Clinical Trial Compliance: New Focus on IRBs

• Date: December 08, 2009
• Source: www.abanet.org

Institutional Review Boards have been constituted to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of research subjects. They are vested with the responsibility of enforcing federal regulations that apply to clinical trials. IRBs are responsible for the following

•     Annual reviews of research (or more regularly based on risk)
•     Determining if independent review of the investigator is required to determine if material changes have occurred since previous review
•     Ensuring that any changes to research plans are communicated to and approved by the IRB
•     Suspending or terminating approval of research that is being conducted outside of IRB requirements
•     Approval of informed consent documents

IRBs are expected to be mindful of their role in protecting human subjects and must carefully screen all documents received by them from sponsors for their efficacy.