Coronavirus (COVID-19) Updates: uc.edu/publichealth
Coronavirus Impacts - Minimizing Research: research.uc.edu/coronavirus-impacts-minimizing-research
Coronavirus Impacts – Return to on-campus Research: https://research.uc.edu/coronavirus-impacts-return-to-on-campus-research

Human Research Protection Program

The Human Research Protection Program provides training and support for research involving human subjects including Institutional Review Board (IRB) protocols and FDA submissions and supports the IRB.

< Back to Announcements

Clinicaltrials.gov

04/19/2018

Effective January 18, 2017 more studies require registration in clinicaltrials.gov and the reporting requirements have increased. Investigators have 90 days to come into compliance. The NIH is mandating that all clinical trials with any NIH funding register. Summary results information must be submitted for more trials, including FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA. Reporting changes include uploading the full IRB protocol and providing more information regarding adverse events. Clinicaltrials.gov reporting takes a substantial time investment, you should consider including effort in your proposal budget. Additionally, many journals require registration before the first research participant is enrolled. Enforcement for noncompliance includes the termination or withholding of grant funding.

Contact

Mailing Address

Human Research Protection Program (ML0567)
University of Cincinnati
University Hall, Suite 300
P.O. Box 210567
Cincinnati, OH 45221-0567

Street Address

University Hall, Suite 300
51 Goodman Drive
Cincinnati, OH 45221-0567

View on map

General Inquiries

Phone: 513-558-5259

Email: irb@ucmail.uc.edu

To report compliance concerns: Email: research.compliance@uc.edu 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