Book Chapters : 2009-10

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Ethical concerns in clinical trials in India: an investigation. Sandhya Srinivasan

This report is the product of a journalistic investigation on clinical trials. It set out to identify ethical concerns in clinical trials that were conducted in India and used for approval of new drugs in the European Union (EU). It was initiated after discussions with the health advocacy organisation Wemos and the research organisation Centre for Research on Multinational Corporations (SOMO), both based in Amsterdam. Wemos has been campaigning with EU regulatory authorities to prevent the use of unethically conducted clinical trials towards marketing approval in the EU. The plan was to document available information on up to three trials and the ethical concerns that they raised. _____________________________________________________________________________________________________________________________________

Third Krishna Raj Memorial Seminar on Contemporary Issues in Health and Social Sciences Instituted by Anusandhan Trust, CliniCal Trials and Health Care Regulation in india, YMCA International Centre, Mumbai Central, Saturday 10th January, 2009. Centre for Studies in Ethics and Rights

This report summarises the presentations and discussions at the seminar. It starts with an overview of ethical concerns in clinical research from the perspectives of Indian activists and those in the West. It then presents the summary findings of an investigation into four trials. Important issues identified in the ensuing discussions are given: the nature of consent from vulnerable groups, the impact of incentives and inducements, and the ethics of placebo controlled trials. The third part of this meeting focused on regulation: in healthcare research, the manufacture of medical devices, and the provision of health services. Presentations were made by a researcher studying ethics committees, a drug manufacturer, and a health activist. Drawing the links between these sections… one can see the interrelatedness of ethics, equity and governance. ___________________________________________________________________________________________________________________________________