FDA Assistance

FDA Regulated Research

Research-How2 Link

Click the button to try our new ResearchHow2 website for easy access to all the forms and policies for the Office of Research.

The Investigational New Drug (IND) or Investigational Device Exemption (IDE) 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

 

To protect researchers and UC, the IND/IDE Assistance Program (IAP) must review IND/IDE applications prior to submissions to FDA whenever a UC researcher is serving as Sponsor-Investigator (per UC HRPP policy III.08).  Studies in which a UC researcher is acting as Sponsor-Investigator will be more closely followed using HRPP quality assurance and improvement processes.  Please contact the HRPP office for a comprehensive list of relevant documents.

For additional information, see:

 

For questions about the IAP, please contact:

Angela Braggs-Brown, MA, RAC, CIP Director
Human Research Protection Program
558-3005
broag@uc.edu

Kareemah Mills, CIP, Assistant Director
Human Research Protection Program
558-3576
millsks@uc.edu


Contact Us


Human Research Protection Program
(ML0567)
University Hall, Suite 300
51 Goodman Drive
PO Box 210567
Cincinnati, OH 45221-0567
General Inquiries:
513-558-5259
irb@ucmail.uc.edu

Click here to identify the person dedicated to serving your research group

 

Angela Braggs-Brown, RAC, CIP, MA
Director
513-558-3005
angela.braggs-brown@uc.edu

Kareemah Mills, CIP
Assistant Director
513-558-3576
kareemah.mills@uc.edu

Claudia Norman, CIP
Education and Outreach Specialist
513-558-5784
claudia.norman@uc.edu

Human Protection Administrators
Laura Goins
513-558-0479
laura.goins@uc.edu

Martina Harmon, MS
513-558-1881
martina.harmon@uc.edu

Tara Knipp, CIP
513-558-3731
tara.knipp@uc.edu

Christa Preston, CIP
513-558-2087
christa.preston@uc.edu

Deborah Quinones-Stewart
513-558-6915
deborah.quinones-stewart@uc.edu

Quality Assurance Auditors
Jackie Glass, CCRP
513-558-0453
jacklyn.glass@uc.edu


StrokeNet CIRB

Susan Roll, RN, BSN, CCRP
CIRB Liaison
513-558-6061
susan.roll@uc.edu

Jo Ann Behrle
Human Protection Administrator
513-558-5273
joann.behrle@uc.edu

Keeley Hendrix
CIRB Coordinator
513-558-5209
keeley.hendrix@uc.edu