Welcome to the University of Cincinnati Medical Institutional Review Board

The University of Cincinnati has established three Institutional Review Board panels to review all proposed research involving human subjects to ensure that the subjects' rights and welfare are adequately protected. The human subjects review process is administered through the Institutional Review Board Office for the University, as well as University Hospital, Inc., the Shriners Institute for Burned Children, The Cincinnati Veterans Affairs Medical Center, and The Drake Center. The IRBs are composed primarily of faculty members from disciplines in which research involving human subjects is integral to that discipline's work, as well as several members from the community whose primary interest is in non-scientific areas.The Board(s) membership, policies, and procedures are governed by an Assurance agreement with the Federal government.

Human Subjects Research - A Definition

"Human Subjects Research" subject to IRB review and approval includes all activities which either:

Meet the Department of Health and Human Services' definition of "research" as any "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45 C.F.R. § 164.501); and which involve person(s) who qualify as "human subjects" within the meaning of relevant regulations of the US Food and Drug Administration as any "living individual about whom an investigator conducting research obtains

(i) data through intervention or interaction with the individual, or

(ii) identifiable private information, or data from which the identity of the subject is or may readily be ascertained by the investigator.”

(45 C.F.R. 46.102(f).

2. Qualify under the Food and Drug Administration regulations as an “Investigational use” involving any use of an approved product in the context of a clinical study protocol (21 C.F.R. 312.3(b)) and which involves one or more “human subjects” as defined in relevant regulations as individual(s) who are or become participant(s) of a test article or as a control. A subject may be either a healthy human or a patient (21 C.F.R. 56.102(e); 812.3(p)). “Research activities subject to review include clinical investigations regulated by the Food and Drug Administration under sections 45 C.F.R. 505(i) and 520(g), including any use of a drug, other than the use of an approved drug in the course of medical practice, and clinical investigations regulated by the Food and Drug Administration under section 45 C.F.R. 520(g), including any use of a medical device, other than the use of an approved medical device in the course of medical practice.”

This includes both funded and non-funded research, including dissertations, masters theses, pilot studies, class projects, and non-funded, faculty-directed research if the following conditions are met:

the research is sponsored by the University, or
the research is conducted by or under the direction of any University employee or agent of this institution in connection with his/her institutional responsibilities, or
the research is conducted by or under the direction of any University employee or agent of this institution using any University property or facility, or
the research involves the use of the University's non-public information to identify or contact human research subjects or prospective subjects

Studies involving drugs, devices, or other invasive interventions will be reviewed by the Medical IRBs. Those studies involving surveys, interviews and observation techniques will be reviewed by the Behavioral and Social Sciences Board.

Statement regarding International Conference on Harmonisation and Good Clinical Practices

The University of Cincinnati Medical Center Institutional Review Board is duly constituted (fulfilling FDA requirements for diversity), has written procedures for initial and continuing review of clinical trials: prepares written minutes of convened meetings, and retains records pertaining to the review and approval process; all in compliance with requirements defined in 21 CFR Parts 50, 56 and 312 Code of Federal Regulations. This institution is in compliance with the ICH GCP as they correspond to FDA/DHHS regulations.

"Determining Whether an Activity is Human Research: Any proposed activity involving contact with live persons (whether or not it is viewed as 'research') which involves UC faculty, staff, students and qualifies under the definitions which appear above should be submitted for IRB review and approved using the process described in this website. Questions about the nature of an activity as research requiring review may be discussed with the Institutional Review Board Staff [558-5259]. The Chair(s) of the appropriate IRB will then make a determination concerning whether the activity is subject to IRB review and approval, and a written response will be promptly provided."