17.72 The 1996 IEC Reportreceived submissions suggesting a need for greater transparency, monitoring and supervision of HRECs. However, the report stated that there was
no persuasive evidence of unsatisfactory or poor conduct in the current operation of IECs [as HRECs were then known] to justify the introduction of more stringent inspection (for example, external independent audits) of IECs. Independent audits and the like should not be routinely introduced and should be a ‘last-choice’ option used when there is evidence of misconduct. There was little support in the submissions for the conduct of random audits.
17.73 The 1996 IEC Reportconcluded that the most effective method to ensure the accountability of the institutional ethics committee system was more detailed reporting by HRECs to AHEC and by AHEC to the NHMRC.
17.74 The present Inquiry did not identify evidence of poor performance or conduct on the part of HRECs. However, submissions expressed much support for the accreditation of HRECs, reflecting a significant shift in opinion in the years since the 1996 IEC Report. Submissions argued that accreditation would help ensure high and consistent standards of review, suitable expertise, adequate and continuous training and sufficient resources to fulfil the institutional responsibilities of HRECs.
17.75 The HGSA expressed its support for accreditation and related the need for accreditation to standards and resourcing.
HGSA supports the accreditation of HRECs to ensure that ethical oversight is of the highest standard and also to stimulate organisations to provide an appropriate level of resourcing.
17.76 The Department of Human Services South Australia agreed that accreditation would be a ‘positive move’. The Australian Biospecimen Network saw accreditation as part of a solution to the problem of multi-site approvals.
Moreover, it would be helpful if members of HRECs were provided free training in all aspects relevant to their membership of an HREC, preferably with some form of formal recognition of this training. Such a formal training would then provide a means for ‘accreditation’ of an ethics committee, which would permit more free reciprocal agreements between HRECs.
At the moment, the requirement to make multiple submissions to potentially dozens of HRECs for multicentre trials implies that not all HRECs are equal, and that by extension individual HRECs are not ‘recognised’ by other HRECs as having authority to give approval. This absurd situation makes a mockery of the ideal that each HREC abides stringently to the National Statement.
We propose that training be provided to volunteer members of HRECs to provide a certificate of competence to abide by the National Statement, and that completion of such by each member of an HREC provide de facto accreditation to that HREC such that its decisions are recognised as sufficient for reciprocal approval by other HRECs. Random scrutiny of an approved protocol by AHEC would ensure standards are adhered to according to the National Statement and would ensure the individual HRECs provide adequate reporting on how their approval was provided, as well as clear reasons as to why projects were not recommended for approval.
17.77 The Centre for Law and Genetics stated that there ‘is no pressing case for the introduction of a formal system of accreditation of HRECs’ but, along with several other submissions, argued that although the present system is satisfactory it needs work to ensure that HRECs and institutions are fully aware of their responsibilities.The Australian Red Cross Ethics Committee stated that:
In view of the type of applications considered by our Committee, we believe that it is not inappropriate for HRECs dealing with human tissue research applications to be more regulated than other HRECs. Such research raises unique issues … Our Committee would not object to accreditation procedures being developed.
17.78 In North America, accreditation of human research ethics review processes has been either recommended or implemented. In Canada, a task force set up by the National Council on Ethics in Human Research (NCEHR) recommended in March 2002 that the NCEHR affirm the need for nationwide oversight of ethics review processes, in the form of an accreditation program to be conducted by ‘an arm’s-length, non-governmental organization’.
17.79 In the United States, the Institute of Medicine recommended accreditation as one mechanism for enhancing the effectiveness and reliability of programs for the protection of human research participants. The Institute reaffirmed these recommendations in a later report. In a comprehensive and detailed report, the United States National Bioethics Advisory Commission (NBAC) also recommended accreditation of those programs.
17.80 There are several current accreditation programs in the United States. One is conducted by the American Association for Accreditation of Human Research Protection Programs Inc, a non-profit corporation that offers accreditation of programs on a user pays basis, using site visits. The National Committee for Quality Assurance administers an accreditation program that is mandatory for all health centres operated by the Department of Veterans Affairs. The Office for Human Research Protections, within the Department of Health and Human Services, has established a program of quality improvement based on an initial self-assessment, followed by site visits and assistance.
17.81 The term accreditation is capable of referring to a wide range of processes, from simple registration based on annual returns, to detailed scrutiny of committee procedures and decision making processes. The essential characteristics were described by the NBAC as follows:
These programs generally involve experts and peers developing a set of standards that represents a consensus of the best practices in the profession. Therefore, the choice of standards and the criteria for evaluating whether an institution has met them are critically important. The emphasis of these programs should be on education, on assuring that appropriate protections are in place, and on avoiding excessively bureaucratic procedures. Accrediting programs may lose their value if they are seen as merely another administrative burden.
Despite concerns that accreditation might add another layer of bureaucracy to an already regulated environment, several advantages of accreditation programs have been noted. They are generally voluntary and represent a profession’s desire to self-regulate. Many accrediting programs strive to meet higher standards than are required by law, so that having the credential implies a higher level of competence than what may be minimally required. Properly governed and organized, accrediting bodies can improve competence (and thus performance) within a profession, which helps to achieve the goals of the profession and build public trust (Hamm 1997). In addition, accreditation serves an educative role.
Institutions seeking accreditation, for example, usually go through a periodic review process involving a self-study and a site visit from a team of experts in the profession. The self-evaluation of the institution in preparation for a site visit helps it identify strengths and weaknesses in its programs and make improvements. The site visit can be an especially useful learning experience that encourages the institution to sustain best practices.
17.82 Consistently with submissions to the Inquiry, an accreditation system would need to be based on the articulation of detailed standards of performance, an initial quality improvement phase to inform, train and equip HRECs, and commitment of institutions to those standards. There may need to be a process of site visits and certification for identifying and remedying defects. These initiatives would require a significant increase of resources for AHEC.
17.83 The Inquiry has concluded that a system of formal accreditation offers the prospect of substantially strengthening HREC review of human genetic research proposals. As such, the Inquiry believes that accreditation is worthy of further detailed consideration by the NHMRC, but that such a scheme is feasible only when clear standards for consistency, efficiency, transparency and accountability of HREC review of human genetic research have been established.
17.84 The Inquiry notes the developments in the regulatory framework for review of research proposals by HRECs, which followed the 1996 IEC Report and the extensive consultations prior to the publication of the National Statement in 1999.
17.85 The Inquiry also notes that many of the HREC reforms proposed in submissions and consultations do not relate solely to human genetic research but to the conduct of research involving humans generally. In Chapter 14, the Inquiry has recommended that the NHMRC review mechanisms for achieving compliance with the National Statement, with particular regard to human research conducted wholly within the private sector.
17.86 The Inquiry considers that, on the basis of submissions and consultations, the present ethics review system could be significantly improved. The weaknesses identified have attracted criticism and may constitute threats to the effectiveness and public standing of the system.
17.87 The evidence available to the Inquiry does not show that the conduct of review and monitoring of human genetic research has exposed research participants to unacceptable risks. However, the evidence does show that many HRECs lack resources and relevant expertise. Submissions also suggest that improvements in reporting by HRECs are needed to ensure that the relevant standards are consistently and expertly applied.
17.88 The Inquiry has concluded that the first priority for the NHMRC should be to develop and implement a quality improvement program for HRECs to promote consistency, efficiency, transparency and accountability in the review of human genetic research by HRECs. A second priority should be for the NHMRC to undertake a detailed examination of the need for an accreditation system for HRECs. Fundamental to both initiatives is the provision of adequate resources by institutions to enable HRECs to fulfil their responsibilities.
Recommendation 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.
Recommendation 6–2 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.
Recommendation 6–3 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.
 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.
 Ibid, 54.
 Ibid, 54.
 Human Genetics Society of Australasia, Submission G267, 20 December 2002; J Fleming, Submission G241, 20 December 2002; Queensland Institute of Medical Research, Submission G190, 26 November 2002; Australian Biospecimen Network, Submission G238, 19 December 2002; Department of Human Services South Australia, Submission G288, 23 December 2002; Australian Red Cross Ethics Committee, Submission G292, 6 January 2003; Medicines Australia, Submission G302, 12 February 2003.
 Human Genetics Society of Australasia, Submission G267, 20 December 2002.
 Department of Human Services South Australia, Submission G288, 23 December 2002.
 Australian Biospecimen Network, Submission G238, 19 December 2002.
 Centre for Law and Genetics, Submission G255, 21 December 2002.
 Department of Health Western Australia, Submission G271, 23 December 2002; NSW Health Department, Submission G303, 13 January 2003.
 Australian Red Cross Ethics Committee, Submission G292, 6 January 2003.
 The National Council on Ethics in Human Research, Final Report of the Taskforce to Study Models of Accreditation for Human Research Protection Programs in Canada (2002), The National Council on Ethics in Human Research, Ottawa.
 Institute of Medicine, Preserving Public Trust: Accreditation and Human Research Participation Protection Programs (2001), National Academies Press, Washington.
 Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Participants (2002), National Academies Press, Washington.
 National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants Vol I: Report and Recommendations of the National Bioethics Advisory Commission (2001), National Bioethics Advisory Commission, Bethesda.
 Ibid, 49.