Consensus Statement | Ethics

Developing an Ethics and Policy Framework for Psychedelic Clinical Care:

A Consensus Statement
Amy L. McGuire, JD, PhD; I. Glenn Cohen, JD; Dominic Sisti, PhD; Matthew Baggott, PhD; Yuria Celidwen, PhD; Neşe Devenot, PhD; Sabrina Gracias, CFA;
Charles Grob, MD; Ifetayo Harvey, BA; Brent Kious, MD, PhD; Mason Marks, MD, JD; Michael Mithoefer, MD; Elizabeth Nielson, PhD; Dost Öngür, MD, PhD;
Alexandra Pallas, BA; Andrew Peterson, PhD; Eduardo E. Schenberg, PhD; Paul Summergrad, MD; Brett Waters, JD; Monnica T. Williams, PhD; David B. Yaden, PhD

Abstract Key Points

Question What does ethical integration
IMPORTANCE As government agencies around the globe contemplate approval of the first
of psychedelic medicines look like?
psychedelic medicines, many questions remain about their ethical integration into mainstream
medical practice. Findings This consensus statement
reports 20 points of consensus on
OBJECTIVE To identify key ethics and policy issues related to the eventual integration of managing 5 ethical issues related to the
psychedelic therapies into clinical practice. upcoming integration of psychedelic
medicines into clinical practice and
EVIDENCE REVIEW From June 9 to 12, 2023, 27 individuals representing the perspectives of identifies areas for further research and
clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, deliberation.
training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor
Meaning As psychedelic medicines
Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic
near government approval, it is essential
medicine. Responses were categorized into 6 broad topics: research ethics issues; managing
to plan ahead for their ethical use.
expectations and informed consent; therapeutic ethics; training, education, and licensure of
practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant
expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., + Supplemental content
D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and Author affiliations and article information are
disagreement, which were discussed and revised as a group. listed at the end of this article.

FINDINGS This consensus statement reports 20 points of consensus across 5 ethical issues
(reparations and reciprocity, equity, and respect; informed consent; professional boundaries and
physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will
be responsible for implementation. Areas for further research and deliberation are also identified.

CONCLUSIONS AND RELEVANCE This consensus statement focuses on the future of government-
approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting
and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.

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Introduction
Psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) have recently been approved by
Australia’s Therapeutic Goods Administration and appear to be on the cusp of gaining Food and Drug
Administration (FDA) approval in the US for treatment of depression and posttraumatic stress
disorder (PTSD), respectively. Health Canada and European Union approvals will likely also come in
short order. This follows a long history of Indigenous peoples’ use of sacred medicines, and 20th
century experimentation in the Global North with what came to be known as psychedelic medicines,
which was ultimately ended by the racialized War on Drugs. Government approval represents a shift

Open Access. This is an open access article distributed under the terms of the CC-BY License.

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from what was primarily underground, illegal use based on popular knowledge, to the integration of
a parallel system of regulated use based on scientific evidence and clinical indication. Are health care
systems ethically prepared for mainstream clinical use of psychedelic medicines, including classic
psychedelics and MDMA?

Methods
In June 2023, a multidisciplinary and diverse group of individuals representing the perspectives of clini-
cians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training pro-
grams, and bioethicists convened for a 2.5-day workshop to identify and discuss key ethics and policy
issues related to the eventual integration of psychedelic therapies into clinical practice. We focused on
bioethics and regulatory issues in the US, which may be generalizable globally. Meeting attendees were
selected by the organizers (A.L.M., I.G.C., D.S.) for their expertise and with the goal of broad representa-
tion of interests and perspectives. In preparation for the meeting, attendees were asked to submit ethics
and policy issues for psychedelic medicine. The meeting organizers categorized responses into 6 broad
topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training,
education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. At-
tendees with relevant expertise presented on each of the topics at the meeting, followed by group dis-
cussion. At the end of each day, the meeting organizers facilitated a discussion to agree on key ethics and
policy issues raised. At the conclusion of day 2, meeting organizers drafted a summary of key issues
raised and recommendations made, as well as points of disagreement and future research needs. The
summary was reviewed, discussed, and refined by meeting attendees on day 3. Further refinements
were made by email following the meeting. Here we report consensus recommendations from the group
on 5 issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries
and physical touch; personal experience; and gatekeeping) and identify areas for further research and
deliberation (Table). The quality of evidence related to each of these issues was not addressed.

