13.1 This chapter introduces Part D, which considers ethical, privacy and related issues concerning the use of genetic samples and information in the conduct of research involving humans (referred to as human genetic research).

13.2 This chapter briefly summarises the present regulatory framework for the ethical conduct of research. This framework is centred on the National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Research Involving Humans (the National Statement)[1] and on review of research proposals by Human Research Ethics Committees (HRECs).[2]

13.3 Some of the complexities involved in regulating human genetic research were summarised by William Lowrance in a recent report for the Nuffield Trust:

Debates in the coming era over genetic information are likely to severely test the legal concepts of privacy and autonomy, and also the fundamentals of bioethics, which are already stretched thin. Informational privacy will have to be distinguished from decisional autonomy. Progress will have to be made in sorting-out the rights of relatives of data-subjects. And the public health aspects of genetics will become more prominent and have to be dealt with.[3]

13.4 The adequacy or otherwise of the existing regulatory framework has been the subject of much comment in the course of the Inquiry. The nature of this comment, and the issues raised in consultations and submissions, are reflected in this chapter and those that follow.

[1] National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra.

[2] The role of HRECs is discussed in more detail in Ch 17.

[3] W Lowrance, Learning from Experience: Privacy and the Secondary Use of Data in Health Research (2002), The Nuffield Trust, London, 59.