What is an Institutional Review Board (IRB)?
Under Food and Drug Administration (FDA) regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with Office for Human Research Protections guidelines and 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.
- adapted from 1998 FDA Information Sheets
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The Ochsner IRB
The Ochsner IRB reviews research protocols involving human subjects to ensure that subjects are not placed at undue risk and that they give uncoerced, informed consent to their participation.
With representation from a wide range of scientific disciplines and from the local community, the IRB gives rapid but individualized attention to the numerous research protocols at Ochsner.
A protocol is first reviewed in its proposal stage--even before subjects are recruited. Each approved protocol is reevaluated at least annually. The IRB works with investigators to modify protocols to ensure adequate protection of subjects' rights and welfare.
Ochsner’s process for protecting human research subjects reflects the ethical principles of the Belmont Report as well as federal regulations developed in response to reported research abuses around the country. The Department of Health & Human Services (HHS) OHRP oversees the operation of the IRB, and the FDA enforces regulations for the use of experimental drugs and devices.
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