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2022 PRIM&R Annual Conference

IRB Basics

F04 - Risky Business: The Basics of Evaluating Research Risk

Thursday, December 15, 2022
11:45 AM – 12:45 PM ET
Location: Livestreamed
Livestreaming Session Icon CIP Accredited Human Subjects Research Deep Dive Series
One of the more challenging parts of learning the ropes of IRB review is evaluating the risks of a study. To really grasp the risks of a study a reviewer needs to be able to parse research risks from risks of daily life or even routine procedures, evaluate the probability of the risk, including mitigation strategies, and consider the magnitude of the risks. In this session, speakers will explore a methodical approach to risk evaluation through case studies to help participants master the key steps to evaluating risks and documenting their risk assessments. Participants will practice applying this knowledge to a series of illustrative case studies based on real research protocols.

Learning Objectives:

  • Define risk as it relates to human subjects research, including risk to individual participants as well as community and social risks
  • Learn how to distinguish the magnitude of the risk from the probability of the risk, and understand how risk mitigation strategies may impact probability but not magnitude of risks
  • Consider how to distinguish relative risks versus standard risk when applying the "minimal risk" definition