Participant Safety in Psychedelic Therapy

We encourage you to read and follow for detailed information regarding MAPS Code of Ethics for Psychedelic Psychotherapy and our practices to create a culture of safety in psychedelic therapy. 

You may safely and confidentially direct misconduct reports related to MAPS-sponsored studies, MAPS staff, MAPS PBC staff, or collaborators to MAPS’ Compliance Team via email or by calling (844) 627-7722.

All stakeholders at the Multidisciplinary Association for Psychedelic Studies (MAPS) and MAPS Public Benefit Corporation (MAPS PBC) are committed to providing quality and comprehensive training and supervision to support therapy providers in delivering ethical care within MAPS-sponsored study protocols. We recognize that individuals have been harmed by misconduct in therapy, including psychedelic-assisted therapy, and we embrace our obligation to protect participant safety in MAPS-sponsored studies and the safety of others who are associated with our programs. 

We take seriously our obligation to ethically and thoroughly review allegations of misconduct related to MAPS-sponsored studies, MAPS staff, MAPS PBC staff, and our collaborators. In service of these commitments, we are examining, carefully developing, and implementing policies and practices to prevent, reasonably detect, and thoroughly respond to allegations of misconduct.

We hope that our work encourages others to adopt similar commitments. We invite you to review the carefully-considered practices outlined here and adapt them for your communities. 

Individual Expectations

Practitioners of MDMA-assisted therapy, including licensed therapists and unlicensed members of the therapy and clinical teams, are required to abide by the MDMA-Assisted Therapy Code of Ethics. Among other elements, the Code of Ethics requires the highest standards of practice regarding safety, confidentiality and privacy, transparency, therapeutic alliance and trust, use of touch, sexual boundaries, diversity, and special considerations for non-ordinary states of consciousness. The Code of Ethics explicitly forbids sexual relationships both during the therapeutic relationship and after its termination.

MAPS and MAPS PBC staff are expected to act in alignment with ethical standards of conduct described in the Employee Manual. Staff are required to report allegations or instances of misconduct to their supervisor or a member of the Compliance Team. 

MAPS’ Compliance Team records, reviews, and determines the veracity of all received reports of misconduct by individuals employed by MAPS or MAPS Public Benefit Corporation (MAPS PBC), practitioners conducting therapy in MAPS-sponsored clinical trials, or others or associated with MAPS. The Compliance Team recommends appropriate discipline to MAPS leadership and the Board of Directors, which may include termination of employment or collaborative activities and filing formal reports with any governing bodies the accused is associated with. 

What we’ve done

  • Developed a living Code of Ethics: MAPS’ MDMA Therapy Training Program staff, with contributions from psychedelic therapy practitioners and guidance from professional organizations, began creating the MAPS Therapy Code of Ethics in 2018 and published the original version in 2019. It was revised in 2020. 
  • Established a Compliance Team: Multiple MAPS staff and a member of the Board of Directors are responsible for receiving, reviewing, and making recommendations for all complaints. A hotline and email address were established explicitly for compliant reporting. 
  • Increased discussion of sexual harm in therapist training: Particular attention has been given to provide extensive training on sexual harm and other ethical considerations in the MAPS MDMA Therapy Training Program. 
  • Fully informed participants in MAPS-sponsored trials through additions to the Informed Consent Form of the risks of psychedelic-assisted therapy including, but not limited to, greater participant suggestibility, the particular need for sensitivity regarding consent, and the likelihood of stronger and more complex transference and countertransference.
  • Researched risks through our ongoing clinical trials. Since 2004, these trials have provided evidence regarding the safety and risks of MDMA for evaluation by the FDA. From those findings, we are developing psychological and cardiovascular risk mitigation recommendations. See MDMA Research Resources for more details included in the Investigators Brochure and Development Safety Update Report, updated annually.
  • Adopted policies encouraging disclosure of confirmed misconduct, particularly in MAPS-sponsored trials. 

Opportunities for improvement

We recognize that policies and practices, no matter how thorough, will not entirely prevent abuses of power. In the interest of continual improvement, we have continually identify and develop strategies to address opportunities for improvement including independent oversight, guidance and evaluation for practitioners, and internal policies. Developments will be posted on this page.

  • Developing an Independent Ethical Review Board. Independent Review Boards (IRBs) serve as the ethical review body for clinical trials but do not serve as independent, ethical oversight bodies for organizations or for clinical practice after a drug is approved. Research has been initiated to form an Independent Ethical Review Board for MAPS and MAPS PBC. At a meeting of the Board of Directors on September 17, 2021, MAPS’ Board members and leadership staff set a deadline to convene the Independent Ethical Review Board no later than December 31, 2021. 
  • Publishing summaries of established practices. In some cases, we have an opportunity to improve the availability of information regarding established practices or policies. As of September 2021, we have identified the following areas where we can provide information in a clearer fashion:
    • The two-therapist protocol, which has been an element of providing the highest standard of care since the first Phase 2 trial in 2004. We will seek to more clearly communicate the reasons for this element of the protocol which include, but are not limited to, supporting appropriate boundaries.
    • Nurturing touch in MDMA-assisted therapy, which is described in: