Old World News: Unity in Diversity

Abstract

We have known for years that e ability of research ethics committees to provide adequate protection of human research subjects in the United Kingdom is very varied. It has been argued that they might do their job better were there to be legislation controlling them. The U.S. National Research Act of 1974, underpinning the institutional review board (IRB) system, was quoted as a law that produced effective protection. Until last summer, that was. Then came the report on IRBs from the Inspector General of the Department of Health and Human Services.[1] To Europeans, statements such as [a]n estimated 3,000-5,000 IRBs can be found across the country were a revelation. If the government has so little idea even of how many IRBs there are, perhaps the law offers rather less protection to research subjects than had been assumed. For this writer, the revelations continued at the November meeting of IRB members and administrators in San Diego, organized by Public Responsibility in Medicine and Research and the Applied Research Ethics National Association. In the past, English food may have been chips with everything; this meeting was regulations with everything. Nor was there just one set of regulations: IRBs had to be familiar both with those of the Food and Drug Administration and those of the Office for Protection from Research Risks, and know when to apply which set of everchanging regs. Perhaps most startling to a European observer was the realization that even this plethora of regulations did not apply to research that was privately funded: some gruesome examples of research conducted without federal funds, and thus without IRB scrutiny, were given. On both sides of the Atlantic, then, we have diverse systems of ethical review of research, with wide internal variations in how they function, unified by providing less secure protection of human subjects than is desirable. But this presents us all with a great opportunity to learn from each others' systems what seems to work, whether at the level of what principles to apply or what computer software to use. One obvious starting point is to have meetings, such as that in San Diego, where IRB members and staff learn from each other. In the U.K., an association of research ethics committees has now been set up to provide support and advice and, hopefully, input into discussions of how RECs should function. There has been no REC input into the preparation of at least four recent sets of rules and guidelines that fundamentally affect how RECs work in the U.K. and Europe. One of those is a draft European Union directive on the conduct of clinical trials, written largely at the behest of the pharmaceutical industry, to put statutory, and very short, time limits on the process of ethical review. …