Office of Research Affairs
6150 East Broad Street
Columbus, Ohio 43213
Mount Carmel's Office of Research Affairs provides administrative support for the Institutional Review Board (IRB). Its functions include, but are not limited to:
- Ensuring that all human subject research at Mount Carmel adheres to Federal, State, and institutional regulations regarding research
- Overseeing administration of the Institutional Review Board
- Monitoring the status of all research projects
- Providing support and guidance to research investigators and their staff
- Providing educational opportunities for all research investigators, research staff, IRB members, and hospital administrators
What is the IRB?
The Institutional Review Board (IRB) is a hospital-based committee established to protect the rights and welfare of participants involved in human subject research conducted under the auspices of Mount Carmel and its affiliated research organizations. The IRB reports to the Mount Carmel Board of Trustees.
The IRB is responsible for ensuring that human subject research is conducted ethically, and in compliance with Federal regulations, the requirements of applicable law, Mount Carmel's Federal-Wide Assurance, and Mount Carmel's policies and procedures.
The IRB fulfills these responsibilities by conducting prospective and continuing review of human subject research, including review of the protocol and funded grant applications or proposals (for Federally supported research), the informed consent process, procedures used to enroll subjects, and any adverse events or unanticipated problems reported.
Scope of the IRB's Authority
All research projects involving human subjects or human materials must be reviewed and approved by the Mount Carmel IRB prior to initiation of any research related activities, including recruitment and screening activities.
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 that, even in part, involve such research, regardless of sponsorship, are subject to IRB review if one or more of the following apply:
- The research is sponsored by institutional authorities
- The research is conducted by or under the direction of any physician, employee, faculty member, staff member, student, or agent of the Institution in connection with his or her institutional responsibilities
- The research is conducted by or under the direction of any physician, employee, faculty member, staff member, student, or agent of the Institution using any property or facility, partially or wholly owned by the Institution
- The research involves the use of the Institution's nonpublic information to identify or contact human research subjects
- A research subject crosses the threshold of a Mount Carmel facility (partially or wholly owned)
- Any research protocol uses Mount Carmel resources in any manner (i.e. lab testing, X-ray, CT, MRI, and/or Mount Carmel personnel, etc.)
- Mount Carmel is a party to the Clinical Trial Agreement (contract)