Abstract
Background and aims
Psychedelic-assisted therapy (P-AT) has been shown to reduce post-traumatic stress disorder (PTSD), depression, and anxiety symptoms, and is likely to be approved in the United States (US) in the coming years. However, concerns about participant safety in these early trials have surfaced, including allegations of sexual misconduct. This paper aims to illuminate how potential risks have been communicated to P-AT participants via informed consent documents and to suggest how existing policy might be modified given the unique risks involved in P-AT trials.
Methods
Publicly available informed consent forms (ICFs) were gathered by searching clinicaltrials.gov. Queries were applied to filter trials involving the use of a classical psychedelic (psilocybin, LSD) or psychedelic-adjacent substance (MDMA, ketamine) in tandem with psychotherapeutic intervention and those with a status of “completed,” “recruiting,” or “active.”
Results
Nineteen ICFs met inclusion criteria and were reviewed to determine what risks, benefits, and safety protocols were communicated to participants in their respective trials. The primary finding from this review of ICFs from P-AT trials revealed that studies were in compliance with federal regulation. However, there were missing elements related to the vulnerability experienced while under the effects of psychedelics that warrant inclusion in future ICFs in P-AT trials.
Conclusion
Although the ICFs for P-AT trials examined in this study covered several important areas related to risk, benefits, safety, and accountability as required by federal regulations in the US, future research should consider ways to expand this content in order to assure that consent is truly informed prior to enrolling subjects.
Introduction
Entering the consciousness of mainstream media are narratives espousing psychedelic-assisted therapy (P-AT) treatments as a new hope for mitigating the mental health care crisis (Piore, 2021). Since Michael Pollan's book How to Change Your Mind: What the New Science of Psychedelics Teaches us About Consciousness, Dying, Addiction, Depression and Transcendence was published in 2018, major media outlets have continued making anticipatory claims like Newsweek's “Magic Mushrooms May Be the Biggest Advance in Treating Depression Since Prozac” (Piore, 2021). Less publicized are the ethical and scientific concerns around clinical trials, such as implementing and ensuring blinding in a P-AT study, the potential for negative outcomes, risks of abuse, lack of ethnoracial representation, the use of therapeutic touch, and consent for treatments involving altered states of consciousness (Grau et al., 2022).
Although psychedelic use for health and healing has existed for millennia in varying Indigenous communities, the current surge in Western P-AT clinical trial research treating varying psychiatric diagnoses, its unique funding, regulations, and media attention, is unprecedented. Additionally, widespread use of P-AT in clinical practice appears to be imminent. Given that currently available treatments have failed many people (Akiki & Abdallah, 2018), and with early trial results showing long-term relief or remission (in small trial samples) P-AT potentially offers a more effective option (Luoma, Chwyl, Bathje, Davis, & Lancelotta, 2020). As such, the Biden administration as formed a federal task for to review and coordinate the unique challenges associated with P-AT approval by the FDA should that determination be made in the near future.
Before approval and widespread dissemination, it is critical to address concerns about the ethical practice of P-AT, which is typically shaped by the clinical research and regulatory oversight in clinical trials. In the United States (US), FDA-approved clinical research trials shape treatment models, guide the ethical practice and standards of care, and set precedents for the ways risk is communicated and accountability is implemented. Although the US has regulations for the protection of human subjects, not all P-AT clinical trial participants have been immune from harm. Concerns about participant safety have been reported, including recent cases of sexual abuse in research settings (Goldhill, 2020; McNamee, Devenot, & Buisson, 2023; Nickles & Ross, 2022). Despite the fact that harmful abuses of power in the therapeutic relationship between patient and therapist have occurred within all treatment disciplines (AbuDagga, Carome, & Wolfe, 2019; Alpert & Steinberg, 2017; Capawana, 2016), the altered state of consciousness experienced in P-AT trials may amplify risk by putting patients in a vulnerable situation. As an example of the importance of understanding the vulnerability associated with P-AT, one should consider that MDMA-assisted psychotherapy, the first P-AT likely to be federally approved, has been used to treat patients specifically with PTSD (Mitchell et al., 2021). Because PTSD is a common outcome of sexual abuse (Scott et al., 2017) and is a diagnosis that has a disproportionate impact on people of color (Roberts, Gilman, Breslau, Breslau, & Koenen, 2010) and LGBTQIA2S+ communities (Livingston, Berke, Scholl, Ruben, & Shipherd, 2020), it is important that clinical trials include diverse and representative samples, and adequately address ethical challenges associated with working with traumatized populations. Further, racial trauma (or race-based traumatic stress [RBTS]), an unrecognized diagnosis in The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSMV]), is often comorbid in PTSD participant populations in the BIPOC community who have experienced prolonged exposure to racism (Williams, Haeny, & Holmes, 2021). The concerning lack of ethnoracial representation in P-AT clinical trials (Smith, Faber, Buchanan, Foster, & Green, 2022) impairs researchers' and clinicians' ability to offer culturally sensitive trial design (including informed consent), evidence-based P-AT PTSD treatment, and inhibits the detection of cross-cultural differences in treatment response (Fogg, Michaels, de la Salle, Jahn, & Williams, 2021).
