Article: India’s new policy to protect rese arch participants: Urgent need to deal wit h its unintended consequences
- Dear friends,Last week, an editorial co-authored by me with colleagues from Hopkins was published in the BMJ on some of the unintended consequences and shortcomings of India's recent regulatory policy changes for clinical trials. We stress that regulatory overhaul is necessary and the steps taken are positive, but the haste and lack of clarity in the regulations might create problems for planning and conducting clinical trials, especially in the areas of public health research on areas such as TB, malara, TB. We suggest that public health research should be treated differently from pharma clinical trials, though ensuring ethical conduct is important in both.This might be of interest to those of you interested in or working on issues around clinical trials. An excerpt from the article is below. The full article is unfortunately not open access-- if any of you would like a copy, please write to me directly and I will send it ot you.The article can be accessed at http://www.bmj.com/content/ 347/bmj.f4841Best,AnantArticle excerpt: 'A recent policy that was meant to mitigate important ethical concerns may have profound and unintended consequences for public health and may threaten the viability of clinical research in India. Although efforts to provide robust protections to research participants and to enhance the quality and integrity of research should be applauded, some aspects of this policy are worrying.Promulgating overarching regulations that are not sensitive to science can ultimately undermine public health and harm those whom the regulations were intended to protect...it is essential that the unintended consequences of the new policy are dealt with effectively but rapidly to help ensure that India remains an active partner and leader in global health efforts.'