The Declaration of Helsinki, as a foundational document outlining international ethical principles for medical research, has for the first time called for the protection of healthy volunteers in medical studies and addressed structural inequalities in medicine and society. It not only requires doctors but all researchers involved in medical science to adhere to its principles. Since its adoption in 1964, the Declaration has been revised multiple times. On October 19, 2024, during the 75th General Assembly of the World Medical Association (WMA) held in Helsinki, Finland, the Declaration underwent the most significant and important update since its publication. This revised version was published in the Journal of the American Medical Association and drafted by a core group that included members from the United States, China, Germany, Denmark, among others. The drafting process involved eight regional meetings and extensive global consultation.

The Declaration had previously been updated in 2013.

Key Revisions

1. Terminology Change: The term “subject” has been changed to “participant” to emphasize the active role and dignity of research participants.

2. Focus on Vulnerable Groups: The update includes increased attention to the “vulnerability” of special groups, ensuring better protection of their rights in medical research.

3. Informed Consent: There is an emphasis on free and fully informed consent, ensuring that participants voluntarily join the research after being fully informed about it.

4. Risk-Benefit Assessment: Research must carefully evaluate and balance the risks and benefits to participants before starting and continually monitor them throughout the study.

5. Environmental Sustainability: Research design and implementation should avoid or minimize environmental harm, striving for sustainability.

6. Research Ethics Committees: Research protocols must be reviewed and approved by independent ethics committees to ensure compliance with ethical standards.

7. Privacy and Confidentiality: All measures must be taken to protect participants' privacy and confidentiality of personal information.

8. Post-Trial Provisions: Before clinical trials, sponsors and researchers must ensure that participants continue to receive necessary interventions after the trial ends.

9. Research Registration and Results Dissemination: All medical research must be registered in public databases, and results—whether positive, negative, or inconclusive—must be published.

Brief Summary

The main focus of this update is to compare the 2013 and 2024 versions of the Declaration of Helsinki, helping people understand the latest revisions and updates.

Declaration of Helsinki

2013

2024

Time and Place

In October 2013,the 64th General Assembly of the World Medical Association held in Rio de Janeiro, Brazil.

On October 19, 2024, the 75th General Assembly of the World Medical Association held in Helsinki, Finland.

Preamble

It emphasizes the ethical responsibility of physicians in medical research, covering both human participants and identifiable human materials or data.

It emphasizes that all individuals, teams, and institutions involved in medical research must adhere to ethical principles, covering both human participants and identifiable human materials or data.

General Principles

It emphasizes the responsibility of physicians to protect the health, well-being, and rights of participants. Progress should be based on research; research should have clear objectives and adhere to ethical standards; environmental harm should be minimized; studies combined with medical care must have potential therapeutic value; and compensation and treatment should be provided for any harm caused.

Building on the original foundation, the updates further emphasize the respect and protection of all participants, with special attention to the vulnerability of certain groups. It highlights the importance of upholding the ethical principles of the Declaration, especially during public health emergencies. Additionally, the update stresses the need to consider the research context of structural inequalities. It also underscores the importance of allowing participants and their communities to share their priorities and values, enhancing engagement, understanding, and the dissemination of research findings.

Subject

Use the subject.

Use the participant.

Vulnerability

It's barely mentioned

Increased focus on the vulnerability of specific groups, emphasizing special support and protection for these vulnerable populations.

Research Ethics Committee

Emphasizes the independence and authority of research ethics committees, requiring transparent operations and resisting undue influence.

Further emphasizes the independence, resources, education, and diversity of research ethics committees, adding requirements for familiarity with local circumstances and contexts. Additionally, the committees must include at least one member from the general public.

Informed Consent

Emphasizes the importance of free and fully informed consent, particularly in situations involving dependency relationships.

Provides more detailed specifications for the requirements of informed consent, including the witnessing and documentation of electronic consent and non-written consent.

Placebo

Allows the use of placebos or the absence of intervention when no proven therapeutic measures are available.

Retains the conditions for using placebos but places greater emphasis on avoiding the misuse of placebos.

Post-test Regulation

Requires the arrangement of post-trial provisions before clinical trials to ensure that participants receive beneficial and reasonably safe interventions.

Retains the requirement for post-trial provisions and adds a clause that exceptions must be approved by the ethics committee.

Scientific Requirements and Study Protocol

Emphasizes the scientific validity and rigor of the research, requiring that research protocols include a statement of ethical considerations.

Retains the scientific requirements and the expectations for research protocols while adding an emphasis on respect for animal welfare.

Privacy and Confidentiality

Emphasizes the protection of research participants' privacy and the confidentiality of their personal information.

Retains the requirements for privacy and confidentiality while adding regulations regarding the secondary use of data and biological materials.

Unproven Interventions in Clinical Practice.

Allows the use of unproven interventions in the absence of adequate therapeutic measures, provided that expert advice and informed consent are obtained.

Retains this provision and adds requirements for the documentation and sharing of data to avoid impacting clinical trials.

The Declaration of Helsinki was drafted and published in response to ethical issues surrounding human experimentation that arose during and after World War II and the Cold War, calling for the protection of volunteers in medical research. Although the declaration is not legally binding, it has been referenced in the legislation of some countries, and its broad principles are supplemented by more detailed documents, such as ethical guidelines issued by the Council for International Organizations of Medical Sciences (CIOMS).

One key change reflected in the 2024 version is the shift from referring to “subjects” to “human participants in research.” This change signifies a new approach that views research as being conducted by individuals who have a strong desire to participate, rather than potential victims of abuse.

Another significant language change addresses the protection of vulnerable populations. Previous versions did not specifically mention the circumstances of groups such as pregnant women, minorities, and members of racial or ethnic groups, who are often excluded from trials in many studies. This inequality is acknowledged in the current revision, which states that excluding these groups may exacerbate inequality and emphasizes the need to weigh the potential harms of participation against the risks of exclusion from trials.

The updated general principles also include a statement that “during public health emergencies, there may be an urgent need for new knowledge and interventions, but it remains essential to adhere to the ethical principles of the Declaration during such emergencies.”This is likely a response to the COVID-19 pandemic, during which some medical researchers promoted ineffective treatment protocols, such as hydroxychloroquine and ivermectin. The revision reflects a new consensus regarding ethical practices in the context of public health crises, serving as a lesson learned during the pandemic.

Of course, the Declaration itself is a relatively brief document, spanning only four pages. It raises questions about potential omissions or the need for updates as technology advances to ensure its continued relevance. Nevertheless, this update is undeniably an important step forward.

Credit:

https://www.wma.net/policies-post/wma-declaration-of-helsinki

https://www.wma.net/wp-content/uploads/2024/10/DoH-Oct2013.pdf