Information for Researchers
About UC’s IRB
An Institutional Review Board (IRB) is a committee that oversees, reviews, and monitors research involving human subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating in the research. This review serves an important role in the protection of the rights and welfare of human research participants. The UC IRB serves as the primary IRB of record for the University of Cincinnati, UCHealth, Cincinnati VA Medical Center, Cincinnati State Technical and Community College, and the StrokeNet Central IRB.
All researchers engaged in human subjects research at the University of Cincinnati must complete training prior to engaging in research. Training is provided online using Collaborative Institutional Training Initiative (CITI) at the Biomedical Research Alliance of New York (BRANY). Training modules are tailored to the research project. In addition to CITI training, all principal investigators, co-principal investigators, and study coordinators engaged in FDA regulated research are required to complete UC specific FDA training. For questions regarding training, please contact your HPA/IRB Coordinator or email@example.com.
Research Administration Portal (RAP)
RAP is the electronic database utilized by the IRB for all human research activities. This new system will offer efficiencies in the areas of account creation and maintenance, reduced redundancy in the submission forms, as well as centralized access to training videos and templates. Information archived from ePas will be available in the legacy database. If you have questions/concerns, please contact your HPA/IRB Coordinator or firstname.lastname@example.org.
The sponsor of the clinical trial is responsible for registering the clinical trial on ClinicalTrials.gov. Regulations allow for the sponsor to delegate this responsibility to the principal investigator. However, the sponsor should be the party to handle registering the trial. For clinical trials sponsored by industry, a consortium of cooperative group, another institution or organization, where the UC faculty member is conducting the study as a single site or as one of multiple sites, the UC PI should not be responsible for registering the trials on ClincialTrials.gov. For clinical trials, designed, initiated and/or sponsored by a member of the UC faculty that is conducted at UC or at one or more institutions, the UC PI is responsible for registering the trial on ClinicalTrials.gov. Investigators must contact the Human Research Protection Program (HRPP) for access to an account. The HRPP will provide the investigator with login information and instructions on how to register the trial. The Investigator is responsible for entering the data. The HRPP only provides administrative oversight. Contact Jacklyn Glass in the HRPP Office at (513) 558-0453 to register your clinical trial.
The FDA Assistance program has three primary objectives:
- To work with UC researchers to facilitate communication with FDA including IND and IDE submissions.
- To provide regulatory assistance for Sponsor-Investigators (the person who both initiates an FDA regulated study and has the regulatory responsibility; sponsor in this roles is not related to funding). Also see definition according to 21 CFR 312.3(b).
- To serve as a resource and facilitate compliance.
For additional information on Quality Assurance Activities, please contact Kareemah Mills in the HRPP Office at (513) 558-3576.
Quality Assurance Auditing
QA Auditing reviews both research and IRB management of studies to promote high quality, ethical research by facilitating the identification and resolution of compliance concerns and by identifying, disseminating, and promoting best practices. Receiving notification that a study has been selected for an auditing visit does not imply that wrongdoing is suspected. Any research involving human subjects may be audited. Quality assurance and improvement activities are applied to all university researchers, departments, and units engaged in IRB approved human subjects research, including those whose research is conducted at non-university sites. For additional information on Quality Assurance Activities, please contact Kareemah Mills in the HRPP Office at (513) 558-3576.
To report compliance concerns: Email: email@example.com or Call - 513-558-5034
Toll-Free Anonymous Compliance Hotline - (800) 889-1547
You may also file a report via the web: Anonymous Online Reporting