17.41 Research organisations and HRECs have responsibilities to ensure that there is appropriate monitoring of approved research projects. The National Statement requires that regular reporting, at least annually, is a minimum monitoring requirement. Reports should address progress of the research, maintenance and security of records, compliance with the approved protocol and with any conditions of approval. Additional monitoring mechanisms may be employed by the HREC. HRECs are directed to require that researchers report immediately anything that might warrant review of the ethical approval of the project, including serious or unexpected adverse effects on participants, proposed changes to the protocol and unforeseen events that might affect the continued ethical acceptability of the project. HRECs are to impose, as a condition of approval, the requirement that researchers inform the HREC, with reasons, if the research is discontinued before the expected date of completion.
17.42 Where an HREC is satisfied that a research project is not, or cannot be, conducted in accordance with the approved protocol and that, as a result, the welfare and rights of participants are not, or will not, be protected, it may withdraw ethical approval, inform the researcher and institution of such withdrawal, and recommend to the institution that the research be discontinued or suspended.A researcher is required to discontinue research if ethical approval is withdrawn.
17.43 The Inquiry has received differing views on the adequacy of the current monitoring practices, which vary widely in different types of research, from clinical trials to social science research. Some individuals and organisations were critical of the existing arrangements for monitoring of research by HRECs. However, the resource implications of implementing more thorough monitoring were also widely recognised.
17.44 The New South Wales Genetics Service Advisory Committee stated that there should be uniform policies and guidelines on the reporting and monitoring requirements of HRECs. Privacy NSW submitted that monitoring should be conducted by HRECs throughout the research period and that the current minimum requirement of annual inspection was inadequate. Professor Nick Saunders and Associate Professor Paul Komesaroff stated that, in general, HRECs do not effectively monitor approved research.
It is likely that to achieve adequate monitoring a fundamental change in approach will be needed, including possibly routine questioning of research participants. This is an important question that will in due course require detailed attention.
17.45 The Queensland University of Technology stated that it currently exceeds the requirements in the National Statement by conducting ‘limited random audit of active ethical clearances’. The University noted that this approach should be considered as an additional minimum monitoring requirement. The University is also in the early stages of considering compliance audits to capture research not submitted for review. Other suggested additions to the monitoring process included mechanisms to check on consent processes and the development of criteria for identifying genetic research that involves high risks and requires more intensive monitoring.
17.46 The NHMRC Research Committee emphasised the resource constraints on monitoring.
Monitoring of research by HRECs presently requires annual reports and the HREC can undertake further monitoring if this were felt to be essential. Again, the administrative load currently required of a HREC would make the requirement for more active or frequent monitoring difficult to implement unless some other part of the regulatory process could be relaxed or simplified.
17.47 Other submissions highlighted the importance of adequate resources.
The current minimum monitoring requirements by HRECs are adequate. The existing provisions allow HRECs to use discretion when monitoring human research proposals, including human genetic research. The limiting factor for adequate monitoring by HRECs is their lack of adequate resources.
17.48 The existing provisions of the National Statement relating to monitoring of research are flexible and allow institutions and HRECs to monitor the conduct of human genetic research to the extent that they consider appropriate, or practicable. However, given the importance of effective monitoring procedures and the concerns expressed to the Inquiry, monitoring procedures should be reviewed by the NHMRC as part of the quality improvement program recommended below.
Needs of HRECs, HREC members and researchers
17.49 The resourcing of HRECs was examined by the 1996 Report of the Review of the Role and Functioning of Institutional Ethics Committees (the 1996 IEC Report). Concerns about the overall resources available to HRECs, not only for monitoring of research, were expressed in submissions and consultations. For example, the Office of the Federal Privacy Commissioner (OFPC) argued that while the current structures for ethics review are ‘fundamentally sound’ there needs to be sufficient resources made available to support members of HRECs.
The current HRECs structure currently depends heavily on the good will of respected members of Australian society, who generously give their already limited time to this very important process. HRECs are finding it increasingly difficult to meet additional obligations and processes as they are introduced.
17.50 With particular reference to privacy compliance, the OFPC stated that:
From a privacy perspective, compliance with HRECs requirements by researchers should be at a premium. If the growing research challenges are to be met in the interests of the community and participants, HRECs will need every assistance by way of resourcing and administrative support and in the provision of guidance on such matters as applying the Guidelines under [the Privacy Act].
