Reference:WMA Declaration of Helsinki 2024 -
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 | - |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | The most important ubiquitous principles |
Content
GENERAL PRINCIPLES [...] 7. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve preventive, diagnostic and therapeutic interventions; and ultimately to advance individual and public health. These purposes can never take precedence over the rights and interests of individual research participants.
8. While new knowledge and interventions may be urgently needed during public health emergencies, it remains essential to uphold the ethical principles in this Declaration during such emergencies.
9. [...] The responsibility for the protection of research participants must always rest with physicians or other researchers and never with the research participants, even though they have given consent.
10. Physicians and other researchers must consider the ethical, legal and regulatory norms and standards for research involving human participants in the country or countries in which the research originated and where it is to be performed, as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research participants set forth in this Declaration.
11. Medical research should be designed and conducted in a manner that avoids or minimizes harm to the environment and strives for environmental sustainability. [...] 13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research. [...] Risks, Burdens, and Benefits 16. In medical practice and in medical research, most interventions involve risks and burdens. Medical research involving human participants may only be conducted if the importance of the objective outweighs the risks and burdens to the research participants. [...] Individual, Group, and Community Vulnerability [...] Scientific Requirements and Research Protocols 21. Medical research involving human participants must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid research waste. The research must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected. [...] Research Ethics Committees [...] Privacy and Confidentiality […] Free Informed Consent […] Research Registration and Publication and Dissemination of Results […] Unproven Interventions in Clinical Practice
