Introduction

17.1 In DP 66 the Inquiry discussed possible reforms to the operation of Human Research Ethics Committees (HRECs).^[1] Some of these reforms would require changes to the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Research Involving Humans (the National Statement).^[2] Others would be matters for the Australian Health Ethics Committee (AHEC), or research institutions themselves, to examine further. This chapter discusses the options for strengthening ethical review by HRECs and the responses that the Inquiry received to the issues raised in DP 66.

17.2 The Inquiry received a wide range of comment on the adequacy of the existing system of research ethics review—from those who felt that despite resource constraints the current system works well, to those who were critical of it. A number of submissions suggested possible reforms aimed at strengthening the current system of ethical review of human genetic research proposals and the role of HRECs within that system. While the Inquiry has focused on human genetic research, changes to the ethics review process may have implications for all human research reviewed by HRECs.

17.3 The Inquiry has concluded that there is a need to improve consistency, efficiency, transparency and accountability in HREC review of human genetic research. The Inquiry recommends that the NHMRC initiate a systematic quality improvement program that addresses the range of concerns discussed in this chapter.

The National Statement, AHEC and HRECs

17.4 TheNational Statement is the foundation of the Australian system of ethical review of research involving humans. As discussed in Chapter 13, the primary purpose of that Statement is the protection of the welfare and rights of participants in research,^[3] but an important secondary purpose is to ‘facilitate research that is or will be of benefit to the researcher’s community or to humankind’.^[4]

17.5 AHEC advises the NHMRC on ethical issues relating to health and develops guidelines for the conduct of medical research involving humans. AHEC therefore has an ongoing role in developing proposals for improving the system of ethical review. During the 2000–2002 triennium, a major element of the strategic plans of AHEC and the NHMRC was to strengthen the level of support provided to HRECs, by way of training workshops, access to advice, and the production of the Human Research Ethics Handbook.^[5] The National Statement is scheduled for formal review by AHEC during the 2003–2005 triennium, consistently with NHMRC policy of revising guidelines that have been in place for five years.

17.6 This chapter focuses on the role, function, responsibility and accountability of HRECs, but there are other components of the system of ethical review. These should not be discounted. The National Statement makes it clear that the design and conduct of human research, the integrity of researchers, and their conformity to ethical values and principles are also central to achieving the purposes of the National Statement.

Human Research Ethics Committees

17.7 The National Statement states that the functions of HRECs are to review and, where appropriate, approve all proposals for research involving humans, and to monitor the conduct of that approved research.

Institutional status

17.8 The status, functions, responsibilities and accountability of HRECs are set out in the National Statement. The National Statement provides that research projects involving human participants must be reviewed and approved by an HREC. HRECs are established by and advise an institution or organisation regarding ethical approval for research projects.^[6]

17.9 Institutions or organisations in which such research is undertaken should establish, adequately resource and maintain an HREC, or have research projects reviewed and monitored by an HREC established by another institution.^[7] When establishing an HREC, an institution must set out its terms of reference, scope of responsibilities, accountability and reporting mechanisms.^[8] Institutions must accept legal responsibility for decisions and advice received from the HREC and agree to indemnify its members.^[9]

17.10 Institutions with HRECs are required to establish mechanisms for receiving and promptly handling complaints or concerns about the conduct of approved research projects.HRECs must nominate a person to whom complaints may be made and make their identity known to the research participants. Institutions are also required to establish procedures for receiving and promptly handling complaints from researchers about review of research proposals by an HREC.^[10]

17.11 At present there are 216 HRECs in Australia registered with AHEC, of which 102 are in hospitals, 47 in universities, 35 in government and 32 in other institutions.^[11] The workload of HRECs varies significantly. Some review in excess of 300 proposals each year, while others deal with far fewer.

Functions and responsibilities

17.12 The primary function of an HREC is to protect the welfare and rights of participants in research.^[12] All research projects involving humans must be reviewed by an HREC and must not be undertaken or funded unless and until approval has been granted. HRECs are required to maintain a record of all proposed research projects including specified information. HRECs must also keep a copy of research protocols in the form in which they were approved.

17.13 Institutions and HRECs each have responsibilities to ensure that there is appropriate monitoring of the conduct of projects until their completion, at least by an annual report.^[13] The frequency and type of monitoring should reflect the degree of risk to participants, and may utilise existing institutional mechanisms for this purpose.^[14]

Membership and procedures

17.14 The National Statement specifies a minimum membership for HRECs and requires that the membership has a balance of suitable expertise. The current system of ethics review aims to combine peer review and community involvement. The National Statement also addresses HREC meetings,^[15] managing conflicts of interest,^[16] documentation and recording of decisions,^[17] and expedited review of minimal risk projects.^[18]

Accountability

17.15 HRECs are accountable to their institutions through reporting and other processes. These may vary among institutions. In addition, the National Statement establishes further accountability processes that relate to the national system of ethical review of research involving humans.

