Abstract

The development of ethical guidelines and regulations regarding human subjects research has focused upon protection of vulnerable populations by relying on a limited typology of vulnerabilities. This results in several challenges: First, Institutional Review Boards struggle to interpret and apply the regulations because they are often vague and inconsistent. Second, applying the regulations to subjects who fit within multiple categories of vulnerability can lead to contradictions and the rejection of research that would be permissible if only one category were applicable. Finally, some potential subjects have social and other context-based vulnerabilities that are not described in the federal regulations...