2024 Update of the Declaration of Helsinki
January 23, 2025
The Declaration of Helsinki (DoH) is a “statement of ethical principles for medical research involving human participants”. Adopted for the first time in June 1964 in the Finnish capital, it was amended for the 9th time during the 75th General Assembly of the World Medical Association (WMA), which again returned to Helsinki in October 2024. The English version of this latest revision was published on the WMA website on December 13, 2024.
Our medical writing team assists clients in the drafting of the regulatory and clinical documentation necessary for the implementation of medical research, and in the writing of manuscripts for peer-reviewed journals reporting the research results. It was therefore important for us to share this news!
We analyzed the changes made in the 2024 version, 11 years after the previous update.
Although the Declaration of Helsinki is not an official legal document, this code of ethics has been respected and has guided medical research for six decades. It should be noted that peer-reviewed journals usually require authors to specify in their manuscripts whether research involving human participants was conducted in accordance with the Declaration of Helsinki. Its fundamental ethical principles are sustainable, and successive revisions allow for the adaptation of these recommendations to contemporary developments in medical research.
The Declaration of Helsinki contains 37 paragraphs: 2 in the “Preamble” section and 35 in the “General Principles” section, the last 22 being divided into 10 sections:
- Risks, Burdens, and Benefits
- Individual, Group, and Community Vulnerability
- Scientific Requirements and Research Protocols
- Research Ethics Committees
- Privacy and Confidentiality
- Free and Informed Consent
- Use of Placebo
- Post-Trial Provisions
- Research Registration, Publication, and Dissemination of Results
- Unproven Interventions in Clinical Practice
Key changes to the Declaration of Helsinki in 2024
Use of the word “participants”
In both the title and content of the Declaration of Helsinki, the major change made in 2024 is the use of the word “participants” or “human participants” instead of “human subjects”, “those who are involved” or “patients”. This amendment emphasizes the commitment of patients and healthy volunteers as partners in research.
The Declaration of Helsinki is not only for physicians
In the preamble, paragraph 2 has been reworded to emphasize the need for the principles set out in this Declaration to be respected by physicians, as well as by other persons and organizations involved in medical research. Other paragraphs of this 2024 version also include the terms “physicians or other researchers” or “physicians or other qualified individuals.”
Rigor and Integrity
The notion of scientific integrity has been introduced in paragraph 12.
In the section “Scientific Requirements and Research Protocols”, the following sentence has been added at the beginning of paragraph 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“.
Text incorporated into paragraph 22 also states that the research protocol should mention “provisions to protect privacy and confidentiality” in addition to the other information previously indicated. This notion has also been added to paragraph 26 of the “Free and Informed Consent” section, which specifies the information that a participant must receive and states that this information should be provided “adequately” and “in plain language“.
Reference is now made to the WMA Declaration of Taipei in paragraph 32 concerning the use, collection and storage of data or biological material from research participants.
Concerning “the publication and dissemination of research results“, the notion of timeliness has been added to the existing notions of completeness and accuracy (paragraph 36).
Vulnerable Populations
Paragraphs 19 and 20 (section “Individual, Group, and Community Vulnerability”) and paragraph 28 (section “Free and Informed Consent”) have been expanded to detail the ethical conditions for the inclusion or exclusion of vulnerable groups and individuals from a research project.
Research Ethics Committees
It is now specified that the ethics committee to which the research protocol is submitted “must collectively have adequate education, training, qualifications, and diversity“, and that it “must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research.“. Previously, only the “right to monitor ongoing studies” was mentioned.
In addition, the 2024 version of the Declaration specifies that “the research protocol must be approved by research ethics committees in both the sponsoring and host countries” if collaborative research is conducted internationally.
Post-Trial Provisions
Paragraph 34 has been enriched to specify that the possibilities for making tested interventions “identified as beneficial and reasonably safe” available to participants after the clinical trial should be arranged in advance and be communicated to participants. In addition, this paragraph states that any exceptions to this post-trial provision need to be approved by an ethics committee.
Safeguards
The need to uphold the ethical principles of this Declaration during public health emergencies has been added in paragraph 8, and it is now specified in paragraph 37 that unproven interventions in clinical practice “must never be undertaken to circumvent the protections for research participants set forth in this Declaration.”