Institutional Review Board (IRB) and the Scope of Its Authority

An IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with the applicable laws and regulations, the IRB has responsibility for approving, requiring modification in (to secure approval), or disapproving research. An IRB also has the authority to suspend or terminate research, if such action is believed to be in the best interest of research subjects; reasons for this action may include, but are not limited to, hazard to subjects, continued noncompliance with the applicable laws and regulations, or IRB findings, determinations, and initial and continuing review procedures.

A designated IRB’s primary responsibility is to protect the rights and welfare of participants involved in human subject research. In doing so, the designated IRB monitors human subject research to determine that it is conducted ethically, and in compliance with applicable laws and regulations, this institution’s Assurance, and this institution’s policies and procedures. The designated IRB fulfills these responsibilities by conducting prospective and continuing review of human subject research, including review of the protocol and grant applications or proposals, the informed consent process, procedures used to enroll subjects, as well as any adverse events or unanticipated problems reported to the IRB.

All human subject research conducted at GU-Q must be prospectively reviewed and approved by an IRB. No human subject research may be initiated or continued at GU-Q without prospective approval of a designated IRB.