| Points covered in informed consent documents (ICDs) | Analysis | |||||||
| Year of submission of trial to Ethics Committee | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 |
| No of ICDs reviewed | 2 | 6 | 4 | 8 | 26 | 17 | 44 | 12 |
| Number of ICDs where compensation was to be provided in case of research related injury was mentioned | – | – | – | 4 (50%) | 16 (62%) | 12 (71%) | 40 (91%) | 10 (83%) |
| Type of compensation that would be provided | ||||||||
| a) Reimbursement of medical expenses | 2 (8%) | 1 (6%) | 10 (23%) | – | ||||
| b) Medical care | 1 (17%) | – | 4 (50%) | 9 (35%) | 1 (6%) | 15 (35%) | 12 (100%) | |
| c) Monetary Compensation | – | – | – | – | 2 (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? | NM | NM | NM | NM | No-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 treatment | – | – | – | – | 1 (4%) | – | 7 (16%) | 4 (33%) |
| b) All types of injuries | – | – | – | – | – | – | – | |
| c) Only if subject does not have any other medical insurance | – | – | – | 1 (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