The Declaration of Helsinki
- International document
The World Medical Association's ethical principles for medical research involving human beings; its latest revision is from 2024.
What it is
The Declaration of Helsinki is the World Medical Association (WMA) document that sets the ethical principles for medical research involving human beings, including research on identifiable samples and data. It was adopted in Helsinki (Finland) in 1964 and has been revised several times; the current version was approved by the 75th General Assembly, again in Helsinki, in October 2024. Since that revision it speaks of «participants» rather than «subjects». Its core rules: the participant's welfare comes before the interests of science, every protocol goes through an independent ethics committee, consent is free and informed, placebo has strict limits and results are published, positive or negative.
Key points
- Para. 7: the goals of research can never take precedence over the rights and interests of individual participants.
- Para. 15: appropriate compensation and treatment must be ensured for anyone harmed by taking part.
- Paras. 19–20: groups in vulnerable situations receive specific protection; research with them is done only if it responds to their needs and they can benefit.
- Para. 23: before the start, the protocol is approved by an independent, transparent ethics committee with at least one member of the public, which can monitor, suspend or withdraw approval.
- Paras. 25–32: free consent, informed in plain language; legal representative and assent when the person cannot consent; consent also for samples and data.
- Para. 33: the new intervention is compared with the best proven intervention; placebo is the exception.
- Para. 34: before the trial, continued access to a beneficial intervention is planned for those who still need it.
- Paras. 35–36: public trial registration and publication of all results, with funding sources and conflicts of interest.
Historical context
- The WMA adopted it at its 18th General Assembly (Helsinki, June 1964), to guide physicians after Nuremberg.
- Revisions: Tokyo 1975, Venice 1983, Hong Kong 1989, Somerset West 1996, Edinburgh 2000, Seoul 2008, Fortaleza 2013 and Helsinki 2024; notes of clarification in 2002 and 2004.
- The 1975 revision introduced review of the protocol by an independent committee.
- Debates on placebo and on trials in low-resource countries shaped the revisions from 2000 to 2013.
Revisions of the Declaration of Helsinki
| Year | Place | Milestone |
|---|---|---|
| 1964 | Helsinki, Finland | Original adoption |
| 1975 | Tokyo, Japan | Review by an independent committee |
| 2000 | Edinburgh, Scotland | Broad rewrite; placebo debate |
| 2013 | Fortaleza, Brazil | Compensation for harm to participants |
| 2024 | Helsinki, Finland | Current version; «participants» instead of «subjects» |
Today
- Many journals and committees require a statement that the study was done in accordance with the Declaration of Helsinki.
- Para. 8 (2024) recalls that in public health emergencies the principles still apply, even when knowledge is urgently needed.
- Para. 10: no national or international requirement should reduce the protections of the Declaration.
- In Colombia, Resolution 8430 of 1993 and Resolution 2378 of 2008 apply these principles with legal force.
Revisions and official text
- Current version: October 2024 (75th WMA General Assembly, Helsinki, Finland).
- Official text verified on 2026-11-05 at wma.net.
- It is revised from time to time: always cite the year of the version you use.
Test yourself
Think of the answer, then tap the question to see it.
Which is the current version of the Declaration of Helsinki and where was it approved?
The October 2024 version, approved by the 75th General Assembly of the World Medical Association in Helsinki, Finland.
When does the Declaration of Helsinki allow placebo?
When no proven intervention exists, or for compelling methodological reasons and with no added risk of serious or irreversible harm to those given placebo (para. 33).
Who is responsible for protecting the participant according to Helsinki?
Always the physician or researcher, never the participant, even after the participant has consented (para. 9).
What does Helsinki say about the negative results of a trial?
They must be published or made public just like positive and inconclusive ones, declaring funding and conflicts of interest (para. 36).
What must happen before the first participant is recruited?
The protocol must be approved by an independent ethics committee (para. 23) and the study registered in a public database (para. 35).
Connections
Educational content on ethics and health law; not legal advice. Laws and case law change: each page links the official text and says when it was last checked. For a real case, read the text in force and ask a lawyer or the medical ethics tribunal.
Sources: WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants (World Medical Association, 2024).
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Representative model, for educational purposes only.