HUMC - Institutional Review Board

Authority

An institution's IRB is established and empowered under the auspices of that institution's executive authorities, and, if federal funding is used to support human subject research in whole or in part, by the institution's assurance with the federal Office for Human Research Protections (OHRP). There may be more than one IRB, but all must subscribe to the same underlying principles and authorities. This institution requires that all research projects involving humans as subjects or human material be reviewed and approved by the IRB(s) prior to initiation of any research-related activities, including recruitment and screening activities.

The IRB is established to review biomedical and behavioral research involving human subjects regardless of the source of funding and location of the study. Except for research in which the only involvement of humans is in one or more of the categories exempted or waived under 45 CFR 46 Section 101(b)(1-6) or 101(i), all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, are subject to these policies and procedures if one or more of the following apply:

The research is sponsored by institutional authorities; and/or
The research is conducted by or under the direction of any employee, faculty, staff, student or agent of the Institution in connection with his or her institutional responsibilities; and/or
The research is conducted by or under the direction of any employee, faculty, staff, student or agent of the institution using any property or facility of the institution; and/or the research involves the use of the institution's nonpublic information to identify or contact human research subjects.

The IRB has the authority to ensure that research is designed and conducted in such a manner that protects the rights and welfare of participating subjects. Specifically:

The IRB may disapprove, modify or approve studies based upon consideration of human subject protection aspects;
The IRB reviews, and has the authority to approve, require modification in, or disapprove, all research activities that fall within its jurisdiction;
The IRB has the authority to conduct continuing review as it deems necessary to protect the rights and welfare of research subjects, including requiring progress reports from the investigators and auditing the conduct of the study, and observing the informed consent process and/or auditing the progress of any study under its jurisdiction as it deems necessary to protect the rights and welfare of human subjects;
The IRB may suspend or terminate approval of a study; and
The IRB may place restrictions on a study.

Regarding federally funded research, if the study is part of an application to a federal sponsoring agency, the human protocol must be reviewed by the IRB before or when the application is processed and prior to expenditure of any grant funds.

The IRB also has a relationship to other institutional research review committees. The IRB functions independently of, but in coordination with those other committees. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by institutional officials or other committees. However, those officials or committees may not approve research if it has been disapproved by an IRB.

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