Kate Gallin Published in The New England Journal of Medicine: A Framework for Including Involuntarily Hospitalized Patients in Clinical Research

For academic medical centers, hospitals, universities, and research sponsors, enrolling involuntarily hospitalized psychiatric patients in clinical research raises hard questions about consent and fairness. A new framework offers a consistent path forward.

In an article published by The New England Journal of Medicine, Kate Gallin, Member of the Firm and Board of Directors at Epstein Becker Green and counsel to academic medical centers and research institutions on human subjects protection, co-authored the piece with two psychiatrists. The article argues that these patients should not be excluded from research by default, but should be included only when institutions verify that they can make the decision and that their participation is voluntary.

The article treats decision-making capacity and voluntariness as separate tests. A patient may lack capacity for a treatment decision yet still be able to make a specific research decision at a specific time. Voluntariness is a different question altogether, because an involuntarily hospitalized patient may agree to enroll simply to improve relations with staff. The authors recommend that institutions assess both before enrollment and repeat those assessments throughout participation, using assessors independent of the research and clinical teams.

Safeguards should scale with risk. Minimal-risk studies require independent voluntariness assessments, while greater-than-minimal-risk studies add independent capacity evaluations, participant advocates or consent monitors, and reassessment at major study milestones. The framework also cautions against enrolling this population for recruitment convenience and recommends deferring consent discussions until hospitalization ends when timing allows.

For institutional review boards (IRBs) and research teams, the takeaway is that blanket bans and blanket permissions both fall short. The authors recommend case-by-case review, asking questions such as whether a study can wait until discharge and whether the research could be conducted in a different population. Patients must be told that enrolling or declining will not change their legal status or the length of their stay.

Get in Touch

To discuss how your institution’s IRB policies and consent processes should handle research involving involuntarily hospitalized patients, contact Kate Gallin at kheffernan@ebglaw.com.