14. Enforcing Compliance with the National Statement
14–1 The National Health and Medical Research Council, as part of its review of the National Statement on Ethical Conduct in Research Involving Humans (the National Statement) in the 2003–2005 triennium, should review the mechanisms for achieving compliance with the National Statement, with particular regard to human research conducted wholly within the private sector.
15. Human Genetic Research and Consent
15–1 The National Health and Medical Research Council (NHMRC), as part of its review of the National Statement on Ethical Conduct in Research Involving Humans (the National Statement) in the 2003–2005 triennium, should amend the National Statement to provide that Human Research Ethics Committees (HRECs) must report annually to the Australian Health Ethics Committee (AHEC) with respect to human genetic research proposals for which waiver of consent has been granted under the National Statement. Until such time as the National Statement has been so amended, the NHMRC should exercise its existing authority to request information from HRECs to require them to report annually to AHEC with respect to such human genetic research proposals.
15–2 The NHMRC, as part of its review of the National Statement in the 2003–2005 triennium, should ensure that the provisions of the National Statement relating to waiver of consent and reporting of decisions are consistent with privacy laws and, in particular, with guidelines issued under s 95 and s 95A of the Privacy Act 1988 (Cth).
15–3 The NHMRC, in strengthening the level of training and other support provided to HRECs in accordance with Chapter 17 of this Report, should ensure that adequate attention is given to: (a) the interpretation of the waiver of consent provisions of the National Statement; and (b) HREC decision making in relation to such waiver.
15–4 The NHMRC, as part of its review of the National Statement in the 2003–2005 triennium, should amend the National Statement to provide clear guidance to researchers about obtaining consent to unspecified future human genetic research.
16. Encouraging Best Practice in Human Genetic Research
16–1 The National Health and Medical Research Council (NHMRC) should develop information and advice for the preparation of human genetic research protocols, including examples and practical guidance on:
- the mechanisms for coding or de-identifying genetic samples and information used in research, and the relative advantages and disadvantages of each approach in different research contexts;
- the use of independent intermediaries, in appropriate cases, to hold codes linking genetic samples or information with the identifiers;
- the discharge of legal and ethical obligations to inform research participants about the health implications of testing of genetic samples; and
- disclosure by researchers to research participants of information about actual or anticipated commercial arrangements connected with human genetic research proposals.
16–2 The NHMRC should develop information and advice for preparing consent forms for human genetic research, including examples and practical guidance on such matters as:
- graduated consent options;
- disclosure by researchers about actual or anticipated commercial arrangements;
- ownership or property interests in genetic samples or information;
- methods of protecting the privacy interests of participants; and
- withdrawal of consent by participants.
17. Strengthening Review by HRECs
17–1 The National Health and Medical Research Council (NHMRC) should develop and implement procedures to promote consistency, efficiency, transparency and accountability in the review of human genetic research by Human Research Ethics Committees (HRECs). In developing such procedures, the NHMRC should initiate a systematic quality improvement program that addresses:
- consolidation of ethical review by region or subject-matter;
- the membership of HRECs and, in particular, the balance between institutional and non-institutional members;
- the need for expertise of HRECs in considering proposals for human genetic research;
- on-going monitoring of approved human genetic research projects;
- the education and training of HREC members;
- payment of HREC members for their work in reviewing research proposals;
- independent audit of HREC processes; and
- standardised record keeping and reporting to the NHMRC, including in relation to commercial arrangements.
17–2 In the course of developing a quality improvement program for HRECs in accordance with Recommendation 17–1, the NHMRC should review the need for an accreditation system for HRECs in their ethical review of human genetic research.
17–3 As part of the process of strengthening HREC review of human genetic research, each relevant institution and organisation should provide adequate resources to enable its HREC to fulfil its institutional responsibilities and achieve the standards set in accordance with Recommendations 17–1 and 17–2.