The rights and interests of participants as limits to clinical trials

Abstract

Point 8 of the Declaration of Helsinki requires that the rights and interests of research participants must always prevail over the scientific interests of the research. Recently, it has been proposed that point 8 be modified to indicate the opposite, that is, that it is acceptable for scientific interests to prevail over the interests of the participants. This article argues against this change. What happened with the masked placebo-controlled trials of experimental vaccines against SARS-CoV-2 is held up as an example. When the high efficacy of the vaccines became evident, questions arose as to what should be done, whether to keep the trials masked until data on long-term efficacy, immunogenicity, and safety were obtained or to unmask the trials and offer the vaccine that had been shown to be efficacious to participants who received the placebo. The latter was the correct approach, which translates point 8 into practice.