Essentials of Informed Consent to Psychedelic Medicine.

Importance: Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system. Observations: Despite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings. Conclusions and Relevance: Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.

Financial conflicts of interest and the ethical obligations of medical school faculty and the profession.

Despite their potential benefits, relationships linking medical school faculty and the pharmaceutical and device industries may also challenge the professional value of primacy of patient welfare, a point highlighted in a recent Institute of Medicine report. Academic medical centers and professors have the added professional obligation to ensure the unbiased, evidence-based education of future doctors. This essay argues that faculty financial conflicts of interest may threaten this obligation by propagating the bias introduced by these relationships to students. This could occur directly through the process of curriculum determination and delivery, and also indirectly through the "hidden curriculum," which deserves particular attention, as its lessons may conflict with those professed in the formal curriculum. The essay concludes with guiding principles to consider when developing a conflict of interest policy at academic medical centers.

Legal concerns in psychosomatic medicine.

In the practice of psychosomatic medicine, the psychiatric consultant is likely to be confronted with questions at the interface of psychiatry and law. These issues generally emerge around questions of confidentiality and exceptions to confidentiality, assessments of a patient's ability to consent to and refuse treatment, and concerns about malpractice liability. Overall, psychiatrists should approach the care of patients clinically, while understanding the applicable laws and regulations of the jurisdictions in which they practice. In addition, clinicians should be aware of the legal and risk management resources available to them should a complex situation arise. Finally, the psychiatric consultant should make use of consultation when complex issues emerge at the interface of psychiatry and law.

Psychotic symptoms in the elderly.

Lessons Learned at the Interface of Medicine and PsychiatryThe Psychiatric Consultation Service at Massachusetts General Hospital (MGH) sees medical and surgical inpatients with comorbid psychiatric symptoms and conditions. Such consultations require the integration of medical and psychiatric knowledge. During rounds, Dr. Stern and the chief resident discuss the diagnosis and management of conditions confronted. These discussions have given rise to rounds reports that will prove useful for clinicians practicing at the interface of medicine and psychiatry.