India is seeking comments on draft guidelines that detail sponsors’ clinical trial injury compensation responsibilities.
Pfizer, PPD, Quintiles, and other clinical research businesses have already paid compensation in India but a firm policy is yet to be agreed. To end uncertainty around the process and payments the Indian Council for Medical Research (ICMR) has published draft policy laying out compensation principles.
“Compensation [will] be provided to the research participants when temporary or permanent injury occurs due to participation in the clinical research”, the ICMR wrote in its draft guidelines . Payment is also due if the injury is caused by actions to manage an adverse reaction or occurs to a child in-utero.
The research participant, or legal heir in case of death, can make claims to the sponsor through the investigator. If there is a dispute about the cause of the injury or the amount of compensation due, committees, for ‘grievance redressal’ and arbitration respectively, will be appointed to decide.
To cover payments sponsors must buy a clinical trials liability insurance policy. The amount of compensation due is outside the remit of the ICMR draft but the Central Drugs Standard Control Organization (CDSCO) of India is reported to be working on guidance for payments .
The ICMR lists two instances when a patient may be ineligible for compensation, namely when: a wrongful act is committed by a third party, defined here ; or negligence by the research participant has contributed to the injury.
A list of other, non-injury related scenarios that will not lead to compensation is also included. For example, patients are not eligible for compensation if the investigational product fails to have its intended effect.
Industry has until December 31 to submit comments to the ICMR.