Structure of ethics review

17.16 The National Statement requires that research proposals be reviewed by an HREC. However, organisations may apply additional levels of review or delegate functions to subcommittees.^[19]

17.17 A separate committee may review the scientific aspects of the project. For example, the Peter MacCallum Cancer Institute utilises a two-stage review process. Research proposals are first reviewed by a biomedical committee to assess the scientific and research value of the proposals, and then by an HREC. One advantage of this approach is that the composition of the HREC can more easily accommodate non-expert and non-institutional members.^[20]

17.18 Two-stage review may also be used to review issues arising out of human genetic research involving collectivities, such as research involving Aboriginal and Torres Strait Islander peoples. A joint HREC of the Menzies School of Health Research and the Royal Darwin Hospital convenes an Aboriginal Sub-committee that reviews such research proposals. The sub-committee (assisted by a scientific adviser) reviews proposals; consults with leaders of the relevant Aboriginal communities; and may veto proposals where ethical concerns remain.^[21]

17.19 Some submissions suggested that human genetic research should be subject to a more centralised system of ethics review.^[22] For example, Privacy NSW suggested the establishment of ‘an independent, national ethics review committee with substantial lay and community representation’ and ‘a single, independent and transparent complaints mechanism to deal with decisions made by any HREC’.^[23]

17.20 A system of centralised review would represent a significant change to the present institutionally based system. In Australia, as in the United States, Canada, New Zealand and the United Kingdom, ethics review committees are based in an institution—usually a research institution within which the research is conducted—or are established within a regional authority, such as an area health service.^[24]

17.21 Complete centralisation of the ethics review process would probably be impractical. The volume of research proposals requiring review is likely to exceed the capacity of a single national body, or series of regional review bodies. The resource implications of establishing a national committee would be significant.

17.22 A centralised system of ethics review would need to include mechanisms to respect the legitimate interests and knowledge of institutions concerning the suitability of their facilities and staff to conduct the proposed research. A centralised system of review also risks introducing a narrow ethical range of perspectives, which are less responsive to community and institutional commitments and change. An institutionally based ethical review system accommodates HREC decisions that may differ in how they apply the principles and values set out in the National Statement.

17.23 One precedent for a national centralised level of review is the Gene and Related Therapies Research Advisory Panel (GTRAP). GTRAP is a subcommittee of the Research Committee of the NHMRC, and was established to provide the NHMRC and HRECs with advice on human gene therapy trials, and to assist researchers in the establishment of best practice standards.^[25] Although GTRAP is primarily an advisory body, it plays a role in the HREC approval process for human gene therapy trials. AHEC has stated that HRECs should not approve research that involves gene therapy without the prior approval of both the Institutional Biosafety Committee and GTRAP.^[26]

17.24 This review process was thought necessary because gene therapy involved ‘novel approaches to treatment, the short or long term potential for harm was still undetermined, and it would be difficult for HRECs to gain expertise as the number of research studies would be small’.^[27] It needs to be emphasised that this approach was specifically based on the possibility that human gene therapy might accidentally affect the germ cell line and that it was therefore unreasonable for a single HREC to be expected to make ethical judgments on such studies without access to the best available scientific advice.

17.25 The Inquiry does not believe that there are cogent reasons to establish a national ethics committee to review human genetic research and not other research involving humans. While human genetic research involves a particular constellation of ethical issues, the ethical hazards are no greater than some other categories of research—such as clinical trials or research involving vulnerable persons. Similarly, while some genetic research may involve the need for access to specialised scientific advice, much will not.

17.26 The Inquiry considers that there are a number of ways to strengthen review of human genetic research by HRECs without establishing a centralised system. As discussed below, these include revised procedures, improved resources, and better education and training. Nevertheless, the NHMRC, as part of the quality improvement program recommended below, should consider whether there is a need for greater consolidation of ethical review, by region or subject-matter.

