Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30
From GxPlex
| 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 | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.4 |
| Scope | G |
| Document part | Paragraph 29 – 30 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Incapacitated subject, Assent, Informed consent, Legal representative |
Content
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 individual must seek that assent in addition to the consent of the legally authorized representative, considering any preferences and values expressed by the potential participant. The potential participant’s dissent should be respected.
30. Research involving participants who are physically or mentally incapable of giving consent (for example, unconscious patients) may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group.
In such circumstances the physician or other qualified individual must seek informed consent from the legally authorized representative.
If no such representative is available and if the research cannot be delayed, the research may proceed without informed consent provided that the specific reasons for involving participants with a condition that renders them unable to give informed consent have been stated in the research protocol and the research has been approved by a research ethics committee. Free and informed consent to remain in the research must be obtained as soon as possible from a legally authorized representative or, if they regain capacity to give consent, from the participant.