The answer to ensuring safety within clinical trials, and thus providing a framework for how to ensure safety when treatments are approved by the FDA, is often believed to lie within the process of institutional review board (IRB) approval and detailed informed consent forms (ICF) for participants. All research using human participants in the US must be monitored and approved by an IRB (Schneider, 2015). Each academic institution or organization appoints its IRB from its own faculty, clinicians, and staff as well as the local community, and members of IRB committees should have enough expertise related to the investigation carried out by the trial to consider the breadth of unique ethical considerations related to it (Schneider, 2015). Following IRB approval, potential participants should be adequately informed of the risks, benefits, safety, and accountability of these trials. However, little is known about the content of ICF for P-AT trials, this review represents a first step towards studying the content of ICF for P-AT trials.
Despite the regulations and procedures in place to reduce risks associated with clinical trial participation, very little is known about how adequate the consent process is for trials of psychedelic drug administration. In an effort to address this gap, the present review sought to 1) illuminate how risk and accountability are currently communicated to P-AT participants via ICFs; and 2) suggest how existing research policy might be updated to make working with patients under altered states of consciousness safer and to ensure that consent is truly informed prior to enrollment.
Methods
In the first iteration of the search process, inclusion criteria for viable trial ICFs were defined as: 1) involving the use of a psychedelic for the treatment of PTSD, and 2) have a status of “completed,” “recruiting,” or “active.” Using clinicaltrials.gov, the search function was used to query for “posttraumatic stress disorder” in the field for “condition or disease.” Trials whose status was marked as “terminated” or “withdrawn” were filtered out along with the “no longer available” and “temporarily not available” categories under “expanded access.” Filters for eligibility criteria, study type, study results, study phase, and funder type were not used. This initial search yielded 1,575 studies related to PTSD. To provide context for MDMA in relation to other commonly researched psychedelics, I further filtered the 1,575 studies by the category “drug interventions, alphabetical,” and limited “psychedelic” substances to those commonly used at high doses to invoke an altered state of consciousness in P-AT trials, which include: MDMA, psilocybin, LSD, and ketamine. Once sorted by substance, the final filter was implemented for trials containing uploaded ICFs, yielding 10 ICFs for review (see Table 1).
Number of studies examining PTSD treatment by psychedelic (or psychedelic-adjacent) drug intervention with uploaded ICFs. (clinicaltrials.gov)
| PTSD study by drug intervention | Number of active or completed studies* *as of February 2023 | Number of uploaded IC forms* *as of February 2023 |
| 3,4-Methylenedioxyamphetamine (MDMA) | 17 | 9 (56%) |
| Ketamine | 24 | 1 (0.4%) |
| Psilocybin | 5 | 0 |
| Lysergic acid diethylamide (LSD) | 0 | 0 |
With the initial search yielding only ten ICFs, a search was performed to determine if this lack of availability is exclusive to P-AT trials. Additionally, under the revised Common Rule 45 CFR 46.116(h), it is required that for “each clinical trial conducted or supported by a federal department or agency, one IRB approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the federal department or agency component conducting the trial” (Office for Human Research Protections, 2022). However, the FDA has never adopted this requirement. Even without FDA adoption of this provision, 19 government agencies (including, most notably, NIH) are beholden to the 45 CFR 46.116(h) informed consent upload requirement. In reality, the number of available ICFs for not only P-AT-related trials, but all clinical trials listed on clinicaltrials.gov, remains extremely small (just over 1.5%) (see Table 2). Although only three years of government-funded trials are bound by the new Common Rule posting requirement, there is no rule prohibiting sharing ICFs and protocols publicly.
