Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.” You’ve really got to read the whole thing, but some of the provisions are pretty remarkable:
- “In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.” Note that this doesn’t say anything about the injury being study-related.
- If an injury is related, then the subject is also entitled to financial compensation above any medical expenses.
- If the subject dies as a result of clinical trial participation, his or her “nominees” would be entitled to financial compensation.
- Injury or death will be considered related to trial participation in a variety of usual circumstances, including adverse effects of the investigational product and protocol violation or negligence. But here’s the kicker: injury or death will be deemed trial-related, and therefore eligible for care/compensation, if it results from “failure of investigational product to provide intended therapeutic effect” or “use of placebo in a placebo-controlled trial”. Read that again – if an investigational product doesn’t work, the sponsor will be liable for free medical care and further financial compensation.
Like all of the presidential bioethics commissions and many others that have considered this issue, I’m all for the adoption of reasonable and appropriate compensation systems to make subjects whole in the event of study-related injury. And I think US policy is woefully inadequate on this score. But the pendulum can also swing too far in the other direction. Will sponsors take their trials elsewhere or will research in India still be worth it?
[H/T to Rebecca Li for the head's up re: publication of the new rules.]