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Research into “classic” tryptamine psychedelics [e.g., psilocybin, lysergic acid diethylamide (LSD), and dimethyltryptamine (DMT)] is proliferating at a rapid rate. Database searches reveal more than a doubling in the number of peer-reviewed publications relating to psychedelics in the last decade (1). Among this surge is a growing number of clinical and non-clinical trials exploring the action of psychedelics in human subjects (2, 3). Around the globe, research centers choosing to focus on psychedelics shape the manner and direction in which we choose to approach this frontier. Historically, academic research has been carried out with little to no involvement of those outside the core research team, with patients and members of the public seen as a sources of data on which to build and test hypotheses (4). This is changing, rising ethical standards are placing more weight on addressing the inherent power imbalance between researchers as “knowledge creators,” and those who stand to benefit from that knowledge (5).

Within the context of scientific enquiry, patient, and public involvement (PPI) is defined as research performed “with” or “by” patients and members of the public, rather than “to,” “about”, or “for” them (6). Involving patients and public in research is becoming more commonplace, and has risen from a “desirable” to “essential” criteria for many research funding bodies, such as UK Research & Innovation (UKRI), an assembly of six organizations with a combined budget of over £8 billion (7). Furthermore, updated legislation now makes it a duty for healthcare providers to involve patients in the commissioning and decision making process in several governing organizations including the UK's National Institute for Health Research (NIHR) (8), the United Nations Children's Fund (UNICEF) (9), and several Canadian regional health boards (10). Such a collective reprioritization signifies a new gold standard for conducting research, particularly in clinical populations where those with lived experience offer a pragmatic, real world perspective on the development of interventions. Neglecting to recognize the reality of how data will be used downstream can lead to impractical “blue sky” research which ultimately fails to get adopted (11).

Besides a moral and ethical imperative for involving patients and the public in research, a growing evidence base indicates how PPI can strengthen research by improving priority setting (12), recruitment and retention (13, 14), diversity among participants (15, 16), and impact and dissemination of findings (17, 18). Other purported benefits of PPI can be difficult to capture, leaving them open to criticism, for example, a public contributor could gain more agency, or a researcher may improve their ability to explain concepts in plain language (19, 20).

There is limited evidence of PPI taking place in psychedelic studies to date. None of the 16 contemporary clinical trials on classic psychedelics describe PPI activities in their methods or give acknowledgment to public contributors (21–36). While this may not entirely rule out public involvement in these studies, it highlights how reporting is non-essential for the majority of publishers. Notably, a number of these psychedelic studies have come under criticism for a lack of diversity among participants (37, 38), a concern not exclusive to psychedelic research which continues in spite of efforts such as the NIH Revitalization Act (39) and the NIHR INCLUDE project (40, 41). PPI may offer one way to balance inequalities; a study using the psychoactive drug 3,4-Methylenedioxymethamphetamine (MDMA) described PPI methods as a means of improving the relevance of recruitment materials to underrepresented groups (42, 43). Additionally, psychedelic research organizations such as The Chacruna Institute embed PPI principles into their mission statement with the purpose of recognizing the contributions of the traditional healers who have long used naturally occurring psychedelic compounds (44). These are only some examples of the possible benefits of PPI to psychedelic research that remain to be explored.

In spite the growing internal and external incentives for PPI in research, delivery remains a challenge. As a supplementary activity for many, established researchers lack awareness around benefits and methods of PPI (5, 45). Doctoral students often cite restraints on resources or time leading to “tokenistic” or abbreviated attempts at PPI that fail to be recorded in the literature (17). Barriers to PPI in research may result in issues such as stagnant participation rates for people of color, or the overall decline in community engagement over the course of the COVID-19 pandemic (46).

