Psychedelics are making a bold comeback and are poised to revolutionize modern medicine as we currently know it. With MDMA-assisted psychotherapy receiving the coveted “Breakthrough Therapy” designation by the U.S. Food & Drug Administration, the world is on the verge of constructing a new paradigm by which trauma-based disorders and mental illness are treated. While these powerful tools do indeed hold immense promise, establishing a sound ethical framework for their use is just as important. This review will highlight some of the major factors that require consideration in the ethical development and deployment of psychedelic medicine in the treatment of debilitating mental health disorders.

Ensuring Patient Safety Is Critical in the Emerging Field of Psychedelic Medicine

Psychedelic research has been the target of significant controversy for many years. Their integration into the modern medical establishment raises various ethical challenges. The most notable of these concerns revolve around protecting the safety of vulnerable patients, especially considering the fact that these drugs are being deployed to treat serious mental illness. The construction of healthy participant trials to address these debilitating mental health issues must adequately address patient safety. It is important for practitioners and policymakers to be aware of the inherent vulnerability of the types of patients seeking these therapies. Patients suffering from severe depression, PTSD, and even end-of-life distress due to terminal cancer are just some of the affected patients that psychedelic medicine stands to benefit. Clearly, the importance of safety cannot be overstated, given the inherent vulnerability associated with the patient population being treated. Equally important is the need to establish guidelines for adequately obtaining informed consent in the practice of psychedelic assisted psychotherapy.

Adequately Obtaining Informed Consent Is Another Ethical Imperative

Ensuring that patients can genuinely provide informed consent for treatment is a hallmark of medical ethics and research. It is particularly important as it relates to psychedelic medicine due to the incredibly profound changes that generally accompany a psychedelic experience. While it is indeed these profound effects that give psychedelics their extraordinary promise, they also pose some unique ethical challenges—especially with respect to obtaining patient consent. This is heavily contrasted from current pharmaceutical therapies that generally don’t radically alter one’s personal identity or reformat their foundational beliefs. Researchers and clinicians must be extra mindful of this fact and approach customizing treatment protocols to best facilitate the transformational change taking place for the patient during therapy. As per a notable MAPS bulletin, establishing such an ethical framework “requires a sophisticated kind of ethical wisdom and virtue that is beyond simple rule-following or maintaining compliance with federal regulations.”1 Looking to the currently established principles of ethical research can help the medical establishment adopt appropriate guidelines for psychedelic medicine research and utilization in clinical practice.

The Belmont Report Establishes 3 Major Principles of Ethical Research

First published in 1979, the Belmont Report lays out three guiding principles of ethical research: Respect for Persons, Beneficence, and Justice.2 These historic guidelines have powerfully impacted the evolving landscape that is clinical research, and should be utilized in the construction of ethical regulations for the psychedelic medicine space. This landmark report characterizes various issues surrounding medical ethics, including the boundaries between biomedical and behavioral research, the risk-benefit criteria when choosing subjects, and the nature of informed consent.2 Ultimately, the goals of this document can be encapsulated by forming ethical principles on the basis of compassion and what is therapeutically best for the patient. The greater movement to establish an ethical framework in which psychedelic therapy can be utilized must carefully investigate current ethical guidelines for drug research and clinical practice to see how they can be adopted and expanded to fit the impending new treatment paradigm offered by psychedelic drugs.

The Need for Radical Transparency in Psychedelic Medicine Research

The field of science and medicine is both expanded and held accountable by the practice of radical transparency. This is achieved by researchers publishing their protocols, drug sourcing information, outcomes, ancillary data and finances in every study so there are no conflicts of interest that could bias the results.3 With clinical trials being the “most publicly visible component of the biomedical research enterprise,” ensuring this sense of radical transparency is fundamental for the safe and ethical use of these compounds. It is up to the pioneers in science, medicine and policy to work collaboratively to establish guidelines to ensure that this takes place in the emerging field of psychedelic medicine.

Unique Ethical Concerns Related to Psychedelic Assisted Psychotherapy

The incredible therapeutic potential that is promised with psychedelic compounds comes with some unique ethical challenges when compared to traditional pharmaceutical drugs. As mentioned above, obtaining informed consent from someone who has never before taken a psychedelic drug can be challenging. The experience is generally accompanied with such profound changes and shifts in consciousness that it is difficult to truly wrap one’s head around it until they have experienced it and are able to integrate the experience. To provide just one specific example currently being discussed in the industry, the concern of patients falling in love with their therapist is a genuine one with respect to MDMA-assisted psychotherapy. The profound feelings of love and compassion induced by MDMA, while the goal of such therapy, can certainly lead to such concerns—and they must be adequately addressed.  Ultimately, it is the same therapeutic power that gives psychedelic medicine its immense promise, and that also further highlights the significant need for establishing compassionate ethical standards for optimal patient safety and wellness.

A Look Ahead to the Future of Ethical Psychedelic-Assisted Psychotherapy

The issues discussed in this review require that the promise of psychedelic medicine be reasonably tempered by a necessary discussion surrounding ethics. The construction of a sound ethical framework that accounts for patient safety, adequately obtaining informed consent, the allowance for radical transparency, justice, and fairness are all pivotal parts to building this new treatment paradigm.

Works Cited 

1. Creating an Ethical Framework for Psychedelic Therapy Research: MAPS

2. Department of Health, Education, and Welfare & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. J. Am. Coll. Dent. 81, 4–13 (2014).

3. Hudson, K. L., Lauer, M. S. & Collins, F. S. Toward a New Era of Trust and Transparency in Clinical Trials. Jama 316, 1353–1354 (2016).