PHA-Exchange> Developing nations 'need effective ethics review committees'

[Claudio]

> Source: The Lancet
>
> Leading ethicists have called for the establishment of
> effective national and institutional ethics review
> committees in developing countries 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.2695
7.1
> * Free registration with The Lancet is required to view this
> article.
>
> Developing countries need effective ethics review committees
>
>
> At the 2nd Symposium on Ethical Issues in Health Research in
> Developing 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 exploitation.
>
> "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 explained.
> And ERCs, where they exist, don't function as they should,
> according to Jesani. As a result, issues such as provision
> of possible 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 vulnerable 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 hiring 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
> treatment for individuals participating in externally funded
> clinical trials in developing countries as would be provided
> to participants in the country funding the study.
>