Registering IECs and IRBs in India

To conduct animal experiments in India, the protocol has to be approved by a registered Institutional Animal Ethics Committee (IAEC). The activities of IAECs are monitored by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), New Delhi, which registers and gives approval for IAECs in the country.

To conduct clinical trials and studies on humans, the protocol and the informed consent forms are approved by IECs/IRBs (Independent Ethics Committees/Institutional Review Boards), but these committees do not have to register themselves with any central agency. Nor is there any agency to oversee or monitor the activities of these committees. Institutes are asked to form ethics committees as per Schedule Y of the Drugs and Cosmetics Rule, and it is assumed that all is well thereafter.

The scenario outside India is different. As per ANVISA (the Brazilian regulatory authority) guidelines, the IEC/IRB should be registered under the local government (1). In the USA, the IEC/IRB can function after getting itself registered by the Office for Human Research Protections (OHRP) under the United States Department of Health and Human Service (2). European countries such as France and Germany also have separate councils for registering IRBs/IECs.

In India, many pharmaceutical companies, research institutes, contract research organisations and medical colleges are involved in clinical trials and bioequivalence and bioavailability studies and they form their own IEC/IRB as per E6 Guidelines (Guideline for Good Clinical Practice) or Schedule Y to approve their study protocols (3). But there is no mechanism to check whether the members of the committees are qualified and experienced enough to run the committees in the best interests of subjects and patients volunteering to take part in clinical studies.

Further, one often hears complaints about inefficiency and bias of the committees which adversely affects the researchers. In the current scenario, there is no way one can get IRB-related grievances redressed. There seem to be no regulations on the formation and functioning of Independent Ethics Committees (4). Registration and monitoring by a central agency, along the lines of the CPCSEA for IAEC, will solve some of the problems associated with the current functioning of human research ethics committees. The total number of committees, details of the members, and the activities, will be readily available if a database of all the ethics committees in the country is created. Such a database is a must for administrative reasons and it would make things easy for the registering authority to monitor, educate and direct them when new developments occur. The registering authority will also be able to take corrective action in case of complaints or grievances against a committee or any of its members.

Corrections

In the article: “A new approach for teaching nursing ethics in Iran”(Nasrabadi AN, J Soodabeh, Parsa-Yekta Z, Bahrani N, Noghani F, Vydelingum V. Indian J Med Ethics2009 Apr-Jun; 7(2); 85-89) the affiliation of the corresponding author, Soodabeh Joolaee, is the Iran University of Medical Sciences.

In the article by S Chhattopadhyay, “Teaching ethics in an unethical setting” (Indian J Med Ethics. 2009 Apr-Jun; 7(2): 93-6). the author’s affiliation details were incorrect. They should have been given as follows: Professor of Physiology and Member, Institutional Ethics Committee, Kalinga Institute of Medical Sciences, Bhubaneswar 751 024 Orissa INDIA email: [email protected]

In the article by Geetha Desai and Prabha Chandra, “Ethical issues in treating pregnant women with severe mental illness (Indian J Med Ethics. 2009 Apr-Jun; 7(2): 75-7), the statement that the paper was presented at the Second National Bioethics Conference in November 2007 should be corrected; the Second NBC was held in December 2007.