Compensation for Injured Clinical Trial Participants
This NEJM piece (free full text) has more, arising out of, among other things, the TGN1412 debacle. The lack of uniformity of insurance and compensation infrastructure is surprising to me. The conclusion:
Although the ethical arguments for compensating injured research subjects are compelling, the practical details are complicated — particularly the determination of the extent and duration of coverage and the assignment of the responsibility for paying compensation. However, the actuarial expense of covering direct medical costs may be relatively low, because serious injuries are unusual. In the United States, national leadership — from the clinical-trials industry, academic medical centers, and the federal government — will be needed to catalyze major change.