Journal of Law, Medicine and Ethics 38 (1):143-148 (2010)
AbstractThe World Medical Association's Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States.
Similar books and articles
The 2008 Declaration of Helsinki: some reflections.S. Giordano - 2010 - Journal of Medical Ethics 36 (10):598-603.
Neonatal Pain Relief and the Helsinki Declaration.Robert S. Van Howe & J. Steven Svoboda - 2008 - Journal of Law, Medicine and Ethics 36 (4):803-823.
After helsinki: Unresolved issues in international research.Ruth Macklin - 2001 - Kennedy Institute of Ethics Journal 11 (1):17-36.
The three official language versions of the Declaration of Helsinki: what's lost in translation?R. V. Carlson, N. H. van Ginneken, L. M. Pettigrew, A. Davies, K. M. Boyd & D. J. Webb - 2007 - Journal of Medical Ethics 33 (9):545-548.
Disputing the ethics of research: The challenge from bioethics and patient activism to the interpretation of the declaration of helsinki in clinical trials.Simon Woods & Pauline Mccormack - 2013 - Bioethics 27 (5):243-250.
Placebo and the helsinki declaration — What to do?Professor Bozidar Vrhovac - 2004 - Science and Engineering Ethics 10 (1):81-93.
Improving the Helsinki Declaration's guidance on research in incompetent subjects.Anna Eva Westra & Inez de Beaufort - 2015 - Journal of Medical Ethics 41 (3):278-280.
Patients, doctors and experimentation: doubts about the Declaration of Helsinki.A. Belsey - 1978 - Journal of Medical Ethics 4 (4):182-185.
The ethics of research related to health care in developing countries.J. R. McMillan - 2004 - Journal of Medical Ethics 30 (2):204-206.
Who Cares? The Declaration of Helsinki and 'The Conscience of Physicians'.James Appleyard - 2008 - Research Ethics 4 (3):106-110.
More considerations on post-trial obligations in the Declaration of Helsinki 2013.Ignacio Mastroleo - manuscript
The declaration of Helsinki.Richard Ashcroft - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 141--148.
Placebo: Its action and place in health research today. [REVIEW]Dr Randolph Smoak Jr - 2004 - Science and Engineering Ethics 10 (1):9-13.
Added to PP
Historical graph of downloads
Citations of this work
Procedure versus process: ethical paradigms and the conduct of qualitative research. [REVIEW]Kristian Pollock - 2012 - BMC Medical Ethics 13 (1):25-.
Misleading by Omission: Rethinking the Obligation to Inform Research Subjects about Funding Sources.Neil C. Manson - 2017 - Journal of Medicine and Philosophy 42 (6):720-739.
From ‘Consent or Anonymise’ to ‘Share and Protect’: Facilitating Access to Surplus Tissue for Research Whilst Safeguarding Donor Interests.Catherine Blewett - 2021 - Health Care Analysis 29 (3):213-230.
In defence of Helsinki and human rights.A. Plomer - 2012 - South African Journal of Bioethics and Law 5 (2).
References found in this work
Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects.World Medical Association - 2009 - Jahrbuch für Wissenschaft Und Ethik 14 (1):233-238.
International Ethical Guidelines for Biomedical Research Involving Human Subjects CIOMS.Udo Schuklenk - 1994 - Bioethics 8 (2):189-189.
The ambiguity and the exigency: Clarifying 'standard of care' arguments in international research.Alex John London - 2000 - Journal of Medicine and Philosophy 25 (4):379 – 397.