Results
Reparations and Reciprocity, Equity, and Respect
Western clinical use of psychedelic medicines builds upon historical use among Indigenous
communities with vastly different systems and values. Western medicine is grounded in
Enlightenment concepts of scientific realism, individual autonomy, and rationality and prioritizes
evidence-based practice. By contrast, many Indigenous healing and scientific traditions are grounded
in relationality, a system based on “physical, emotional, cognitive, and spiritual qualities that make
Indigenous systems interdependent, participatory, and ecologically based.”1
The dissonance between these ideologies and how that unfolds in the developing field of
psychedelic medicine is not merely an intellectual or philosophical matter. It is our belief that it is
deeply connected to political and economic conflict and colonization, as well as the profound
experiences reliably induced by classic psychedelic medicines. Therefore, it has practical implications
for the ethical administration of psychedelic medicines within Western health care systems. Many of
the traditional frameworks of bioethics and drug policy are inadequate to meet the moment. It is our
view that what is needed instead is a framework centered on reparations and reciprocity, equity,
and respect.
A commitment to open science is consistent with these principles, recognizing that much of our
current understanding of psychedelic medicines is ultimately rooted in Indigenous traditions and
culture, which have been passed down for generations and form the basis of a knowledge commons
that demands cooperative stewardship and collaboration.2 Given how much we still have to learn,
data sharing is also desirable for psychedelic substances developed in the 20th century, such as
lysergic acid diethylamide (LSD) and MDMA.

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Policymakers must also ensure that Western medical practices and health policies do not
interfere with or attempt to dictate Indigenous or spiritual uses.3-5 As the use of psychedelic
medicines scales up in Western culture, our practices and policies should be governed by norms of
respect for non-Western forms of knowledge, recognizing Indigenous Peoples’ sovereignty and
authority, and respecting Indigenous rights.1,6,7 For example, journal editors should require
appropriate acknowledgment of Indigenous sources of knowledge, training programs ought to
create opportunities to include Indigenous expertise and worldviews into training programs, and key
beneficiaries should commit to effective and appropriate forms of reciprocity with Indigenous
communities.1 The question of setting ethically reasonable limits on intellectual property claims and
benefit sharing remains hotly debated and requires further deliberation.8
Equity-based obligations extend beyond Indigenous populations to other marginalized groups.
For example, Black people have been substantially and disproportionately harmed by the War on
Drugs and may be reluctant to use psychedelic medicines.9-11 These disparities can only begin to be
addressed if efforts are made to ensure robust representation of historically marginalized
populations in training programs and as research participants and patients, as well as in governance
and policy making.

Table. Summary of Consensus Recommendations With Relevant Actors

Reparations and reciprocity, equity, and respect
Western medical practices and health policies should not interfere with Policymakers
Indigenous or spiritual and religious uses
Historically marginalized populations should be represented in policymaking at Policymakers
all levels
The expertise and worldviews of Indigenous and other historically marginalized Researchers, training programs
populations should be included in training and certification programs
Indigenous sources of knowledge should be appropriately acknowledged in Journal editors
publications
Diversity and inclusion should be central in research and clinical use Researchers, clinicians
Data sharing should be encouraged and promoted Sponsors, researchers
Informed consent
Patients should be informed about the range of experiences they may have, Researchers, clinicians
including the possibility of no response
Clinical trials should be conducted to understand the impact of informed consent Researchers, sponsors
on therapeutic outcomes
Professional boundaries and touch
Patients should be informed that safety touch will be employed as necessary and Researchers, clinicians
should participate in shared decision making about the use of supportive touch
A patient should always be able to refuse supportive touch during a session, Researchers, clinicians
regardless of capacity at the time of refusal
Psychedelic therapy sessions should be videorecorded if mutually agreed upon Researchers, clinicians
Facilitators should be carefully vetted by professional oversight groups Professional societies, training
programs
Clinical trials should be conducted to understand the role of supportive touch Researchers, sponsors
Personal experience
Personal experience with psychedelic medicines should not be required for Training programs, professional
training, certification, or licensure societies, state licensing boards
Clinical trials should be conducted to explore the impact of personal experience Researchers, sponsors
on the therapeutic relationship
Gatekeeping
Core competencies should be established for training and certification Professional societies, training
programs
Psychedelic medicines should be covered by public and private insurance Payers
(including Medicaid and Medicare in the US) in parity with other drugs used in
treating mental illness
Clinical trials should be conducted to better understand how therapy and/or Researchers, sponsors
psychosocial support contribute to clinical outcomes
Gatekeeping specific to the US
DEA should consider rescheduling psychedelic drugs with accepted medical use DEA
FDA-approved psychedelic medicines should be prescribed by licensed health State licensing boards Abbreviations: DEA, US Drug Enforcement Agency;
care providers
FDA, US Food and Drug Administration.

