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Cone Health Institutional Review Board

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 on the staffs or who have professional or educational assignments at the institution.

The IRB operates in conformity with Federal regulations for 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, Title 45, Public Welfare, Part 46--Protection of Human Subjects (45 CFR 46), as revised and amended from time to time, and in conformity with the rules published by the US Food and Drug Administration (FDA) for research related to new drugs and medical devices and conforms with OHRP’s Guidance on Written IRB Procedures date January 15, 2007.

The Cone Health IRB has jurisdiction over all research involving human subjects performed by members of the various staffs of The Moses H. Cone Memorial Hospital Division; which includes Wesley Long Hospital, The Women's Hospital of Greensboro, Behavioral Health Hospital; Annie Penn Hospital Division (Reidsville NC), Cone Health Cancer Center; Regional Center for Infectious Disease, The Health Services Division; including for all divisions the Medical and Dental Staff, the Nursing Staff, the Pharmacy Staff and the Educational Faculty and Staff of The Greensboro Area Health Education Center (AHEC).  The Cone Health IRB will be the IRB of record for all research that involves employees of the Health System and patients who are recruited, enrolled, or treated in the Health System, either as an in-patient or as a Health System outpatient.

Through agreements between Cone Health and Randolph Hospital, Asheboro NC, the Cone Health IRB reviews research protocols to which subjects may be recruited in those two hospitals as well, and accordingly, the IRB includes representatives from their respective communities.

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.