The World Medical Association recently revised the Declaration of Helsinki at its General Assembly in Seoul, it has been reported. Of particular interest in the new version, which replaces all the previous ones, are paragraphs 19 and 30. Paragraph 19 states that 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 healthcare areas and all countries. The register is administered by Current Controlled Trials, a sister company to BioMed Central. According to BioMed Central, the company and its journals insist on public registration of clinical trials, and will follow with interest any increase in up-take of public registration following the revision of the Declaration of Helsinki.
According to Paragraph 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 reportedly 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 - is seen to complete the scientific record. It is also projected to avoid publication bias, which can have serious consequences for evidence-based medicine practices.
