The Declaration of Helsinki, a set of ethical principles governing medical research involving humans, has been reviewed by the World Medical Association and now includes an explicit reference to tackling scientific misconduct. The document, which establishes such principles as the requirement for consent from people participating in scientific experiments, incorporated the following sentence: “Scientific integrity is essential in the conduct of medical research involving human participants. Involved individuals, teams, and organizations must never engage in research misconduct.”
Epidemiologist Matthias Wjst of the Technical University of Munich, Germany, told Retraction Watch that the new text reinforces the importance of scientific integrity in experiments involving humans and emphasizes that the responsibility lies not only with individuals, but also with research teams and institutions. “Including research integrity in the canonical version of the famous Declaration of Helsinki is a significant step forward,” he said. The guidelines, which have been updated eight times previously, had not been changed since 2013. The new version was published in the Journal of the American Medical Association.
It also includes changes motivated by the pandemic, stating that “while new knowledge and interventions may be urgently needed during public health emergencies, it remains essential to uphold the ethical principles in this Declaration during such emergencies.” The text specifically highlights the promotion of treatments with no scientific evidence, as occurred with hydroxychloroquine and ivermectin during the emergency response to COVID-19. During the pandemic, advocates of these therapies claimed they were supported by the declaration when proposing unorthodox solutions for patients in the hope of saving lives. The revised text states that when an unproven intervention is adopted in an attempt to alleviate a patient’s suffering because approved options are inadequate or ineffective, it must subsequently be subject to further studies to evaluate its safety and efficacy. “Physicians participating in such interventions must first seek expert advice, weigh possible risks, burdens, and benefits, and obtain informed consent. They must also record and share data when appropriate and avoid compromising clinical trials. These interventions must never be undertaken to circumvent the protections for research participants set forth in this Declaration.”
The story above was published with the title “New version of the Declaration of Helsinki influenced by the pandemic and scientific integrity” in issue 346 of December/2024.
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