View source for Reference:WMA Declaration of Helsinki 2024 Paragraph 22

{{ReferenceData
|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=
|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]]
|comment=Scientific requirements: risk assessment before research
|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.
}}