Various tools have been developed to help support PPI in research; a 2019 systematic review identified and classified 64 frameworks (47), these were rarely adopted outside the research groups that developed them, showing how a one-size-fits all approach to PPI guidance may not work. While a number of existing frameworks may be used to help inform PPI in psychedelic research (8, 48–50), none of these account for the unique position which this field of research finds itself, namely: a highly complex socio-political landscape; rapidly changing drug policy; a wealth of knowledge stemming from a long tradition of psychedelic use pre-dating modern research; an underrepresentation of women, Black, Asian, and ethnically diverse populations; the social stigma associated with recreational use; and the 20-year hiatus in psychedelic research. All of these factors are not only important considerations for researchers conducting studies, but also for those taking part, particularly considering the potential for long-term impact on a participant's life (51). In response, the aim of this project was to co-develop guidance for planning PPI in psychedelic research which: (1) is sensitive to the unique challenges faced in psychedelic research, (2) draws on the experience of researchers, those with experience participating in psychedelic trials, and those with experience in PPI, (3) is harmonious with UK standards for PPI, and (4) is rated highly on quality measures for PPI guidance.

The Oxford English Dictionary (OED) defines the word guidance as “help or advice about how to do something.” In an attempt to make the guidance generalizable between both clinical and non-clinical psychedelic trials, we do not aim to provide study specific suggestions. Instead, we hope that guidance will be adaptable and broadly applicable to all types of research conducted in the psychedelic space.

A steering group was formed to plan, oversee and review all activities over the course of the production process. Group members comprised of four psychedelic researchers including one clinical academic, a public advisor and a PPI lead. Prior to starting, co-design objectives and methods were circulated, appraised and agreed upon in meetings between group members. Due to existing high quality PPI guidance, it was agreed that a completely original approach would not be necessary or appropriate. For this reason, and to ensure our approach accorded with national standards, we grounded our co-design process in the UK Standards for Public Involvement (8). This is a framework intended for use in public involvement research and is based on six core areas: inclusive opportunities, working together, support and learning, governance, communications, and impact.

Once organized by the steering group, the co-design workshop was attended by a total of 26 people, a breakdown of the groups in attendance is shown in Table 2. Workshop and breakout discussions ran without interruption from technical issues, and were captured on both video recording and in writing.

Concept mapping of the workshop is shown in Figure 2. Discussions exposed the main themes relevant to PPI in psychedelic research, these could be classified by four distinct but interrelating values and principles described below and illustrated in Figure 3. Suggestions for how these principles could be incorporated into the psychedelic research were arranged into the guidance document by steering group members.

Guidance for creating a patient and public involvement strategy in psychedelic research were developed by researchers and patient and public collaborators. Using co-design methods, we identified fundamentals to PPI in psychedelic research and built these into a guidance document to help inform psychedelic research teams and their collaborators. Four key values: purpose, inclusivity, learning, and trust emerged as central to PPI in psychedelic research.

To our knowledge there is no published guidance which seeks to address PPI in the field of psychedelic research. At a fundamental level, our document holds a number of parallels with existing PPI guidance (49, 64) including the UK National Standards for Public Involvement upon which our workshop was based (8). This is likely a reflection of the common premise of PPI, which is grounded in ideals of equity and democracy. Significantly, the majority of content is original and distinct from generalized as it places more emphasis on the fundamental importance of building trusting relationships with public collaborators in research specific to psychedelics. Trust has long been placed at the center of guidance related to psychedelic research (65–69) in which participants are encouraged to “trust, open, and let go” (70). In this context, the responsibility lies with the researcher to be trustworthy, rather than a participant to be trusting (71). We propose that psychedelic research built on open and trusting PPI will result in superior outcomes and experiences for participants. The vocabulary used when developing participant information, outcome measures and interventions for psychedelic research might feel alienating or less socially acceptable to some audiences (72). Seeking the advice of others can help build empathy and help researchers to understand the fears and beliefs of potential participants of psychedelic research. This is particularly important, as researchers often knowingly or unknowingly act in a guiding capacity for participants, and can consequently influence expectancy bias (73).

