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An institutional review board/independent ethics committee (IRB/IEC) (also known as ethical review board) is a group that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the subjects. In the United States Food and Drug Administration (FDA) and HHS regulations have empowered IRBs to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

US mandate

In the United States, IRBs are mandated by Title 45 CFR (Code of Federal Regulations) Part 46.[1]This Research Act of 1974, which defines IRBs and requires them for all research that receives funding, directly or indirectly, from what was the Department of Health, Education, and Welfare at the time, and is now the Department of Health and Human Services (HHS). IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within HHS. IRBs were developed in direct response to research abuses earlier in the twentieth century. Two of the most notorious of these abuses were the experiments of Nazi physicians that became a focus of the post-World War II Nuremberg Trials, and the Tuskegee Syphilis Study, an unethical and scientifically unjustifiable project conducted between 1932 and 1972 by the U.S. Public Health Service on poor, illiterate black men in rural Alabama.

Naming and Composition

IRB" is a generic term used by the FDA and HHS. Regardless of the name chosen, the IRB is subject to the FDA's IRB regulations when studies of FDA-regulated products are reviewed and approved.

Originally, IRBs were committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical problems.

Today many IRB reviews are done by for-profit organizations. These are known as independent or commercial IRBs. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same federal regulations.
a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

IRB at ISBHT

The Institute has established an IRB for some of its on-going studies and the composition of the Committee is as follows:

Chair

Gundu Rao, Ph. D., Basavanagudi, Bangalore.

Members

i) Vivek Benegal, M.D., Associate Professor of Psychiatry, Deaddiction Centre, National Institute of Mental Health and Neurosciences, Bangalore, India.

ii) Hrishikesh Damle, Ph. D., Managing Director &CEO, Atrimed Pharmaceuticals Pvt. Ltd., 15 M.G. Road, Bangalore

iii) Ishdeep Kohli, Public Health Consultant, Mumbai, India

iv) Ananth Rao, Ph.D., FRS, FAMIC., Narayana Hrudayalaya, Bangalore

v) T. Ramakrishna, Ph. D. Additional Professor of Law, National Law School of India University, Nagarbhavi, P.B.7201, Bangalore, India

vi) K. C. Raghu, Managing Director, Pristine Organics Pvt. Ltd., Bangalore