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 in the opposite direction, i.e., that it be acceptable for scientific interests to prevail over the interests of the participants. This article argues against this change and uses as an example what happened with the experimental SARS-CoV-2 vaccines versus placebo masked trials. When the high efficacy of the vaccines became evident, the question arose as to what should be done, whether to keep the trials masked until long-term efficacy, immunogenicity and safety data were obtained, or to break the masking and offer participants who received placebo the vaccine that had been shown to be efficacious. The latter was the correct attitude that translated point-8 into practice.