The Psychedelic Safety Institute (PSI) is committed to making psychedelic use safer and more beneficial for those who choose to engage with these substances. We work to align the psychedelic ecosystem and those stakeholders adjacent to the psychedelic ecosystem through shared understanding, coordination, thoughtful action, and education.

Our deck explains more about PSI’s work and mission.

While misconduct and ethical violations are found across all therapeutic environments, psychedelic experiences may present greater risk and susceptibility to these types of violations. Similar to other therapeutic environments, one type of harm people experience in psychedelic spaces stems from misconduct and ethical violations. To address this, PSI has been investigating what infrastructure and systems might help prevent and address such violations.

The Psychedelic Safety Institute (PSI), through its partner entity Now Conscious Inc., was contracted by the Center for Consciousness Medicine Inc., operating as Gather Well Psychedelics (“Gather Well”) in January 2024, and PSI concluded this work on September 27, 2024. This contract between PSI and Gather Well aimed to integrate the ethics reports and the foundational elements of an ethics infrastructure developed by professional bioethicists into an operationalized ethics framework tailored explicitly for Gather Well. The framework was informed by input and reviews from 14 stakeholders, including professional bioethicists. Gather Well has recruited its inaugural ethics committee, with an anticipated launch in Q4 2024.

Gather Well is a non-profit psychedelic training organization that shares a history with practitioners accused of ethical violations. While those practitioners ceased their involvement in Gather Well’s previous iteration, CCM, by October 2021, have no direct influence on the operations or programs of Gather Well, and were not consulted in the development of the ethics framework, it is important to explicitly state this context and invite those interested to read more to review Gather Well’s statement here and Tehseen Noorani and Neşe Devenot’s concerns about Gather Well’s engagement of bioethicists here.

Here are some further resources discussing the practitioners accused of ethical violations for those interested: the New York Magazine’s podcast on the ethical violations here, Inverse’s article on the ethical violations here, and Will Hall’s direct account here.

The current Gather Well leadership expressed a desire to metabolize their experiences being in proximity to these ethical concerns into something that would help prevent and transparently respond to potential future ethical violations and hold themselves accountable to their stated ethical principles. This included establishing sound and transparent ethical practices and effective accountability systems for their organization, practicing guides, trainees, employees, and other stakeholders. Prior to engaging PSI, Gather Well had initiated internal discussions about developing an ethical framework based on the bioethicists' reports. PSI reviewed these reports from professional bioethicists who did an analysis to identify ethical barriers and risks with the Gather Well approach and its organizational policies and plans and recommended a high-level blueprint for an ethics infrastructure overseen by an independent ethics committee. 

It’s important to note that one member of Gather Well leadership is related to the accused practitioners. The framework considered and is designed to address this and other types of conflicts of interest that can arise in organizations. 

PSI decided to undertake this project with Gather Well because it provided a valuable real-world case study. Working with an organization with an intimate view of ethical challenges helped us understand how ethical frameworks need to operate in practice to be effective and identify key questions, challenges, and opportunities that emerge during implementation. 

Now that our contract is concluded, Gather Well is independently responsible for implementing this framework with the oversight of the Ethics Committee they have established. We wish them well in this process. 

The framework includes robust informed consent procedures, a practitioner and stakeholder code of conduct, an ethics committee and independent oversight body, guidelines on inter-practitioner relationships and conflicts of interest, accountability procedures, and mandatory transparent reporting to the public. It is designed to provide clear expectations and agreements surrounding conduct and behavioral standards which are visible to all stakeholders, transparent systems for receiving and processing any potential future ethical claims in a way that prevents distortion or manipulation, and a governance structure with checks and balances to limit conflicts of interest and increase the quality of reporting and transparency. 

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The framework we have developed includes:

• Clear codes of conduct
• Agreements and forms 
• Oversight structures
• Reporting mechanisms
• Protocols for investigating reported concerns and implementing corrective actions
• Mandatory public reporting by the ethics committee, board, and IOB 
• Transparency guidelines
• Checks and balances
• Operational tools and best practice guidelines 

For more information on how this framework is applied at Gather Well, please refer to their announcement here.