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Informed Consent
Psychedelic substances are considered sacred medicines by many Indigenous communities. In
Western culture, they have been described as “transformative” by radically changing a patient’s point
of view or core preferences,12 or “self-transcendent” by dissolving a patient’s sense of self and
providing access to increased feelings of unity.13 At the very least, they provide an experience that is
potentially quite different from anything patients have experienced before.
This presents a tension during the informed consent process. Physicians should discuss the
possibility that the patient will experience personality changes14 and could have a transformative or
self-transcendent experience and its clinical implications, while also addressing the potential risks,
including long-term distress,15 worsening psychiatric symptoms,16 and cardiovascular effects,17
especially for patients with a personal or family history of psychosis or taking contraindicated
medications, and the potential disappointment a patient might experience if they do not respond as
expected. It is widely accepted that set (the mindset and expectations of those taking psychedelic
medicines) and setting (the physical and cultural context in which the medicines are taken) play a
clinically meaningful role in determining the content and outcomes of a psychedelic experience.18
However, the informed consent process itself may prime patients for the experience, influencing
their mindset and the therapeutic milieu.
This should be studied through well-designed clinical trials that vary how information is framed
during the informed consent process to understand if there are differences in how patients respond.
In the meantime, practitioners should discuss a range of experiences patients may have using general
terms, including the possibility of no-response. Informational videos, virtual reality simulations, and
educational materials developed by experienced experts may prove especially helpful in the early
days of clinical adoption.

Professional Boundaries and Physical Touch

We envision psychedelic treatment as an ensemble that combines government-approved medicine
with supportive psychotherapeutic care. We do not, however, advocate for any particular care
model, as there is currently insufficient evidence to support any specific modality.
Regardless of approach, boundary violations are a risk when patients are in an altered state. In
the context of psychoanalysis and many other contemporary talk-based therapies, physical touch is
generally considered a boundary violation.19 In psychedelic therapy, as in some other somatically
oriented therapies (eg, somatic experiencing, sensorimotor psychotherapy) reassuring or
therapeutic touch, including providing resistance to facilitate release,20 is often used and considered
necessary by some. It is also not uncommon in many Indigenous practices for healers to use physical
touch as part of their modality. The risk of boundary violations through physical touch is a
foreseeable risk, and there have been high-profile abuses in North American psychedelic research,21
bringing urgency to the issue.
In developing policies and ethics guidelines, it is important to distinguish different types of
touch. Touching to ensure safety (eg, to monitor vital signs or prevent falls) is always appropriate;
sexual touch is never appropriate. The real question is whether supportive touch is appropriate and
in what circumstances. At a minimum, as part of the informed consent process, practitioners should
inform their patients that safety touch will be used as necessary, and patients should participate in
shared decision making about the use of supportive touch. A patient who agrees to supportive touch
should always have the right to refuse supportive touch during the session, regardless of their
capacity at the time of refusal. More controversial is what a practitioner should do if a patient refuses
supportive touch during the consent process but changes their mind during the psychedelic session.
One approach would be to ask the patient during the informed consent process what they want the
practitioner to do if they change their mind mid-session. The more conservative approach would be
to honor the patient’s original refusal to promote safety. The use of supportive touch can then be
revisited during postexperience integration, and if more than 1 session is planned, the patient can
always change their consent for future sessions.

