IRB Overview

The IRB (Institutional Review Board for human subjects) was designed for the protection of human subjects. The IRB requires compliance with basic ethical principles of research provided by the U.S. Department of Health and Human Services. BYU has a federally regulated IRB committee that reviews proposals submitted for research with human subjects.

All research studies conducted by or participated in by BYU faculty, staff, or students which use human subjects are required to be reviewed by the University Institutional Review Board for Human Subjects (IRB) or the appropriate college/department human subjects review committee.

There are seven college/department committees that function as subcommittees of the University IRB. They are authorized to review student coursework research projects within their college/department over which they have jurisdiction, provided vulnerable subjects are not being used and external funding or agency support is not being sought. Student coursework research cannot use vulnerable subjects without such research being reviewed by the University IRB. Note that student coursework does not include theses or dissertations.

The Office of Research and Creative Activities will make the initial determination of whether a study should be reviewed by expedited or full board review. The main purpose of the review of research, which uses human subjects, is to safeguard the rights and welfare of human research subjects. The University IRB assesses whether a protocol conforms to various ethical standards including reasonable balance of risks and benefits, adequate provisions for informed consent, and equitable selection of subjects. The committee only considers scientific design to the extent that if the research is so poorly designed that it wastes the subject’s time or if the research would place the subjects at risk.

In accordance with Title 45 CFR Part 46, the BYU IRB shall have authority to suspend or terminate a research project if it is found that one or more of the following conditions exist:

1. If the research is not being conducted in accordance with the IRB’s requirements.
2. If unexpected and/or serious harm to subjects has occurred; or if unanticipated problems or risks for subjects develop.
3. Under conditions of fraud or misconduct on the part of any associated with a project.

Any Federal agency or department, which financially supports a research project, also has authority to suspend or terminate that research if it finds the Institution has materially failed to comply with the terms of Title 45 CFR Part 46; or, if in the judgment of the agency/department the Institution materially failed to protect the rights of the human subjects.

Any suspension or termination of approval of the IRB shall include a statement of the reasons for the IRB’s action. The action will be reported promptly to the Investigator, the Institutional research administration office, and the sponsoring Federal agency or department.

Under conditions 1, and 2, and following the suspension or termination of the research the IRB must review the research again, stipulating new requirements and develop safeguards against the cause(s) of suspension or termination; or must deny further approval of the research.

Under condition 3, and following the suspension or termination of the research, the IRB actions are governed by established University policy concerning faculty misconduct. As noted above the action of suspension or termination is reported to the Investigator, Institutional Research Administration office, and the sponsoring Federal agency or department. The IRB in conjunction with the Office of Research & Creative Activities then provide all evidence and other information concerning the alleged misconduct to the Associate Academic Vice President who will conduct an investigation under the direction of the Academic Vice President. The Academic Vice President’s Council will review all information and take action, as they feel necessary.