Institutional Review Board (IRB)

Institutional Review Boards (IRBs) are made up of people qualified to evaluate new and ongoing clinical trials on the basis of scientific, legal, and ethical merit. They include medical specialists as well as lay members of the community. The IRB determines whether the risks involved in a study are reasonable with respect to the potential benefits. 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, safety and welfare of human research subjects.

FDA requires IRB registration. It is important to determine if the institution conducting the study has its own IRB. If the study is conducted at a site that does not have its own IRB, the investigators should be queried to see if they are affiliated with an institution with an IRB that would be willing to act as the IRB for that site in the study. There are also independent/contract IRBs that can be contracted with, to act as the IRB for a site. Additionally, an IRB can be established in accordance with 21 CFR 56.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights, safety and welfare of humans participating as subjects in the research. If an IRB determines that an investigation involves a significant risk device, it must notify the investigator and, if appropriate, the sponsor. The sponsor may not begin the investigation until approved by FDA.