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2023 PRIM&R Annual Conference

IRB Basics

Flexibility and Innovation in Research Oversight Processes

HRPP/IRB Administration/Management and Process

D10 - [IN-PERSON ONLY] Research or Not? Applying the Common Rule "Carve‐Outs"

Tuesday, December 5, 2023
1:00 PM – 2:00 PM ET
Location: Room 202 AB
Human Subjects Research Call for Session Proposal Learning Lab Series
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 Common Rule “carves out” four types of activities as not meeting the definition of research, (1) scholarly and journalistic activities, (2) public health surveillance activities, (3) criminal justice agency’s collection and analysis of material for law or court ordered criminal justice or criminal investigative purposes, and (4) authorized operational activities for national security missions. What should HRPP professionals understand about these types of activities and how they relate to human research protections? Representatives from federal organizations will provide an overview of these Common Rule “carve-outs” and share perspectives and case studies for discussion.

Learning Objectives:

  • Understand the four categories of activity deemed not to be research
  • Recognize the role of public health authorities, or agency officials, in certain categories of “carve-outs”
  • Learn best practices for making and documenting these determinations though reviewing case studies