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2023 PRIM&R Annual Conference

IRB Basics

Flexibility and Innovation in Research Oversight Processes

SBER

B09 - [IN-PERSON ONLY] Determining the Undefined: Research Development and Generalizable Knowledge

Monday, December 4, 2023
2:15 PM – 3:15 PM ET
Location: Room 151 AB
Human Subjects Research Call for Session Proposal Learning Lab Series CIP Accredited
This session is being held in-person only at PRIMR23. It will not be recorded for on-demand access or for the PRIMR23/SBER23 Virtual Meeting.

The terms "research development" and "generalizable knowledge" are not formally defined in HHS regulations, but both are facets of the regulatory definition of “research.” This session will present multiple perspectives and interpretations of these phrases, propose a framework for assessing whether an activity constitutes research development, explore what does and does not make knowledge generalizable, and explore when QA/QI and user experience activities are in fact research activities, per the Common Rule regulatory definition.  

Learning Objectives:

  • Explore institutional interpretations of "research development" and "generalizable knowledge"
  • Discuss novel and discipline-specific definitions of these terms and consider the challenges with shifting programmatic approaches to these concepts and definitions within specific disciplines (SBER included)
  • Apply definitions of "research development" and "generalizable knowledge" to QA/QI/UX activities and demonstrate how QA/QI and user experience activities can be research activities