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Pharmaceuticalisation and ethical review in South Asia: Issues of scope and authority for practitioners and policy makers

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  • Simpson, Bob
  • Khatri, Rekha
  • Ravindran, Deapica
  • Udalagama, Tharindi

Abstract

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.

Suggested Citation

  • Simpson, Bob & Khatri, Rekha & Ravindran, Deapica & Udalagama, Tharindi, 2015. "Pharmaceuticalisation and ethical review in South Asia: Issues of scope and authority for practitioners and policy makers," Social Science & Medicine, Elsevier, vol. 131(C), pages 247-254.
    • Handle: RePEc:eee:socmed:v:131:y:2015:i:c:p:247-254
    DOI: 10.1016/j.socscimed.2014.03.016
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    References listed on IDEAS

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    1. Ezekiel J Emanuel & Trudo Lemmens & Carl Elliot, 2006. "Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?," PLOS Medicine, Public Library of Science, vol. 3(7), pages 1-1, July.
    2. Timmermans, Stefan & Almeling, Rene, 2009. "Objectification, standardization, and commodification in health care: A conceptual readjustment," Social Science & Medicine, Elsevier, vol. 69(1), pages 21-27, July.
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    Cited by:

    1. Sariola, Salla & Ravindran, Deapica & Kumar, Anand & Jeffery, Roger, 2015. "Big-pharmaceuticalisation: Clinical trials and Contract Research Organisations in India," Social Science & Medicine, Elsevier, vol. 131(C), pages 239-246.
    2. Chiumento, Anna & Rahman, Atif & Frith, Lucy, 2020. "Writing to template: Researchers’ negotiation of procedural research ethics," Social Science & Medicine, Elsevier, vol. 255(C).

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