Clinical Research at CaroMont Health is comprised of two departments:

• Office of Research Administration
• Office of Human Research Ethics / Institutional Review Board(IRB)

Clinical research is subject to the regulations of the Food and Drug Administration (FDA), and follows ethical and professional guidelines, including Good Clinical Practice (GCP).

CaroMont Health currently has ongoing clinical trials in several therapeutic areas, including cardiology and infectious disease, and oncology trials offered through the CaroMont Cancer Center.

 

Office of Research Administration

The Office of Research Administration is responsible for the conduct of clinical research trials at CaroMont Health, including training and education.

CaroMont Health provides research staff with training through the CITI Program, and utilizes a leading clinical trials management system for comprehensive project management.

If you have any questions about clinical research at CaroMont Health, please call (704) 834-3805 or email rogerswj@caromonthealth.org

 

Office of Human Research Ethics (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 CaroMont Health Department of Human Research Ethics
The CaroMont Health IRB is administered by the CaroMont Health Office of Human Research Ethics (HRE). HRE is responsible for ensuring the IRB’s compliance with Federal regulations and institutional policies and procedures. HRE 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 HRE at 704-834-3891.

 

Contact Information

Office staff:
Michelle Cook, MS, MPH
Director
cookml@caromonthealth.org

Celena Oliver
Administrative Assistant
oliverch@caromonthealth.org

Phone: 704-834-3891
Fax: 704-834-3838

Address: CaroMont Health Institutional Review Board
Gaston Memorial Hospital
2525 Court Dr
Gastonia, NC 28054

Interdepartmental Mail: Human Research Ethics / IRB

Tube #: 59