Welcome to the University of Cincinnati Human Research Protection Program
The University of Cincinnati is committed to the highest standards of
ethical conduct in our Human Research Protection Program (HRPP). The
protection of human subjects participating in research is a shared
responsibility of researchers and the institution. Our policies and
standard operating procedures (SOPs) ensure that we act responsibly,
ethically, and in compliance with federal, state, and local regulations.
Below is a description of the various services we have in place to
protect human participants.
The Institutional Review Board (IRB) is a federally mandated committee
comprised primarily of faculty researchers. The IRB reviews and
oversees research that involves human participants in accordance with
our Federalwide Assurance (FWA). The IRB is supported by Human
Protection Analysts (HPAs) who facilitate the development and
modification of protocols for IRB review.The IRB website contains
information on the IRB, the protocol process, HIPAA waivers, forms,
procedures, regulations, and FAQs.
Quality Assurance (QA) Monitoring is designed to ensure protection of
human research participants and also facilitate compliance. QA
Monitoring is performed by Human Research Auditors who work with
researchers to identify and rectify errors and/or omissions in research.
All studies involving human subjects may be audited; however, emphasis
is placed on studies with moderate to high risk to subjects, FDA
regulated investigator initiated studies, studies involving vulnerable
populations, studies for which there are or may be a conflict of
interest, and studies where monitoring does not already occur. The QA
Monitoring website contains information on FDA warning letters,
regulatory mandates and policies, and FAQs.