9_Sunder Rajan - Experimental Values

9_Sunder Rajan - Experimental Values - sunder rajan...

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sunder rajan: Clinical Trials 75 with ensuring extra care in gathering informed consent from illiterate subjects and in considering what might constitute ‘ethical’ compensa- tion for poor subjects recruited into early-stage trials—the logic here being that lucrative remuneration can actually act as a coercive incentive. One Mumbai-based cro executive, Arun Bhatt, was typically emphatic about the importance of Schedule Y and good clinical practice: ‘We are new. We don’t want to play with the evolution of ethics.’ 13 Outside the enforcement potential of Schedule Y, however, a larger regulatory body with the scope of the fda is still absent. As mentioned earlier, the Drug Controller-General of India is the nominal equivalent, but its remit is still basically limited to approving drugs for the market or for import into the country. Part of the regulatory effort currently under way in India consists in building a more substantial regulatory body with oversight powers that parallel those of the
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