New version of the Declaration of Helsinki

Last week the World Association of Medical Editors announced the new version of the Declaration of Helsinki. This document, which was first drawn up in 1964, is essential reading for everyone doing research on human participants. The revision was the result of a huge amount of international consultation, and along with many other organisations, PLoS and the Committee on Publication Ethics, which I am also involved with, provided input into this document. Everyone involved in research on humans, as a researcher, author, editor or reviewer should look at this new document but I’d particularly highlight some of the new additions to the text.

Paragraph 30 now makes editors’ duty clear on the publication of research including the duty to make it “publicly” available. The paragraph in full is:

“Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.” We were keen to have some wording on Open Access incorporated; perhaps next time …

Another key point made is in paragraph 19, “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.”

And, finally, in these days of samples often ending up being used for studies far removed from the original reason for collection, the text in paragraph 25 notes that “For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse.”

What do readers think – is there anything essential missing from this last version?

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