STAT+: Helsinki Declaration says researchers must disclose trial results on a timely basis

In a boost for clinical trial transparency, the Declaration of Helsinki was updated so that medical researchers are now responsible not only for making study results public, but also for doing so in a timely manner.

Specifically, medical researchers are now told they “have a duty to make publicly available the results of their research on human participants and are accountable for the timeliness, completeness, and accuracy of their reports.” The language was formally adopted last week at a World Medical Association General Assembly meeting in Helsinki, Finland.

The revision to the Declaration, which was developed by the WMA six decades ago to provide ethical guidance for medical research, comes after ongoing controversy surrounding the disclosure of clinical trial work. In recent years, efforts have intensified to push regulators and lawmakers to increase oversight of clinical trial registration and publication.

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