- July 22, 2015: OHRE welcomes our new Director, Elizabeth Kipp Campbell, Ph. D., CIP. Dr. Kipp Campbell comes to us from Purdue University, where she served as Director of the Human Research Protection Program. She received her Ph. D. from Pennsylvania State University in Human Development and Family Studies, and brings more than twenty years of IRB experience in both the biomedical and non-biomedical areas.
- April 9, 2015: The Radiation Safety Committee (RSC) has determined that five (5) or less of the following scans/x-rays represent no greater than minimal risk and therefore do not require review and approval by the RSC (i.e., you do not need to complete an Application for Human Use of Radiation in Research):
- DEXA scans
- Chest x-rays
- Planar x-rays of extremities (as defined by NRC – hands, forearms, elbows, feet, knees, leg below the knees, and ankles)
- Dental x-rays
Please note that one procedure could have multiple views/scans (e.g., AP and Lat view for chest x-ray).
The following statement must be included in the risk section of the consent form:
“This research study involves exposure to radiation from (insert maximum number scans and type of procedure). Please note that this radiation exposure is not necessary for your medical care and is for research purposes only.
For comparison, the average person in the United States receives a radiation exposure of 0.3 rem (or 300 mrem) per year from natural background sources, such as from the sun, outer space, and from radioactive materials that are found naturally in the earth’s air and soil. The dose that you will receive from participation in this research study is less than amount you receive from these natural sources in one year.
The amount of radiation you will receive in this study has a minimal risk and is below the dose guideline established by The University of North Carolina Radiation Safety Committee for research subjects.”
- For older items, see News section
The Office of Human Research Ethics (OHRE) is responsible for ethical and regulatory oversight of research at the University of North Carolina at Chapel Hill that involves human subjects. OHRE supports and oversees the work of the Institutional Review Boards (IRBs). The IRBs at the University of North Carolina at Chapel Hill are organized by area of expertise. The IRBs are:
Biomedical IRB (Committees A through D): Reviews research involving School of Medicine, School of Pharmacy, UNC Hospitals, and research in other units that involves biomedical interventions. Expertise is focused on medical, surgical, physiological or pharmacological studies. Includes research with drugs, devices, counseling, or other interventions. Studies that require dental expertise are reviewed by Biomedical Committee B.
Non-Biomedical IRB (Committee E): A combination of the former Behavioral and Public Health-Nursing IRBs. Reviews research in psychology, child development, education, anthropology, information and library science, social work, journalism, and many other disciplines under Academic Affairs, as well as studies from the School of Public Health, School of Nursing, nursing-related studies at UNC Hospitals, non-medical research from the Injury Prevention Research Center, Carolina Population Center, Health Promotion Disease Prevention, and Sheps Center. Expertise is focused on research in behavioral and social sciences, the humanities, epidemiology and other research in a public health or nursing context.
Committee F: This committee handles submissions that are atypical or otherwise outside the norm, as well as Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) and other compliance issues, Humanitarian Use Devices (HUDs), emergency research on single patients under a single subject treatment IND. It meets monthly but can be convened rapidly should circumstances require.
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105 Mason Farm Road
Chapel Hill, NC 27599-7097
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