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2023 PRIM&R Annual Conference

Flexibility and Innovation in Research Oversight Processes

A08 - [IN-PERSON ONLY] One Million or More Considerations for Regulatory Management of a Large Scale Multi‐Site Research Program

Monday, December 4, 2023
1:00 PM – 2:00 PM ET
Location: Room 149 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.

Responsibility for protecting research participants goes beyond the IRB. Whether it's a national consortium, a network of local or regional researchers, or a single site study, researchers and research staff play a critical role in ensuring the safety and wellbeing of participants. Building a trusting relationship between stakeholders including the IRB, researchers, and community can enhance these efforts. In this session, speakers will explore best practices and the challenges encountered “where the rubber meets the road,” including inclusivity of under-represented populations, data sharing mechanisms and future use of data, and how to address variable local context.  

Learning Objectives:

  • Explore best practices for collaborating with numerous internal and external stakeholders to protect research participants
  • Identify and problem solve challenges associated with projects spanning multiple institutions and states, with multiple different roles
  • Discuss best practices for interactions with the IRB in the context of projects involving multiple engaged and non-engaged stakeholders