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More research is needed to better understand the role of supportive touch; in the meantime, it
should only be used by practitioners with specialized training, and strategies to mitigate the risk of
abuse should be adopted. For example, all facilitators should be carefully vetted to ensure safety.
Video recording and/or having more than 1 facilitator monitor the patient may help discourage
inappropriate behavior. This article focuses on the use of physical touch with competent adults;
additional considerations are necessary when psychedelic medicine involves minors and other at-risk
populations.

Personal Experience
There is debate about whether psychedelic practitioners must have personal experience with
psychedelic medicines to effectively guide patients,22 or whether having such experiences biases
practitioners in a way that impedes the therapeutic process.23,24 Indigenous healers may have
extensive personal experience with the medicine, and all therapists who participated in the
Multidisciplinary Association for Psychedelic Studies (MAPS) phase 2 trials, and most of the
therapists who participated in phase 3 trials were offered personal experience with MDMA-assisted
therapy through a separate research trial. The same is not true of psilocybin trials25 (though personal
use was reported by some therapists in at least 1 psilocybin clinical trial26), and it is unknown how
likely it is to be true in clinical settings.
For some practitioners, there are medical contraindications or personal reasons not to use
psychedelic medicines. Furthermore, under the current regime, the use of psychedelic medicines
outside a clinical trial setting could expose clinicians to professional injury, including sanctions or
termination from employment, and legal risk. Moreover, even though some psychotherapy training
programs include a training therapy experience, the norms of Western medicine do not typically
require physicians to have personal experiences with therapy to be an effective clinician.
Future research should explore the effect of personal experience on the therapeutic
relationship and treatment process, study whether there is something unique about psychedelic
medicine that confers benefit on practitioners having their own personal experience, and examine
potential conflicts of interest or bias that might arise when practitioners with personal experience
advocate for or prescribe psychedelic drugs. In the meantime, psychedelic training programs should
not require that practitioners undergo psychedelic therapy as a condition of training, and personal
experience should not be required for certification or licensure.27 Determining whether training
programs should offer or advocate for psychedelic experiences for trainees requires further
investigation.

Gatekeeping
As we prepare for the clinical use of psychedelic medicines, there are countervailing interests
between ensuring usage is monitored, safe, and well-regulated on the one hand, and providing broad
and equitable access to patients on the other. Several gatekeepers stand in the currents of this
dialectic, and understanding their roles is crucial.

Regulatory Agencies
As regulatory agencies, including the US FDA, contemplate approval of the first psychedelic drugs,
they must determine how such products will be labeled to promote safe and effective use. Most
psychedelic clinical trials have been conducted with some form of psychological intervention. In the
US, the FDA could include a drug label that endorses this approach. For example, the label for
buprenorphine sublingual tablets,28 which is used to treat opioid use disorder, specifies that it
“should be used as part of a complete treatment plan to include counseling and psychosocial
support.” The FDA may also consider requiring a Risk Evaluation and Mitigation Strategy (REMS) that
requires some form of psychological intervention. At the same time, the FDA is limited in its ability
to specify conditions of use that may veer into regulating the practice of medicine, which is typically
a matter for state law.29

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Better understanding of whether and how therapy and/or psychosocial support contribute to
clinical outcomes will be important, not just for drug product labeling and to guide appropriate risk
mitigation strategies, but to inform how these drugs are administered (on and off label) and by
whom. In some countries with stringent criminalization of psychedelic medicines, more may be
needed. For example, in the US, a more general review by the US Drug Enforcement Agency (DEA) of
the scheduling of psychedelic drugs will also be important to facilitate future research and ensure
equitable access.30

