[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
bioethics: Case Discussion I
>Dear all,
>
>Prof Baboo is raising important questions. I have worked in international
>collaborations, and the success of collaborations depend not on how much the
>Researchers from developed world want to involve their counter parts from
>developing countries. Its important for the Researchers in the developed
>world to seek and take opportunities to build capacities. I hope
>collaborations have memorandum of understandings, which provide guidelines
>as to what the obligations and responsibilities of each part are. Why
>signing the agreement if you see things you do not subscribe to? What I see
>being more dangerous is that people do not want to refer to these
>memorandums at all!!!!
>
>Your point of bulkness of informed consent is not valid, I think. I would
>like a situation where participant are told all they are supposed to be
>told, and if its too much information so lets it be. The important thing is
>not about bulkness but about whether information is crafted in simple
>language, simple enough to be well understood by the participants. Informed
>consent is not about slim or bul documents; its about ensuring that
>participants understand everything about a study in which they are enrolled.
>
>You also raised the issue of translation. It is important, if not cardinal,
>to me that participants get informed consent in the language they best
>understand. Anything short of that is a research fraud because there is no
>understanding.
>
>The collaborations I have worked with always emphasise the need for local
>understanding of ethics and GCP guidelines to override international ones.
>But its my basic understanding that the principles of Research ethics and
>GCP are universal, although their application is sutiational
>
>Tinofa Mutevedzi
>
> >From: "Prof. Baboo" <ksbaboo@coppernet.zm>
> >Reply-To: bioethics@hsphsun2.harvard.edu
> >To: bioethics@hsphsun2.harvard.edu
> >Subject: bioethics: Case Discussion I
> >Date: Tues Nov. 25, 2003
> >
> > >Dear all I have no problem of any body coming and doing research in
> >Zambia.
> > >but there are certain atticates and mannerizms which need to be
> > >fallowed.Take for example the fallowing.
> > >1. Funding. 70% of the funding goes for the maintinance of the foreign
> > >collaboraters.
> > >2. Authership. you land up being 6th or 7th auther.
> > >3. Concent.It is not uniform. US or UK regulatios are not applicable to
> >the
> > >developing countries.Concent forms are often very bulky and time
> > >consuming.Translation is another issue.
> > >4. Insentives given to paricipants ofen comprises the research.
> > >5. Big question is those who are conducting HIV related studies, how many
> >of
> > >these investigaters have trainig in Human Participants Protection Progarm
> >or
> > >have OHRP certification to do HIV studies.
> > >6.Any new drug to be used in any country should be approved by the Drug
> >and
> > >Poisons commission and the Reserch and Ethics committee (IRB) of
> >individual
> > >countries.
> > >7. How do you bring reserch to places where there is no infra
> >structure.By
> > >giving few computers and furniture here and there is not infrastructure
> > >development.
> > >8.CIOME, Helsinki Declaration and WHO guide lines are not uniform.There
> >are
> > >no universal guidelines which are suitable to all.There fore the need to
> > >fallow each case by its own merit.
> > > Prof K S Baboo
> > >Former Cair of Ethics Committee(1993-2000).University of Zambia.
> > >
> > >
> > >-----Original Message-----
> > >From: owner-bioethics@hsphsun2.harvard.edu
> > >[mailto:owner-bioethics@hsphsun2.harvard.edu]On Behalf Of
> > >nipuna@stmail.lk
> > >Sent: Monday, November 17, 2003 12:00 AM
> > >To: bioethics@hsphsun2.harvard.edu
> > >Subject: bioethics: Case Discussion - Double Standard for an AIDS Drug
> > >
> > >
> > >
> > > > >dear all
> > > > >
> > > > >This case brings out important ethical issues of international
> > > > >collaborations.
> > > > >
> > > > >1. Why they choose south African country to do a "rough comparison of
> > > > >efficacy" and to take quick and dirty first look
> > > > >
> > > > >Will any of the euro-American countries refuse such a study to be
> > >conducted
> > > > >in their country
> > > > >why did not they do it in France
> > > > >AIDS is not a tropical illness only
> > > > >will these institutions would show the same enthusiasm for developing
> > >drugs
> > > > >for dengue and malaria
> > > > >
> > > > >Developed countries should not do any clinical trials in the
> >developing
> > > > >world exclusively for diseases that are common to both worlds. It
> >only
> > > > >appears just if they do it simultaneously in both worlds or replicate
> >a
> > > > >trial done in developed world.
> > > > >
> > > > >The case and the questions seems eurocentric as the main
> >epistemological
> > > > >foundations of the bioethics
> > > > >
> > > > >sisira
> > > > >Dr Sisira Siribaddana
> > > > >Endocrinologist
> > > > >Researcher
> > > > >Sri lankan Twin Registry
> > > > >Coordinator
> > > > >Bio-ethics Initiative
> > > > >Forum for Research & Development
> > > > >Dedicated to build research capacity in Sri Lanka
> > > > >www.forumforresearch.org
> > > > >
> > > > >
> > > > >
> > > > >-
> > >
> > >
> > >*****
> > >Susie Welty
> > >Program Manager
> > >Program on Ethical Issues in International Health Research
> > >Department of Population and International Health
> > >Building I -- Room 1104
> > >Harvard School of Public Health
> > >665 Huntington Avenue
> > >Boston, MA 02115
> > >
> > >Telephone: 617-432-3998
> > >Fax: 617-566-0365
> > >E-mail: swelty@hsph.harvard.edu
> > >Website: http://www.hsph.harvard.edu/bioethics
> >
> >
> >*****
> >Susie Welty
> >Program Manager
> >Program on Ethical Issues in International Health Research
> >Department of Population and International Health
> >Building I -- Room 1104
> >Harvard School of Public Health
> >665 Huntington Avenue
> >Boston, MA 02115
> >
> >Telephone: 617-432-3998
> >Fax: 617-566-0365
> >E-mail: swelty@hsph.harvard.edu
> >Website: http://www.hsph.harvard.edu/bioethics
> >
>
>_________________________________________________________________
>Add photos to your messages with MSN 8. Get 2 months FREE*.
>http://join.msn.com/?page=features/featuredemail
*****
Susie Welty
Program Manager
Program on Ethical Issues in International Health Research
Department of Population and International Health
Building I -- Room 1104
Harvard School of Public Health
665 Huntington Avenue
Boston, MA 02115
Telephone: 617-432-3998
Fax: 617-566-0365
E-mail: swelty@hsph.harvard.edu
Website: http://www.hsph.harvard.edu/bioethics