| Question | No 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 trial | 16 (53) | 17 (74) | 24 (89) |
| Whether the institution/organisation has a policy for managing compensation issues | 12 (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