Editorial

Ethics committees: is reform in order?

Ethical review of multicentre studies is necessarily complex, but the system is improving

MJA 1999; 170: 9-10

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Until the early 1990s, most research involving humans was conducted within individual institutions; this was reflected in the NHMRC Statement on human experimentation and supplementary notes,² where emphasis was placed on institutional responsibility for ethical oversight. Only passing reference was made to the possibility of multicentre research, with the stipulation that an IEC shall "give its own consideration to projects that involve research in more than one institution", accompanied by a footnote indicating that "An IEC is free to discuss a project with other IECs if it chooses, with due regard to confidentiality."

In 1991, in response to perceived bureaucratic delays within the Therapeutic Goods Administration in its centralised approval process for clinical trials, the Baume Report recommended decentralisation of the system, with IECs assuming responsibility for evaluating study design and safety as well as ethical aspects.³ Despite initial uncertainties and difficulties, the clinical trials notification system has proved enormously popular. Notifications have risen from 147 trials at 350 sites in financial year 1991-92 to 400 trials at nearly 1500 sites projected for 1997-98. These figures demonstrate not only increased overall clinical trial activity in Australia, but also a substantially greater number of multicentre studies.

Difficulties in the handling of multicentre studies within the IEC system soon became apparent, and were a major focus of discussion at a series of ethics workshops organised by NHMRC in 1995.⁴ From the researchers' point of view, problems identified included duplication of effort, inconsistencies in documentation requirements and in decisions between IECs, and delays in approval. For IECs, problems included inadequate resources, and uncertainties about the implications of an IEC accepting another committee's decision without its own detailed consideration of the proposal.

In this issue of the Journal, Jamrozik and Kolybaba⁵ raise the possibility of centralised ethics approval of multicentre studies, a suggestion which has been advocated by others in the pages of the MJA recently.^6-9 Similar ideas were canvassed at the 1995 NHMRC workshops, and discussed in a 1996 review of the role and functioning of IECs,¹⁰ but were not recommended for several reasons. First, institutions have ethical obligations and legal duties towards their own patients, students or staff who become research subjects, and IECs are loath to transfer these responsibilities. Second, important aspects of ethical review are "local". For example, local IECs have the best knowledge of the expertise of investigators, the availability of facilities and resources to support particular types of research, institutional administrative requirements, and the ethnic and cultural mix of the local community.¹¹ Thus, centralised review could assist, but not substitute for, local IEC review of multicentre research. Similar considerations in other countries have led to the conclusion that central review is likely to increase rather than decrease unnecessary bureaucracy and paperwork.^12,13

Are other solutions possible? National introduction of a standardised application form, acceptable to all IECs, is currently under consideration by the Australian Health Ethics Committee (AHEC) as a means of minimising inconsistencies and reducing the duplication involved in preparing applications for multiple IECs. Independent initiatives are already under way in NSW and Victoria, where common application forms, developed collaboratively, are undergoing evaluation by local IECs, and there have been expressions of interest from other States. Also, in the not-too-distant future, electronic submission of applications via the Net will become a practical proposition, further reducing the amount of time and paperwork involved in making multiple submissions.

Jamrozik and Kolybaba highlight the lack of consistency in decisions reached by different IECs considering the same proposal. Two approaches are relevant. First, to maintain scientific and ethical validity in multicentre studies it is essential for there to be agreement on study design and safety aspects. This could be achieved by participating IECs being prepared to accept a single scientific assessment by an appropriate expert panel. This would not preclude an IEC from drawing on additional advice from its own assessors, but scientific disagreements should be resolved collectively before final ethical approval by the participating IECs. Approaches of this kind have already been suggested,^14,15 and the NSW Health Department has established a working party to explore the practicalities. Secondly, participating IECs can be encouraged to harmonise their views on general ethical concerns through better communication (via email, for example, or by teleconferences of the secretaries and chairmen of the IECs involved).

Is reform of the IEC system necessary? Although it may not yet be apparent, this is already under way. New NHMRC guidelines on ethical conduct of research involving humans are currently undergoing the final stages of public consultation and revision, and are due for release in early 1999. The need for better resourcing of IECs and training of their members is now recognised. In relation to multicentre research, the guidelines will allow for more procedural flexibility and will shift the emphasis towards a more cooperative approach. Electronic communication, thought to be impractical at the 1995 NHMRC Ethics Workshops, is now a reality. An electronic discussion forum has been enthusiastically embraced by NSW IECs, and is now becoming national. Ultimately, it is to be hoped that widespread formal and informal networking among IECs and researchers will encourage a convergence of views on the solutions to ethical problems, promoting a more consensual culture in the ethical review of research.¹⁶

Robert H Loblay
Chairman, Ethics Review Committee
Central Sydney Area Health Service (RPAH Zone)
Email: roblobATmed.usyd.edu.au

Donald R C Chalmers
Chairman, Australian Health Ethics Committee
National Health and Medical Research Council

1. McNeill P. The ethics and politics of human experimentation. Melbourne: Cambridge University Press, 1993: 61-62, 65.
2. National Health and Medical Research Council. Statement on human experimentation and supplementary notes 1992. Canberra: NHMRC, 1992.
3. Baume P. A question of balance: report on the future of drug evaluation in Australia. Canberra: AGPS, 1991.
4. Australian Health Ethics Committee. Report of 1995 ethics workshops. Canberra: NHMRC, 1995.
5. Jamrozik K, Kolybaba M. Are ethics committees retarding the improvement of health services in Australia? Med J Aust 1999; 170: 26-28.
6. Beran RG. Should there be an accredited ethics committee system for centralised review of multicentre clinical research? Med J Aust 1998; 168: 174-176.
7. Clarke CW. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 169: 283.
8. Henman MJ, Tattersall MHN, Brown RF. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 169: 283-284.
9. O'Brien EA, Saltman DC, Berglund CA. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 169: 284.
10. Report of the review of the role and functioning of Institutional Ethics Committees. Report to the Minister for Health and Family Services. Canberra: AGPS, 1996.
11. Weeramanthri T, Currie BJ. Isn't one institutional ethics committee's approval enough [letter]? Med J Aust 1994; 161: 398-399.
12. Moran J. Local research ethics committees: Report of the 2nd national conference. J Roy Coll Physicians Lond 1992; 26: 423-431.
13. Montgomery J. Improving review of multi-centre trials. Bull Med Ethics 1994 (February): 19-22.
14. Cohen M. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 168: 528.
15. Gandevia SC, McKeown T, Wright M, et al. Should there be an accredited ethics committee system for centralised review of multicentre clinical research [letter]? Med J Aust 1998; 169: 285.
16. Chalmers D, Pettit P, on behalf of the Australian Health Ethics Committee. Towards a consensual culture in the ethical review of research. Med J Aust 1998: 168; 79-82.

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