded by the current provisions under which HRECs may waive consent requirements in granting ethical approval for research proposals. A related issue concerns the extent to which researchers are able to obtain consent from potential research participants for the use of their genetic samples or information for unspecified future research.

13.37 Chapter 15 examines issues of consent in human genetic research. The Inquiry recommends new reporting obligations for HRECs with respect to proposals for which waiver of consent has been granted under the National Statement. The Inquiry also recommends that training and other support for HRECs be augmented in relation to decision-making on waiver of consent. In the Inquiry’s view, the National Statement should also be amended to provide clear guidance about obtaining consent to unspecified future human genetic research.

Encouraging best practice in human genetic research (Chapter 16)

13.38 Submissions and consultations suggested that it may be useful for the NHMRC to develop information and advice, including examples and practical guidance, for the preparation of human genetic research protocols and consent forms for human genetic research.

13.39 The intention of these documents would be to give further guidance to researchers and HRECs on what the NHMRC considers to be best practice in the conduct of human genetic research. The content of these documents is discussed in Chapter 16. Particular concerns relate to the coding and de-identification of genetic samples and information, and to the disclosure to research participants of the potential commercialisation of research outcomes.

Strengthening ethical review by HRECs (Chapter 17)

13.40 Submissions and consultations suggested a range of possible reforms aimed at strengthening the current system of ethical review of human genetic research and the role of HRECs within that system.

13.41 A range of options is discussed in Chapter 17, including possible reforms relating to:

• the structure of ethics review;

• the quality of ethics review, including the membership of HRECs, their expertise and sources of advice;

• monitoring the conduct of research approved by HRECs;

• the needs of HRECs, HREC members and researchers, in terms of resources, education and training;

• the accountability of HRECs, including reporting on review of research proposals by HRECs; and

• the accreditation of HRECs.

13.42 In Chapter 17 the Inquiry recommends that the NHMRC develop and implement procedures to promote consistency, efficiency, transparency and accountability in HREC review of human genetic research, through a systematic quality improvement program.