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Institutional Review Board (IRB)
An institutional review board (IRB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done. The number one priority of IRBs is to protect human subjects from physical or psychological harm.
In the United States, Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are "scientific," "ethical," and "regulatory."
All nonexempt Human Research must be reviewed by an IRB that has been designated by the Organizational Official. The list and scope of review for IRBs designated by the Organization Official to be relied upon are listed in the IRB rosters available from the Human Research Protections Office (HRPO).
The IRBs relied upon by this organization have the authority to:
- Approve, require modifications to secure approval, and disapprove all Human Research overseen and conducted by the organization. All Human Research must be approved by an IRB designated by the Organizational Official. Officials of this organization may not approve Human Research that has not been approved by the IRB.
- Suspend or terminate approval of Human Research not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
- Observe, or have a third party observe, the consent process and the conduct of the Human Research.
- Determine whether data may be used that was not collected in accordance with the IRB's requirements.
- Evaluate financial interests of investigators and research staff and have the final authority to decide whether the financial interest and management plan, if any, allow the Human Research to be approved.
IRB members and IRB staff have the responsibility to follow Human Research Protection Program policies and procedures that apply to IRB members and staff.
Upon prior approval of the Organizational Official, this organization may rely upon the IRB of another organization provided one of the following is true:
- The IRB is the IRB of an AAHRPP-accredited organization.
- This organization’s investigator is a collaborator on Human Research primarily conducted at another organization and the investigator's role does not include interaction or intervention with subjects.
- The organization is engaged in the Human Research solely because it is receiving federal funds.(Employees and agents of the institution do not interact or intervene with subjects, gather or possess private identifiable information about subjects, nor obtain the consent of subjects.)
IRB EXECUTIVE COMMITTEE (EC)
The Executive Committee has been organized to identify and assure careful integration of new and ongoing components of the Human Research Protection Program policies and procedures necessary to optimize the performance of the IRB panels, while maintaining compliance with federal regulations and assuring the protection of human subjects.
IRB RELATED DOCUMENTS
- IRB Roster Regulatory Compliance Letter (2-8-2012) — Regulatory Compliance Letter that confirms the IRB's adherence to federal guidelines.
- FWA Update — A copy of University of Maryland, Baltimore's (UMB) Federal Wide Assurance (FWA) approved by the Office for Human Research Protections (OHRP).
- Terms of Federal Wide Assurance (FWA) — Terms of the Federal Wide Assurance for the protection of human subjects (FWA)
- Letter Approving Electronic Signatures — From the IRB chair documenting electronic signatures on IRB Letters of Determination,