Kate Gallin Heffernan, Member of the Firm, will participate in the panel discussion, “Ethical, Legal, and Regulatory Challenges of Conducting Research on Involuntarily Admitted Patients,” at the 2020 Advancing Ethical Research Conference, hosted by Public Responsibility in Medicine and Research (PRIM&R).
Patients are involuntarily admitted to psychiatric hospitals for a variety of conditions, including acute suicidality, severe psychosis, and inability to care for themselves, among others. Such patients are unable to leave the hospital on their own accord and are a particularly vulnerable population on the basis of their legal status. In some jurisdictions, even patients admitted voluntarily to psychiatric hospitals have restrictions placed on their ability to leave the unit immediately and experience some degree of this same vulnerability. Research on particular psychiatric conditions benefits from the inclusion of these subjects (e.g., looking to prevent suicidality or to understand the neurobiology of fulminant psychosis). Federal research regulations do not provide specific protections required for research in this population. Institutions have handled research in this population differently, with some outright banning it altogether, and others permitting it with additional safeguards for subjects in place (e.g., limited to minimal risk research or with special considerations for assurance of the consent process).
This panel will discuss the ethical, legal, and regulatory challenges of conducting research on involuntarily admitted patients. The panel will aim to provide a framework and pragmatic advice for IRBs to review studies of this nature, including specific safeguards that can be put in place to conduct this research most effectively and safely.