Research ethics committees: what is their contribution?

The Nuremberg Code,1 the Helsinki Declaration,2 and even the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans (the Statement),3 are not documents with which many researchers can claim significant familiarity. The reasons for their existence are faintly recalled, and current debates are only of interest if they impede research with which the researcher has a personal concern. Once an ethics committee has made its decision, there is no need to consider “ethics” again unless there is a significant adverse event.

Although they undoubtedly provide a “safety net” to detect and prevent grossly unethical research, ethics committees must not and cannot be seen as the repositories for moral decision-making.

Consider an imaginary (but highly plausible) ethics committee. It meets the Statement’s requirements for membership. Some members have attended the occasional seminar sponsored by the Australian Health Ethics Committee (AHEC), and some diligently read the AHEC Bulletin sent to registered committees. Some, though not all, of the members have actually read the Statement all the way through. One committee member doesn’t really agree with some of the content. The committee faces regular criticism by researchers for the amount of paperwork that must be submitted to it, and significant anger when it wishes to alter an aspect of a proposal for a multicentre trial.

Although the committee’s deliberations are thorough, most of its recommendations consist of minor changes to the plain language and consent statement. It faces considerable (and understandable) pressure to reach rapid consensus. Rarely does a member ever register his or her dissent concerning a decision about which all other members of the committee feel comfortable. The committee is proud that it has never ultimately rejected any proposal. Some members of the committee are aware that they have acquiesced in decisions about which they had some misgivings. One or two of the most senior members know they can nearly always sway the committee to their point of view.

In a recent editorial discussing clinical ethics committees, Margaret Somerville noted that:

She uses the real-life example of decisions to shorten life by withholding treatment, or aborting a fetus, and the physicians doing this being morally reassured by the involvement of an Acute Clinical Ethics Service.

She asks

Although clinical ethics committees perform a somewhat different function to human research ethics committees, there are significant similarities as far as the points made by Somerville are concerned.

There is indeed comfort in allowing ourselves to be relieved of having to think about the implications of our actions, especially when the research dollar is concerned. It is problematic when the ethics review process is seen as a test of how much we are able to get away with. It cannot be persuasively argued that actions must be ethical because they have been approved by another person thought to be morally wiser. Nor is it helpful to allow oneself to be influenced to reach a decision in a group setting because of reasons of time, or because others have already reached consensus.

If researchers have not thought through the ethical implications of their proposals, but instead leave that to the committee, and the committee makes decisions about which some of its members would be individually uncomfortable, this cannot be regarded as a satisfactory process.

Perhaps the most essential preparation for members of research ethics committees is not studying the content of the Statement or the relevant law, but undertaking a week of intensive training in critical thinking. Perhaps we all must consider how best to deal with situations about which not all agree, and about which objections are morally relevant. Furthermore, there are many issues that are not well addressed by guidelines or law. What research should be done in the first place? How should communities from which participants are drawn be involved in the planning, implementation, monitoring and evaluation of research? What are the human rights implications of a study (particularly in populations significantly deprived of rights)? What responsibilities do researchers have to the larger community from which their subjects are drawn, and what do they owe to subjects after their research is completed? These questions and many more have important ethical dimensions. Many researchers are unaccustomed to thinking through the broader implications of their work. However, they are capable of doing what is necessary in order to fill out a form.

In a seminal article in the New England Journal of Medicine, Henry Beecher stated

In concluding his lecture, Gaita rejected the notion of a “moral expert”, and called for us all to identify and rigorously analyse morally important issues without sentimentality.

It is very difficult to improve on this.