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If medical research proposals are subject to ethics committee scrutiny, should the same not apply to the process of clinical audit, which, it can be argued, is no more than another kind of potentially intrusive form of clinical investigation?
Dr Martin Talbot tries to tackle the question by first discussing how different clinical audit is from medical research, concluding that “research is finding out how one should be doing something”—clearly not an adequate definition of research, whereas “audit ensures that it is done correctly.” He then continues with a philosophical digression on the nature of knowledge, in which he demonstrates his sympathy with a relativistic, postmodern view: one must beware of theoretical assumptions about the structure of reality, thereby encouraging one to keep an open mind on just about anything.
With this nihilistic attitude, he turns to a subjective approach, to his patients and his clinical practice, and concludes that because audit is closer to knowing one's patient than is medical research, there is no need for ethics committee scrutiny of audit proposals.
There are issues in this which, although not altogether subjective, are nevertheless matters of judgment: is the process of audit totally value free? If not, might anyone suffer as a result? Is this a problem which might be sufficiently widespread and serious as to merit the imposition of yet another bureaucratic, time consuming, and therefore expensive committee intervention?
Audit cannot be value free. The audit process is set to predetermined standards for any given healthcare activity. Best practice is bound to set priorities, and conflicts will arise between benefit to individual patients and demands of management, or perceptions of what is best for the community. Staff shortages, finally officially recognised, have forced the health service to make compromises, which in turn influence the determination of standard setting. These compromises clearly involve value judgments. Care of the mentally ill, the elderly, and the dying currently provide examples where scarce human resources limit best practice. Even in an ideal world, the process of standard setting has to keep up with changes in medical practice as well as keeping abreast of cultural changes.
Ethics committees were brought into the evaluation of research proposals largely because, when unacceptable abuses came to light worldwide, it became necessary for limits to be set on the conduct of research. Clinical audit has tended to be more parochial and less publicly transparent, and if troublesome information has come to light, the public has been less aware of it. Openness is limited by the need to retain confidentiality of those participating in the clinical audit process so as to encourage staff to record the truth fearlessly. Here independent ethics committees— in the United Kingdom every health trust has access to one—can intervene when required to protect the vulnerable. Conflicts may follow from this and the process leading to publication of National Health Service performance league tables.
Ethics committees should be available to evaluate clinical audit, but their involvement should follow strict guidelines of confidentiality, and for reasons already stated hearings probably ought to be by special request in the event of conflicts of interest rather than routine.