This charter was drafted by Ray Allen and Leslie Booher and approved by the MAPS PBC board of directors on Wed., Jan. 26, 2022. This charter was last updated 1/19/22.
Preamble
MAPS Public Benefit Corporation (“MAPS PBC”), as an organizer of clinical trials to investigate psychedelic-assisted therapies and train providers of such therapies, and its parent the Multidisciplinary Association for Psychedelic Studies, Inc. (“MAPS”) are committed to helping create, disseminate, and foster a safe and healthy environment for psychedelic assisted therapy to occur with an emphasis on legal and regulatory compliance, ethical conduct, and accountability. To facilitate the fulfillment of these commitments, MAPS has recommended and MAPS PBC authorizes the formation of an internal Ethics Review Board ( the “ERB”) to inform the continual iteration and improvement of ethical requirements governing those conducting research or offering care utilizing MAPS protocols and/or drug product as well as the teachings and practices disseminated as part of the MAPS Therapy Training program based on reports of real-world circumstances. This charter is drafted to set forth the purpose, membership, authority, and duties of the ERB and the members thereof.
Statement of Purpose
The initial role of the ERB is to oversee and iteratively improve the MAPS Psychedelic Assisted Psychotherapy Code of Ethics (the “Code of Ethics”) and its implementation, including, as appropriate, making recommendations for how the Code may be amended or supplemented from time to time, investigating and/or analyzing the investigation of concerns related to conduct subject to the Code, promulgating guidance on the interpretation or implementation of the Code, and making recommendations for corrective action and/or mitigation, as necessary. The ERB 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.
Committee Membership
The ERB shall consist of at least three members, none of which are employees or board members of MAPS or MAPS PBC, and who have relevant experience in reviewing psychotherapy ethics. The MAPS PBC Board (the “Board”) may nominate candidates for consideration, vet nominees with the assistance of the MAPS PBC Compliance Officer, and appoint members of the ERB for one-year, renewable terms. Members may be selected from ethics professors, leaders in the American Academy of Psychotherapists, the American Counseling Association, state licensure boards for psychotherapist, etc. The Board will strive for a diverse composition of committee members, including gender and racial diversity. At least one member shall be an advocate for survivors with lived experience of abuse or misconduct in a psychotherapeutic context. The Board will appoint one member as the ERB Chair. The Board may fill vacancies on the ERB. Removal of an ERB member for cause must be done by a majority vote of the Board followed by a subsequent majority vote of the MAPS board of directors.
Authority
The ERB has oversight over the following matters:
- Reviewing and recommending updates to the Psychedelic Assisted Psychotherapy Code of Ethics and any supplementary or guidance documents related thereto;
- Reviewing and recommending updates to the forthcoming MDMA-Assisted Therapy Participant Bill of Rights;
- Reviewing and making recommendations on the context or details of aspects of MAPS study protocols covering participant safety from ethical transgressions, including standards and procedures for review of audio/visual records and informed consent forms;
- Investigate Psychedelic Assisted Psychotherapy Code of Ethics violations (including allegations of sexual misconduct by therapists)—to the extent that the ERB is the appropriate or authorized body to do so under any relevant and governing rules, regulations, or laws, as determined by the MAPS legal department;
- Reviewing reports of ethical concerns outside the direct scope of research—subject to the Code of Ethics for applicable concepts or circumstances to be taken into consideration in the conduct of numbers 1–4, as the ERB deems relevant with pre-review input from the MAPS legal department.
Duties
The ERB will meet with such frequency and at such intervals as it determines are necessary to fulfill its duties and responsibilities, and in any case not less than four times per year. A majority of the ERB shall constitute a quorum for the purpose of conducting business. To the extent it is relevant, the ERB shall comply with HIPAA and any other relevant terms of confidentiality, as recommended by the MAPS PBC Compliance Officer, in the conduct of its activities. For ERB actions or recommendations on matters over which it has authority, if the ERB has only three members, then ERB actions will require unanimous vote, otherwise ERB actions will require a vote of a majority of the ERB members. The ERB will give timely notification to the MAPS PBC Compliance Committee (the “Committee”) of ERB-approved actions or recommendations, and the MAPS PBC Board shall have final adoption and implementation authority. The MAPS PBC Compliance Officer will oversee the ERB, to the extent necessary, in its day-to-day activities. The ERB will report its activities to the Board regularly and at least on a quarterly basis. At least semiannually, the ERB will also report its activities to the MAPS Board of Directors. The ERB will review its charter at least annually and recommend any proposed changes to the Board for review.
