Clinical trials: Volunteers to get insurance cover, compensation in India

Syed Akbar
Hyderabad:  Volunteers participating in clinical trials will now
be covered by insurance and they will get compensation in case the
investigation process goes wrong.

Six years after formulating ethical guidelines on clinical trials on
humans, the Indian Council of Medical Research has now proposed to
make payment of compensation mandatory to volunteers if they suffer
harm from the trials. The quantum of compensation is yet to be worked
out. Every volunteer will be insured for adequate medical and
financial compensation.

The Indian Society for Clinical Research (ISCR) and Forum for Ethics
Committees in India (FERCI) have prepared draft guidelines on
compensation for research related injury. The ICMR has called for
public comments before December 31, and based on them, the final
guidelines and quantum of compensation will be fixed.

The debate on the need for compensation for volunteers renewed after a
number of pharma companies violated the ethical guidelines and used
illiterate people as guinea pigs Andhra Pradesh leads the country in
the number of clinical trials thanks to the location of a large number
of pharma companies and research institutions. “Participation in
clinical research carries inherent risks, which could lead to direct
or indirect physical, psychological, social or economic harms. These
risks are sometimes
foreseeable, sometimes unpredictable,” points out the document on
draft guidelines.

The new guidelines will apply to all clinical research, whether
sponsored by pharmaceutical or medical device industry, government,
academia, or individual investigators. Compensation will be provided
to the research participants when temporary or permanent injury occurs
due to participation in the clinical research. There will also be
compensation in case of injury to a child in-utero (unborn) through
the participation of the parent in clinical research.

The Informed Consent Document (ICD), which volunteers sign before
joining clinical trials, should clearly state that the research
participant has a right to claim compensation in case of research
related injuries and whom to contact in the Institutional Ethics
Committee for their rights as research participants.

According to the new guidelines, the sponsor of the clinical research
must purchase a ‘clinical trials liability insurance policy’. If there
is no provision for such a policy in Indian insurance firms, the
policy should be purchased from a foreign insurer with legal validity
in India.