Human Research Protections Office (HRPO)

Research Compliance

Institutional Compliance

Safeguarding the rights and welfare of human participants in research and other research activities is a general Institutional policy delegated by the President of UMB through the Dean, School of Medicine. The Dean, School of Medicine, serves as the Institutional Official and is, overall, responsible for the Human Research Protections Program (HRPP). It is the Institutional Official's responsibility to exercise appropriate administrative oversight to assure that UMB's policies and procedures designed for protecting the rights and welfare of human participants are effectively applied in compliance with its Federal Wide Assurance.

Federal Wide Assurance (FWA)

The FWA is a contract or agreement that establishes standards for human subjects research as approved by the Office for Human Research Protections (OHRP).

It is the policy of the University of Maryland, Baltimore (UMB) Institutional Review Board (IRB) to uphold its Assurance as filed with the OHRP. The identification number assigned to the UMB IRB FWA is FWA00007145. A copy of the approval can be found below:

• Assurance # FWA00007145 (PDF)
• Terms of Federal Wide Assurance (FWA)

Institutional Review Board (IRB) Compliance

It is the responsibility of the University of Maryland, Baltimore (UMB) Institutional Review Board (IRB) Committee Members to review all human participants research activities under University of Maryland, Baltimore's jurisdiction.

The mission of the UMB IRB is to protect the rights and welfare of human research participants recruited to partake in research activities conducted by UMB Investigators through ethically responsible and scientifically valid research, continuous education of the research community, monitoring of research activities, and compliance with the federal regulations and institutional policies and procedures.

Committee members will have an understanding of basic ethical principles, the regulatory requirements, and the mechanics of serving on the IRB. Committee members will conduct prospective and continuing review of proposed research activities according to DHHS regulations 45 CFR 46, FDA regulations 21 CFR 50 and 56 and when applicable, VA regulations 38 CFR 16 and 17, Federal, State and local laws, and institutional policies and procedures including the IRB.

The IRB Roster Letter/Regulatory Compliance Letter

The IRB Roster is considered confidential and is not available for distribution. In general, requests for the UMB IRB Roster are sponsor driven and provide assurance that the IRB is in compliance regarding appropriate IRB membership as outlined in Federal regulations and guidelines involving human subjects protections in research, namely DHS 45 CFR 46, and FDA guidelines 21 CFR 56.

In place of an IRB roster, the IRB provides a Regulatory Compliance Letter (PDF) which confirms the IRB's adherence to the Federal guidelines, and information regarding the UMB's FWA to conduct research at this institution.

• Regulatory Compliance Letter from March 8, 2007 to March 8, 2010 (PDF)
• Regulatory Compliance Letter from June 28, 2007 to June 28, 2010 (PDF)

Investigator Compliance

It is the Investigator's responsibility to be knowledgeable regarding his/her role and responsibilities as an Investigator. With each initial submission to the IRB the Investigator is signing an Assurance Statement affirming that they agree to uphold the protection of the rights and safety of human research participants through adherence to Federal, State, and local laws, the Human Research Protections Program or UMB IRB policies and procedures, Veteran's Affairs (VA) research policies and procedures, if applicable, and institutional policies.

The Investigator assumes responsibility for compliance with all Federal (DHHS regulations 45 CFR 46, FDA regulations 21 CFR 50 and 56), State, local, institutional and VA (VA regulations 38 CFR 16 and 17) rules and regulations, if applicable, related to research involving humans and, if applicable, to the Good Clinical Practice Guidelines as adopted by the Food and Drug Administration (FDA) available at http://www.fda.gov/oc/gcp/default.htm.

The Investigator is responsible for knowing and upholding the ethical principles of The Belmont Report. The Investigator is the ultimate protector of the participant's rights and safety. The Investigator should have the resources required to conduct research in a way that will protect the rights and welfare of participants. These resources might include personnel, space, equipment, and time. Investigators should also consider proximity or availability of other resources. For example, the proximity of an emergency facility for care of participant injury, or availability of psychological support after participation. Investigators should not commence a research study without adequate resources to protect participants, and should stop a research study if resources become unavailable.

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