Institutional Review Board (IRB)

Ensuring rights & welfare of human subjects in research

Research conducted by NEOMED using human participants is overseen by the Institutional Review Board (IRB). The primary purpose of the NEOMED IRB is to facilitate the review, approval, modification, and disapproval of human subject research protocols, while ensuring the rights and welfare of human subjects are protected while participating in research.  The NEOMED IRB is registered to review research governed by the Office of Human Research Protections (OHRP).  NEOMED has partnered with Advarra, a commercial outside IRB, to provide review and oversite of research governed by the Federal Drug Administration (FDA).

The IRB process at NEOMED is based on rules and regulations for federally funded research, primarily the Code of Federal Regulation (45 CFR 46) and supporting materials such as the Belmont Report.

Board

IRB Chair: Mehool Patel, M.D. ext. 6251
IRB Vice-Chair:  Natalie Bonfine, Ph.D. ext. 6182
Human Protections Administrator: Rebecca German, Ph.D. , ext. 6467
Committee Coordinator: Trish Wilson, CRA, ext. 6364
Please submit all materials electronically for IRB review to Trish Wilson, CRA, Regulatory Affairs Coordinator, paw@neomed.edu.

Application Review and Meeting Dates

Applications received for projects which meet the exempt or expedited review categories will be reviewed by the IRB chair or other members in the order received and are subject to the reviewer’s availability and workload.  Please expect up to 10 working days to receive an initial written review of your project.

Projects determined to be above minimal risk will require review by the convened IRB committee .  Contact the IRB coordinator at paw@neomed.edu for the next scheduled meeting date.   Please note all materials requiring full board review must be submitted two weeks prior to the full board meeting date.  Submit all materials electronically to the IRB Coordinator at paw@neomed.edu.

The IRB Submission and Review Process

Contact

Trish Wilson, CRA
Regulatory Affairs Coordinator
Phone: 330.325.6364
Email: paw@neomed.edu

Institutional Review Board (IRB)

Research Administration at NEOMED