“If It Ain't Broke, Don't Fix It”

In the last year of the millennium, the New World very nearly caught the Old World napping. We had known of the debate about the ethics of medical research in less developed countries but had not taken seriously the idea that for many Americans the solution was to alter radically the Declaration of Helsinki. However, a proposed rewriting of the Declaration at the World Medical Association Council meeting in April 1999 finally made the Old World sit up and take notice. In its thirty-five years, the Declaration of Helsinki has achieved an astonishing level of acceptance worldwide, not just by the medical community that produced it but throughout health care research. The laws of several countries require that medical research be conducted according to its precepts, and almost every pharmaceutical trial protocol includes the Declaration. One reason for its acceptance may be that, although there have been major changes in medical research, the Declaration has undergone only minor evolution since 1975. Thus the American proposals for revolutionary change belatedly set alarm bells ringing. One response, by the Bulletin of Medical Ethics and the European Forum for Good Clinical Practice, was to arrange a workshop in London in early September. At short notice 125 people from twenty-five countries came together to discuss whether the Declaration needed change, and if so, what? They included academics, presidents of national medical associations, senior officials from government regulatory authorities, representatives from international organizations such as the World Health Organization and the European Commission, and patients and research subjects. Africa, Asia, and South America were there, as well as central and eastern Europe and the rich countries. The most important conclusion of the workshop was that, given its worldwide acceptance, it would be a serious mistake to rewrite the Declaration of Helsinki. The only substantial support for rewriting came from some U.S. participants. Others wanted either minor alteration or a reversion to a simple statement of the basic principles of medical research ethics, like the original 1964 version. In either case, the Declaration would continue to be a relatively brief set of principles that might remain unaltered for many years. More detailed guidance, such as was proposed by the Americans, could be provided in accompanying commentaries--on, for instance, how "independent" committees should function, or how to obtain informed consent in less developed countries. Three main issues were central to the revisionists and to workshop discussions: (a) Is there any need to distinguish therapeutic and nontherapeutic research? …