Number of studies overall and associated number of uploaded IC documents. (clinicaltrials.gov)
| Total studies (unfiltered) on clinicaltrials.gov *as of February 2023 | Total with informed consent documents* *as of February 2023 |
| 456,602 | 6,946 (1.5%) |
With the initial results limited to 10 forms, inclusion criteria were revised and expanded with the intention of capturing more ICFs eligible for review. The filter limiting trial results exclusive to the examination of PTSD was eliminated and the substances queried were expanded to trials examining individual psychedelic or psychedelic-adjacent (ketamine) substances for all purposes, yielding 34 ICFs (see Table 3). Ketamine, though not a classical psychedelic, was included to capture other trials that may be addressing issues related to altered states of consciousness. The updated inclusion criteria were applied to the 34 studies yielded by this expansion requiring the trials to be 1) involving the use of a classical psychedelic (psilocybin, LSD) or psychedelic-adjacent substance (MDMA, ketamine) in tandem with psychotherapeutic intervention; and 2) have a status of “completed,” “recruiting,” or “active.” Ultimately, 19 study forms met the inclusion criteria, these were reviewed to determine what risks, benefits, and safety protocols were communicated to participants in their respective trials (see Table 4).
Number of studies listed by psychedelic (or psychedelic-adjacent) drug, with an uploaded ICF (clinicaltrials.gov)
| Drug intervention | Number of active or completed studies* *as of February 2023 | Number of uploaded IC forms* *as of February 2023 |
| 3,4-Methylenedioxyamphetamine (MDMA) | 49 | 11 (22%) |
| Ketamine | 1,056 | 18 (0.02%) |
| Psilocybin | 130 | 4 (0.03%) |
| Lysergic acid diethylamide (LSD) | 21 | 1 (0.05%) |
Clinical trials used for informed consent analysis
| Study title | Status | Page length | Listed affiliated party(s) | Clinicaltrials.gov ID |
| A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping with Mental Health | Completed | 19 | Field Trip Health | NCT05604794 |
| MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD | Completed | 21 | Multidisciplinary Association for Psychedelic Studies | NCT02876172 |
| Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD | Completed | 8 | Multidisciplinary Association for Psychedelic Studies | NCT02102802 |
| Lysergic Acid Diethylamide (LSD)-Assisted Psychotherapy in People with Illness-related Anxiety | Completed | 7 | Multidisciplinary Association for Psychedelic Studies | NCT00920387 |
| Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People with Posttraumatic Stress Disorder | Completed | 5 | Multidisciplinary Association for Psychedelic Studies| Swiss Medical Association for Psycholytic Therapy | NCT00353938 |
| Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial | Completed | 18 | Multidisciplinary Association for Psychedelic Studies | NCT01458327 |
| A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1) | Completed | 25 | Multidisciplinary Association for Psychedelic Studies | NCT03537014 |
| Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada) | Completed | 22 | Multidisciplinary Association for Psychedelic Studies | NCT03485287 |
| Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD | Completed | 25 | Multidisciplinary Association for Psychedelic Studies | NCT03282123 |
| MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening Illness | Completed | 31 | Multidisciplinary Association for Psychedelic Studies | NCT02427568 |
| Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults | Completed | 22 | Multidisciplinary Association for Psychedelic Studies| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | NCT02008396 |
| Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD | Completed | 28 | Multidisciplinary Association for Psychedelic Studies | NCT01793610 |
| Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People with Chronic PTSD | Completed | 14 | Multidisciplinary Association for Psychedelic Studies | NCT01689740 |
| Study Comparing Three Doses of MDMA Along with Therapy in Veterans With Posttraumatic Stress Disorder | Completed | 22 | Multidisciplinary Association for Psychedelic Studies | NCT01211405 |
| MDMA-Assisted Psychotherapy in People with Posttraumatic Stress Disorder | Completed | 21 | Multidisciplinary Association for Psychedelic Studies | NCT00090064 |
| Psilocybin Therapy for Depression in Bipolar II Disorder | Recruiting | 14 | University of California, San Francisco | NCT05065294 |
| Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease | Recruiting | 14 | Joshua Woolley, MD/PhD| University of California, San Francisco | NCT04932434 |
| Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors | Completed | 13 | Joshua Woolley| Heffter Research Institute| River Styx Foundation| Usona Institute| Stupski Foundation| University of California, San Francisco | NCT02950467 |
