Update:
The General Assembly of the WMA, meeting in Seoul, passed the proposed
amendments on October 18th. Many of the amendments originated with FAB,
although there is much work to be done.

The text of this sixth revision (Version 7) can be downloaded from:
http://myweb.dal.ca/mgoodyea/Documents/Ethics/Declaration%20of%20Helsinki%20VII%20October%202008.doc

Apparently a number of people had difficulty accessing the editorial, 
despite a
link provided by the journal. By trial and error, an alternative link which
works better is:
http://www.bmj.com/cgi/content/full/337/oct17_2/a2128?ijkey=2VSyCFemFVXLaaR&keytype=ref

There is no pdf version and this list will not accept attachments. I have
therefore provided a Word version at:
http://myweb.dal.ca/mgoodyea/Documents/Ethics/Helsinki%20editorial%202008.doc

alternatively these and related documents can be downloaded from my ethics
website:
http://myweb.dal.ca/mgoodyea/ResearchEthics.htm

-- 
Michael Goodyear, Department of Medicine, Dalhousie University, Canada
Email: [log in to unmask]
Website: http://myweb.dal.ca/mgoodyea/goodyear.html
Resource directory: http://myweb.dal.ca/mgoodyea/Documents/

Tel: Work 902-473-6015 Home 902-420-9680
Fax 902-473-6186
Cell/Mobile 902-476-2053




----- Message from [log in to unmask] ---------
    Date: Fri, 17 Oct 2008 12:56:48 -0300
    From: Dr Michael Goodyear <[log in to unmask]>
Reply-To: Feminist Approaches to Bioethics <[log in to unmask]>
Subject: Using Helsinki to rethink comprehensive ethical research
      To: [log in to unmask]


> This is the third product from FAB on the Declaration of Helsinki, 
> which should
> help to raise our profile.
>
> Hopefully this link will work for you:
> http://www.bmj.com/cgi/content/full/337/oct17_2/a2128??ijkey=2VSyCFemFVXLaaR&keytype=ref
>
> as long as it does not wrap, in which case cut and paste. If you have 
> difficulty
> accessing it let me know.
>
> Since the acknowledgements are not yet posted on line I will add them here:
>
> <P>  Acknowledgements
>
> <P>  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.
>
> <P>  Additional references
>
> <P>  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
>
> <P>  DeAngelis CD, Fontanarosa PB. Impugning the integrity of medical
> science: the adverse effects of industry influence. JAMA. 2008 Apr
> 16;299(15):1833-5
>
> <P>  Brody BA, McCullough LB, Sharp RR. Consensus and controversy in
> clinical research ethics. JAMA. 2005 Sep 21;294(11):1411-4
>
> <P>  Jansen LA, Wall S. Paternalism and fairness in clinical research.
> Bioethics. 2008 EPub Apr 24.
>
> <P>  Chan S, Harris J. Free riders and pious sons - why science research
> remains obligatory. Bioethics. 2008 Epub April 25.
>
> <P>  Brody BA. Making informed consent meaningful. IRB. 2001 Sep-
> Oct;23(5):1-5
>
> <P>  Justo L. Participatory research: a way to reduce vulnerability. Am J
> Bioeth. 2004 Summer;4(3):67-8; discussion W32
>
> <P>  Faden R, Beauchamp T. A History and Theory of Informed Consent.
> Oxford, NY 1986
>
> <P>  (Editorial.) Trials on trial. Nature. 2008 May 22;453(7194):427-8.
>
> <P>  Tadd W. The Helsinki Declaration: why all the fuss? Nurs Ethics. 2000
> Sep;7(5):439-50.
>
> <P>  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
>
> <P>  Related articles in BMJ
>
> <P>  Regulation?the real threat to clinical research
> Paul M Stewart, Anna Stears, Jeremy W Tomlinson, and Morris J Brown
> BMJ 2008 337: a1732.
>
> <P>  Update
>
> <P>  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
>
> Michael, Lisa and Carolyn (absolutely non-hierarchically)
>
> --
> Michael Goodyear, Department of Medicine, Dalhousie University, Canada
> Email: [log in to unmask]
> Website: http://myweb.dal.ca/mgoodyea/goodyear.html
> Resource directory: http://myweb.dal.ca/mgoodyea/Documents/
>
> Tel: Work 902-473-6015 Home 902-420-9680
> Fax 902-473-6186
> Cell/Mobile 902-476-2053
>


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