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Declaration of Helsinki, 2008: Implications for stakeholders in research
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Journal Article
Declaration of Helsinki, 2008: Implications for stakeholders in research
2009
Overview
The Declaration of Helsinki (DoH) was adopted by the World Medical
Association (WMA) in 1964, as a statement of ethical principles, to
provide guidance to physicians and other participants in medical
research involving human subjects. Having undergone several amendments,
the most recent version was approved on 18 October 2008, by the WMA
General Assembly at Seoul, South Korea, replacing all previous
versions. This version highlights issues such as, participant safety,
the need to include participants from otherwise underrepresented
groups, clinical trial registration, post-study access, usage of data
and human tissues, compensating participants with research-related
injury, and usage of placebo. In this article, we discuss the major
aspects of the 2008 version, including the impact of this version on
all stakeholders in research, including, investigators, ethics
committee members, sponsors, authors, editors, and reviewers.
