FDA Assistance

FDA Regulated 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

Brianna Mills
513-558-2286
brianna.mills@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 Lynch
CIRB Coordinator
513-558-5209
keeley.lynch@uc.edu