Pharmaceuticalisation and ethical review in South Asia: issues of scope and authority for practitioners and policy makers.
Ethical review by expert committee continues to be the first line of defence when it comes to protecting human subjects recruited into clinical trials. Drawing on a large scale study of biomedical experimentation across South Asia, and specifically on interviews with 24 ethical review committee [ERC] members across India, Sri Lanka and Nepal, this article identifies some of the tensions that emerge for ERC members as the capacity to conduct credible ethical review of clinical trials is developed across the region. The article draws attention to fundamental issues of scope and authority in the operation of ethical review. On the one hand, ERC members experience a powerful pull towards harmonisation and a strong alignment with international standards deemed necessary for the global pharmaceutical assemblage to consolidate and extend. On the other hand, they must deal with what is in effect the double jeopardy of ethical review in developing world contexts. ERC members must undertake review but are frequently made aware of their responsibility to protect interests that go beyond the 'human subject' and into the realms of development and national interest [for example, in relation to literacy and informed consent]. These dilemmas are indicative of broader questions about where ethical review sits in institutional terms and how it might develop to best ensure improved human subject protection given growth of industry-led research.
Department of Anthropology, Durham University, Dawson Building, Lower Mountjoy, Stockton Rd., Durham DH1 3LE, UK. Electronic address: robert.simpson@durham.ac.uk.
Bob
B
Simpson
Social Science Baha, Nepal; Biomedical Health Experimentation in South Asia Project.
Rekha
R
Khatri
Biomedical Health Experimentation in South Asia Project; Anusandhan Trust/Centre for Studies in Ethics and Rights, Mumbai, India.
Deapica
D
Ravindran
Biomedical Health Experimentation in South Asia Project; University of Colombo, Sri Lanka.
Tharindi
T
Udalagama
D057191:Capacity Building / Q000941:ethics; D002986:Clinical Trials as Topic / Q000941:ethics*; D016265:Conflict of Interest; D003906:Developing Countries; D028744:Ethics Committees, Research; D004994:Ethics, Pharmacy; D032984:Ethics, Research; D006805:Human Experimentation / Q000941:ethics; D006801:Humans; D007194:India; D038622:Internationality; D009390:Nepal; D011050:Policy Making; D010818:Practice Patterns, Physicians' / Q000941:ethics*; D000067490:Prescription Drug Overuse / Q000941:ethics*; D013188:Sri Lanka
Capacity-building; Clinical trials; Ethical review; ICH-GCP; South Asia