India’s Research Participant Protection Policy Needs To Be Tweaked, Experts

Experts say urgent action is needed to deal with possible unintended consequences of India’s new policy to protect research participants.

Asian Scientist (Aug. 6, 2013) – Four experts in bioethics and medicine have warned in an editorial in BMJ that urgent action is needed to deal with possible unintended consequences of India’s new policy to protect research participants.

India’s Drugs and Cosmetics Act (First Amendment) Rules, passed earlier this year, was meant to address ethical concerns with potential serious consequences for public health.

However, in their editorial, the experts highlight several specific concerns that could lead to the policy having the opposite effect.

Firstly, although providing compensation for research injury is consistent with prominent international guidelines, it is unclear how injuries that require compensation will be deemed directly attributable to participation in a clinical trial.

Secondly, the experts believe that attributing specific conditions such as “failure of investigational product to provide intended therapeutic benefit,” “use of placebo in a placebo controlled trial,” and “adverse effects due to concomitant medication, excluding standard care” to research injury is problematic.

This is because clinical trials are mainly conducted to see whether the investigational product reaches its intended therapeutic benefit. Failure to do so should not be deemed a clinical trial injury and grounds for compensation.

Furthermore, if a trial includes placebo controls, causality of harm is assumed in the new policy, but placebos are not necessarily harmful. Indeed the use of a placebo is often the only way of truly assessing whether the agent under study is associated with undue risk or significant benefit.

Thirdly, the policy requires that ethics review committees and the licensing authorities help determine compensation for research injuries. However, the experts doubt if they would have relevant skills and resources to make such determinations.

The authors give short and anticipated long-term ramifications of the policy, noting that at least 35 collaborative research projects funded by the US National Institutes of Health have been suspended since March 2013, most investigating large scale public health problems.

They note that India is the main supplier of antiretrovirals to donor supported HIV treatment programs in developing countries, and the dramatic fall in clinical trial applications that is already taking place could have a ripple effect on the availability of registered drugs.

“It is essential that the unintended consequences of the new policy are dealt with effectively but rapidly,” the authors write.

The editorial can be found here: Sugarman et al. (2013) India’s New Policy To Protect Research Participants.

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Source: JHU; Photo: deouro/Flickr/CC.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

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