17.51 The need for resources to enable HRECs to carry out their functions was repeated in many submissions. Submissions linked the inadequacy of resources to all functions of HRECs. The Human Genetics Society of Australasia (HGSA) stated that the role of HRECs is ‘constrained by resources and lack of expertise’.
Additional resources are needed to allow HRECs to carry out their assessment of research submissions and to meet their reporting and monitoring obligations. Members of HRECs, most of whom are unpaid volunteers, should be provided with general training and any specific training that relates to the type of research carried out in their institution. However, it is essential that the additional resources do not come from the limited funding available in Australia for research.
17.52 The Queensland University of Technology submitted that there is a need for greater resourcing for the exchange of information between HRECs, for the promotion of excellence in the ethics review, and for the training of HREC members and researchers. The Australian Biospecimen Network commented on the need for better resources to streamline administrative processes.
Resources should be made for improved secretarial support and for online facilities for expedited completion of ethics applications. Such online facilities would provide links to all relevant sections of the National Statement, recommendations on how to ensure compliance including model consent forms. Such a facility would solve many of the issues related to the time needed to fill in an ethics application by an investigator, the quality of such submissions and therefore the time taken to have it reviewed and its reciprocal acceptance by other HRECs.
17.53 Although there was widespread agreement that HRECs needed more resources, there was no unified opinion as to the source of those resources. For example, while the HGSA opposed the use of research grants for these purposes, the OFPC stated that:
specific funding allocations should be made in research grants to enable researchers to properly inform HRECs of all pertinent issues and to comply with the relevant protective guidelines, such as the Section 95 and 95A Guidelines under the [Privacy] Act. Those research grants should also include specific funding allocations for the involvement of HRECs in the research project.
17.54 The cost to researchers of complying with ethics review and other requirements is a related issue. Professor Nick Martin, Head of the Queensland Institute of Medical Research stated:
We receive no extra budget to cope with compliance costs, and inevitably this means less research gets done. For example, simply to comply with ethical requirements for my own projects requires 1.5 FTE positions. In the US, the National Institutes of Health have now recognised this and now add 8% for compliance costs to all successful grants. I hope that your report will recommend a similar measure here. The government and community have to recognise that they simply cannot have this degree of regulation without paying for it. Furthermore, the amount of time now required to look after compliance issues greatly decreases job satisfaction for scientists and I know many who are now actively avoiding tackling important clinical problems for this reason. I don’t believe this is in the community’s best interest.
17.55 The Inquiry recognises that, under the National Statement, it is the responsibility of institutions to resource HRECs. However, submissions and consultations indicated that this responsibility is not always fulfilled. The Inquiry recommends that, 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 required by the quality improvement program recommended below.
Education and training
17.56 The need for education and training of HREC members was recognised by the 1996 IEC Report.The report recommended that AHEC should develop a statement of core competencies for HREC (then called an Institutional Ethics Committee) members to assist in the development of courses for their in-service training and that institutions should make available sufficient ongoing funding to enable their committee members to take up opportunities for training and development.
17.57 The Inquiry received similar suggestions in submissions. The Inquiry considers that the education and training requirements of HREC members and support staff should be addressed by the NHMRC, as part of the quality improvement program recommended below.
Payment of HREC members
17.58 HREC members are not paid a sitting fee but may be reimbursed for out-of-pocket expenses. Many HREC members are employed by the institution within which the HREC is located. These ‘institutional members’ may be remunerated for work connected with service on HRECs (as it forms part of their duties of employment). Non-institutional members are usually unpaid. However, Commonwealth agencies with HRECs pay sitting fees to non-institutional members on the Remuneration Tribunal scale. This applies, for example, to non-institutional members of HRECs in the Australian Institute of Health and Welfare, the Department of Health and Ageing, and the Department of Defence.
17.59 Payment of HREC members was raised in submissions to the Inquiry and had also been identified in the 1996 IEC Report. It has been suggested that lack of payment for non-institutional members may present a barrier to the effective operation of HRECs.
