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... (shrink)

Mrs. Duong had coronary artery disease, ischemic cardiomyopathy, and mildly altered mental status when her case was presented before an advanced heart therapy medical review board. She was accepted for left ventricular assist device placement pending additional insight into her cognitive state. Before the LVAD could be implanted, however, Mrs. Duong went into cardiogenic shock, and her heart failure team placed an intra‐aortic balloon pump in her subclavian artery. Within two weeks, Mrs. Duong became IABP dependent and deconditioned. The attending (...) deemed her as lacking capacity to make complex medical decisions, and the medical review board officially declined her for LVAD placement. The heart failure and CICU teams feel that Mrs. Duong is not being helped by the care they are giving her. They recommend terminal weaning of the IABP and initiation of comfort care. Her family disagrees, pointing to activities like continued eating and interacting with family. At an impasse after yet another family meeting, the attending for the heart failure team asks the clinical ethics consultant, “Do we have to replace the balloon pump when it fails?”. (shrink)