Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28
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 | |
|---|---|
| Scope | G |
| Document part | Paragraph 25 – 28 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Free and informed consent as a component of respect for persons |
Content
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 research must be voluntary. Although it may be appropriate to consult family members or community representatives, individuals capable of giving informed consent may not be enrolled in research unless they freely agree.
26. In medical research involving human participants capable of giving informed consent, each potential participant must be adequately informed in plain language of the 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 potential participant must be informed of the right to refuse to participate in the research or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information and communication needs of individual potential participants as well as to the methods used to deliver the information.
After ensuring that the potential participant has understood the information, the physician or another qualified individual must then seek the potential participant’s freely given informed consent, formally documented on paper or electronically. If the consent cannot be expressed on paper or electronically, the non-written consent must be formally witnessed and documented.
All medical research participants should be given the option of being informed about the general outcome and results of the research.
27. When seeking informed consent for participation in research the physician or other researcher must be particularly cautious if the potential participant is in a dependent relationship with them or may consent under duress. In such situations, the informed consent must be sought by an appropriately qualified individual who is independent of this relationship.
28. In medical research involving human participants incapable of giving free and informed consent, the physician or other qualified individual must seek informed consent from the legally authorized representative, considering preferences and values expressed by the potential participant.
Those persons incapable of giving free and informed consent are in situations of particular vulnerability and are entitled to the corresponding safeguards. In addition to receiving the protections for the particularly vulnerable, those incapable of giving consent must only be included if the research is likely to either personally benefit them or if it entails only minimal risk and minimal burden.
