Ethics committee review of medical audit: a personal view from the United Kingdom.

Until now, medical practice in the United Kingdom has, unlike in medical research, largely resisted ethics committee scrutiny of clinical audit. I support this position. On what grounds do I do so? Are there suYcient diVerences between medical research and medical audit to reliably sustain this thesis? I shall argue that research ethics committees may be operating under philosophical constraints which, in the main, go unrecognised; they therefore have no, as it were, prima facie rights and their potential involvement in medical audit raises serious questions, not least because audit is a creature of an entirely diVerent nature from research. For me, the situation is straightforward but others, of course, are welcome to refute my assertions. It is said that research is finding out how one should be doing something, and audit whether one is actually doing it, or, as Rawlins says, “Research discovers the right thing to do: audit ensures that it is done right.” He explains the view of the British Medical Association’s clinical audit committee and calls for a scrutiny of proposed audit projects by audit ethics committees, rather than ethics research committees. But he rather begs the question of the validity of this position by suggesting that, otherwise, ethics research committees would be overburdened by work. Taking the contrary view, the Royal College of Physicians clearly states that medical audit (among other activities such as epidemiological surveillance and morbidity and mortality reviews) is medical practice and, as such, does not require ethical review. Kinn disagrees with most definitions of medical audit, believing that the purpose of audit is to “raise general clinical standards” (and thus, I interpret her to say, has more in common with research) yet refers only to specific instances where audit must be based on sound ethical principles. I suggest that the two operations of research and audit are diVerent, although others diVer. Although a recent survey of health authorities’ views has acknowledged similarities that include a systematic, rigorous approach to data collection and a number of common methodologies. Also, it is by no means clear, for example, that audit is carried out in the clinical sphere and research is not, since all of us can think of many examples of first rate clinical research. And so, Rix and Cutting suggest that not to open up audit to outside review is paternalistic. They see very few, if any, diVerences between the two activities, and deny that research is always productive of new knowledge. Audit, on the other hand, may generate new understandings: these may, in turn, be introduced into daily clinical practice and, therefore, require scrupulous external review. Smith agrees and Kinn makes the case for ethical review before the submission for peer reviewed publication of a suYciently meritorious audit project. However, I rather subscribe to the view of Häyry, who has said that paternalism is: “ . . .demolished at a stroke by asking the subject what they would have chosen if their will . . . (were) . . . not encumbered . . . (or if they) . . . wish us to find out if we are operating according to the available or acceptable standards of the day?” (p 32) “Finding out if we are operating according to the available or acceptable standards of the day” is, I assert, audit. On the other hand, is all research the sort that requires external review, always capable of the kind of rigorous previous quantification which research ethics committees often seem to seek? Further, are the foundations of scientific medical research so fundamental that we can base a whole ethical system upon it? I believe the answers to these questions to be “No.” The paradigm here is epistemology and the philosophy of science rather than moral philosophy, and devolves around questions such as, “What is knowledge?” (which may be unanswerable, and which Ayer considers to be relatively unimportant as a question), or rather “What propositions are true and how do we know them to be true?” The most widely accepted definition of knowledge is “justifiable true belief.” A seemingly fairly straightforward idea, yet from where have we acquired our ideas on the nature of knowledge, on how knowledge is acquired, and on how it is formed? The nature of knowledge is precarious: not only since knowledge itself seems continually to be changing, but because, as a concept, a definition of knowledge is notoriously elusive. From the dawn of early Western philosophy in ancient Greece, the Athenian scholars (particularly Socrates and Plato) are to blame for telling us that, firstly, there are absolute truths and, secondly, that the everyday, material world is an inferior copy of some perfect, transcendent one. The Athenians were particularly influential on the development of, firstly, Renaissance thought and, secondly, the thinking of the Enlightenment. This legacy was mediated by medieval scholars who were forced to utilise this “positivism” to champion the cause of the early church against the challenges of the heretics. Sex Transm Inf 2001;77:69–72 69