Because non-institutional members are volunteers, one feels constrained not to ask too much of them and so meetings are not scheduled frequently enough. I believe the solution is to offer payment for attendance at [HREC] meetings at consultancy rates, so the institution does not feel embarrassed at calling on people’s voluntary time. I see no conflict of interest for members in accepting such payments, any more than should be felt by any other consultant such as an auditor. Of course, [HREC] members are free to waive their fee if they prefer that their service be seen as for the public good, but this should not be expected. I believe that only in this way can [HRECs] attain the efficiency now required for their important role in the regulatory process for medical research.
17.60 The Inquiry notes that there is no necessary correlation between making payment to non-institutional members and an improvement in the system of ethics review. Most people who agree to assist institutions by becoming members of HRECs do so for altruistic reasons, according to the findings of the 1996 IEC Report. Formalising the HREC system, including introducing member payments, may not necessarily attract the right sort of HREC members. Time, rather than money, may be the more important limiting factor on members’ involvement in ethics review. Funding ways to optimise the use of members’ time, for example by streamlining expedited ethics approval of low risk research, augmenting HREC secretariat resources and using information technology may be better means of achieving improved ethics review than paying members.
17.61 The New South Wales Health Department suggested that further consideration be given to the issues involved. The Inquiry makes no specific recommendation in this regard but notes that the issue of payment for HREC members would be appropriate for the NHMRC to consider, in the course of implementing the recommendations in this chapter.
 National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans (1999), NHMRC, Canberra [2.35].
 Ibid [2.36].
 Ibid [2.37].
 Ibid [2.38].
 Ibid [2.44]–[2.45].
 New South Wales Genetics Service Advisory Committee, Submission G094, 25 January 2002.
 Office of the Privacy Commissioner (NSW), Submission G118, 18 March 2002.
 N Saunders and P Komesaroff, Submission G084, 9 January 2002.
 Queensland University of Technology, Submission G109, 14 March 2002.
 H Saleh and others, Submission G218, 3 December 2002.
 Department of Health Western Australia, Submission G271, 23 December 2002.
 National Health and Medical Research Council Research Committee, Submission G128, 18 March 2002.
 NSW Health Department, Submission G303, 13 January 2003. See also J Fleming, Submission G241, 20 December 2002.
 D Chalmers, Report of the Review of the Role and Functioning of Institutional Ethics Committees: Report to the Minister for Health and Family Services (1996), Commonwealth of Australia, Canberra.
 Office of the Federal Privacy Commissioner, Submission G143, 22 March 2002.
 Office of the Federal Privacy Commissioner, Submission G294, 6 January 2003.
 Human Genetics Society of Australasia, Submission G267, 20 December 2002; J Fleming, Submission G241, 20 December 2002; Department of Health Western Australia, Submission G271, 23 December 2002; Australian Biospecimen Network, Submission G238, 19 December 2002; Androgen Insensitivity Syndrome Support Group Australia, Submission G290, 5 January 2003; Office of the Federal Privacy Commissioner, Submission G294, 6 January 2003; Queensland Institute of Medical Research, Submission G190, 26 November 2002; NSW Health Department, Submission G303, 13 January 2003.
 Human Genetics Society of Australasia, Submission G267, 20 December 2002.
 Queensland University of Technology, Submission G109, 14 March 2002.
 Australian Biospecimen Network, Submission G238, 19 December 2002.
 Office of the Federal Privacy Commissioner, Submission G294, 6 January 2003.
 Queensland Institute of Medical Research, Submission G036, 14 January 2002.
 D Chalmers, Report of the Review of the Role and Functioning of Institutional Ethics Committees: Report to the Minister for Health and Family Services (1996), Commonwealth of Australia, Canberra Ch 7.
 Ibid, Rec 14–15.
 Human Genetics Society of Australasia, Submission G267, 20 December 2002; Queensland Institute of Medical Research, Submission G190, 26 November 2002; NSW Health Department, Submission G303, 13 January 2003; Australian Biospecimen Network, Submission G238, 19 December 2002; Department of Human Services South Australia, Submission G288, 23 December 2002.
 Most institutional members add HREC membership to their duties, while a small number, especially committee chairpersons, are relieved of other duties in order to serve as HREC members. Some institutions pay non-institutional members. For example, the Alfred Hospital in Melbourne pays HREC members $150 per meeting.
 N Martin, Correspondence, 22 April 2002.
 NSW Health Department, Submission G303, 13 January 2003.