Tim Dare: Health ethics committees up with world standards

Last year was the 20th anniversary of the Cartwright Inquiry into cervical cancer research at National Women's Hospital, research conducted without participating patients' consent and which ultimately gave rise to New Zealand's current system of ethical review of health research.

Shaun Holt argues (Herald, March 2) that the system has itself become unethical, wasting researchers' time and depriving New Zealand of the benefits of research.

He proposes that the Minister of Health should approve "private fee-paying ethics committees, to operate according to international guidelines". Five-member committees would make decisions within a week, in contrast to the present 12-person committees which drag researchers through a "10- to 12-week nightmare".

Dr Holt is moved in part by his experience as a former ethics committee member and researcher. He recently sought approval for a study looking at whether honey helped treat a common childhood skin condition.

"Only 15 children were required," he reports, "and all the caregivers had to do was to apply the honey, cover with a dressing and see if it seemed to help."

The ethics committee refused permission, he says, raising more than 40 objections. He gives as an example of its obstructive approach a requirement for Maori consultation.

This is misleading. I was a member and chair of New Zealand's busiest health research ethics committee for seven years. Some very difficult applications, such as those requiring the development of new policy, took a long time. But the vast majority were dealt with at the meeting following their receipt (within two or three weeks), as required by national guidelines. Even allowing time for letters following that meeting, few were still open six to eight weeks after receipt.

Delays beyond that were often because researchers took time responding to committee requests for clarification or amendment.

Dr Holt suggests New Zealand committees are slower than their international counterparts. A recent British standard specifies a 60-day turnaround. New Zealand committees would not be troubled by that.

As to the size of committees, Dr Holt speaks of international guidelines requiring five members, rather than New Zealand's 12 (with a quorum of seven), but it is difficult to find the international guidelines he has in mind. Comparable British committees have a maximum membership of 18. Australian guidelines can be satisfied with as few as seven, but then so can New Zealand's quorum. Denmark's guidelines are fairly typical in Europe and call for between seven and 15 members.

I know of no jurisdiction with a norm of private fee-paying committees. Given these sorts of international comparisons, it is unlikely the ethical review system is a significant factor in decisions about pharmaceutical investment in New Zealand.

Dr Holt's account of the treatment of his own proposal is also less than complete. Ethics committee minutes are publicly available. The minutes for Dr Holt's study before the Auckland committee (to see them, run NTX/08/09/085 through Google) indicate that the committee deferred a decision on Dr Holt's honey project because they were concerned about its validity.

They seem concerned the study did not have enough participants and that parents were required to change dressings and wash the affected area during the study without an indication how Dr Holt would know whether it was the honey or the washing that made the difference. There is mention of Maori consultation, but it is not given as the primary reason for deferral.

These are very ordinary concerns about research validity: one of the legitimate roles of an ethics committee is to ensure that health therapies cannot claim to have been shown effective unless the research is rigorous and sound.

Note that the committee did not decline approval: they deferred a decision. Dr Holt chose to not clarify or amend his study.

It is not true that New Zealand's system of review is especially onerous or cumbersome or slow by international standards. But discussion will not be helped by focusing on a misleading caricature of the system.

* Dr Tim Dare is head of the department of philosophy at the University of Auckland and chairman of the Health Research Council ethics committee.