TO: UTK Research Community
FROM: Dr. Colleen Gilrane, IRB Chairperson
Dr. Robert Nobles, Assistant Vice Chancellor for Research
DATE: May 4, 2015
SUBJECT: Updates related to the Institutional Review Board
The Institutional Review Board (IRB) and the Office of Research and Engagement (ORE) have worked over the past semester to ensure that the appropriate infrastructure is in place for human subjects research oversight on campus. In February, we communicated with you about the need to make programmatic enhancements to meet the needs of our research community. Since then, the IRB has focused on ensuring that the needs of campus are being met by meeting with concerned individuals and departments, reaching directly out to students in efforts to assist them, and providing presentations and informational sessions upon request. As we continue to make enhancements, we will continue our outreach efforts with the goal of enhancing the IRB infrastructure by the end of the summer. We have some important updates and strategies to share with you.
First, earlier this year, in concert with Research Council and the Executive Committee of the Faculty Senate, we developed a strategy to bring in national experts on IRB best practices. This past Monday, April 27th, Dr. Charlotte Coley from University of North Carolina and Dr. Monika Markowitz from Virginia Commonwealth University came to campus through the Public Responsibility in Medicine and Research (PRIM&R) training organization and met with over 50 participants in a full day workshop. Discussions occurred around ethical and regulatory requirements, criteria for each of the review categories (exempt, expedited, and full board), and some of the national conversations regarding suggested modifications to the regulations.
Second, our sole compliance officer, Sonya Sullivan is returning to her home in Charlotte, NC. Her last day will be May 31st. An active search is underway to fill this position. Dr. Marlys Staudt, IRB Vice Chair, is leading this search committee and potential candidates are expected on campus within the next six weeks.
We are aware of the issues around support of students, process time, and ease of use of the electronic system, iMedRIS. To this end, there are a number actions that are directly responsive to these concerns:
1) Increasing IRB staffing: Currently there are active searches for three IRB staff positions. The searches will result in two IRB Compliance Officers (one replacement for Sonya Sullivan and one new position) and an additional IRB Compliance Specialist—a net increase of two positions. Dr. Staudt is chairing the search committee for both of the compliance officers. Dairin Malkemus, compliance officer, is chairing the search for the new IRB Compliance specialist position.
2) Expanding the IRB membership and leadership: Approximately ten faculty members and an additional Vice Chairperson, Dr. Tami Wyatt, Associate Professor, College of Nursing, will be appointed to serve on the IRB beginning July 1, 2015. This will result in a net increase in the IRB size from 17 to approximately 25.
3) Expanded Review Support: ORE is providing summer stipends to four faculty IRB members who have committed to perform Exempt and Expedited submission reviews during the gap between the departure of our current IRB compliance officer and onboarding of our three new IRB compliance staff.
4) Student Support: We will be assigning one of the new Compliance Officers and/or one of the Faculty Chairs to serve as liaison(s) for student submissions. Further, we will be enhancing efforts to assist undergraduate and graduate student researchers. Since approximately 25% (n = 625 studies typically) of new IRB submissions are from student researchers, we are and will continue to work with colleges to provide support for student submissions to the IRB and for enhanced instructional documentation and training to streamline the review and approval process. This support system will be in place by the end of July, 2015.
5) Additional Training: We will enhance opportunities for college, department, programs or class level trainings related to IRB regulation and the submission process. The IRB is interested in assisting all researchers with their human subjects research questions and will collaborate with any college, department, program or class with an identified training request. All requests for trainings can be sent directly to firstname.lastname@example.org for coordination.
6) Process Time: We will use iMedRIS to develop metrics around submission receipt and review efficiency, queue size, and responsiveness along the various stages of the review process. We expect to come back to the research community in the Fall, after we are fully staffed, with improved turnaround goals for each category of review.
7) iMedRIS Ease of Use: We will perform a usability assessment with participation from the user community to improve the use and help features of iMedRIS.
8) iMedRIS support: We have trained our support personnel to assist you with any iMedRIS submission questions that you may have. April Griffin is the lead liaison for iMedRIS and will be happy to assist any member of the research community (faculty, staff, students). April can be reached by email at email@example.com or by calling 974-2152.
We will reach out and share information periodically during the summer as continuous improvements are made with each of these actions. With your support and engagement, we believe that these improvements will improve the submission and review processes associated with the conduct of human subjects research on campus. We anticipate having most of these improvements implemented this summer in preparation for the new academic year beginning this August.
If you have questions or concerns, please don’t hesitate to reach out to the chairperson of the IRB, Dr. Colleen Gilrane (firstname.lastname@example.org, 974-7697, IRB line) or the Assistant Vice Chancellor for Research, Dr. Robert Nobles (email@example.com, 974-3053, direct line)