Ethics Committees in India have come a long way

Around 2004 when I asked a friend from Pfizer Outcomes Research the hassles of conducting phase trials in India, top on his concern list was the weak ethical review climate that prevailed in India then. His company would bring in more trials to India if they felt confident that Indian Institutional Ethics Committees (IECs) and their review of project proposals would comply with international norms. As per our own admission on the FERCAP website (http://www.fercap-sidcer.org/home.asp), the Indian regulators were not confident of our Ethics committees in 2006. The web page on India has a posting that had confessed about the situation prevailing then:

“Transparency and accountability in (Indian Medical) research currently depends on individual institution which may have allegiance to different groups, and may be in need for benefits from Sponsors. (Indian) IECs are used to closed door meetings and generally communications from IECs focus on final decisions without specifying reasons or information on how to improve the research study to the researchers”

But that was 2006. In mid-2009, while the Medical Research Ethics Committees in India are still an evolving breed, they have clearly moved in the right direction since then. Two developments are worth noting. One, the Indian Council of Medical Research (ICMR) and the Indian chapter of FERCAP have made a move towards registration and accreditation of IECs. We also expect some oversight by the Indian regulator DCGI. Second, India’s clinical trial registry (www.ctri.in) is now operational and compliant with the WHO Trial Registration 20-item Data Sets (http://www.who.int/ictrp/network/ctri/en/index1.html) and other norms (http://www.who.int/ictrp/network/ctri/en/index.html)

FERCI

The Forum for Ethical Review Committee in India (FERCI) was formed in Dec 2002 as the Indian chapter of FERCAP. It was not very active for a few years after formation but has recently been rejuvenated and one of its recent initiatives is IEC accreditations in India (personal communication with ex-Deputy Director ICMR Dr. Nandini Kumar). Two leading Indian research sites - King Edward Memorial (KEM) Hospital and Tata Memorial Hospital, both in Mumbai - have invited audit teams and have been accredited under the SIDCER/FERCAP program. The audits went smoothly with only a few discrepancies and the Tata Memorial online approval process was also found to be acceptable. I see that many other IECs are to follow in this program. FERCI objectives include:

• Establish & foster communication between IECs in India
• Act as a national collaborating agency for ethics reviews
• Organize & facilitate meetings, trainings & symposia on ethical review processes
• Assist in the development & implementation of SOPs for ethical review based on WHO guidelines
• Co-ordinate national communications & issues with other global bodies

CTRI

The Indian Clinical Trial Registry is available / encouraged for all clinical research except Bioavailability and Observational trials. Registration is free and presently can be done for on-going studies also. CTRI registration requires some parameters beyond the WHO recommendation that may be essential from an Indian perspective. For example, name of the IECs/ Institutional Review Boards (IRBs) that have approved the study/sites and DCGI approval status are required. Later, CTRI may even insist on approvals from accredited IECs. Conversely, not all IECs in India currently insist on the WHO data set and CTRI registration while reviewing study proposals.

ICMR guidelines for IECs have existed since long and are by and large adopted as Standard Operating Procedures (SOPs) by most IECs in India including for-profit and non-profit IRBs. While Indian IECs have come a long way since the 2004 observation of my American friend, they still need to invest in further training of members and institute transparent functioning in order to avoid a Coast IRB situation in India.

Jayesh Chaudhary

CEO

VEDIC LIFESCIENCES P LTD

jayesh.chaudhary@vediclifesciences.com