Table 2 Responses received to the questionnaire survey on research injury related issues
QuestionNo of (%) Stakeholders with positive replies
Investigator (30/140)EC member (23/96)Sponsor/CRO (27/37)
General awareness of the requirements as per Indian laws and guidelines regarding provision of clinical-trials insurance and/or compensation for injuries during clinical trial16 (53)17 (74)24 (89)
Whether the institution/organisation has a policy for managing compensation issues12 (40)7 (30)27 (100)
Whether the institution/organisation has mechanisms for grievance redressal of a research subject?11 (37)14 (61)14 (52)
Number of instances where compensation been provided?1 (3)2 (9)4 (15)
Do you agree that the subject should be compensated for the loss of time/wages due to injury?6 (20)4 (17)13 (48)
Does your institution make provisions in the trial budget for research related injury claims?6 (20)20 (74)
Does your ethics committee expect a deposit in advance from the sponsor to manage research related injuries prior to granting permission for a clinical trial?4 (13)4 (17)2 (8)
Does the sponsor have to bear the entire financial responsibility of the compensation claim?30 (100)3 (13)27 (100)
Does your organisation enter into a contract with an insurance agency regarding the finances for research related injury claims?5 (17)4 (17)20 (74)
Is it required for the subject to pay first and then be compensated after providing proof of such a payment?20 (67)11 (48)11 (41)
Is legal advice sought prior to accepting compensation claims?11 (37)6 (26)25 (93)
  • CRO, contract research organisation; EC, ethics committee