Licensure and Certification

When it comes to the therapeutic use of psychedelic medicines, it is important to distinguish the
prescribing of psychedelic medicines from the provision of psychedelic-assisted psychotherapy or
support. In the US, dating back to the late 1800s, states have established state licensing boards to
determine who qualifies for a medical license,31 which is typically required to prescribe drugs.32 The
US DEA also relies on state licensing boards to determine whether a practitioner is qualified to
dispense, prescribe, or administer controlled substances and which substances.33
What is more contentious is what, if any, licensure should be required to provide therapy or
psychosocial support during a psychedelic medicine administration session. Licensure adds a level of
professional accountability, with the potential for professional disciplinary action and duties such as
confidentiality. However, it may also decrease access, because the more licensure is required, the
more costly the treatment will be and the fewer eligible clinicians there will be to deliver treatment.
Specialized training and certification might also be required by payers or hospital credentialing
committees as a prerequisite for providing psychedelic medicines, at least in certain cases. Training
can be expensive (on the order of US $5000 to $10 000), such that if not required, there may not be
sufficient incentive for adoption.
To our knowledge, there is not currently enough evidence on the efficacy of different training
programs to guide policymakers. As more programs are established, it will be important for existing
professional groups and emerging professional societies to identify relevant required core
competencies, including professional ethics (eg, professional boundaries, confidentiality, and
informed consent), understanding psychedelic medicines’ roots in Indigenous traditions and
practices, and structural approaches to stigma and health inequities.34
Our focus has been on clinical use of psychedelic medicines; there has at times been confusion
between such models and supported adult use models. Oregon’s facilitator regime, for example, is
explicitly a supported adult use model, not one involving prescribing by licensed physicians.35 In
jurisdictions where both models coexist, it will be important to ensure that potential clients are not
confused by this distinction and that those providing help in a supported adult use framework do not
mistakenly make medical claims. Further confusion is likely to emerge in states such as Colorado,
which contemplate licensed health care practitioners working within their traditional scope of
practice while facilitating natural medicine sessions.

Payers
Government approval, licensure, and certification all may play a role in ensuring that clinical use of
psychedelic medicines is safe and efficacious, but the work of each of these gatekeepers also
increases the cost of administering psychedelic medicines. There is a risk that those who may be
most in need of these medicines simply cannot afford them unless payers, public and private, are
willing to cover these products and services. While results from clinical trials, including adverse
events, will be important for creating the evidence base for payers, postmarketing research,
including clinical evidence regarding use of approved psychedelic medicines will be important to
inform reimbursement rates, especially in countries such as the US without national health insurance.
A positive sign of potential insurance coverage of psychedelic medicines in the US is the American
Medical Association’s announcement of a new Current Procedural Terminology (CPT) code for
“Psychedelic Drug Monitoring Services” effective January 1, 2024.36 A key next step will be the

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calculation and assignment of an appropriate level of relative value units to this therapy, an essential
element to how reimbursement is handled by public and private payers.37

Discussion
This consensus statement reports recommendations from a multidisciplinary group of individuals in
academia, government, and industry on 5 topics relevant to the integration of psychedelic therapies
into mainstream clinical practice. Clinician education and training will be necessary to ensure safe and
effective use, and new policies will need to be implemented to minimize inequities in access. The
approved medical use of psychedelic medicines in the US and globally will present new variations on
perennial ethical issues, such as how to obtain informed consent for a potentially transformative
experience, the appropriate role of supportive touch during a therapeutic session, and whether
clinician experience with psychedelic drugs is necessary, or even appropriate for patient care.
Approved medical use will also be accompanied by novel ethical and policy challenges. In the
US, states continue to experiment with different models for regulation and legalization. A challenge
in the postapproval period will be how medical use for clinical indications interacts with recreational
or supervised use models in states where they are pursued. If the medical care system becomes too
restrictive, it may divert patients with serious clinical conditions toward these nonmedical settings.38
Even within medical systems, we are likely to see innovation in terms of delivery (including
telemedicine), as well as potential off-label uses that will raise new challenges.

Conclusions
This is a hopeful moment, as psychedelic medicines offer potential new options for the treatment of
mental illnesses. It is critical that clinicians and policy makers take seriously the challenges ahead,
while not losing sight of the rich cultural histories and traditions from which contemporary medical
uses of psychedelic medicines have emerged.

