Introduction

16.1 The National Health and Medical Research Council’s (NHMRC) National Statement on Ethical Conduct in Research Involving Humans (the National Statement)^[1] offers guidance on, rather than prescription of, ethically sound research design and practice.

16.2 In relation to human genetic research, comprehensive guidance is provided on a range of issues, including the social significance and consequences of genetic research, privacy and confidentiality, consent, waiver of consent and genetic counselling.^[2] The Human Research Ethics Handbook^[3] provides further advice on the provisions of the National Statement for the assistance of Human Research Ethics Committee (HREC) members, researchers and research participants.

16.3 The Inquiry considers that the provisions of the National Statement provide appropriate general ethical guidance and, in most respects, do not require revision. However, in the course of the Inquiry, suggestions were made about a range of desirable practices in the conduct of human genetic research. These included suggestions about the content of consent forms and participant information sheets, de-identification of genetic samples or information, and disclosure of commercial interests.

16.4 In DP 66, the Inquiry proposed that the Australian Health Ethics Committee should develop model research protocols to provide guidance on various aspects of human genetic research and guidelines for preparing consent forms for human genetic research.^[4] Submissions indicated widespread support for these proposals.^[5] For example, the Australian Biospecimen Network submitted that model protocols and consent form guidelines ‘are essential to the effective working of HRECs and would greatly aid the writing of and consideration of ethics applications’.^[6] The Centre for Law and Genetics stated that the Inquiry’s proposals would ‘accelerate and achieve more uniform approaches to best practice in research that directly addresses critical issues of participant privacy in human genetic research’.^[7]

16.5 Some cautioned against the risk of these becoming inflexible rules and standards in the face of likely rapid change.^[8] Others emphasised the need for education of researchers and HREC members to ensure sound use of the National Statement.^[9]

16.6 The Inquiry has concluded that these submissions support the development and publication by the NHMRC of advice and information on good research practice and consent documentation in research involving genetic information. The function of this advice and information would be to augment the National Statement, as revised, to give further guidance to HREC members, researchers and research participants on what the NHMRC considers to be best practice in the conduct of human genetic research. The range of issues to be included in that advice and information is discussed below.

16.7 The Inquiry notes the suggestions for appropriate involvement of professionals^[10] and community members^[11] in the development of the advice and information. The topics on which advice and information is recommended arise not only in research involving genetic information, but also in research involving any personal information. Indeed, genetic research is now a component of much health research.^[12]