Declaration of Helsinki calls for mandatory registration of clinical trials

The World Medical Association revised the Declaration of Helsinki on 18 October 2008 at its General Assembly in Seoul, South Korea. The new version replaces all previous versions. Of particular interest are paragraphs 19 and 30:

19. Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.

Existing trial registers include the ISRCTN register,
which is open to all study designs in all health care areas and all
countries. The register is administered by Current Controlled Trials, a
sister company to BioMed Central. BioMed Central and its journals
insist on public registration of clinical trials and will follow with
interest any increase in up-take of public registration following this
revision of the Declaration of Helsinki.

30. 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.

A number of BioMed Central journals including BMC Research Notes and Trials are working with the scientific community to encourage complete and transparent reporting of scientific research, including clinical trials. Making all information potentially relevant to patient care freely available – via publication in an open access journal – completes the scientific record and avoids publication bias, which can have serious consequences for evidence-based medicine practices.

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