Safety review by ethics committee Out of 34, 14 responders felt that safety review by ECs was adequate but 20 responders did not feel so. Those who were satisfied with the safety review, suggested to: a) improve the review process viz. conduct of actual site visits for close monitoring by EC members; b) audits learn more of EC performance by third parties; c) EC minutes of meeting to reflect safety review; d) face-to-face discussions with study team while evaluating safety reports and comparison of data with frequency of similar events at other sites/countries; e) have a safety committee with experts to review the adverse events and suggest appropriate safety management plan; and f) EC to query the site or place a hold on recruitment if subjects are exposed to undue safety risk.

Those who were not satisfied with the safety review suggested that: a) ECs should vigilantly scrutinize the adverse events for protocol deviations or negligence on the part of the investigator; and b) the total number of trials handled by the EC should be limited to only a certain number at any given time. Compensation for clinical trial related injuries Thirty out of 34 responders were in favor of compensation to trial subjects for trial related injuries and four responders felt that compensation is not justified. Opinion was also sought on the amount and the factors to be considered to determine the same. Majority of responses (n = 12) suggested that the amount should be commensurate as per the recent Central Drugs Standard Control Organization guidelines.

It was also mentioned that the number of dependents of the trial subject should be considered and the amount should be adequate to compensate the subject’s contribution to scientific improvement. A word of caution was raised by one respondent that the amount should not act as an inducement for trial participation such that relatives would end up taking advantage for seriously ill patients (e.g. oncology Batimastat studies). Opinion was also sought on who should be deciding the compensation [Table 4]. Twenty eight of 34 responders suggested that multiple authorities should join hands to next collectively decide the compensation amount.