|An institutional review board (IRB), also known as an independent ethics committee or ethical review board, 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||
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physical or psychological harm. In the United States, the 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 non-exempt 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
Determine whether data may be used that was not collected in accordance with the IRB’s
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 member 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 at primarily conducted
at another organization and the investigator’s role does not include interaction or intervention
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
IRB Executive Committee (EC)
IRB Related Documents
- IRB Roster Regulatory Compliance Letter (2-8-2012) - Regulatory Compliance Letter which confirms the IRB's adherence to the Federal guidelines
- Assurance # FWA00007145 - 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)
- Download Letter - from the IRB Chair documenting electronic signatures on IRB Letters of Determination