Declaration of Helsinki

International, professional declaration without direct legal force. The World Medical Association adopted the Declaration of Helsinki at its general assembly in Helsinki in June 1964, building on the Nuremberg Code of 1947, and has revised it repeatedly, notably in 1975 (independent ethics committees), 2000 and 2008 (placebo and post-trial access), 2013 (compensation for harm, registration of trials) and October 2024, when the 60th anniversary revision was adopted in Helsinki. Primary text: the WMA's page publishes the current text.

What it says: research must be based on sound science and a favourable risk-benefit assessment; vulnerable groups need particular protection and should not be excluded without reason; every protocol must be reviewed by an independent research ethics committee; participants must give voluntary informed consent, with proxies for those who cannot; trials must be registered before enrolment and results published, negative as well as positive; placebo or no treatment is acceptable only when no proven intervention exists or when compelling methodological reasons and no serious risk justify it; and sponsors should arrange post-trial access to interventions found beneficial. The 2024 revision replaced 'subjects' with 'participants', addressed community engagement, data and biobanks, and research in emergencies.

Why it matters in oncology and the arguments: the placebo clause and post-trial access are live issues in global cancer trials, where a control arm of 'best supportive care' in a country that cannot afford the standard of care has been called both pragmatic and exploitative. The FDA stopped referring to the Declaration in 2008 in favour of ICH good clinical practice, partly over these clauses; the EU's Clinical Trials Regulation cites it, and the US Common Rule and ICH guideline are the instruments that give its principles legal force.