Institutional Review Board

Responsibilities & Authority

All human and animal subjects research carried out at Methodist University or under its auspices must be reviewed and approved or determined exempt from further review by the IRB prior to the involvement of human and animal subjects in research. To initiate review of research, please complete the following IRB Submission Form (MS Word) and e-mail all information to [email protected].

The Methodist University IRB reviews human or animal subjects research sponsored by the University; conducted by or under the direction of any employee or agent of the University in connection with his or her institutional responsibilities; conducted by or under the direction of any employee or agent of the University using any property or facility of the University; or, involving the use of Methodist University non-public information to identify or contact human and animal subjects.

The IRB must conduct initial and continuing reviews of research and report the findings and actions to the investigator and the institution. These reviews include the review of all research involving human and animal subjects at a convened meeting of the IRB (except research classified as exempt or evaluated in expedited review); the approval of research with the concurrence of the majority of IRB members; the evaluation of proposed changes in approved research protocols; and, the determination if any project requires verification from sources other than the investigator that no material changes have occurred since previous IRB review. In addition:

• The IRB has responsibility for oversight of all human and animal subjects research that is not exempt from IRB review;
• The IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities;
• The IRB shall have authority 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. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, Institutional Official, Provost, and appropriate federal regulatory agency.

With approval of the Institutional Official, the Executive Vice President and Provost, Methodist University may enter into an agreement to permit an outside institution to serve as the designated IRB. The MU Agreement for Outside Organization Designated IRB Review Form must be completed and submitted to the Office of the Provost for review and signature and then reviewed and signed by the Institutional Official at the designated institution.

The IRB at the Designated Institution/Organization will follow written procedures for reporting its findings and actions to appropriate officials at Methodist University. Relevant minutes of IRB meetings will be made available to Methodist University upon request. Methodist University remains responsible for ensuring compliance with the IRB’s determinations and with the Terms of its OHRP-approved FWA. The signed MU Agreement for Outside Organization Designated IRB Review Form must be kept on file by both parties and provided to OHRP upon request.

Agreements to Provide IRB Review of Research Conducted by Unaffiliated Investigators

Occasionally Methodist University may be asked to provide IRB review for investigators who are affiliated neither with Methodist University nor with another institution that has an IRB.

Circumstances in which this arrangement might be considered would typically involve a study based at Methodist University in which the unaffiliated investigator is collaborating. It will generally not be considered appropriate to extend IRB oversight to research by unaffiliated investigators in which Methodist University is not otherwise engaged.

All requests for Methodist University to serve as the IRB of record for an unaffiliated investigator should be referred to the Chair of the Methodist University IRB. The Provost, in consultation with the IRB will determine whether the University will agree to extend IRB oversight to the unaffiliated investigator. If the decision is that Methodist University will provide IRB oversight for the unaffiliated investigator, the Chair of the IRB will be responsible for documenting this arrangement. Copies of this documentation will be returned to the unaffiliated investigator and kept on file in the Office of the Provost.