What is an Institutional Review Board?
Under FDA regulations, an Institutional Review Board (IRB) is a 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. Institutional Review Boards are used to ensure the rights and welfare of people participating in clinical trials both before and during their trial participation. 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. IRBs at hospitals and research institutions throughout the country make sure that participants are fully informed and have given their written consent before studies ever begin. IRBs are monitored by the FDA to protect and ensure the safety of participants in medical research. An IRB must be composed of
Related Questions
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- What categories of research involving children can an Institutional Review Board approve?
- When does human stem cell research need to be reviewed by the Institutional Review Board?
