In January 2024, Prescrire responded to a public consultation organised by the World Medical Association on a proposed update to the Declaration of Helsinki, the gold standard for clinical trial ethics.

Prescrire's comments related to the following sections of the text:

• Regarding the requirement for research ethics committees to be transparent, we suggested clarifying that this includes transparency over the comments, guidance and approval provided on the research protocols submitted to them;
• Regarding informed consent to participate in a trial, we suggested adding that patients' level of health literacy must be taken into account;
• We suggested clarifying the exceptional circumstances that would render a comparative trial impossible, and those in which the use of placebo is not practicable (1).

The updated version of the Declaration of Helsinki, published in October 2024, takes into account Prescrire's second comment, specifying that the information provided to potential trial participants must be presented in "plain language" (2).

References
1- Prescrire Rédaction "Prescrire comments - World Medical Association Declaration of Helsinki 2024 Revision: Phase 1 Public Comment Document" 31 January 2024: 14 pages.
2- World Medical Association "WMA Declaration of Helsinki – Ethical principles for medical research involving human participants" October 2024: 6 pages.

 ©Prescrire 1 June 2025

Source: "Update to the Declaration of Helsinki" Prescrire Int 2025; 34 (271): 167. FREE.