Table 2 Compensation for clinical trial-related injury and death to participants
Serious adverse event | Formula for deriving the compensation amount | Parameters |
|---|---|---|
Death | (B × F ×  R)/99.37 | B = Base amount, i.e., 800,000 INR F = Factor depending on the age of the subject R = Risk factor depending on the seriousness and severity of the disease, presence of co-morbidity and duration of the disease of the subject at the time of enrollment in the clinical trial between a scale of 0.5 to 4 |
Permanent disability to subject | (D × 90 × C) /(100 × 100) | D = Disability percentage. C = Compensation amount for payment to the participant’s nominee(s) in case of death of the participant |
Congenital anomaly/ birth defect | B/2 | B = Base amount, i.e., 800,000 INR |
Life-threatening disease | 2 x N × W | N = Number of days for life-threatening situation requiring medical care, irrespective of days of hospitalization W = Minimum wage per day of the unskilled worker (in Delhi) |
