2024 Version of the Declaration of Helsinki has Landed!

Why should we care? The Declaration of Helsinki is THE ethical foundation for non-interventional studies...globally. We state in our protocols that we will abide by (comply with) with the ethical principals of the Declaration of Helsinki...this is our GCP.

The 2024 revision of the Declaration of Helsinki [ref 1] introduces several key updates from the 2013 version [ref 2] (download comparison table). It replaces the term "subject" with "participant" throughout, broadening applicability to include not only physicians but all individuals, teams, and organizations in medical research. The purpose of medical research now explicitly extends to advancing both individual and public health. There is reinforced emphasis on “free and” informed consent, acknowledging that researchers may be physicians, other researchers, or qualified individuals. Research ethics committees are now required to have adequate diversity, education, and familiarity with local contexts to effectively review research.

During public health emergencies, such as the COVID-19 pandemic, the ethical principles of the Declaration must be upheld. The design of research must avoid or minimise environmental harm and strive for sustainability. Vulnerability considerations now encompass individuals, groups, and communities, and research must have scientifically sound and rigorous designs to prevent research waste.

The Declaration emphasises ethical mandates, often using "must," as with the requirement for collaborative international research to gain ethics approval in both the sponsor and host countries.

Ethics committees must also oversee database and biobank use, and post-trial provisions must be arranged for participants who benefit from trial interventions. Additionally, data and biosample collection for multiple uses should align with the Declaration of Taipei [ref 3].

The key revisions to the 2024 Declaration of Helsinki relative to the 2013 version include:

• Change of the term ‘subject’ to ‘participant’ (§ 1, 2, 5, 6. 7, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 35, 36, 37)
• Applicability of the Declaration of Helsinki beyond physicians i.e., “all individuals, teams, and organizations involved in medical research” (§ 2)
• Primary purposes of medical research expanded to include advancement of individual and public health (§ 7)
• Additional emphasis on the importance of "free and” informed consent (§ 25)
• Emphasis that the researcher can be a physician or “other researcher” (§ 9, 10, 18, 27, 31) or “other qualified individual” (§26, 28, 29, 30, 32).
• Research ethics committees should collectively have adequate “diversity" [new] in addition to education, training and qualifications, in order to effectively evaluate each type of research it reviews and have sufficient familiarity with local circumstances and context (§ 23)
• The need to uphold the ethical principles of the Declaration of Helsinki during public health emergencies (e.g., COVID-19 pandemic) (§ 8)
• Emphasis on designing research to avoid (new) or minimise possible harm to the environment and to strive for environmental sustainability (§ 11)
• Expands considerations for vulnerable individuals and groups to vulnerable ‘individuals, groups and communities’ (§ 19, 20)
• New emphasis on medical research having? “a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid research waste” (§ 21)
• Introduction of ethical mandates (rather than ethical principles) emphasised by the word “must” (§ 23)...

1. Collaborative research performed internationally MUST be approved by research ethics committees in both the sponsoring and host countries? (§ 23)
2. A research ethics committee MUST approve the establishment and monitor ongoing use of such databases and biobanks (§ 32)
3. In advance of a clinical trial, post-trial provisions MUST be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or host country governments for all participants who still need an intervention identified as beneficial in the trial (§ 34)
4. Collection and storage and health data and biosamples for multiple and indefinite uses should be consistent with requirements set forth in the Declaration of Taipei ?(§ 32) [ref 3]

Access a tabulated summary of the changes implemented in the 2024 version vs the 2013 version: HERE

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References

1. World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants (October 2024)

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

2. World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (2013)

Link: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

3. World Medical Association - Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks (2016)

Link: https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/

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About Stuart McCully...

Stuart is a real world research (RWR) regulatory scientist and thought leader.?With his background as a pharmacologist working on traditional pre-approval clinical trials, he became frustrated with the operational inefficiencies and support gaps for non-interventional (observational) studies. As a result, Stuart created CHCUK which became a global leader in supplying regulatory and operational intelligence for non-interventional studies. Currently, Stuart is a co-founder of RWR-Regs, a regulatory compliance solutions platform for real world research.