What is an Institutional Review Board (IRB)?
An Institutional Review Board (IRB) is a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in all research. Institutional Review Boards must review projects annually. Most universities, hospitals, and government agencies have an Institutional Review Board. Federal law requires that a prisoner advocate serve on the board for research involving prisoners. Expedited review boards for initial approval are not acceptable. For more information, please see the website for the Office for Human Research Protections (OHRP).
Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
The purpose of IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of volunteers participating in research studies. Under FDA regulations, an IRB is an appropriately constituted group formally designated to review and monitor research studies involving humans. An IRB has the authority to approve, require medications, or disapprove research studies.
The federal government established the Institutional Review Board (IRB) as a way of uniformly regulating human research protocols across the United States. The IRB is designed to protect the rights and welfare of human research subjects who have been recruited to participate in research activities. Human subjects are defined as living individuals about whom an investigator (whether professional or student) conducting research obtains data through (1) intervention or interaction, or (2) identifiable private information. The IRB functions in an autonomous role at the University. The IRB performs its federally mandated role without undue influence from either the University or the investigators conducting research at, or on behalf of, the University. The IRB’s primary responsibility is the protection of the human research subject. An IRB is made up of men and women who meet and discuss all research-related protocols. By law, there are at least five (5) members who make up an IRB. Of these
Under federal regulations, an IRB is a group of individuals that has been formally designated to review and monitor research involving human subjects. In accordance with federal regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols (study plans) and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. CIRB members most commonly act under the authority of the regulations of the Food and Drug Administration (21 CFR 50 and 56) and the D
Related Questions
- Our organization requires review of all research projects by our Institutional Review Board (IRB). Do we need to secure final IRB approval for the proposal process?
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- Do I need to complete Institutional Review Board, IRB, training for the DNP program?