| Comparing the Effects of Psilocin and Psilocybin in Healthy Adults | Recruiting | 17 | Sponsor: University of California San Francisco Collaborator: Filament Health | NCT05317689 |
Results
After reviewing the final 19 forms to determine what risks, benefits, and safety protocols were communicated to participants in their respective trials, the results were assessed under four categories: risks, benefits, safety, and accountability; and evaluated with respect to their perceived compliance with FDA regulations outlined in 21 CFR 50. For studies that are subject to FDA regulation (and are not eligible for exemption), ICFs must meet requirements of 21 CFR 50.20. Overall, each ICF examined demonstrated compliance with FDA elements of informed consent regulations (See Tables 5–8 as examples of adherence to each rule). Thematically, there were more commonalities than differences among forms, likely since the majority of available trials have the same institutional or sponsorship affiliation.
Common themes related to risk
| Theme and FDA code of regulation | Example |
| Cognitive 21CFR50.25(2) A description of any reasonably foreseeable risks or discomforts to the subject. | “Alteration of perception, mood, consciousness, cognition, or behavior.” |
| Physical 21CFR50.25 (a)(2) A description of any reasonably foreseeable risks or discomforts to the subject. | “Nausea, “blurred vision,” “elevated heart rate.” |
| Information-based 21CFR50.25 (a)(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. | Storage of HIPAA-protected data. Sensitive genetic material stored for future research purposes. Video and/or audio footage of P-AT trial participants |
| Statement of potential unknown risks 21CFR50.25(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: 21CFR50.25(b)(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable. | “It is important to note that psilocybin may have side effects that no one knows about yet.” |
| Emotional 21CFR50.25 (a)(2) A description of any reasonably foreseeable risks or discomforts to the subject. | “Questions about sensitive issues (such as alcohol use, illegal drug use, and your mood): questions could make you feel uncomfortable and lead to feelings such as anxiety, distress, sadness, or embarrassment.” |
Common themes related to benefits
| Theme and FDA code of regulation | Example |
| Contribution to Society 21CFR50.25 (a)(3) A description of any benefits to the subject or to others which may reasonably be expected from the research. | “You may enjoy the feeling of contribution to knowledge in the health or social sciences field.” “We do know that the information from this study will help doctors learn more about psilocybin therapy as a treatment for bipolar II disorder. This information could help other patients.” “Information obtained from this study may help doctors and researchers to improve treatment for PTSD and relationships in the future. |
| Financial 21CFR50.25 (a)(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. | Treatment at no cost with financial compensation. “In return for your time and effort, you will be paid up to $500 for completing all parts of this study.” |
| Substance- or symptom-specific 21CFR50.25 (a)(3) A description of any benefits to the subject or to others which may reasonably be expected from the research. | “Administration of psilocin27 may lead to more consistent beneficial effects and have fewer negative effects compared to psilocybin.” “Recent studies have shown that psilocybin may improve depression and anxiety in people with cancer. We believe that it may also be helpful for people living with bipolar II disorder.” “Your symptoms of PTSD may improve while taking part in this study.” |
Common themes related to safety
| Theme and FDA code of regulation | Example |
| Preparation 21CFR50.25 (a)(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental research. | “[You will have] one preparation session with your facilitator. This will be in person. We will familiarize you with what to expect during your psilocybin session including the physical space where you will take psilocybin.” “A preparatory session is where you meet with a facilitator (trained therapist) to prepare for the drug experience, by discussing expectations, practicing therapeutic touch, and listening to music. An integration session is where you meet with the same facilitator the morning after your drug experience to discuss how the session went for you and any side affects you experienced after or are currently experiencing.” |
| Physical Safety 21CFR50.25 (a)(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. | “While you are on study drug, your facilitator will monitor your heart, blood pressure, temperature, and how you are feeling. EEG measures will also be collected during the first hour and a half of each dosing session. A study physician will be available at all times.” |
