According to the new guidelines for compensation in the case of any untoward incident during a clinical trial, in case of death, the income of the deceased per month should be determined. Out of the said income a deduction (50 per cent in case of death and 40 per cent in case of injury) should be made in regard to the amount which the deceased would have spent on himself by way of personal and living expenses.
“The balance, which is considered to be the contribution to the dependant family, constitutes the multiplicand,” it said.
In cases where the monthly income is less than what is prescribed under the minimum wages act, his/her notional monthly income would be taken as minimum wage prescribed under the act.
The authority to decide the compensation, however, lies with the ethics committee, which, according to the new guidelines, will recommend whether or not the trial subject shall be entitled to financial compensation.
The guidelines, likely to be notified soon, come more than a year after the drug regulator decided that drug companies will have to compensate those affected during clinical trials. Concerns were recently raised in Parliament regarding payment of compensation in cases of injury or death in clinical trials.
The new guidelines say that in case of death, their dependents are entitled to “material” compensation. The guidelines also say that it is the obligation of the sponsor to pay the compensation.