This presentation is part of the Seminar on Legal and Ethical Issues inPsychiatry sponsored by The Center for Law, Ethics, and Psychiatry, Department of Psychiatry, Columbia University Irving Medical Center.
Unique and complex legal issues surround psychiatric research. Researchactivities straddle a fine line between care and discovery, the individual andsociety. The tensions between those aims when conducting clinical trials havethe potential to provoke malpractice and other litigation. For decades,research malpractice was infrequently litigated, but the incidence of lawsuitsrelating to research activities has increased substantially since the late 20thcentury. We will explore the distinctions between clinical and researchmalpractice liability, the ethical framework that guides research practicestandards, the institutional and legal regulatory oversight structure, and thelearning curve that clinical researchers face.
