Office of Human Research Protection

The Office of Human Research Protection provides a focus and guiding set of principles to assure patient safety, the provision of full and informed consent by participants, and guidelines for researchers as to the ethical conduct of research and the ensuing scientific publication.

For questions or to learn more about the Office of Human Research Protection, contact:

Lynda J. Dimitroff, PhD, MSEd, BSN, LMHC-LP, RN, MCHES, PCC
Chair, Institutional Review Board
[email protected]

Renee Capizzi, RN, RAC
IRB Administrator
[email protected]

Lauren Fenclau
IRB Coordinator
[email protected]

Resources

Human Research Subject Protection Certifications

• CITI Course Program Course Instructions
• CITI Human Research Subjects Certification Training
• Committee members – take IRB member modules
• Principal and sub investigators – Principal Investigation modules
• Coordinators – research coordinator modules
• Renewals (every 3 years) – refresher course every 3 years modules
• Human Research Subjects Protection Training

Institutional Review Board

• 2022 IRB Meeting Schedule

RRH Institutional Review Board Policies & Procedures

• 2020 Human Research Protection Program Policies & Procedures

Federal Regulations

• Code of Federal Regulations Title 21 Part 312 (FDA IND Regs)
• Code of Federal Regulations Title 21 Part 812 (FDA IDE Regs)
• Code of Federal Regulations Title 21 Part 50 (Protection of Human Subjects)
• Code of Federal Regulations Title 21 Part 56 (Institutional Review Board)
• Belmont Report
• CenterWatch Clinical Trials
• Center for Disease Control
• Medical Dictionary

Application for a New Research Study

To apply for a new study, complete the application for review form. Once you've completed the form, please send via email to [email protected] or Lauren Fenclau at [email protected].

• Elements required when writing a protocol
• Generic consent form
• HIPAA language sponsored study
• HIPAA language non-sponsored study