How Do You Audit An Institutional Review Board (IRB)?
An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB) is a group of people responsible for reviewing, approving and monitoring clinical studies involving human volunteers. Their main responsibility is to protect the rights, safety and welfare of clinical research volunteers by monitoring the investigator. Clinical Investigators are required to get approval from an IRB prior to starting a clinical trial. Many hospitals and established research centers have onsite IRB’s to oversee research activities. Doctors in private practice generally do not have an IRB. For multi-centered clinical trials and private practicing clinicians, sponsors tend to hire a central IRB. Institutional Review Boards were originally “non-profit” organizations comprised of volunteers from various walks of life. As clinical research evolved, several “for-profit” organizations emerged along with concerns about ethics and the bio-ethic groups. Now that e
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?
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