For Healthcare Professionals

IRB

The CaroMont Health Institutional Review Board

The CaroMont Health Institutional Review Board (IRB) is a federally mandated body established under the DHHS and FDA regulations for the Protection of Human Subjects (45 CFR 46 and 21 CFR 56).

The primary purpose and role of the CaroMont Health IRB is to protect the rights and welfare of human subjects participating in research at CaroMont Health. The IRB fulfills this role by reviewing and approving human subject research that occurs at CaroMont Health. The IRB also serve as CaroMont Health’s HIPAA Privacy Board for reviewing the use of HIPAA regulated Protected Health Information (PHI) for research purposes. The IRB committee members come from a variety of disciplines and include physicians, nurses, pharmacists, clergy, and representatives from the community.

The Office of Human Research Ethics

The CaroMont Health IRB is administered by the CaroMont Health Office of Human Research Ethics (OHRE). OHRE is responsible for ensuring the IRB’s compliance with Federal regulations and institutional policies and procedures. OHRE maintains IRB policies and procedures and also provides guidance and assistance to researchers in order to facilitate the IRB review process.

If you have any questions about the IRB review process, please contact OHRE at 704-834-3891.

IRB Resources

IRB Policies and Forms

CaroMont Health Institutional Review Board Policies and Standard Operating Procedures and IRB forms can be downloaded from the CHIP Intranet or can be obtained by contacting the Office of Human Research Ethics.

Ethical Guidance

Regulations

Guidance


Contact Information

Michelle Cook, MS, MPH, CIP
Director
michelle.cook@caromonthealth.org

CaroMont Health Institutional Review Board
CaroMont Regional Medical Center
2525 Court Dr
Gastonia, NC 28054

Phone: 704.834.3891
Fax: 704.834.3838