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Declaration of Helsinki 2024

Updates to the Declaration of Helsinki

The Declaration of Helsinki (DoH), the first international set of ethical guidelines for medical research involving human participants, marked its 60th anniversary this year. The members of the World Medical Association (WMA) General Assembly gathered to and unanimously approved significant revisions to the DoH. The DoH has always established that medical research involving human participants must be guided by informed consent and a careful assessment of risks vs benefits. However, the DoH is a dynamic document, evolving through several revisions- the latest being in 2013.

It is crucial for the DoH to adapt to new risks, emerging research challenges, and societal advancements in order to stay relevant while also sustain its core ethical principles. This development is necessary because ethical principles can sometimes clash, resonating differently across cultures and regions. Addressing these complexities head-on ensures that DoH remains impactful and meaningful in the ever-changing landscape of medical research.

What are the key updates in the Declaration of Helsinki?

According to the Revisions to the Declaration of Helsinki on Its 60th Anniversary, some of the key updates in the DoH includes honoring the rights and roles of individuals as active partners in research by replacing “subjects” with “participants”. Overall, there are changes in the DoH to emphasize the importance of engaging with participants and their communities throughout the research process, recognizing them as co-creators.

New wording in paragraph 2 broadens the application of ethical principles to all individuals and organizations involved in medical research. This acknowledges the interdisciplinary nature of research, where responsibilities extend beyond physicians to include other researchers. This shift ensures that the ethical principles of respect, autonomy, and dignity are upheld universally, not just within the medical profession.

Paragraph 6 also highlights the need for fairness in how the benefits and burden of research are distributed, addressing issues of global justice and structural inequities. Although medical research cannot resolve all societal issues, the revisions call for ethical considerations in this regard.

Paragraph 32 is re-written to address modern concerns about biobanking and data privacy. In light of advancements in technology and data usage, this revision stresses the importance of informed consent and ethical oversight in storing and using biological material and personal data.

The COVID-19 pandemic also influenced revisions, particularly in paragraph 8, which underscores that ethical principles must be upheld even during public health emergencies. Additionally, changes to paragraph 37 clarify the limitations on using unproven interventions outside of clinical trials.

Conclusion

The revisions to the DoH strengthen its focus on participant protection, environmental sustainability, research integrity, and the role of ethics committees. These updates ensure that the DoH remains relevant and responsive to the evolving landscape of medical research, making it one of the most significant updates in its history.

At DDReg, our regulatory consulting and regulatory service offerings are aligned with international standards. Reach out to the team to know more about its offerings and read from our experts here: Faster Access to Clinical Trial Information in Europe –