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.

Returning Individual Research Results from Digital Phenotyping in Psychiatry.

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants' locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant's real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas.

State-Regulated Psychedelics on a Collision Course With FDA.

This Viewpoint examines how US states are reforming legislation to allow access to psychedelics for therapeutic use, but federal laws consider these agents to be Schedule I drugs, and the discordance between state and federal law may create confusion and conflict.

AI Chatbots, Health Privacy, and Challenges to HIPAA Compliance.

This Viewpoint examines the privacy concerns raised by medical uses of large language models, such as chatbots.

AI-Generated Medical Advice-GPT and Beyond.

This Viewpoint describes medical applications of generative pretrained transformers (GPTs) and related artificial intelligence (AI) technologies and considers whether new forms of regulation are necessary to minimize safety and legal risks to patients and clinicians.

The varieties of psychedelic law.

After decades of prohibition, psychedelics are generating intense public and private interest. Scientists are researching the therapeutic properties of these substances, and mounting evidence supports their ability to treat a variety of mental health conditions. Meanwhile, dozens of cities and states are proposing or enacting psychedelics legislation to promote research, increase therapeutic and non-therapeutic access, and decrease criminal penalties associated with producing, possessing, or consuming psychedelics. This article is the first to produce a typology of state and local psychedelic laws, which fall into five general categories: decriminalization, supported adult use, medical use, clinical research, and policy analysis. The article defines each category and explains how some jurisdictions create hybrid psychedelic laws that blend elements of multiple categories. Following enactment, government agencies can shift laws from one category to another during the rulemaking process. This article is part of the Special Issue on "National Institutes of Health Psilocybin Research Speaker Series".

Governing AI-Driven Health Research: Are IRBs Up to the Task?

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be adapted in order to provide an effective mechanism of oversight for health-related AI research.