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EDITORIALS: Michael D E Goodyear, Trudo Lemmens, Dominique Sprumont, and Godfrey Tangwa Does the FDA have the authority to trump the Declaration of Helsinki? BMJ 2009; 338: b1559 [Full text]

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Acknowledgements and additional references

Michael Goodyear, Trudo Lemmens, Dominique Sprumont, Godfrey Tangwa   (21 April 2009)

What is ICH?

Ali H Bardy   (9 June 2009)

Acknowledgements and additional references 21 April 2009
Michael Goodyear, assistant professor of medicine Department of Medicine, Dalhousie University, Trudo Lemmens, Dominique Sprumont, Godfrey Tangwa Send response to journal: Re: Acknowledgements and additional references	We would like to thank the World Medical Association for the opportunity to make submissions on the most recent revision of the Declaration of Helsinki, and to attend the workshops organised by the WMA Ethics Unit. We offer the following additional references: Rennie S. The FDA ditches the Declaration of Helsinki, Global Bioethics Blog May 6 2008 http://globalbioethics.blogspot.com/2008_05_01_archive.html Shah S. FDA Puts Medical Test Subjects in Danger, The Nation, May 19 2008 http://www.thenation.com/doc/20080602/shah The Pharmaceutical Market: USA, Opportunities and Challenges. Espicom October 2008 https://www.espicom.com/Prodcat.nsf/Search/00000087?OpenDocument Rehnquist J. The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. Office of Inspector General Department of Health and Human Services 2001. http://oig.hhs.gov/oei/reports/oei-01-00-00190.pdf Lavery JV, Putting International Research Ethics Guidelines to Work for the Benefit of Developing Countries, Yale J. Health Policy, Law & Ethics 2004; 4: 319-36 Lustgarten A Drug testing goes offshore. Fortune. 2005 Aug 8;152(3):66-70, 72. http://money.cnn.com/magazines/fortune/fortune_archive/2005/08/08/8267653/index.htm Thiers FA, Sinskey AJ, Berndt ER. From the analyst's couch: Trends in the globalization of clinical trials. Nature Reviews Drug Discovery 7, 13- 14 (January 2008) Wolinsky H. The Battle of Helsinki. Nature (EMBO) 2006 7(7): 670–672 http://www.nature.com/embor/journal/v7/n7/full/7400743.html Hirtle M, Lemmens T, Sprumont D. A comparative analysis of research ethics review mechanisms and the ICH GCP Good Clinical Practice Guideline. European Journal of Health Law 2000 7:75-102 Schuklenk U. Declaration of Helsinki should be strengthened: All countries must have common standards for international research ethics. BMJ. 2001 Feb 3;322(7281):300 http://www.bmj.com/cgi/content/full/322/7281/299/a Global 500: Pharmaceuticals. Fortune. 2008 July 21 http://money.cnn.com/magazines/fortune/global500/2008/industries/21/index.html WMA News: Revising the Declaration of Helsinki. World Medical Journal 2008 54(4) 120-5 http://www.wma.net/e/publications/pdf/wmj20.pdf Lurie P, Wolfe SM. Proposed revisions to the Declaration of Helsinki. Paving the way for globalization in research. West J Med. 1999 Jul;171(1):6. http://www.ncbi.nlm.nih.gov/pubmed/10483334 Katz J. The education of the physician-investigator. In: Freund PE, ed. Experimentation with Human Subjects. Dedalus, 1969 International Conference on Harmonization (ICH). E6(R1). Good Clinical Practice: Consolidated Guideline. ICH 1996 http://www.ich.org/cache/compo/475-272-1.html#E6 Macklin R. Double Standards in Medical Research in Developing Countries. Cambridge, 2004 Ateudjieu J. Training Needs Assessment in Research Ethics Evaluation among Research Ethics Committees Members in Three African Countries: Cameroon, Mali and Tanzania Developing World Bioethics 2009 (in press) Competing interests: None declared
What is ICH? 9 June 2009
Ali H Bardy, neurologist Eira Hospital, Helsinki 00150 Send response to journal: Re: What is ICH?	Your editorial BMJ;338:b1559 "Does the FDA have the authority to trump the Declaration of Helsinki?" refers to ICH as "the International Conference on Harmonisation". However, ICH is an abbreviation for "The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use". The ICH GCP guideline is essentially neither an ethical code nor a guideline on good clinical (trial) practice. As you correctly state, it is procedural regulatory manual and should only be regarded as such. Competing interests: None declared