In case of death resulting from clinicals trials, the deceaseds age, income, seriousness and severity of the disease he was suffering from at the time of enrolling into the trial is expected to be taken into account. In case of an injury that has resulted from clinical trials, an additional factor the percentage of permanent disability would be measured to arrive at the financial compensation that the clinical trial victim is entitled to.
This is a departure from health ministrys earlier line of thinking wherein the financial compensation was not proposed to be standardised but was expected to be decided on a case to case basis by the ethics committee of an ongoing trial.
However, for now the formula has been proposed as an interim measure before a final notification on deciding the amount of financial compensation comes into place. For now it appears that ethics committee would have to arrive at the amount of financial compensation that a clinical trial related victim is entitled to, on the basis of the formula proposed.
To incorporate specific provisions for procedures to be followed for payment of compensation in case of trial related injury or death, draft rules have already been published which is under consideration for finalisation, a draft guidance report from health ministry said.
The proposed draft rule 122 DAB in clause (1) and (2) provides that in case of trial related injury or death financial compensation will be provided in accordance with the recommendations of the Ethics Committee as per the guidelines prescribed for the purpose. By the time the amended rules come into force, the guidelines should be in place for the purpose of implementation of the rules. This guidance document describes the methods to be followed by the Ethics Committees for calculating the quantum of financial compensation to be paid in case of clinical trial related injury or death, it added.
While calculating the compensation for the deceased, income per month would be taken into account. Of the monthly income of the victim, a deduction (50 % in case of death and 40% in case of injury) should be made in regard to the amount which the deceased would have spent on himself for personal and living expenses had he lived on. The balance, which is considered to be the contribution to the dependant family, would be factored in for calculation of financial compensation.In cases, where monthly income is less than what is prescribed under the minimum wages Act, his notional monthly income would be taken as minimum wage.