Introduction

15.1 The concept of consent is fundamental to the legal and ethical conduct of research and to the protection of privacy. This chapter examines issues related to consent in research using genetic samples or information.

15.2 The National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Research Involving Humans (the National Statement)^[1] generally requires consent to the use of human tissue samples, genetic material and genetic information in medical research. The general consent requirement may be waived by a Human Research Ethics Committee (HREC) in certain restricted circumstances.

15.3 In addition, the Privacy Act 1988 (Cth) (Privacy Act) imposes legal requirements to obtain consent for the collection, use or disclosure of personal information, including genetic information. These requirements may also be waived by an HREC where collection of the information is carried out in accordance with guidelines under s 95 or s 95A of the Privacy Act (the s 95 and s 95A Guidelines).^[2]

15.4 A central concern of this chapter is the extent to which waiver of consent under the National Statement or under the s 95 and s 95A Guidelines may undermine privacy protection. A related issue concerns the extent to which researchers are able, under the National Statement, to obtain consent from research participants for the use of their genetic samples or information for unspecified future research.