Authority of IRB

The IRB has the authority and responsibility to approve, require modifications in, or disapprove all non-exempt human subject research, before it is initiated, to comply with ethical principles, federal, state, local laws, and university requirements. This includes exempt research activities for which limited IRB review is a condition of exemption.

The IRB has the authority to suspend or terminate IRB approval of research that is not being conducted in accordance with their requirements, or that has been associated with unexpected serious harm to subjects.

The IRB is responsible for prompt reporting to appropriate officials and entities (university, federal or state agencies, regulatory bodies, Office for Human Research Protections, U.S. Food and Drug Administration, sponsor agency, reliant IRB, etc.) of any unanticipated problems involving risks to subjects or others, of any serious or continuing noncompliance with federal regulations or IRB requirements, and of any suspension or termination of IRB approval.

Research that has been approved by the IRB may be subject to further review and approval or disapproval by officials of the institution based on institutional policies. However, institutional officials may not approve the research if it has not been approved by an IRB.

More information can be found in IRB Policy: Responsibilities of the IRB.