The New Drugs and Clinical Trials Rules, 2019 mandates all ethics committees undertaking the review of clinical trials, bioavailability/bioequivalence study or biomedical and health research projects to be registered with the concerned authority. For the purpose of registration, ethics committees are categorized into two broad categories, - (i) Ethics committee for clinical trial, bioavailability and bioequivalence study to be constituted under rule 7 and registered with Central Licencing Authority under rule 8; (ii) Ethics committee for biomedical and health research to be constituted under rule 16 and registered with Department of health Research (DHR), Ministry of Health and Family Welfare under rule 17. As a result any institution who intends to conduct clinical trial or bioavailability/bioequivalence study or biomedical and health research is required to have two separate ethics committees duly registered with the concerned authority.

‘Biomedical and health research’ has been defined as a research including studies on basic, applied and operational research designed primarily to increase the scientific knowledge about diseases and conditions (physical or socio-behavioural), their detection, cause and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation including clinical research. The ethics committee for biomedical and health research is required to be constituted in accordance with the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants issued by the Indian Council of Medical Research and must function in compliance with the said guidelines.

Ethics Committee refers to an independent body, constituted of medical professionals and non-medical members, whose responsibility is to ensure the protection of the rights, safety and well being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. Ethics committee may also be called as Institutional Review Board (IRB), Institutional Ethics Committee (IEC) and Ethics Review Board (ERB).

The guidelines categories the types of review in three broad categories, - (i) Exemption from review; (ii) Expedited review and (iii) Full committee review. Exemption from review may be granted for research that presents less than minimal risk to the human subjects involved in the study. For example, research conducted on data available in the public domain for systematic reviews or meta-analysis; observation of public behaviour when information is recorded without any linked identifiers; quality control and quality assurance audits in the institution; comparison of instructional techniques, curricula, or classroom management methods; consumer acceptance studies related to taste and food quality; public health programmes by Government agencies (where there are no individual identifiers). The proposals presenting no more than minimal risk to research participants may be subjected to expedited review whereas, all project proposals presenting with more than minimal risk or which do not qualify for exempted or expedited review and involve vulnerable population and special groups is required to be subjected to full committee review by all the members.

Catalyst Clinical Services Pvt. Ltd., a leading contract research organization is a frontrunner in the field of bioethics, clinical research and GCP and has so far imparted training to 10,000+ personnel across 27 countries over the last 16 years. Further, Catalyst has helped a number of institutions in getting their ethics committees registered with the concerned authorities by providing assistance in the development of the standard operating procedures (SOPs), training and certification of ethics committee members as well as preparation of submission packages for the registration of EC with the concerned authorities. For further details get in touch at [email protected]