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 subjects
research that occurs at CaroMont Health. The IRB also serves 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.
Accreditation & Regulatory Affairs
The CaroMont Health IRB is administered by the CaroMont Health Accreditation
& Regulatory Affairs department. Accreditation & Regulatory Affairs
is responsible for ensuring the IRB’s compliance with Federal regulations
and institutional policies and procedures. Accreditation & Regulatory
Affairs 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
the Human Protections Administrator at 704.834.2786.
IRB Policies and Forms
CaroMont Health IRB Policies and Standard Operating Procedures and IRB
forms can be obtained by contacting the Human Protections Administrator.
CaroMont Health Institutional Review Board
CaroMont Regional Medical Center
2525 Court Drive
Gastonia, NC 28054