Oregon is a pioneer state that prides itself on public health innovation. Continuing this tradition, in 2020 Oregonians approved Measure 109 to create the nation’s first framework for psilocybin services.
Innovation is challenging. As Oregon grappled with the best ways to implement this new program, stakeholders have raised concerns about the most fair, safe, and sensible approaches to implementation. A key concern is how to balance citizen safety with citizen privacy.
An OPEN Call for Data Stewardship, Not Data Ownership
I wear two separate hats in this frontier: one as a member of the Governor’s Psilocybin Advisory Board (this article does not represent the opinions of that board), and another as a clinician researcher at Oregon Health & Science University. In the latter role, I’m a part of a new research collaboration called the Oregon Psilocybin Evaluation Nexus. OPEN is an interdisciplinary, community-wide, non-commercial research effort housed at OHSU that aims to help measure the effects of the Oregon Psilocybin Services Act.
Our goals are to build stakeholder consensus around core markers of best practices, securely collect voluntary information on client experiences, and to advance public understanding of the Oregon psilocybin experience, free of financial conflicts of interest.
Our OPEN research group has repeatedly affirmed the importance of ethical data collection and public transparency about Oregon’s psilocybin services. We support data stewardship, not data ownership. After two years of thoughtful input from the Advisory Board, the Oregon Health Authority finalized its administrative rules for psilocybin services on December 27, 2022. Among its many provisions, OHA adopted board recommendations that permit, but do not require, data collection in order for clients to receive services. This rule aligns with OPEN’s vision, which can be found in publicly recorded testimony and presentations.
In short, we support data collection, provided that it is done in a way that protects privacy, allows people to voluntarily consent to providing information, and that the data is used for public benefit. Again, we support data stewardship, not data ownership.
In my role at Oregon’s only academic medical center, I am sometimes asked to provide feedback on draft legislation in my area of expertise. I have found that legislation, much like science, is an iterative process. Proposal’s first drafts appropriately evolve in response to community stakeholder input long before bills are put to a vote. That’s how democracy works to develop sound policy. I have not yet discussed the first draft version of SB 303, an Oregon Senate bill that addresses data collection, with any elected officials, but I look forward to offering input as the process moves forward.
Missing Data Are Missing Stories
I do not believe that the solution to very real privacy concerns is to block all data collection. Collecting client information to assess the effects of public policy is essential. When done well, data collection provides an early detection system, so that policies may be improved. It is also the only way to assess whether services are being delivered equitably. For service centers, anonymous, aggregate information can also provide feedback to facilitators to improve or expand access to services.
The absence of rigorous policy evaluation, as the administrative rules for Measure 109 currently stand, puts the psilocybin program in jeopardy. At some point, a client will experience a serious negative outcome, since even supervised psilocybin use carries some risk. With information about outcomes at our disposal, we can understand the bad outcomes in relation to the good. But without being able to compare the number of bad outcomes with the number of good outcomes, there is a genuine possibility that the danger of the program will be sensationalized out of proportion and context.
Lack of data also invites unintended safety consequences. For example, cannabis legalization in Oregon, as in most states, did not include a plan for data collection. This has led to gradual escalation in THC concentrations, and reports of increased adverse events in emergency departments. Without data, we have no way of knowing if these are outliers, a consequence of other secular trends, or due to other unknown reasons.
So why not require data collection for everyone? After all, most states mandate confidential, named-based reporting of new HIV diagnoses and other reportable diseases to aid in contact tracing and inform resource allocation. In the case of psilocybin services, however, facilitators and clients engage with a substance that remains federally illegal. Therefore, the consequences of breach of privacy are greater, potentially including incarceration.
In the long run, we should continue to advocate for the Breakthrough Therapies Act that will reclassify psilocybin and other psychedelics at the federal level. This would decrease or even eliminate these legal risks. In the meantime, we need to adopt a higher level of consent and data security that protects both psilocybin services clients and facilitators.
A Two Level System of Voluntary Consent
The OPEN project has actively engaged with expert psychedelic stakeholders for months, asking them to identify best practices for informed consent and to develop consensus about the most important client information required to assess best practices in community settings. This work is an essential first step toward developing safe and relevant data collection.
While plans evolve in response to community involvement, I envision a network of service centers that contribute information with two levels of voluntary consent:
First, we propose that the most critical client information, as prioritized in direct feedback from expert psilocybin service providers, might be collected by default unless the client declines (“opt-out” consent). For example, anonymous information about safety and equity (e.g. client demographics, psilocybin dose, adverse outcomes, etc.) would be collected as part of the consent for services already approved in administrative rules, which state that a client may decline to contribute their information. Maximizing voluntary participation through “opt-out” consent limits missing data so we can achieve data equity. Missing data are missing people.
Second, for less critical information, clients could be offered a chance to “opt-in” through a standard research consent form process. This could include longer research assessments such as the Mystical Experiences Questionnaire and other research measures. Clients volunteering to participate in in-depth information gathering would be reimbursed for their participation as part of a research study. Anonymous client characteristics of this smaller group could be compared with those of the larger “opt-out” group to assess how well research participants represent the broader population of people receiving services.
Even with two-tiered voluntary consent as outlined above, we still need to carefully consider how to protect client information. Until psychedelics are FDA-approved for use within the healthcare system, HIPAA will not protect information collected in the course of psilocybin services. Data collection systems must be developed to protect facilitators and their clients.
The OPEN project proposes to securely collect information that safeguards privacy, while also supporting safe and equitable psilocybin experiences. We propose an independent system (i.e. without healthcare system or government oversight) for collecting information on psilocybin experiences. Such a system would not need to rely on identified data, in contrast to electronic health record or administrative data.
Our work is guided by our core principles of privacy, transparency, and equity. Our custom-designed, user-friendly information collection system will adhere to state-of the art data security standards (encryption during transfer and at rest), research ethics oversight (the Federal Common Rule), and inability of the government or other parties to access the data (a Federal Certificate of Confidentiality). Facilitators and clients could directly enter their own responses into a user-facing interface. De-identified information could be collated behind, for example, and securely accessed only by academic research analysts, with Institutional Review Board/Ethics Committee oversight. We are confident that the proposed OPEN approach can protect facilitators and their clients.
Data as a Public Good, for the Public Good
OPEN believes that Oregon’s psilocybin services data should be used to protect public health, improve the quality of the services themselves, and ensure health equity. Similar to a natural resource such as clean water, psilocybin data is not an asset to be mined and leveraged. There should be no single entity that “owns” the data, but rather a well-defined and encrypted collective stewardship of the data for the public’s benefit.
It will take time and a great deal of community participation to build secure information collection systems that protect facilitator and client confidentiality and privacy. This first-in-the-nation work exists on a broad plane where there is room and need for all voices. Working together, the Oregon psilocybin experience can inform best practices for consent, data security, and services in community-based settings.
[This editorial represents the author’s personal opinions. He does not speak for the Oregon Psilocybin Advisory Board or OHSU.]