Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight
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Document Information
| 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 Associationâs (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
| Scope | G |
|---|---|
| Document part | Paragraph 23 - Oversight |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Ethics committee right to monitor and recommend protocol changes |
Text
Research Ethics Committees
23. [âŚ] The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research. Where monitoring is required, the researcher must provide information to the committee and/or competent data and safety monitoring entity, especially about any serious adverse events. [...]
