Protecting the Vulnerable and Including the Under-Represented: IRB Practices and Attitudes

Area of Science:

• Medical Ethics
• Clinical Research Governance
• Health Equity

Background:

• Institutional Review Boards (IRBs) were established to safeguard vulnerable participants in research.
• Contemporary ethical considerations prompt examination of IRBs' role in promoting study sample representativeness and inclusion of under-represented groups.
• Potential conflicts exist between protecting vulnerable populations and ensuring inclusion, due to overlapping characteristics.

Purpose of the Study:

• To explore Institutional Review Board (IRB) Chairs' perspectives on protecting vulnerable populations in research.
• To assess IRB Chairs' views on the role of IRBs in ensuring representative study samples and including historically under-represented groups.
• To understand current IRB attitudes and practices regarding these dual ethical responsibilities.

Main Methods:

• A pilot, online national survey was administered to Institutional Review Board (IRB) Chairs.
• The survey collected data on IRB Chairs' perceptions of vulnerability and their roles in participant inclusion.
• Data analysis focused on identifying trends in attitudes and practices related to protecting vulnerable and including under-represented groups.

Main Results:

• IRB Chairs perceive vulnerability broadly, applying the concept to diverse groups depending on research context.
• A majority of IRB Chairs expressed confidence in their ability to protect vulnerable individuals in research settings.
• IRB Chairs largely believe that IRBs have a significant role in promoting representative samples and the inclusion of under-represented groups in research.

Conclusions:

• IRBs acknowledge and embrace a broader role beyond protecting the vulnerable, extending to ensuring research inclusivity.
• The findings suggest a growing awareness among IRB Chairs of the importance of representative sampling for research equity.
• Further research is warranted to explore practical strategies for balancing protection and inclusion in research ethics review.