Article | April 5, 2022

Beginner's Guide To Institutional Review Boards

Source: Advarra

By Meghan Hosely, Marketing Copywriter

Legal & Ethical Considerations For Informed Consent In Clinical Trials

Reasonably, it takes a village to conduct a clinical trial. And among the many vital contributors to successful clinical research in the U.S. is the institutional review board (IRB) – sometimes known as an independent ethics committee (IEC), an ethical review board (ERB), or a research ethics board (REB).

Under Food and Drug Administration (FDA) regulations, an IRB is an independent group of people who review and monitor biomedical and behavioral research involving human subjects. An IRB’s purpose is to protect the participant rights and welfare of human research. In accordance with FDA regulations, an IRB has the authority to approve, require modifications to, or disapprove research when it believes the participant’s rights or welfare are not properly protected.

According to James Riddle, Vice President of Research Services and Strategic Consulting at Advarra, “Probably the most important thing for an individual to know is that, at least here in the United States, there is an independent group of folks who are overseeing research, looking out for your best interest as a patient, somebody other than the sponsor.”

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