IRB and the Office of Human Research Ethics
Update to OHRE SOP # 1401 – Promptly Reportable Information
As of October 1, 2021, the OHRE SOP # 1401 will be updated to better reflect the types of information that require reporting, update the definitions of terms, and reformatting the text and tables. Over the next couple of weeks, the Promptly Reportable Information (PRI) form in IRBIS will be updated with new questions to collect the information needed for review and decrease the request for additional information.
An information session was held via Zoom on September 30, 2021.
Announcement on Cassie Myers Departure
Date: June 7, 2021
To: Deans, Directors, and Department Chairs
From: Terry Magnuson, Vice Chancellor for Research
Subject: Announcement on Cassie Myers’ Departure
It is with great sadness that I write to let you know that effective June 11, Cassandra (Cassie) Myers will be stepping down as Director of the Office of Human Research Ethics (OHRE) and departing the University to begin a new role with the HR Consulting Group. The Office of the Vice Chancellor for Research was fortunate to have Cassie at the helm of OHRE where she successfully led the office through a period of transition, resulting in more efficient and effective operations.
Cassie has served as director of OHRE since 2018. In her role, she oversaw the OHRE staff, Carolina’s six Institutional Review Boards (IRBs), the Safety Committee and the Safety and Welfare Analysis Group. In addition, she ensured that all OHRE staff and IRB members, principal investigators, and study teams, as well as university officials, were provided with on-going training and education. We are grateful for the dedication she showed to all of these responsibilities.
A national search to find a new permanent director will soon be launched. In the interim, John Roberts and Mike Matamoros will serve as co-directors. They will work closely with Senior Associate Vice Chancellor Andy Johns on ethical and regulatory oversight of research at UNC-Chapel Hill that involves human subjects, as well as support and guide the work of the IRBs and all related activities.
Please join me in thanking Cassie for her service to OHRE and UNC Research. She will be greatly missed by her colleagues.
IRBIS Update – May 6, 2021
Beginning 5/6/2021, IRBIS will be updated to include some changes that will allow for more streamlined PI changes and personnel modifications.
1. PI Change process
In order to change the PI on a study, a full study modification must be submitted. Instead of obtaining signatures from the “outgoing” PI and the “incoming” PI on a form, both PI’s will be required to certify the submission in IRBIS. This change removes the requirement to obtain signatures and upload the attachment.
2. Personnel Modifications
The Personnel Modification submission type will allow for personnel modifications to be processed outside of the regular submission pipeline. It is the intent to provide a quicker review of personnel changes since they will not longer be reviewed in conjunction with other study changes.
For studies that do not have a submission started (in draft, routing, or under review) as of this date will have this modification type available beginning Thursday morning.
If you have an active submission, this modification type will be available after the current submission is finalized. There is no need to contact us to activate the Personnel Modification for you as it will be an automatic change.
OHRE’s Coronavirus Update – June 10, 2020.
Resumption of Human Subject Research- Q & A Zoom Session from June 1, 2020: Slides available here.
- October 26, 2020: OHRE/IRB Unsecure Communication Update.
- February 14, 2020: OHRE Announces updated CITI Program Training requirements.
- January 27, 2020: OHRE Announces new Associate Director Regulatory Affairs and Compliance, John Roberts & Associate Director, Operations and Education, Mike Matamoros.
- September 10, 2019: Commercial IRB Utilization, IRBIS Update, and IRB Board Restructuring.
- April 9, 2019: IRBIS System Update related to Automatic Creation of COI Disclosures & New Safety Information.
- For older items, see News section
There are no upcoming events at this time.
Introduction to Human Research Subject Protection at UNC
Last year, over one million people took part in research studies at UNC-Chapel Hill. Who are these participants, who is studying them and why?
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).
IRB Boards A through F review research in a wide variety of areas:
- Biomedical Research: 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 or oncology expertise are reviewed by Biomedical Boards B or D.
- Behavioral and Public Health-Nursing Research: such as 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.
- As well as expertise in reviewing 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.