| Designated Outside Support | “You will be asked to provide the name and contact information for your designated support person who will take you home after your dosing session. “Your designated support person will meet you at our research unit and escort you home. This is for your safety, because you should avoid operating heavy machinery, driving home, etc.” |
| Participation Withdrawal 21CFR50.25 (a)(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. 21CFR50.25 (b)(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. 21CFR50.25 (b)(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject. | "Your Other Options: You do not have to participate in this study. Your other choices may include:
|
| Comprehension Quiz True/False Questions | “1. Participation in this study is voluntary and I may withdraw at any time.” “3. I will complete four drug dosing sessions, each followed by an integration session.” |
| Supervision 25CFR50.25 (a)(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental. | “You will be paired with a team of trained facilitators for the duration of the study” “Your facilitators will be present all day, study staff will be available overnight, and the study doctor will be available the entire time.” |
Common themes related to accountability
| Theme and FDA code of regulation | Example |
| Video Recording & Data Collection 21CFR50.25 (a)(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. 45 CFR 46.116(b)(9) (New Basic Element) “One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility. | “We may share recordings with researchers at our university/other universities who are collaborating with us, or companies that are helping with data analysis (for example, we may have a HIPAA-compliant, secure service transcribe audio recordings to text). Any data transferred outside of UCSF will involve a legally binding, signed agreement to make sure that collaborators use appropriate procedures to protect your privacy. We will not share your name or any additional personal information. When possible, we will only share deidentified data. Any data that we share with collaborators will be destroyed when we finish the analysis. Your data, including audiovisual recordings, will never be accessible to the general public.” “We will be audio and video recording you during this study. We will use these recordings to understand your symptoms and also to make sure our study staff meet quality requirements” |
| Protocol in the event of harm or issues 25CFR50.25 (a)(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. | “What happens if I am injured because I took part in this study? It is important that you tell the study leaders.” “If you wish to ask questions about the study or your rights as a research participant to someone other than the study leaders or if you wish to voice any problems or concerns you may have about the study, please call the office of the Institutional Review Board at ______” |
| Legal Rights 25CFR50.25 (a)(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. | “In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.” |
| Disclosures | Financial and other outside interest disclosures. |
With an emphasis on assessing compliance, forms were initially reviewed to determine how risk, benefits, safety, and accountability are described in the ICF. Common themes related to risk included issues of cognitive, emotional, and physical health risks, information-based risks (storing of HIPAA protected data), and the presence of unknown biological and psychological risks (see Table 5). Common themes related to benefits discussed the rewards of contributing to society (e.g., by participating in advancing science), the financial payment for participation, and substance specific impacts (see Table 6). Common themes related to safety included preparation, physical safety, designated outside support, informed consent comprehension quiz questions, supervision, and safety in the event of participation termination or withdrawal (see Table 7). Common themes related to accountability included statements about video and audio collection, protocol in the event of harm, participants' legal rights, and disclosures of financial or conflicts of interest (see Table 8).
Discussion
The primary findings from this review of ICFs from P-AT trials revealed that studies were in compliance with federal regulation. This finding is unsurprising given that trials must be compliant with regulations in order to pass IRB inspection. Nevertheless, the aim of this review was to explore whether psychedelic-specific themes related to risks, benefits, safety, and accountability were present in ICFs and thus considered important to communicate to potential participants. The following sections discuss gaps in themes discussed in ICFs from P-AT research trials, which could shape the informed consent process going forward (see Table 9).
