Part D examines ethical, privacy and related issues concerning the use of genetic samples and information in the conduct of human genetic research. Chapter 13 summarises the present regulatory framework for the ethical conduct of research centred on the NHMRC’s National Statement on Ethical Conduct in Research Involving Humans (the National Statement) and on review of research proposals by HRECs.
Human genetic research generates knowledge with the potential to improve dramatically the diagnosis, prevention and treatment of serious health and medical problems. Research also can reveal information about an individual’s susceptibility to disease and hence about the individual’s future health. The recommendations in this Part are intended to balance the interests of researchers—who need access to human genetic samples and information from many sources—and the needs of individuals and their relatives—whose autonomy must be respected and whose privacy must be protected.
The requirements for institutions or HRECs to be registered with the NHMRC and to follow the processes set down in the National Statement are incomplete. For example, there is currently no obligation on private research bodies to adhere to the provisions of the National Statement. Chapter 14 examines these matters and, in light of the increasing commercialisation of human genetic research, recommends strengthening of the mechanisms by which compliance with the National Statement is enforced.
The concept of consent is fundamental to the legal and ethical regulation of human research. Other than in limited and defined circumstances, the National Statement generally requires consent to the use of human tissue samples, genetic material and genetic information in medical research. Chapter 15 highlights concerns about various aspects of consent and, in particular, whether the current provisions under which HRECs may waive consent requirements are adequate to the tasks of protecting privacy and autonomy. 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. The Inquiry recommends the imposition of new reporting obligations for HRECs about proposals for which waiver of consent has been granted under the National Statement; and augmenting training and other support for HRECs in relation to decision making on waiver of consent. The Inquiry also recommends amending the National Statement to provide clear guidance about obtaining consent to unspecified future human genetic research.
The Inquiry suggests that it would 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. The intention of these documents would be to give further direction to researchers and HRECs about 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.
Chapter 17 discusses a range of options aimed at strengthening the current system of ethical review of human genetic research and the role of HRECs within that system. 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.
This program should address, among other things: the membership of HRECs and, in particular, the balance between institutional and non-institutional members; the expertise available to HRECs in considering proposals for human genetic research; the on-going monitoring of approved human genetic research projects; the education and training of HREC members; and standardised record keeping and reporting to the NHMRC, including in relation to commercial arrangements. The Inquiry also recommends that the NHMRC should review the need for a formal accreditation system for HRECs in respect of the ethical review of human genetic research.