We may be in danger of bribing volunteers

Editor—Christie's news article has highlighted an important inconsistency in the World Medical Association's fifth revision of the Declaration of Helsinki.¹ This fundamental document, first adopted by the association in 1964, defines the ethical and moral responsibilities of physicians and others participating in research on human subjects.

The document insists that all subjects should be volunteers, having freely given informed consent to the research proposed. The latest revision is also particularly concerned with protecting the rights of economically or medically disadvantaged populations, typified by those in developing countries. Paragraph 29 identifies the concept of testing new treatments against the best existing treatment, where such exists, rather than against placebo. Paragraph 30 takes this theme further by saying that, at the conclusion of the study, every patient entered into the study should be assured of access to the best proved prophylactic, diagnostic, or therapeutic method identified by the study. Christie interprets these statements to mean that people in developing countries would at least get access to the best current treatment if they agreed to take part in research into new treatments.²

Economically or medically disadvantaged populations are those in whom the best or most up to date medical services may not be available. If the principles in the revised declaration are put into practice, then those participating will clearly not have freely consented and will not be volunteers (according to Collins Dictionary of the English Language, a volunteer is a person who does some act without being promised any remuneration³). By promising treatments either during or at the conclusion of a research study that would otherwise be inaccessible to the local population, those organising the study would be tempting or coercing subjects into participation. This is precisely what the Declaration of Helsinki is designed to prevent. Although revision and updating of the declaration is important to ensure that it remains up to date, we must be careful not to stray too far from its original goals.