Abstract

Despite existing federal and state law and regulation, new human subjects research scandals involving “vulnerable” populations continue to surface. Although existing oversight mechanisms were enacted to ensure voluntary informed consent for participants and institutional review board oversight of HSR, these laws and regulations do not provide any special oversight mechanisms or protections to ensure the ethical and safe inclusion of cognitively impaired adults. The absence of rules to ensure consistently ethical conduct of research involving adults who lack consent capacity may either lead to exploitation of this vulnerable population or the dearth of important research into the broad range of diseases that impair cognition. In other words, while some institutions and investigators are conducting research with this group without guidance, others are taking an extremely conservative approach and are excluding these individuals from research. Without safeguards that are adequate and robust but not overly burdensome, conducting research involving this population is ethically and legally challenging.