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In a recent lecture at Monash University, the philosopher Raimond Gaita, Professor of Moral Philosophy at King’s College, University of London, and Professor of Philosophy at the Australian Catholic University, told the story of a woman facing a significant turning point in her life. It was a Friday, and a decision was needed by Monday, but she had unavoidable obligations over the weekend. She had a dear friend, a psychoanalyst and philosopher who had known her all her life. He knew her circumstances, her preferences and even her secret wishes. She contacted him and prevailed upon him to make the decision for her.
In our private lives most of us would find it at least odd, and probably uncomfortable, to hand over responsibility for significant decisions to others. Yet, the prevailing paradigm for human research ethics committees has institutionalised this approach. Researchers themselves often do not consider the ethical implications of their work until it is time to fill out the various forms required by committees. Even then, the main concern is “getting through ethics” with minimal scarring of their proposal.
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:
Committee decisions, as compared with individual ones, can spread the responsibility. A committee can make a decision that no one person — in particular, no committee member — acting alone would make.4
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
Might [this involvement] have allowed the caring team to implement decisions that their moral intuitions were indicating were unethical? While these decisions may have been ethical, we must always be aware that we ignore such intuitions at our ethical peril.4
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
The ethical approach to experimentation in man has several components; two are more important than the others, the first being informed consent . . . Secondly there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.5
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.
Department of Epidemiology and Preventive Medicine, Monash University, Prahran, VIC.
Bebe Loff, MA, LLB, Head, Human Rights and Bioethics.Victorian Infectious Diseases Service and Centre for Clinical Research Excellence in Infectious Diseases, Royal Melbourne Hospital, Parkville, VIC.
Jim Black, MB BS, PhD, FAFPHM, Head, Epidemiology.Correspondence: Ms Bebe Loff, Department of Epidemiology and Preventive Medicine, Monash University, Central and Eastern Clinical School, Alfred Hospital, Prahran, VIC 3181. Bebe.LoffATmed.monash.edu.au
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©The Medical Journal of Australia 2004 www.mja.com.au ISSN: 0025-729X
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