FOR IMMEDIATE RELEASE
- Independent members will inform continual iteration and improvement of ethical governance of MDMA-assisted therapy research and therapist training program
- Independent Ethical Review Board engages outside experts to provide additional layer of review, guiding MAPS and MAPS PBC’s commitment to exceptional ethical practice in MDMA-assisted therapy and fostering a culture of safety for all who receive psychedelic-assisted therapies
- Outside advisors with established expertise in therapy ethics, alongside an advocate for survivors of abuse in a therapeutic context, will review and recommend improvements on MAPS and MAPS PBC’s ongoing development of ethical policies and practices
The Board of Directors of the Multidisciplinary Association for Psychedelic Studies (MAPS) recommended, and the Board of Directors of its wholly-owned subsidiary MAPS Public Benefit Corporation (MAPS PBC) adopted, a charter to form an Independent Ethics Review Board (IERB). Comprised of independent members, the IERB will include experts in ethics and psychotherapy and, in accordance with best practices, an advocate for survivors with lived experience of abuse or misconduct in a psychotherapeutic context.
As a nonprofit organization and a public benefit corporation, MAPS and MAPS PBC embrace a shared responsibility to earn and maintain the public trust. Our demonstrated commitment to transparency, integrity, and ethical practices will be strengthened through the formal input provided by the subject matter experts elected to the Independent Ethical Review Board.
Amy Emerson, CEO, MAPS PBC
MAPS, which has sponsored the clinical trials of MDMA-assisted therapy for PTSD, established MAPS PBC in 2014. MAPS PBC has overseen, organized, and published the results of nine clinical trials of MDMA-assisted therapy; established the MDMA Therapy Training Program; and developed the first Code of Ethics specific to psychedelic-assisted therapy. MAPS PBC is currently administering ten clinical trials of MDMA-assisted therapy and an Expanded Access Program allowing 50 patients to receive MDMA-assisted therapy for PTSD while FDA-regulated Phase 3 trials are completed.
The establishment of the IERB is an important next step in MAPS and MAPS PBC’s commitment to ensuring the best quality therapies are grounded in the best protection of patients and potentially vulnerable parties involved in the administration of MDMA-assisted therapy. The application of an independent lens through the IERB to potential ethical issues that may arise during treatment will strengthen MAPS and MPBC’s ability to proactively and preemptively address prevention with the guidance of independent and expert advisement.
Dawn McCollough, Chair of the Board of Directors, MAPS PBC
It appears that psychedelics are a powerful tool in therapeutic contexts, in part, because they allow patients to experience a greater sense of emotional openness, and that is why we must continue our efforts to develop a high ethical standard alongside a high standard of patient care and scientific integrity. Implementing independent review of our work is one key aspect to realizing the universal vision held by MAPS and MAPS PBC staff and board directors developing a best-in-class ethical framework for trauma-focused and psychedelic therapies.
Victoria Hale, Ph.D., Chair of the Board of Directors, MAPS
In the coming months, the MAPS PBC Compliance Officer, in consultation with the MAPS PBC Compliance Committee, will develop a nomination and evaluation process for prospective members of the IERB. The Board of Directors of MAPS PBC, with a majority of independent directors, will be responsible for nominating qualified individuals who are neither members of staff nor board directors, and will vote to elect at least three members for one year, renewable terms.
The initial purview of the IERB will be to review, iteratively improve, and guide implementation of the MAPS Psychedelic Assisted Psychotherapy Code of Ethics and its implementation. The IERB may review and make recommendations for supplements to or aspects of the practical guidance on the Code of Ethics such as the MDMA Therapy Training Program, the MAPS MDMA-Assisted Therapy Manual, trial protocols, and the forthcoming MDMA-Assisted Therapy Participant Bill of Rights. Additionally, the IERB will investigate or provide analysis of investigations of reports of violations of conduct governed by or implicated in the Code of Ethics and the forthcoming Patient Bill of Rights.
The IERB is not intended to, nor shall it in effect, replace or supersede the authority of any relevant regulatory body or any Institutional Review Board’s (“IRB”) oversight governing the conduct of research or the offering of care utilizing MAPS protocols and/or drug product.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. It is the parent company of MAPS EU, formed to organize and administer clinical trials of MDMA-assisted therapy for PTSD in the United Kingdom and European Union.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since MAPS was founded, philanthropic donors and grantors have given more than $130 million for psychedelic and marijuana research and education. MAPS has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.
Betty Aldworth, Director of Communications