Institutional Review Board - Cone Health - Greensboro, NC

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Institutional Review Board

IRB FORMS

The Office of Research Support was initiated in 2002 as the locus for the Institutional Review Board(s) of the Health System as well as for other research support. Organizationally, Research Support is the responsibility of the Medical Director, Heart and Vascular Center, who as the Human Protections Administrator, supervises the operations of the Moses Cone Institutional Review Board(s) as required by the Federal Office of Human Research Protections (OHRP), and is responsible to the Chief Operating Officer of the Health System.

The Institutional Review Board (IRB) was established at The Moses H. Cone Memorial Hospital in 1987 in order to encourage, facilitate and support the performance of clinical research by the health professionals who are members of the hospital staff or who have professional or educational assignments at the institution.  The IRB is registered with OHRP as IRB00003288 and has received Federalwide Assurance as FWA00004507.

Cone Health IRB is guided by the ethical principles outlined in the Belmont Report for all activities related to research involving human participants. The IRB operates in conformity with regulations put forth by the U.S. Department of Health and Human Services and its Office for Human Research Protections (OHRP) as published in the Code of Federal Regulations (45 CFR 46 including Subparts A, B, C, and D), as revised and amended from time to time, and in conformity with the rules published by the Food and Drug Administration (FDA). These regulations include, but are not limited to the Protection of Human Subjects (21 CFR 50), Institutional Review Boards (21 CFR 56), Investigational Drugs (21 CFR 312), Investigational Devices (21 CFR 812), and Application for FDA Approval to Market a New Drug (21 CFR 340).

Cone Health IRB will be the IRB of record for, and have jurisdiction over all research involving employees or agents of Cone Health and all patients who are recruited, enrolled, or treated at Cone Health, either as an in-patient or as an outpatient. 

Cone Health IRB has a reciprocal agreement with UNCG in which both institutions rely on the designated IRB for review and continuing oversight of human subject research that is minimal to low risk. Cone Health also has agreed to rely on the University of North Carolina at Chapel Hill IRB for review and continuing oversight of human subject research in which UNC Chapel Hill investigators collaborate with investigators at Cone Health.  In accordance with OHRP Guidance the relationships are documented with an IRB Authorization Agreement (IAA) and their IRBs are listed on Cone Health's FWA.

The basic function and mission of the IRB is to review and approve research projects to ENSURE that human subjects recruited for participation in research are NOT subjected to unnecessary risk and that subjects are CLEARLY informed and FULLY AWARE of ANY risk that may be involved BEFORE consenting to participate in such research.

 

Contact Information

Office of Research Support
Cone Health Institutional Review Board (IRB)
Committee for Human Research Protection
Moses Cone Hospital
Room 0040A
1200 North Elm Street, Greensboro, NC 27401

Phone: (336) 832-2330
E-mail: IRB.Coordinator@conehealth.com

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