ARTICLE INFORMATION
Accepted for Publication: March 20, 2024.
Published: June 4, 2024. doi:10.1001/jamanetworkopen.2024.14650
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2024 McGuire AL
et al. JAMA Network Open.
Corresponding Author: Amy L. McGuire, JD, PhD, Center for Medical Ethics and Health Policy, Baylor College of
Medicine, One Baylor Plaza, Ste 310D, Houston TX 77030 ([email protected]).
Author Affiliations: Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas
(McGuire); Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School, Cambridge,
Massachusetts (Cohen); Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia
(Sisti); Tactogen Inc, Palo Alto, California (Baggott); Othering and Belonging Institute, Department of Psychology,
University of California Berkeley (Celidwen); Johns Hopkins University, Baltimore, Maryland (Devenot); Ortus
Foundation, Jackson, Wyoming (Gracias); Harbor-UCLA Medical Center, Torrance, California (Grob); People of
Color Psychedelic Collective, New York, New York (Harvey); Department of Psychiatry, University of Utah Health,
Salt Lake City (Kious); Florida State University College of Law, Tallahassee (Marks); Multidisciplinary Association for
Psychedelic Studies (MAPS) Public Benefit Corporation, New York, New York (Mithoefer); Fluence Training, New
York, New York (Nielson); McLean Hospital, Harvard Medical School, Boston, Massachusetts (Öngür); Beckley
Retreats, Frederick, Maryland (Pallas); Department of Philosophy, George Mason University, Fairfax, Virginia
(Peterson); Instituto Phaneros, Brazil (Schenberg); Departments of Psychiatry and Medicine, Tufts University
School of Medicine, Boston, Massachusetts (Summergrad); Reason for Hope, New York, New York (Waters);
School of Psychology & Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario,
Canada (Williams); Center for Psychedelic and Consciousness Research, Johns Hopkins University School of
Medicine, Baltimore, Maryland (Yaden).

