7th revision of the Declaration of Helsinki: good news for the transparency of clinical trials.

Abstract

In October 2008, the 59th World Medical Association (WMA) General Assembly in Seoul adopted the 7th revision of the Declaration of Helsinki: “Ethical Principles for Medical Research Involving Human Subjects.” This new version is the result of an extensive review process which started in 2007 and which received contributions by various national medical associations, researchers, and medical journal editors (1). The 7th revision of Declaration contains important new requirements related to the registration of clinical trials and reporting of their results. Both requirements are indeed appropriately situated among the core principles of contemporary research ethics (Paragraphs 19 and 30). The main purpose of trial registration is to reduce publication and reporting bias and thus provide reliable evidence for decision making, but it can only achieve this if complemented by public reporting of results. Various controversies over the last decades have confirmed the need to firmly reiterate that medical research involving humans has a clear public purpose and that transparency is a crucial requirement to ensure that this public purpose is respected (2,3). A firm commitment of the medical community to transparency should help rebuild trust in medical research, which has been seriously damaged by these controversies. Ensuring transparency and integrity of data also reflects an ethical commitment to respect for research subjects. Indeed, using research subjects (or as we prefer to call them, participants) for research that remains hidden because of corporate or other interests amounts to using human beings as instruments of marketing and undermines their dignity. Finally, transparency in research on humans is also a core component of promoting the physical well-being of research participants and of patients who will end up consuming the products that result from research. Knowing about trials that have already taken place is crucial in preventing unnecessary exposure to potential harms in research and in promoting safe prescription behavior. Changes made to the Declaration, particularly those related to the need for the registration of clinical trials and results reporting, are a clear sign that the medical community is taking the issue of transparency, and public accountability of research seriously. Here we shall briefly present the background to these provisions and address their implications and some of the remaining challenges.