About the IRB

Function of the Institutional Review Board (IRB)

An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee 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 research subjects. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

In the United States, IRBs are governed by Title 45 CFR (Code of Federal Regulations) Part 46.[1] These regulations implement provisions of the National Research Act of 1974, for example defining IRBs and requiring them for all research that receives support, 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.

Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects (45 CFR 46)

  • Establishes requirements for institutional assurances of compliance with federal requirements related to protection of human research subjects
  • Establishes requirements for obtaining and documenting informed consent
  • Establishes for Institutional Review Boards (IRB) including membership, function, operations, review of research, and record keeping.

Important Definitions from 45 CFR 46

  • Research: ". . . a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."(102.d)
  • Human Subject: ". . . a living individual about whom an investigator (whether professional or student) conducting research obtains

-data through intervention or interaction with the individual, or

-identifiable private information. . . [i.e.,] information about behavior in a context in which an individual can reasonably expect that no observation or recording is taking place or information provided for specific purposes that the individual can reasonably expect will not be made public."(102.f)

  • Minimal Risk: "The probability and magnitude of harm or discomfort anticipated in the research are not greater . . . than those encountered in daily life or the performance of routine physical or psychological examinations or tests."(102.i)
  • Children: ". . . persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted."(402.a)

Requirements of an IRB:

"An independent administrative body established to protect the rights and welfare of human research subjects"

-At least five members

-Varied disciplinary backgrounds

-Qualified to review research

-Diverse

-At least one member with scientific background and at least one with nonscientific background

-No conflicts of interest

-May invite people with specialized expertise to advise on specific reviews where the IRB lacks expertise

Categories of IRB Review

  • Full Review: Research that potentially poses more than minimal risk to human research subjects must be reviewed by the entire IRB.
  • Expedited Review: Certain kinds of research can be reviewed more quickly by one or more experienced IRB members, usually the Chair, either because

-the research is found by the reviewer(s) to involve no more than minimal risk, or

-it involves minor changes in previously approved research during the period (one year or less) for which approval was authorized.

  • Exempt: Determined by the IRB or IRB Chair, NOT the Researcher

-Research conducted in established or commonly accepted educational settings, involving normal educational practices.

-Research involving the use of educational tests, survey procedures, etc., unless the information is identifiable and disclosure would place the subject at risk. (Survey and interview research with children are NOT EXEMPT!)

-Research involving educational tests, surveys, interviews or observation of public behavior if the subjects are elected or appointed public officials or federal statutes require confidentiality without exception.

-Research involving the collection or study of existing data if the sources are publicly available or the information is recorded in a manner in which the subjects cannot be identified.

-Research and demonstration programs designed to study, evaluate, or examine Federal Public Benefit or Service Programs.

TCC