Human Subjects Research

Human Subjects Research

The University of Cincinnati is committed to the highest standards of ethical conduct in our human research programs. Below is a description of the various offices/programs we have in place to ensure the protection of human research participants.

IRB

Human subjects research at the University of Cincinnati is conducted according to a Federalwide Assurance (FWA), unless exempt. The FWA requires that research proposals be reviewed by a convened committee known as the Institutional Review Board (IRB). The IRB Office provides guidance to researchers and supports 2 medical and 1 social/behavioral research IRB committees. The IRB site contains information on the IRB Committees, the IRB Office, and the protocol process. You will also find information on HIPAA waivers, forms, orientation, procedures, regulations, and FAQs.

IRB Home Page

HRP

Human Research Protection (HRP) Program - The protection of human subjects participating in research is a shared responsibility of investigators, key research personnel, and the institution.  Together we have developed policies, procedures and standard operating procedures (SOPs) to ensure that we act responsibly, ethically, and in compliance with federal, state, and local regulations. The HRP site contains: Information for Participants, Definition of Key Personnel, A Message from the Provosts, Templates for Writing SOPs, Research Policies, links to Regulations and UC Rules, and links to the HIPAA Information for Researchers and the Compliance Training sites.

HRP Home Page

Monitoring Program

The Human Subjects Research Post-Approval Monitoring Program ensures that scientific, ethical and regulatory requirements are followed in all IRB (Institutional Review Board) approved protocols. The program is also designed to improve the quality of research by detecting errors and/or omissions that might occur when performing research activities. All studies, including exempt, are subject to quality monitoring. The emphasis of the monitoring program is on studies with moderate to high risk to subjects, investigator initiated studies, studies involving vulnerable populations, studies for which there is or may be a conflict of interest, and studies where monitoring does not already occur. The Monitoring Program site contains: FAQs, FDA Warning Letters, Regulatory Mandates, and Policies.

Monitoring Program Home Page