Reference:WMA Declaration of Helsinki 2024 Paragraph 22: Difference between revisions
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| | |has_document=Document:WMA Declaration of Helsinki 2024 | ||
| | |module=2 | ||
| | |unit=2.1.3 | ||
| | |scope=G | ||
| | |doc_part=Paragraph 22 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
Β | |tags=TAG-00033-Pro-oto ++ TAG-00051-Eth-ngs ++ TAG-00176-Ris-erh ++ TAG-00340-Req-nfo | ||
|tags_display=[[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00051-Eth-ngs|Ethics]], [[Glossary:TAG-00176-Ris-erh|Risk]], [[Glossary:TAG-00340-Req-nfo|Requirements]] | |||
Β | |comment=Scientific requirements: risk assessment before research | ||
|content=Scientific Requirements and Research Protocols | |||
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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 protocol. | 22. The design and performance of all medical research involving human participants must be clearly described and justified in a research protocol. | ||
The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research. | The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research. | ||
In clinical trials, the protocol must also describe any post-trial provisions. | In clinical trials, the protocol must also describe any post-trial provisions. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| 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 Associationβs (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 | |
| Reference Details | |
|---|---|
| Module | Module 2 β Unit 2.1.3 |
| Scope | G |
| Document part | Paragraph 22 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Protocol, Ethics, Risk, Requirements |
Content
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 protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research. In clinical trials, the protocol must also describe any post-trial provisions.
