Continuing education of the research community is a very important function of the UNMC Institutional Review Board (IRB). Once a month, topics of interest will appear in the UNMC Today. Today you will meet the staff in the Office of Regulatory Affairs.
What is the Office of Regulatory Affairs?
The Office of Regulatory Affairs (ORA) is the administrative department responsible for the activities of the Institutional Review Board (IRB).
Where do I send applications and other correspondence?
Send all applications and correspondence through campus mail – ZIP 7830. If you need to come to the office, call 559-6463 and directions will be provided.
ORA Secretaries
Jodi Hume is the primary secretary for the Office of Regulatory Affairs. Jodi answers the main phone line (559-6463); triages e-mails sent to IRBORA@unmc.edu; receives and enters all IRB submissions into the IRB database; and is the primary contact and problem-solver for CITI training.
If Jodi is not available, Terina Leonard steps in. While Terina’s primary responsibility is to the IACUC (Institutional Animal Care and Use Committee), she is ready to provide assistance wherever and whenever needed.
Administrator for Adult Hematology/Oncology and Basic Science Research
Sally Mann, IRB administrator (559-6119), is responsible for the review of all initial IRB applications, Requests for Change, and Adverse Event reports for adult hematology/oncology and basic science. Sally also serves as the IRB liaison for the Eppley Cancer Center Scientific Review Committee (SRC) and liaison and coordinator for the Institutional Biosafety Committee (IBC). Additionally she services as an editor for the CITI modules and updates.
Administrator for Pediatric and Exempt Research
Gail Kotulak, IRB administrator (559-6540), is responsible for the review of all initial IRB applications, Requests for Change and Adverse Event reports for pediatric protocols. Additionally, applications for exempt research are reviewed and approved by Gail. Her other duties include management of the IRB membership and organization of the meetings, as well as management of the office staff.
Administrator for Non-Oncology/Non-Pediatric Research and Expedited Research
Kevin Epperson, IRB administrator (559-2587), is responsible for the initial review of new applications, requests for change, and adverse event reports of all non-hematology/oncology and non-pediatric protocols. Additionally, he reviews all expedited applications, as well as review and approve all advertisements and recruitment materials for any research protocol.
Continuing Reviews
Jeanette (Jan) Gramps, continuing review coordinator (559-6044), handles all aspects of continuing review for both full board and expedited review – notification e-mails, pre-review of the applications for continuing review, and IRB action letters following the meeting. If Jan requests additional information or paperwork pertaining to continuing review, please be sure to send it to her attention.
Protocol Deviations, Violations, Emergency Treatment, Alterations/Waiver of Informed Consent, and Compliance Issues
Gail Paulsen, protocol compliance coordinator (559-3853), is responsible for coordinating the AAHRPP application and IRB certification process, including updating all the IRB policies, procedures, and the Investigator Guidelines. Additionally, all IRB compliance issues, including review, tracking and triage of all protocol deviations, protocol violations, emergency treatment reports, alterations/waiver of informed consent and DSMB reports come to her desk. In the near future she also will carry out on-site monitoring of research protocols through the Quality Assurance and Improvement Program.