Quality of review

Membership of HRECs

17.27 The minimum membership of an HREC must comprise:

• a chairperson;

• at least two members who are lay people, one man and one woman who have no affiliation with the institution or organisation, are not currently involved in medical, scientific or legal work, and who are preferably from the community in which the institution is located;

• at least one member with knowledge of and current experience in the areas of research that are regularly considered by the HREC;

• at least one member with knowledge of and current experience in the professional care, counselling or treatment of people;

• at least one member who is a minister of religion or a person who performs a similar role in a community such as an Aboriginal elder; and

• at least one member who is a lawyer.^[28]

17.28 Institutions must ensure that the membership of their HRECs will equip them to address all relevant considerations arising from the categories of research likely to be submitted to them.^[29] Each HREC must ensure that it is sufficiently informed on all aspects of each research protocol, including its scientific and statistical validity, to decide whether the protocol is acceptable on ethical grounds and conforms to the National Statement. Institutional appointment of additional members with relevant expertise may be necessary, but in making additional appointments institutions should maintain the diversity of categories of members and the relative proportion between institutional and non-institutional members.^[30]

17.29 Institutions may recruit members in such manner and shall appoint them for such terms and on such conditions as they determine—although members are appointed for their expertise and not as representatives of any professional, political or social group. Members should receive a formal notice of appointment together with an assurance that the institution will provide legal protection in the event of claims arising from bona fide conduct of committee duties.^[31]

17.30 There need be only two members of the HREC who have no affiliation with the institution. An informal survey by AHEC of HRECs from the hospital and university sectors conducted in 2002 showed that on average three or four of the six core membership categories were filled by persons who had no affiliation with the institution, although this varied quite widely.

17.31 In submissions and consultations, concerns were expressed about the mix of institutional and non-institutional members on HRECs and the effects of this composition on the independence of HRECs. A particular concern was that some community members may be disempowered in their contributions to the review process by the presence of members with specialist expertise, and by a preponderance of institutional members, who may be employees of the research organisation whose research proposals are being reviewed.

17.32 In expressing concern about the perceived inadequacies in the audit of HRECs’ use of guidelines issued under the Privacy Act 1988 (Cth) (Privacy Act), Privacy NSW stated that:

This lack of transparency is a significant concern in light of the composition of HRECs, which may include interests that are not independent of the interests attached to the research itself. Inevitably, implementation of the Guidelines varies depending upon the personal, institutional and commercial context in which an HREC operates.^[32]

17.33 The New South Wales Health Department made similar points, relating the balance of membership to the transparency of HREC processes.

The structure and transparency of HRECs could be enhanced by including more community representation than is currently required by the National Statement. The current preponderance of ‘institutional’ members may lead to lay and community members feeling disempowered in their contributions to the review process.^[33]

17.34 An alternative view is that institutions are entitled to have their own interests and values maintained by the appointment of persons who hold the values of the institution strongly, including staff members, and that such persons also understand that the primary purpose of the HREC is to protect the interests of human participants. It is not in the interests of institutions to be seen to support unethical research.

17.35 There is an international trend towards stronger community representation on ethics review committees. This consists of a trend towards the appointment of a greater number of community members; the election of chairpersons from among the community members; the selection of people ‘of standing’ as community members because they may be better able to withstand pressure from other committee members; and the appointment of community members as representatives of research participants or particular groups of participants.^[34]

Advice for HRECs on review of human genetic research proposals

17.36 The Inquiry received submissions on the need for HREC members to have sufficient expertise in genetics. The Familial Cancer Centre of the Royal Melbourne Hospital recognised the ubiquity of genetic issues in health research and recommended that:

Since so many research projects now relate to human genetic research, HRECs should include at least one member who has genetic expertise and understands the ethical and social issues relating to such research.^[35]

17.37 This suggestion was supported by other submissions,^[36] and is consistent with the requirement of the National Statement that the membership of HRECs be equipped to address issues arising from the categories of research likely to be submitted to them.^[37]

17.38 Some submissions suggested that HRECs need further sources of advice on ethical considerations related to human genetic research. The Australian Academy of Science stated that:

there are many HRECs that are facing new challenges in areas such as genetics. Each HREC has the responsibility to consider each proposal on its merits, but we recommend that there should be a system in place where HRECs can ask for advice from a central body. If a Standing Advisory Group on Human Genetics is established, either it, or the Australian Health Ethics Committee, or the two together, could fill this role.^[38]

17.39 As discussed in Chapter 15, the Inquiry conducted a survey of all HRECs to determine the number of research proposals that involved human genetic research and were considered by HRECs during 2002. The Inquiry received 82 completed questionnaires (a response rate of 38%). Twenty-six HRECs had considered 129 proposals involving human genetic research in the reporting period.

17.40 Although the number human genetic research proposals submitted for review is likely to increase, the Inquiry does not recommend the establishment of a specialist advice service for HRECs. However, as part of the quality improvement program for HRECs recommended below, the needs of HRECs for expertise, and the obligations of institutions and committees to be satisfied that they have adequate expertise, should be emphasised.