AFRO-NETS> Developing countries need effective ethics review committees

[Claudio Schuftan <aviva@netnam.vn>]

Developing countries need effective ethics review committees
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Source: The Lancet
 
Leading ethicists have called for the establishment of effective na-
tional and institutional ethics review committees in developing coun-
tries to protect biomedical research participants from any possible 
harm or exploitation.
 
The calls came at a symposium on ethical issues in health research in 
developing countries held in Pakistan earlier this month.
 
Participants also recommended the same standard of care and treatment 
for individuals participating in externally funded clinical trials in 
developing countries as would be provided to participants in the 
country funding the study.
 
Link to full article in The Lancet: *
 
http://www.thelancet.com/journal/vol362/iss9384/full/llan.362.9384.news.26957.1 
 
* Free registration with The Lancet is required to view this article.
 
 
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Developing countries need effective ethics review committees
 
At the 2nd Symposium on Ethical Issues in Health Research in Develop-
ing Countries (Karachi, Pakistan; Aug 14-18), leading ethicists 
called for the establishment of effective national and institutional 
ethics review committees (ERCs) in developing countries to protect 
biomedical research participants from any possible harm or exploita-
tion.
 
"There is no robust mechanism in place in many developing countries 
for ethical review of any research", warned Amar Jesani (Centre for 
Enquiry into Health and Allied Themes, Mumbai, India). For example, 
"in India--the hub of biomedical research in developing countries--at 
least 50% of biomedical institutions don't have an ERC", he ex-
plained. And ERCs, where they exist, don't function as they should, 
according to Jesani. As a result, issues such as provision of possi-
ble post-trial benefits to the participants and others in developing 
countries can not be effectively addressed.
 
"The first phase of an externally funded clinical trial of an HIV 
vaccine is scheduled to begin in India early next year, but I am not 
sure whether the vaccine, if found useful, would be cheaply available 
in India", he said. The situation in is even worse in much of Africa. 
For example, in Nigeria, "there is no national ERC to set standards 
for institutional review boards which too are only few", asserted 
Carel Ijsselmuiden (University of Pretoria, South Africa).
 
Asad Jamil Raja of Pakistan's Bioethics Programme expressed concern 
at the way consent is obtained from participants--particularly vul-
nerable people. "They [researchers] don't make sufficient efforts to 
ensure that the participants have understood the information in the 
consent form."
 
This problem, adds Athula Sumathipala (Bioethics Initiative, Forum 
for Research and Development, Sri Lanka), could be addressed by hir-
ing a study ombudsman who could formally witness the consent-taking 
and other phases of a study.
 
The ethicists also recommended the same standard of care and treat-
ment for individuals participating in externally funded clinical tri-
als in developing countries as would be provided to participants in 
the country funding the study. 

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