What is an IRB?
An Institutional Review Board (IRB) is a committee whose primary responsibility is to protect the rights and welfare of human research subjects. In accordance with Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations, an IRB reviews research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects participate in the research. The authority conveyed to the IRB includes decisions to approve, disapprove, require modifications, monitor, suspend and terminate research projects involving human subjects.
The IRB also ensures, as required, that human subjects volunteer to participate in research only after providing legally effective informed consent. Investigators may not solicit subject participation or begin data collection until they have received approval from the appropriate IRB or written concurrence that the research has been determined to be exempt from IRB review.
Certain populations of human subjects may be particularly vulnerable in a research setting, e.g., children, prisoners, pregnant women, fetuses, persons with physical or mental disabilities, and economically or educationally disadvantaged persons. When reviewing research involving these subject populations, the IRB will apply additional protective safeguards as required by federal and state law, institutional guidelines, and any other applicable agency/entity regulations.
All research activities involving human subjects must be reviewed and approved by an IRB unless the Office of Responsible Research Practices (ORRP) can prospectively determine that the research falls into a category of exemption established by federal regulation. See exempt research for more information.
Membership and Composition of the IRB and other Human Subjects Research Committees
Each IRB is composed of a dedicated group of volunteers from The Ohio State University and its surrounding community, and includes a Chair, Vice-Chair(s), members, and alternates (See Human Research Protection Program (HRPP) policy IRB Composition and IRB Member Roles and Responsibilities for more information). There are three internal IRBs at Ohio State that review, approve, and conduct periodic reviews of research involving human subjects (including data and biological materials obtained from human subjects). These IRBs are composed of approximately 140 volunteers who are University faculty, staff, Medical Center employees, and local community members. The Western IRB (WIRB), an independent Board, reviews Ohio State clinical trials that are industry-sponsored and industry-initiated.
The Senior Associate Vice President for Research and the ORRP staff work with department heads, University officials, IRB members, and community liaisons to seek candidates for IRB service, taking into consideration the diversity and specialty requirements of the individual boards. The formal appointment of a three-year renewable term is made by the Senior Associate Vice President for Research who serves as the Institutional Official for the Human Research Protection Program at Ohio State.
The university has an IRB Policy Committee dedicated to
- developing policies and best practices for the Human Research Protection Program,
- receiving input from the University community on ways to optimize IRB and ORRP operations and
- making recommendations on ORRP and IRB resource requirements.
The Privacy Board meets quarterly to regularly review requests for waivers of HIPAA authorization in human subjects research involving protected health information (PHI) that has been determined to be exempt from IRB review.
Each committee meets regularly (see meeting dates) to review human subjects research and related issues. All communications concerning submissions should be directed to ORRP staff, and not to individual committee members.
- IRB Policy Committee
Discusses policies, procedures, and addresses issues in human subjects protection.
- Behavioral & Social Sciences IRB Membership Roster
Reviews research in the social and behavioral sciences.
- Biomedical Sciences IRB Membership Roster
Reviews research in the health and biological sciences.
- Cancer IRB Membership Roster
Reviews research in cancer.
- Privacy Board Membership Roster
Reviews research determined to be exempt from IRB review and that involves PHI
Ohio State holds Federalwide Assurance (FWA) #00006378 from the Office for Human Research Protections (OHRP) in the Department of Health and Human Services. This FWA is an agreement between DHHS and Ohio State to review and approve federally-sponsored research involving human subjects in accordance with the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46.
For more information, and for a copy of Ohio States’s assurance, go to OSU Federalwide Assurance.
Staff and Qualifications
ORRP staff teams support each review board, as well as the IRB Policy Committee and the Privacy Board. Most ORRP staff members are Certified IRB Professionals and all are available to help you navigate the IRB submission procedures. Please consult the IRB Protocol Analysts for routine questions and direct any requests for regulatory guidance and support for more complex protocol submissions to the Senior IRB Protocol Analysts.