18
Jun2020

"Protecting human subjects is more than IRB review." 

The 2019 Advancing Ethical Research Conference (AER19) session "Use It or Lose It- Recalibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate" began with a statement we HRPP professionals know, but sometimes need to hear again as a reminder to advocate for the needs of both the Human Research Protection Program (HRPP) and IRB Office.

The lines often blur between the roles of the HRPP and those of the IRB, and for the most part our jobs involve responsibilities that cover both. Long gone are the days in which the IRB Office was tucked away within another department or on a back hall, avoided by most (including university administration). One of the presenters emphasized that "AAHRPP has assisted with legitimizing the need for discussions around the function of a sound HRPP." So, how can we as HRPP professionals demonstrate the importance of the varied functions within our HRPPs in such a manner to garner the resources needed?

I chose to attend this session because the title appeared intriguing. I’m continually looking for ways to obtain additional funding for resources within our IRB Office/HRPP and often find myself having to justify existing positions. The shift to single IRB (sIRB) review for multi-site research has stretched our resources and challenged us to examine the workload of various positions within our office.

The speakers were from the University of Missouri and Yale University. One institution has separated the roles of the HRPP and IRB Office. The other has one office that serves in both capacities. Their institutions differ in size, funding, and resources; however, both were able to examine the current state of their offices, recognize the need for re-structuring, and obtain the needed FTEs.

The University of Missouri staffing model most closely resembles that of my institution. Similar to our institution, some IRB Office staff have functions in both IRB and HRPP Operations. The reorganization of their office, and their ability to obtain 3 additional FTEs, was encouraging as we are also adapting to the changing regulatory climate and shifting positions based on the sIRB mandate.

Valuable strategies were shared, and I left the session with a sense of confidence having been given some new tools to approach common challenges. I was challenged to think about our approach to staffing and reorganization while maintaining the continuity of knowledge and expertise within the office. If I had the opportunity to interview the presenters I’d dig a bit deeper into how they are able to address some of the overlapping roles that are often contained within an IRB Office. For example, at my institution, the audit of investigators and the IRB are functions of an IRB Office compliance department. From our standpoint, the benefits of having trained, knowledgeable, certified staff conducting audits of studies and the IRB far outweigh the perception of conflict of interest. If their institution has this similar function within their IRB Office, how are they able to manage the perceived conflict of interest?

The timing was perfect to attend this session as it afforded me the chance to see the important role I play in serving an advocate for the IRB/HRPP Office and also the responsibility I have in clearly defining and delineating the roles of the HRPP and IRB Office so that institutional leadership can understand the roles and responsibilities of our office when requests for additional resources are made.

Ivy Tillman, MS, CCRC, CIP, joined the Augusta University IRB Office in 2005 and is currently the Director. She serves as the primary liaison for the Augusta University Human Research Protection Program (HRPP), which is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Augusta University’s IRBs review research for Augusta University, Augusta University Medical Center, and the Charlie Norwood VA Medical Center. Ivy is responsible for overseeing the missions of the IRB Office, which include administrative support to the IRB committees, compliance and oversight of human research studies, and education and training for research team members and the IRB Committee members.

Ivy received her Master of Science in Management with a concentration in Healthcare Management from Troy University and her Bachelor of Arts in Biological Sciences and Modern Languages from Clemson University. A former educator, Ivy’s past roles in human research include working as a clinical research coordinator in pediatric sickle cell and adult neurology studies, and serving as the IRB Office Training Coordinator. She obtained certification as a Certified Clinical Research Coordinator in 2005 and Certified IRB Professional in 2008.

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

 

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