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Author Contributions: Dr McGuire had full access to all of the data in the study and takes responsibility for the
integrity of the data and the accuracy of the data analysis.
Concept and design: McGuire, Cohen, Sisti, Baggott, Celidwen, Devenot, Gracias, Grob, Kious, Marks, Mithoefer,
Nielson, Ongur, Pallas, Peterson, Schenberg, Summergrad, Waters, Williams, Yaden.
Acquisition, analysis, or interpretation of data: Baggott, Celidwen, Harvey, Mithoefer, Nielson, Waters.
Drafting of the manuscript: McGuire, Cohen, Sisti, Celidwen, Gracias, Kious, Marks, Schenberg, Williams, Yaden.
Critical review of the manuscript for important intellectual content: Cohen, Sisti, Baggott, Celidwen, Devenot, Grob,
Harvey, Kious, Marks, Mithoefer, Nielson, Ongur, Pallas, Peterson, Schenberg, Summergrad, Waters, Williams,
Yaden.
Obtained funding: McGuire, Marks.
Administrative, technical, or material support: Sisti, Devenot, Ongur, Pallas, Summergrad, Waters.
Supervision: McGuire, Sisti.
Conflict of Interest Disclosures: Dr McGuire reported receiving personal fees from Lykos Therapeutics (advisor)
outside the submitted work. Dr Cohen reported grants from Saisei Foundation and grants from Gracias Family
Psychedelics Research Initiative and Bootcamp in Ethics Regulation Fund at Harvard Law School during the
conduct of the study; and is a member of the ethics advisory board for Illumina and the Bayer Bioethics Council; he
was also compensated for speaking at events organized by Philips with the Washington Post, attending the
Transformational Therapeutics Leadership Forum organized by Galen Atlantica, and retained as an expert in health
privacy, gender-affirming care, and reproductive technology lawsuits. Dr Sisti reported being an unpaid member
of the Tactogen community engagement board during the conduct of the study; and personal fees from Lykos
Therapeutics outside the submitted work. Dr Baggot reported being cofounder of and holding equity in Tactogen
Inc, a company developing psychedelic derivatives as medicines outside the submitted work; in addition, Dr
Baggot has patents pending (US20230257347, US20230183199, US20230159487) and issued (US20230150963)
Tactogen Inc; and is an advisor to both the Noetic Fund, which has invested in psychedelic companies, and to
Journey Clinical, a provider of ketamine treatments. Dr Devenot personal fees from The ELIPSIS Program at Baylor
College of Medicine during the conduct of the study; personal fees from The Center for Psychedelic Drug Research
and Education at The Ohio State University outside the submitted work; and Dr Devenot is an unpaid board
member of Psymposia, a 501(c3) nonprofit research organization. Ms Gracias reported being founder of the Ortus
Foundation, which funds psychedelic research and provided a grant to Baylor College of Medicine to underwrite
the gathering that produced this manuscript during the conduct of the study. Dr Harvey reported grants from
Open Society Foundations Fellow during the conduct of the study. Dr Kious reported personal fees from Seelos
Therapeutics outside the submitted work. Dr Marks reported personal fees from the Project on Psychedelics Law
and Regulation at the Petrie-Flom Center at Harvard Law School, which is itself funded by the Saisei Foundation, a
nonprofit organization, during the conduct of the study; personal fees from Wired and other publications for
psychedelics-related journalism, which were nominal and outside the submitted work; and served as a volunteer
member of the Oregon Psilocybin Advisory Board. Dr Mithoefer reported personal fees from MAPS Public Benefit
Corp Payments as contractor outside the submitted work. Dr Nielson reported being co-founder of Fluence
International Inc outside the submitted work; and has stock and/or stock options in Beckley Psytech, Good Cap,
and Tactogen. Dr Öngur reported personal fees from Neumora Inc, personal fees from Guggenheim LLC, and
personal fees from Boehringer Ingelheim outside the submitted work. Dr Pallas reported being cofounder and
senior vice president of programs of Beckley Retreats, a psychedelic retreats provider. Dr Schenberg reported
personal fees from Instituto Phaneros as director of a Brazilian nonprofit offering psychedelic therapy research
trainings; and personal fees from Ocama Partners as advisor to investment fund Ocama Partners between July
2021 and June 2023 outside the submitted work. Dr Summergrad reported personal fees from Compass Pathways
Ltd Scientific Advisory Board; personal investments from Sensorium Therapeutics, Karuna Therapeutics, Mental
Health Data Services, Quartet Health, and Eli Lilly; and is a board member with Health and Productivity Services
and received travel fees as an invited speaker for Massachusetts Association for Psychedelic Services outside the
submitted work; and Dr Summergrad is the secretary for finances of the World Psychiatric Association, which
covers travel fees for board/executive committee meetings and international conferences. Mr Waters reported
being cofounder and executive director of Reason for Hope and cofounder of the Veteran Mental Health
Leadership Coalition, whose work has been funded by grants or donations from the Steven & Alexandra Cohen
Foundation, the Joe and Sandy Samberg Foundation, the Jurvetson Foundation, Flourish Trust, The Austin &
Gabriela Hearst Foundation, Michael Cotton, The Cammack Family Gift Fund, Galaxy Gives, and Educational
Foundation of America. No other disclosures were reported.
Funding/Support: This manuscript was produced following a workshop held at the Banbury Center, Cold Spring
Harbor Laboratory. Travel and meeting expenses were provided by the Ortus Foundation and The Banbury Center,
Cold Spring Harbor Laboratory.

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 JAMA Network Open | Ethics Developing an Ethics and Policy Framework for Psychedelic Clinical Care

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection,
management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and
decision to submit the manuscript for publication.
Disclaimer: The views expressed in this article are the authors’ own, and do not necessarily reflect those of their
affiliate institutions.
Data Sharing Statement: See the Supplement.
Additional Contributions: The authors wish to sincerely thank Rebecca Leshan, PhD, and the Banbury Center at
Cold Spring Harbor Laboratory for their combined financial and coordination support and Jonathan Sabbagh, PhD,
National Institute of Mental Health, Mike Davis, MD, PhD, Usona Institute, Tura Patterson, MA, Usona Institute, Joy
Sun Cooper, MBA, Lykos Therapeutics, and Steven Levine, MD, Compass Pathways, for their participation and
contributions at the meeting. As with all participants in the meeting that led to this manuscript, their travel to the
meeting was paid for by a grant that the Ortus Foundation provided to Baylor College of Medicine and by the
Banbury Center at Cold Spring Harbor Laboratory. They were not otherwise compensated for their contributions
to this work.

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SUPPLEMENT.
Data Sharing Statement

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