The Board of Regents at the University of Minnesota adopts and continues its policy that all research involving human subjects conducted at the University of Minnesota shall be conducted in accordance with federal regulations including but not limited to the "Guidelines for Protection of Human Research Subjects" 45 Code of Federal Regulations (CFR) 46 established by the National Institutes of Health, and regulations to protect human subjects, 21 CFR 50, 56, 312, 812 as established by the Food and Drug Administration.

In furtherance of that policy the Board of Regents directs as follows:

1. The University shall establish an Institutional Review Board (IRB) whose members shall be appointed by the Vice President for Research. At the discretion of the Vice President for Research, in consultation with administrative staff of the IRB, IRB panels shall be appointed to managethe research workload. Each IRB panel shall consist of at least five members with diverse backgrounds and expertise, one of whom comes from the community external to the University.

2. The IRB and its staff shall be responsible, in conjunction with administrative officers of the University of Minnesota, for assuring that all University personnel, and student researchers, comply with applicable federal regulations and guidelines. The IRB shall review and approve, require modifications of or disapprove all University research involving human subjects in accordance with the administrative policies and procedures to be established hereunder. In addition, the IRB shall monitor and conduct continuing review of research at intervals of at least once per year. It shall continue to be the responsibility of the administrative officers of the University of Minnesota and each principal investigator to carry out the decisions of the IRB.

3. The IRB has the authority to inspect research facilities, obtain records and other relevant information relating to the use of human subjects in research, and take such actions that are in its judgment necessary to ensure compliance with the federal guidelines and regulations, other applicable federal and state law, and the policies and procedures to be established hereunder, including action to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

4. The IRB shall report to appropriate University and federal government officials: 1) any unanticipated problems involving risks to subjects or serious or continuing non-compliance with IRB requirements; and 2) any suspension or termination of IRB approval of research.

5. The IRB, with responsible oversight by the Vice President for Research, shall establish appropriate administrative policies and procedures to implement this policy.