India’s regulatory framework for research ethics is two pronged. Schedule Y of the Drugs and Cosmetics Act, 1940, of the Government of India (1), lays down the requirements for undertaking clinical trials for drugs and medical devices in India; it also requires compliance with the ICMR’s Ethical guidelines for biomedical research on human participants(2) for such trials. Other health research may use the ICMR’s guidelines but this is not mandatory. The regulatory framework is operationalised through the offices of the Central Drugs Standard Control Organisation. However, the mechanisms of monitoring drug trials using this framework have proved to be rather weak.
The government of India has been making a concerted effort to strengthen the regulatory framework for clinical trials following disclosures of deaths in clinical trials (3) and the Parliamentary review of the status of regulatory mechanisms (4). The recent draft guidance for determining the quantum of financial compensation to be paid in case of trial-related injury or death is a step in that direction (5). The guidance calls for the following criteria to be used for determining compensation: the participant’s i) age, ii) income and iii) health status, iv) the seriousness and severity of the disease of the participant at the time of recruitment into the trial, and v) the extent of disability caused by the research intervention. It suggests a mechanism of combining these criteria using an algebraic formula which is easy to apply.
While this set of criteria may be acceptable, we have concerns about the methodology recommended for computing the compensation. We illustrate this by computing the sums to be paid under various assumptions, and then discuss the ethical dilemmas involved.