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Declaration of Helsinki, 2008: Implications for stakeholders in research

Puri, KS ; Suresh, KR ; Gogtay, NJ ; Thatte, UM

Journal of postgraduate medicine, 2009-04, Vol.55 (2), p.131-134 [Periódico revisado por pares]

India: Medknow Publications and Staff Society of Seth GS Medical College and KEM Hospital, Mumbai, India

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Título:
Declaration of Helsinki, 2008: Implications for stakeholders in research
Autor: Puri, KS ; Suresh, KR ; Gogtay, NJ ; Thatte, UM
Assuntos: Biomedical research ; Clinical trial registration ; Clinical trials ; Clinical Trials as Topic - ethics ; Clinical Trials as Topic - methods ; compensation ; Debates ; Drug Industry - ethics ; Ethical aspects ; Genetic research ; Health care access ; Helsinki Declaration ; Human Experimentation - ethics ; Humans ; International organizations ; Medical research ; Medical societies ; Medicine, Experimental ; Physicians ; post-study access ; Practice Guidelines as Topic ; R&D ; Research & development ; Research - standards ; research ethics ; revised declaration of Helsinki ; Talent agents
É parte de: Journal of postgraduate medicine, 2009-04, Vol.55 (2), p.131-134
Descrição: 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.
Editor: India: Medknow Publications and Staff Society of Seth GS Medical College and KEM Hospital, Mumbai, India
Idioma: Inglês

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Declaration of Helsinki, 2008: Implications for stakeholders in research

Puri, KS ; Suresh, KR ; Gogtay, NJ ; Thatte, UM

India: Medknow Publications and Staff Society of Seth GS Medical College and KEM Hospital, Mumbai, India

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