Old World News: Seeking Harmony in Discord

Abstract

A committee is an animal with four hind legs. To judge by the ferocity of their complaints some British medical researchers feel that they have been dealing with a thousand hind legs when obtaining ethical approval of multicenter projects. There are about 250 local research ethics committees (LRECs) in the United Kingdom--our equivalent of institutional review boards (IRBs). Until late 1997, researchers who wished to carry out research on National Health Service patients, or in NHS institutions, had to obtain approval from the LREC for every district in which they wished to work. Sometimes it took a year to obtain, and invariably different committees sought different amendments to the protocol. That particular difficulty is supposed to have been overcome with a solution typical of the British Civil Service: more committees. Each region now has an MREC (multicenter research ethics committee). All proposals for research at five or more centers are reviewed by an MREC whose decision may not be overridden by LRECs unless there are particular local reasons for refusing approval, such as inadequate facilities. How this uniquely British solution will work remains to be seen. There is, however, a sneaking suspicion that researchers may find little improvement: the first few MREC meetings have already rejected several proposals and required amendments to most. It may just be that the problem all along was not the ethical or administrative incompetence of LRECs, but the poor quality of the researchers' proposals. It is inevitable that there will be differing standards of ethical review both within and between countries, when there are so many different frameworks within which to operate. The earliest European committees were set up in 1966 in the United Kingdom and Sweden at institutions receiving U.S. Public Health Service funds. Elsewhere thought was mostly first given to such committees after the 1975 revision of the Helsinki Declaration. The first coherent national system of committees, in Denmark, became fully functional in 1982. There are seven committees, and each has three medical or scientific members and three lay people, with six alternates. The county councils appoint the lay members. Two members of each committee also sit on a central scientific-ethical committee. The Danish system now has a legislative basis, as does the French system. There is, however, more central control in France, with the Ministry of Health determining how many LRECs there should be (at present there are ninety-three in the regional departements and forty in Paris), who their members should be, and whether an unfavorable opinion should stop a research proposal. Approval by just one committee permits multicenter research to go ahead. …