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2023 SBER Conference

HRPP/IRB Administration/Management and Process

SBER

Populations Requiring Additional Protections

Flexibility and Innovation in Research Oversight Processes

B01 - [IN-PERSON/RECORDED] What Is Greater than Minimal Risk When Studying Populations Engaged in Risk‐Taking Behaviors?

Sunday, December 3, 2023
11:30 AM – 12:30 PM ET
Location: Room 154 AB
Live Session Recorded Human Subjects Research Deep Dive Series CIP Accredited
This session will be offered in-person and recorded for on-demand access by in-person SBER23 registrants, and PRIMR23/SBER23 Virtual Meeting registrants.

A primary responsibility of the IRB is to assess whether research poses a risk to participants that would expose them to greater harm than those ordinarily encountered in daily life. Often, this is measured against the daily life of a "reasonable person." However, how can an IRB make this assessment when the daily lives of the study population is in some way already inherently risky?

Learning Objectives:

  • Identify ways to differentiate the risks/vulnerabilities introduced by the research from the risk/vulnerabilities that exists regardless of the research, and learn how can IRBs avoid overestimating the risks to participants
  • Evaluate how the threshold for what is considered minimal risk can shift based on what population(s) the research may include
  • Consider ways to potentially minimize and mitigate risks unique to these populations, and assess the implications for non-minimal risk determination in research with minors