Open AccessDeclaration of Helsinki, 2008: Implications for stakeholders in research
Author(s) -
Kanchan Puri,
Kallur Suresh,
Nithya J Gogtay,
Urmila M Thatte
Publication year - 2009
Publication title -
journal of postgraduate medicine/journal of postgraduate medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.405
H-Index - 52
eISSN - 0972-2823
pISSN - 0022-3859
DOI - 10.4103/0022-3859.52846
Subject(s) - declaration of helsinki , medicine , helsinki declaration , declaration , human research , research ethics , clinical trial , ethics committee , informed consent , medical research , family medicine , institutional review board , alternative medicine , medical education , pathology , engineering ethics , law , surgery , psychiatry , public administration , political science , engineering
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.