Table 3 Important points observed in the informed consent documents
Points covered in informed consent documents (ICDs)Analysis
Year of submission of trial to Ethics Committee20002001200220032004200520062007
No of ICDs reviewed264826174412
Number of ICDs where compensation was to be provided in case of research related injury was mentioned4 (50%)16 (62%)12 (71%)40 (91%)10 (83%)
Type of compensation that would be provided
    a) Reimbursement of medical expenses2 (8%)1 (6%)10 (23%)
    b) Medical care1 (17%)4 (50%)9 (35%)1 (6%)15 (35%)12 (100%)
    c) Monetary Compensation2 (12%)
Whether Expenses would be borne by the sponsor?1 (17%)4 (50%)15 (58%)5 (29%)27 (61%)5 (42%)
Whether payment for lost wages/disability/discomfort would be provided in case of a trial related injury?NMNMNMNMNo-8 (31%); NM-16 (69%)No-5 (29%) NM-12 (71%)No-15 (34%) NM-29 (66%)No-5 (42%) NM-7 (58%)
Any clauses mentioned regarding when compensation would be provided?
    a) If the injury related to the study treatment1 (4%)7 (16%)4 (33%)
    b) All types of injuries
    c) Only if subject does not have any other medical insurance1 (4%)1 (6%)2 (5%)1 (8%)
    d) Compensation/reimbursement only of the additional amount not covered by subject’s medical insurance?1 (4%)4 (9%)3 (25%)
Did the ICD mention an insurance policy that covers trial related injuries?2 (8%)3 (18%)6 (14%)6 (50%)
  • NM, not mentioned