Background information on the Declaration of Helsinki

The Declaration came into being 60 years ago, in 1964, to protect all people from unethical human medical experimentation. It is a high-level ethical principles document intended to provide guidance on human participant research.

The Declaration of Helsinki 2024 revision process in statistics

• The WMA Declaration of Helsinki revision workgroup representatives came from 19 countries (Bangladesh, Belgium, Brazil, China, Denmark, Finland, Germany, Israel, Japan, Malaysia, Netherlands, Nigeria, South Africa, Taiwan, UK, Vatican, Uruguay and USA)
• 110 partners including World Medical Association constituent members provided comments on suggested draft text during the two public comment periods
• Eight regional and topical meetings were held across all WMA regions:
  • Tel Aviv: Implications of Big Data, Machine Learning, AI
  • São Paulo: Ethical Considerations on Use of Placebo
  • Copenhagen: Emerging Trial Designs
  • Tokyo: Research During Public Health Emergencies / Pandemics
  • Vatican: Research in Resource-Poor Settings, Global Justice
  • Johannesburg: Community Inclusiveness, Post-Trial Access, Vulnerability
  • Munich: Specific and Particularly Vulnerable Groups
  • Washington, DC: Final Consolidation
• The Declaration of Helsinki revision workgroup, and a subset drafting group, under the leadership of Workgroup Chair Dr. Jack Resneck Jr., have met throughout the process to digest feedback from commenters and meeting participants, and present the draft for the consideration of the WMA General Assembly.

A snapshot of the Declaration of Helsinki revisions

1975 (Tokyo): The first major revision emphasized informed consent and the requirement that vulnerable populations receive special protections. It also introduced independent ethical review committees.

1983 (Venice): This update focused on strengthening the standards for placebo use and reemphasized informed consent, refining procedures to protect participants further.

1989 (Hong Kong): This revision emphasized post-study access, stressing that participants should benefit from the research outcomes, especially in developing countries.

1996 (South Africa): The WMA made further clarifications on the ethical principles, specifically for research involving patients from disadvantaged backgrounds.

2000 (Edinburgh): This significant overhaul addressed the ethics of placebo-controlled trials, advocating for their use only when no proven intervention exists. It also strengthened guidelines on post-study benefits for participants.

2008 (Seoul): The declaration added new guidelines on biobank and genetic research, addressing the ethical considerations around biological sample storage and privacy.

2013 (Fortaleza): Revisions further clarified post-trial access to interventions for participants and emphasized researchers’ responsibilities to consider participants’ social and health contexts.