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Document:WMA Declaration of Helsinki 2024

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Document information
Reference WMA Declaration of Helsinki 2024
Validity area WMA
Scope(s) G
Document name Declaration of Helsinki
Version / Revision 2024
Status Current
Document type International guideline
Language(s) EN
Description Declaration of Helsinki

Medical Research Involving Human Participants

The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2024. The current (2024) version is the only official one; all previous versions* have been replaced and should not be used or cited except for historical purposes. The WMA would like to thank all those who submitted comments and suggestions for the most recent revision of the DoH.

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


References

Reference Scope Document part Language Preview
Reference:WMA Declaration of Helsinki 2024 - G - EN GENERAL PRINCIPLES [...] 7. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 23 G Paragraph 23 EN Research Ethics Committees 23. The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the research begins. This committee ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 22 G Paragraph 22 EN Scientific Requirements and Research Protocols [...] 22. The design and performance of all medical research involving human participants must be clearly described and justified in a research ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 9 G Paragraph 9 EN GENERAL PRINCIPLES [...] 9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, autonomy, privacy, and confidentiality of personal ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28 G Paragraph 25 – 28 EN Free and Informed Consent 25. Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals capable of giving informed consent in medical ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 31 – 32 G Paragraph 31 – 32 EN 31. The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of a patient to participate in research or the ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30 G Paragraph 29 – 30 EN 29. When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation in research, the physician or other qualified ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 17 G Paragraph 17 EN 17. All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval G Paragraph 23 - Amendment approval EN Research Ethics Committees 23. […] No amendment to the protocol may be made without consideration and approval by the committee. [...]
Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight G Paragraph 23 - Oversight EN Research Ethics Committees 23. […] The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research. Where monitoring is required, the ...
Reference:WMA Declaration of Helsinki 2024 34 G 34 EN Post-Trial Provisions 34. In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or governments for all ...
Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report G Paragraph 23 - Final report EN 23. [...] After the end of the research, the researchers must submit a final report to the committee containing a summary of the findings and conclusions.
Reference:WMA Declaration of Helsinki 2024 Paragraph 36 G Paragraph 36 EN 36. Researchers, authors, sponsors, editors, and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make ...