Acoustic separation and biomedical research: lessons from Indian regulation of compensation for research injury.

Abstract

In early 2013, the Indian government introduced new rules governing the conduct of clinical trials involving human participants. Among other provisions, the law requires that sponsors of research compensate participants who are injured during the course of their research participation. This article examines the effects of India's compensation law and the efforts that policymakers in India have made to tailor the law since its passage. I use the legal concept of acoustic separation as a framework to explain and justify the approach that India has taken in refining its regulation of research related injuries. I conclude that India's example may provide useful lessons for research sponsors and lawmakers in other regulatory states seeking to promote a well-regulated biomedical research industry.