1. Code of Ethics: This document outlines the ethical standards and principles that members of the organization should adhere to. It covers vision, mission, values, ethical principles, and guidelines for ethical practice. Its purpose is to guide the behavior and decision-making of all members within the organization.
2. Ethics Committee Charter: This document provides a detailed blueprint for establishing, functioning, and governance of an Ethics Committee. It outlines the committee's structure, roles, responsibilities, operational procedures, and financial oversight, ensuring a robust framework for ethical governance within the organization.
3. Code of Conduct for Stakeholders: This document requires a signature and details the standards of behavior expected from all members of the organization community, including Ethics Committee members, board members, employees, and representatives.
4. Code of Conduct for Guides: This document explicitly addresses the ethical responsibilities of guides working with psychedelics in legal settings. It includes detailed policies for maintaining professionalism, respecting clients, handling confidentiality, and avoiding conflicts of interest.
5. Grievance and Transformative Justice Policy and Protocol: This document outlines grievance reporting channels, investigation protocols, and procedures for addressing conflicts and harms within the organization’s community within an optional protocol. 
6. Independent Oversight Body: This document describes the structure and function of an Independent Oversight Body (IOB) to ensure the Ethics Committee's independence, effectiveness, and accountability. 
7. Ethics Committee Member Agreement: This agreement specifies the terms under which individuals agree to serve on the organization's Ethics Committee. 
8. Conflict of Interest Disclosure Form: This form is used by Ethics Committee members to disclose any actual, potential, or perceived conflicts of interest between themselves and Gather Well or others that might influence their judgment or objectivity. 
9. Ethical Principles into Organizational Practice Matrix: A tool for planning the organization’s integration of its ethical principles into its activities and programs.
10. Certification Requirements and Supervision Requirements: A description of the requirements for a guide to become certified by Gather Well, as well as for supervision, continuing education, and other requirements for maintaining certification via renewal.
11. Public Database of Graduates: A regularly updated database of all Gather Well certified guides that will include information about a guide's practice, jurisdictions in which they function and related licensure, current certification status, and ethical standing. 
12. Ethics Committee Recruitment Strategy: This document outlines the recruitment strategy for the organization's Ethics Committee, detailing objectives, member roles and responsibilities, qualifications, selection criteria, and the recruitment process.
13. Ethics Committee Inaugural Meeting Agenda: This agenda details the structure and topics for the organization's Ethics Committee's first meeting. ‍
14. Ethics Committee Budget: This document outlines the financial assumptions and estimates for the organization's Ethics Committee.

PSI aims to integrate learnings and implementation insights from this case study into broader field-level insights, questions, and gaps. We are engaging with ethics thought leaders, bioethicists, and individuals with extensive experience in ethical mediation within the psychedelic field, along with those who have experienced ethical misconduct and stakeholders raising concerns about emerging training organizations.

Through this structured, iterative process, we aim to:

• Identify key issues and questions that need addressing as the ecosystem works to improve its ethical standards
• Surface real-world implementation insights that can serve to strengthen ethical infrastructure across different organizational contexts

We believe theoretical frameworks must be informed by and tested through real-world implementation. By using this work as a case study, we hope to contribute meaningful insights that serve the ecosystem where needed most. We look forward to collaborating with ecosystem stakeholders to advance ethical practices across the field.

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PSI's core values include transparency and accountability. We welcome the community to ask us questions, share thoughts, and provide feedback on how we may collectively improve these tools and elevate the ethical infrastructure of the psychedelic ecosystem. Please contact us at hello@psychedelicsafety.institute. For future updates on PSI’s work in ethics and safety, subscribe to PSI’s newsletter using the form below.

For questions about Gather Well or their implementation of this framework, including their ethics committee selection process, please see their blog post here and contact them directly through their website. A core function of the ethics committee is to be an independent body that can uphold the ethical standards and accountability of Gather Well and its leadership, including receiving and responding to concerns from the public and their stakeholders. 

If you have ethical concerns about Gather Well, you can use their anonymous reporting form, linked here. Submissions go directly to the independent Ethics Committee for review via an email inbox that only the Ethics Committee has access to. If the ethics report presents an HR or legal compliance issue, the Ethics Committee will notify the Gather Well board and appropriate leadership members and provide the relevant information.

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