The Full Story
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 research. To accomplish this purpose, the IRB uses 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.
Regulations require at least one unaffiliated or "outside" member.
FDA requires each IRB in the United States that reviews FDA-regulated studies to register. IRB registration information is entered into an Internet-based registration system maintained by the Department of Health and Human Services (HHS).
The Langford Institute's Review Board is registered under IORG#0006005 and this registration is in force and approved for use through June 30, 2025. The board meets quarterly and on an ad hoc basis.
The IRB Roster Includes:
Dr. Sylvia Gografe*
Dr. Carl Durand*
Dr. William Kirsh
RN Molly Harding
Kenneth Kirby, Chair
* designates "Not affiliated with the Institution" status