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.

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 704.834.2876.

IRB Resources

IRB Policies and Forms

CaroMont Health IRB Policies and Standard Operating Procedures and IRB forms can be obtained by contacting the Human Protections Administrator.

Ethical Guidance

• Belmont Report
• Nuremberg Code
• Declaration of Helsinki

Regulations

• DHHS Regulations 45 CFR 46 -The Common Rule
• FDA 21 CFR 50 – Protection of Human Subjects
• FDA 21 CFR 56 – Institutional Review Boards
• FDA 21 CFR 11 – Electronic Records; Electronic Signatures
• FDA 21 CFR 54 – Financial Disclosure by Clinical Investigators
• FDA 21 CFR 312 – Investigational New Drug Application
• FDA 21 CFR 812 – Investigative Device Exemptions
• FDA 21 CFR 814 – Premarket Approval of Medical Devices

Guidance

• Office for Human Research Protections (OHRP) Policy & Guidance Index
• FDA Device Advice
• FDA Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
• FDA GCP Guidance for Industry

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Contact Information

Marsha Robinson
Email: marsha.robinson@caromonthealth.org
Phone: 704.834.2786
Fax: 704.834.2418

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