IV - 2.10(A) - UMB POLICY ON HUMAN SUBJECTS RESEARCH

Approved by President, UMB - November 11, 2005

1. Protection of the rights and welfare of human subjects of research is a paramount concern for UMB. All research involving human subjects which is carried out by UMB faculty, staff, or students, or by any person using UMB resources, is subject to, and must be carried out consistent with:
   1. Board of Regents Policy IV-2.10, Policy on Human Subjects of Research.
   2. UMB's Federal Wide Assurance concerning protection of human subjects of research: http://medschool.umaryland.edu/orags/hrpo/docs/FWA.pdf
   3. The Policies and Procedures for human subjects research adopted by the Human Research Protections Advisory Committee: http://medschool.umaryland.edu/orags/hrpo/policies.asp
2. No human subjects research that has not been approved by an Institutional Review Board (IRB) of UMB can be carried out by UMB personnel or by any person using UMB resources. The Institutional Official identified in the FWA (the Vice President for Medical Affairs), or his designee, may approve or disapprove any human subjects research that has been approved by the IRB. Each Dean may approve or disapprove human subjects research involving that Dean's faculty, staff or students which has been approved by the IRB. In making decisions to approve or disapprove research, the Institutional Official and the Deans may take into account any relevant information, including liability concerns, financial costs of research, the best interests of UMB and cooperating institutions involved in research, the best interests of patients and participants in research, and the appearance or existence of institutional or individual conflict of interest.
3. All officials and other personnel of UMB, including students, shall cooperate with the IRBs of UMB in the review or proposed research, evaluation of research activities, and other functions of the IRBs. No official or other person shall attempt to influence or coerce an IRB or an IRB member.
4. All personnel of UMB must cooperate with the process of the IRBs in review of human subjects research and all other activities of the IRBs in fulfillment of their responsibilities under University policy, state law, and federal law.
5. Violations of this Policy will be punished by sanctions up to and including termination of employment or academic dismissal.