Our guidelines promote a proactive approach to inclusivity, by prompting researchers to make an active effort to ensure opportunities for engagement are given to a diverse audience. Similarly, “positive action,” a principle relating to employment practices, aims to improve workforce diversity by guiding how candidates are fairly recruited and promoted (60). For many, there is an assumption that with higher ethical standards, contemporary psychedelic research will not follow the same path of discrimination, cultural appropriation (43) and other abuses of power seen in early psychedelic studies (74, 75). However, over 80% of participants in clinical trials are White (38), suggesting that more work has to be done to re-balance this representation. In addition, when conducted in naturalistic settings, psychedelic research risks amounting to cultural appropriation if indigenous communities are not consulted (43). Our guidance recognizes that making psychedelic research accessible requires more than an “open door” recruitment policy. Although unintentional, a passive approach can lead to a perpetuation of the problem of inequality in a field less accessible to minority populations (37) whom are already more inclined to mistrust medical and research institutions (76). A good example of positive actions are described by Williams et al. (42) who use culturally informed research design to help participants from minority backgrounds relate and engage with research into MDMA assisted therapy. Cultural competency is an essential attribute for psychedelic researchers and clinicians (77), we hope the guidance presented here will prompt researchers to take similar purposeful actions, to address gender, socioeconomic, educational and age disparities in psychedelic research (78).

Participating in a psychedelic trial demands great courage, and is often reported as one the most meaningful experiences of a lifetime (51). Creating a space in which contributions can be acknowledged after the completion of participation in the psychedelic study emerged as a priority in the guidance. Our guidance recognizes research as an iterative process (79); for researchers only seeking answers to specific research questions a great opportunity for mutual learning can be lost in failing to engage participants beyond the end of a psychedelic trial. Collaboration with former-participants could feedforward to strengthen future research, especially when knowledge is managed and shared across trials with this specific purpose. Such transparent PPI processes have the potential to counter threats to the legitimacy and potential of the psychedelic renaissance (1).

Psychedelic researchers face a great task in conducting high quality research. Besides the numerous hurdles of procuring heavily regulated drugs, researchers are expected to balance participant welfare with a need to complete trials in a timely and cost-effective manner. As our guidance shows, carrying out good PPI in psychedelics is not straightforward, and as it stands PPI is rarely included as part of undergraduate training for researchers. Subsequently, researchers must seek funding, experience and skills for PPI under their own volition. Greater education and resources for PPI would not only be beneficial to the field of psychedelic research, but medical research more broadly.

There are a number of limitations to our guidelines and the methods used to develop them. At the time of publication, the guidelines were yet to be tested over the course of a whole research cycle, and may need to be adapting accordingly (45). Furthermore, this rapidly evolving field of research makes it difficult to capture the impact of PPI activities. Future studies in this area could seek to evaluate the effects of PPI strategies and the guidance upon which they are based.

One of the appeals of psychedelics shared by researchers and participants alike is the promise of discovery. The quality of present-day psychedelic research means all stakeholders are on the same journey into unknown territory. For many, there is an assumption that with higher ethical standards, contemporary psychedelic research will not follow the same path of discrimination and other abuses of power seen in early psychedelic studies. We hope that the guidelines presented here will assist in greater incorporation of the voices of the wider community in psychedelic research, and that it will continue to develop alongside this exciting field of research. PPI when carried out systematically and thoughtfully, offers a means of creating more valuable psychedelic research through directly addressing the complex power dynamic between research team and the public at large.

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

JC conceptualized the study, acted as lead author and main point of contact for collaborators. JB and MS contributed to the initial design of the study. JB, JC, LL, MP, MS, and SJ oversaw the design, planning and running of the workshop, and contributed to processing the proceedings. JC wrote the first draft. JB, JC, LL, RC-H, MP, MS, and SJ reviewed the manuscript prior to submission. All authors contributed to the article and approved the submitted versions.

Funding for this project was provided by the Imperial College London, Centre for Psychedelic Research.

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.