To Be Human is to Be Vulnerable: Protecting Vulnerability in Human Subjects Research

Abstract: To be human is to be vulnerable. Originally, vulnerability was associated with individuals with certain biologic traits, but recent shifts broadened the definition to rely on a spectrum of biologic reality, socioeconomic status, and contextual circumstance. Its purpose is to protect certain populations in research, requiring a consistent application of ethical principles; yet, its use becomes challenging as perceptions evolve: how do we balance the inclusion of diverse populations in research while also acknowledging the structural biases at play? Our panel seeks to explore the framework that defines a vulnerable research population and seeks to better understand Institutional Review Boards (IRBs) as the appropriate oversight entities. IRBs play a significant role in implementing inclusion aims; however, there is a lack of empirical data on how IRB professionals understand vulnerability and the factors that influence their decision-making, especially given the evolving scholarship. This detail is a crucial piece in the proverbial protection puzzle that determines whether vulnerable persons can be protected consistently. Our panel will feature findings of our recent study on IRB professionals’ perceptions of vulnerability and its implications for research oversight. We will also explore ethical values prioritized during the review and discuss potential differences between the regulation-focused approach that IRB professionals appear to take in their oversight work and their own understandings of vulnerability within the research context.