28
Jun2017

PRIM&R's Regional Connections Program is designed to encourage research ethics professionals in a given geographic area to connect and build relationships. To that end, we offer support to individuals and institutions who would like to organize and host a Regional Connections event for their community.

In this post, Kirstin Morningstar, MBA, CIP, CPIA, regulatory services director, Mary-Colette Lybrand, MS, CCRP, CIP, regulatory services manager, and Alyson Stearns, CIP, regulatory services specialist, in the Office of Research Administration at the University of Texas at Arlington share more about an innovative Regional Connections event initiated by their institution.

North Texas is home to 11 IRB offices within a 30 mile radius, each with its own unique perspective and expertise. These IRB offices manage thousands of open, active human research studies, within and between hospital systems, large universities, private colleges, and health science centers. At the University of Texas at Arlington (UTA) IRB office, we are excited to be a member of this research community and strive to be a positive contributor in all collaborative work.

Given the robust community in our area, our IRB office was motivated to brainstorm ways to increase communication between area IRBs, especially with increasing reliance efforts and new regulations arriving next January. We wanted to be proactive in bridging common interpretation and best practices while focusing on decreasing administrative burden. As part of this focus, we initiated the North Texas IRB Working Group as a way to share resources and strategies for building infrastructure to support the new regulations. We also hope that this working group will provide opportunities for networking and the exchange of ideas for those involved in our human subjects protections programs.

The first meeting of the North Texas IRB Working Group was held on May 31, and our discussions were a great success! The North Texas IRB Working Group currently includes representatives from UTA as well as Baylor Scott & White Health, Cook Children’s Medical Center, Medical City Dallas, Southern Methodist University, Texas Christian University, Texas Health Resources, University of North Texas, University of North Texas Health Science Center, University of Texas at Dallas,  and UT Southwestern Medical Center.

At this initial meeting, the group discussed the following goals (with the understanding that more may develop over time):

  • Establish routine meetings to allow for networking and discussion of program characteristics at each institution
  • Discuss and develop common interpretations of the Final Rule
  • Develop standardized training on the Final Rule that each institution could utilize for outreach
  • Develop processes and IRB reliance agreements for cooperative research

The diverse expertise from each of the participating institutions contributed to a well-rounded representation of perspectives on implementing new regulations. For example, UTA has substantial experience managing exempt and expedited-level projects with benign interventions. The new exempt category for benign interventions is very interesting to our team, and we were able to share real-world examples of how we feel this new category will impact research. Meanwhile, the hospital systems and health care center IRB offices were able to address biospecimens and broad consent, and share what they foresee will be the impact to their human subjects protections programs.

The North Texas IRB Working Group hopes to continue to provide support across the IRB offices for collaboration in our area. We have found that other offices often have ideas and relevant experience that can provide insight to all, and we hope this collaborative model could be helpful to other IRB groups who are also learning to navigate the evolving world of human subjects research regulations.

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