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EDITORIALS: Michael D E Goodyear, Lisa A Eckenwiler, and Carolyn Ells Fresh thinking about the Declaration of Helsinki BMJ 2008; 337: a2128 [Full text]

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Acknowledgements and additional references

Michael D E Goodyear, Lisa A Eckenwiler, Carolyn Ells   (17 October 2008)

Update on the Declaration of Helsinki

Michael DE Goodyear, Lisa A Eckenwiler, Carolyn Ells   (20 October 2008)

Dampening researchers' enthusiasm?

Arun Natarajan   (9 November 2008)

Acknowledgements and additional references 17 October 2008
Michael D E Goodyear, assistant professor Dalhousie University, Halifax, NS, Canada B3H 2Y9, Lisa A Eckenwiler, Carolyn Ells Send response to journal: Re: Acknowledgements and additional references	Acknowledgements We would like to thank the following for inspiration, encouragement and critical comment: Susan Sherwin, Meredith Schwartz, Lynette Reid, Maggie O’Neill, John Noble, Udo Schuklenk, Dana Feinholz, Toby Schonfeld and members of the International Network on Feminist Approaches to Bioethics. Also the Ottawa Group and the World Health Organization for the opportunity to contribute to transparency in research, and the World Medical Association for the opportunity to attend their consultation workshops. Additional references Eckenwiler L, Feinholz D, Ells C, Schonfeld T. The Declaration of Helsinki through a feminist lens. International Journal of Feminist Approaches to Bioethics Spring 2008, Vol. 1, No. 1: Pages 161-177 DeAngelis CD, Fontanarosa PB. Impugning the integrity of medical science: the adverse effects of industry influence. JAMA. 2008 Apr 16;299(15):1833-5 Brody BA, McCullough LB, Sharp RR. Consensus and controversy in clinical research ethics. JAMA. 2005 Sep 21;294(11):1411-4 Jansen LA, Wall S. Paternalism and fairness in clinical research. Bioethics. 2008 EPub Apr 24. Chan S, Harris J. Free riders and pious sons - why science research remains obligatory. Bioethics. 2008 Epub April 25. Brody BA. Making informed consent meaningful. IRB. 2001 Sep- Oct;23(5):1-5 Justo L. Participatory research: a way to reduce vulnerability. Am J Bioeth. 2004 Summer;4(3):67-8; discussion W32 Faden R, Beauchamp T. A History and Theory of Informed Consent. Oxford, NY 1986 (Editorial.) Trials on trial. Nature. 2008 May 22;453(7194):427-8. Tadd W. The Helsinki Declaration: why all the fuss? Nurs Ethics. 2000 Sep;7(5):439-50. Lee K, Bacchetti P, Sim I. Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis. PLoS Med. 2008 Sep 23;5(9):e191. http://medicine.plosjournals.org/archive/1549- 1676/5/9/pdf/10.1371_journal.pmed.0050191-S.pdf Related articles in BMJ Regulation—the real threat to clinical research Paul M Stewart, Anna Stears, Jeremy W Tomlinson, and Morris J Brown BMJ 2008 337: a1732. Update The proposed revisions of the Declaration of Helsinki are due to be presented to the General Assembly of the WMA on October 18 2008, in Seoul. http://www.bosa.co.kr/umap/nzine_view.asp?nzine_PK=1684 Competing interests: None declared
Update on the Declaration of Helsinki 20 October 2008
Michael DE Goodyear, assistant professor Department of Medicine, Halifax, NS, Canada B3H 2Y9,, Lisa A Eckenwiler, Carolyn Ells Send response to journal: Re: Update on the Declaration of Helsinki	The General Assembly of the World Medical Association, meeting in Seoul on October 18th, passed the proposed amendments. A copy of the text of this new sixth revision (or seventh version) can be obtained here: http://myweb.dal.ca/mgoodyea/Documents/Ethics/Declaration%20of%20Helsinki%20VII%20October%202008.doc This was a relatively limited revision compared to the previous one in 2000, although it includes a considerable amount of rephrasing and restructuring, including the integration of the previous "Notes of Clarification" into the text. However it is anticipated that the revision process is a continuous one, and that further proposals for amendments will be produced. Competing interests: None declared
Dampening researchers' enthusiasm? 9 November 2008
Arun Natarajan, Specialist Registrar in Cardiology Essex Cardiothoracic Centre, Basildon Send response to journal: Re: Dampening researchers' enthusiasm?	The impression I get from reading this article in one line is - securing ethical approval for research may become tougher. This process already gives nightmares, especially to clinicians. Yes, there need to be standards, controls and accountability, but I just get the feeling that things are getting out of hand. The seemingly never-ending maze of paperwork, unfortunately, has the potential to curb enthusiasm. Another unwanted layer of difficulty to research in general has been spawned by Modernising Medical Careers which seeks to segregate research from hospital medicine. I don't think this bodes well for medicine in general. The focus instead should be on the researcher with clever ideas - to help him (her) get the project off the ground. Competing interests: None declared