Navigating the Institutional Review Board Process: Insights From Within and Across Institutions

• In Event: Fairmont Roundtable Session Nine
  In Roundtable Session: Transdisciplinary Team Research: Co-Constructing Partnerships and Strategies to Explore Professions Education Research Problems (Table 19)

Abstract

Protecting the rights and welfare of human subjects is a crucial part of the research process. To ensure high-quality educational research, oversight from an Institutional Review Board (IRB) ensures that the research is conducted in a responsible and ethical manner as well as complies with institutional policies and federal laws (DHH, 2011; 2015). Particularly this would be an essential element of the process for multi-site research that requires collaboration and engagement from various stakeholders. In multi-site studies, navigating the process of IRB review from application to approval within and across institutions can be complex and creates novel challenges for a transdisciplinary health professions research team (Cobb et al., 2019; Grady, 2015). Research has found substantial variation in types of protocol submission (e.g., exempt, expedited, full), IRB committee review time (range 1-115 days), requests for additional information during the review (e.g., informed consent letter, survey link, information regarding collaborating investigators at other institutions), and time to approval (range 6-164 days (Abbot & Grady, 2022; Dyrbye et al., 2007).

The complex nature of a transdisciplinary health professions team may result in conflicting responsibilities of team members and evaluating compliance with regulations and laws. Furthermore, the burden of conducting multiple, duplicative ethics reviews by several IRBs in multisite studies (e.g., inconsistency of IRB application and variability in the review process) has been known as a major barrier by obstructing multi-institutional research conduct or investigators choosing not to participate in research (Kano et al., 2015; Menikoff, 2010; Musoba et al., 2014). Despite the increasing needs for transdisciplinary research and the value of multi-site designs in health professions education, there is limited knowledge regarding the IRB process. Strategies should be discussed to overcome challenges related to the IRB review process in low-risk, multi-site educational research. Therefore, this presentation will provide an overview and a framework on how to develop structures/logistics focused on the process for IRB review in multi-site research, recognize the essential roles of the institution, researcher, and research teams, address common issues and problems expected, and provide strategies for effective use of resources.

Authors

• Thuha Hoang, Louisiana State University - Health Sciences Center New Orleans
  Presenting Author

• Hyun-Jin Jun, University of Maryland - Baltimore
  Presenting Author