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bioethics: Case Discussion I
>>Dear All,
>>
>>Prof Baboo also raised the point of Authorship.
>>
>>Academics in both developed and developing countries make it on the carreer
>>ladder of the basis of publications. In many cases, the study grants would be
>>as a result of effort in submitting grant applications by developed country
>>counterparts. It would be un-realistic to expect those that did not get
>>funding
>>to say be firt authors.
>>
>>As a developing country national, i would like to see more effort from our
>>developed country counterparts in developing grant application capacity among
>>colleagues in the less developed countries. From the developing countries, we
>>should also make effort in writing grant appliactions, albeit the "usual"
>>problems we encounter.
>>
>>the other solution could be joint grant applications where then authorship of
>>resultant publications could be decided prior to the study. But is this
>>usual?
>>
>>Boniface
>>
>>LSTM
>>Liverpool, UK.
>>
>>Quoting Tinofa Mutevedzi <tinofamutevedzi@hotmail.com>:
>>
>> >
>> > >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*.
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>> >
>> >
>> > *****
>> > 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
>> >
>> >
>
>
>*****
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*****
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