The Declaration of Helsinki on ethical principles for research involving human participants now includes a statement on scientific integrity and research misconduct.
Adopted in 1964 by the World Medical Association, the Declaration of Helsinki was conceived in response to the atrocities committed during World War 2 in the name of medical research on human subjects. The initial document – which has been updated many times over the last 60 years – included five key principles, including the primacy of informed consent, the need for a rigorous calculation of risks and benefits for a given study, and a consideration of the scientific value of a given study – that is, the experiment should be valuable to science and to the subjects involved.
In the recent process of revising the declaration, the World Medical Association added the following two sentences to the “general principles” section of the document:
Scientific integrity is essential in the conduct of medical research involving human participants. Involved individuals, teams, and organizations must never engage in research misconduct.
“The additions about scientific integrity and research misconduct were not in response to any particular event,” Jack Resneck, chair of the revision workgroup and a dermatologist at the University of California, San Francisco School of Medicine, told Retraction Watch, “but clearly these issues are at the core of ethical conduct of medical research.”
During the revision process, the World Medical Association received several public comments noting the previous version of the declaration didn’t mention scientific integrity or research misconduct, Resneck said. The workgroup agreed language on those issues should be added, and did so in paragraph 12.
“Including research integrity in the canonical version of the famous Declaration of Helsinki is a significant step forward,” Matthias Wjst, a former epidemiology professor at Technical University Munich and group leader at Helmholtz Center Munich, told us. The new language increases the responsibility of institutions for ensuring the integrity of research involving human participants, he said:
From my understanding, the new paragraph 12 emphasizes that proper management and reporting of research results are not just the responsibility of individual researchers, but also of their teams and organizations. Failing to do so could make them part of an organized system of research misconduct.
Rather than focusing solely on securing research funds and accumulating impact points, research organizations such as universities and clinics must invest much more in oversight and safeguards that can detect misconduct at an early stage. Currently, ethical committees review only research proposals and informed consent forms. I believe that under paragraph 12, they will need to take a more proactive role, offering additional supervision and training for clinical trials.
At present, the discovery of misconduct is mostly reliant on individuals with limited authority. There is no major funding initiative, no large-scale association, no formalized training, and only a few publishers even have designated contact persons. Frequently, clear cases of misconduct are overlooked. Science policy, therefore, has considerable work ahead.
In a commentary on the revisions, Andreas Alois Reis, of the World Health Organization’s Health Ethics & Governance unit, and two colleagues from Canada and South Africa called the new paragraph a “welcome addition.” They wrote:
The Declaration places new emphasis on the ethical responsibilities of researchers and institutions by focusing on research integrity and scientifically sound and rigorous design. In light of increasing concerns about retracted studies, plagiarism, generative artificial intelligence (AI), unreproducible results, and concerns with the quality of publishing venues, the new paragraph on scientific integrity and research misconduct is a welcome addition. These unfortunate trends reinforce the fragility of the research ecosystem and highlight the central importance of increasing attention to research integrity in the training of researchers. Because research is a largely unregulated and self-policing practice, academic institutions will need to ensure that all researchers are well prepared for the new realities of the contemporary scientific world and the significant pressures investigators face in a highly competitive landscape.
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