Ethical challenges addressed by examined IC forms*
| Ethical challenge | Addressed by forms examined |
| Abuse of Power Addresses risks of abuse of power, and/or no tolerance for abuse and discrimination, and/or a communicated client bill of rights* (beyond right to privacy/confidentiality). **California sites have supplementary required participant bill of rights. | Trial # NCT05604794 (Field Trip Health): No Trial # NCT02876172 (MAPS): No Trial # NCT02102802 (MAPS): No Trial # NCT00920387 (MAPS): No Trial # NCT00353938 (MAPS): No Trial # NCT01458327 (MAPS): No Trial # NCT03537014 (MAPS): Partial Trial # NCT03485287 (MAPS): No Trial # NCT03282123 (MAPS): No Trial # NCT02427568 (MAPS): No Trial # NCT02008396 (MAPS): Partial Trial # NCT01793610 (MAPS): No Trial # NCT01689740 (MAPS): No Trial # NCT01211405 (MAPS): No Trial # NCT00090064 (MAPS): Partial Trial # NCT05065294 (UCSF): Partial Trial # NCT04932434 (UCSF): Partial Trial # NCT02950467 (UCSF): No Trial # NCT05317689 (UCSF): No |
| Use of Touch Addresses that touch may be used, how it will be used, the process for ongoing consent. | Trial # NCT05604794 (Field Trip Health): No Trial # NCT02876172 (MAPS): No Trial # NCT02102802 (MAPS): No Trial # NCT00920387 (MAPS): No Trial # NCT00353938 (MAPS): No Trial # NCT01458327 (MAPS): No Trial # NCT03537014 (MAPS): No Trial # NCT03485287 (MAPS): No Trial # NCT03282123 (MAPS): No Trial # NCT02427568 (MAPS): No Trial # NCT02008396 (MAPS): No Trial # NCT01793610 (MAPS): No Trial # NCT01689740 (MAPS): No Trial # NCT01211405 (MAPS): No Trial # NCT00090064 (MAPS): No Trial # NCT05065294 (UCSF): No Trial # NCT04932434 (UCSF): No Trial # NCT02950467 (UCSF): No Trial # NCT05317689 (UCSF): No |
| Training and Competency Addresses the training and scope of practice of the therapists' participants will be interacting with. | Trial # NCT05604794 (Field Trip Health): Partial Trial # NCT02876172 (MAPS): No Trial # NCT02102802 (MAPS): No Trial # NCT00920387 (MAPS): No Trial # NCT00353938 (MAPS): No Trial # NCT01458327 (MAPS): No Trial # NCT03537014 (MAPS): Partial Trial # NCT03485287 (MAPS): No Trial # NCT03282123 (MAPS): No Trial # NCT02427568 (MAPS): No Trial # NCT02008396 (MAPS): No Trial # NCT01793610 (MAPS): No Trial # NCT01689740 (MAPS): No Trial # NCT01211405 (MAPS): No Trial # NCT00090064 (MAPS): No Trial # NCT05065294 (UCSF): Partial Trial # NCT04932434 (UCSF): Partial Trial # NCT02950467 (UCSF): Partial Trial # NCT05317689 (UCSF): Partial |
| Long-Term to permanent personality shift and/or increase in psychological symptoms. Addresses potential for mystical experiences, and possible shifts in values, identity, or personality outside of increase in psychological symptoms (e.g. risk of suicidal ideation) | Trial # NCT05604794 (Field Trip Health): Yes Trial # NCT02876172 (MAPS): No Trial # NCT02102802 (MAPS): No Trial # NCT00920387 (MAPS): Partial Trial # NCT00353938 (MAPS): No Trial # NCT01458327 (MAPS): No Trial # NCT03537014 (MAPS): No Trial # NCT03485287 (MAPS): No Trial # NCT03282123 (MAPS): No Trial # NCT02427568 (MAPS): No Trial # NCT02008396 (MAPS): No Trial # NCT01793610 (MAPS): No Trial # NCT01689740 (MAPS): No Trial # NCT01211405 (MAPS): No Trial # NCT00090064 (MAPS): No Trial # NCT05065294 (UCSF): No Trial # NCT04932434 (UCSF): No Trial # NCT02950467 (UCSF): No Trial # NCT05317689 (UCSF): No |
| Culturally Responsive Care or Consent Addresses intersectionality, culturally responsive clinical practice, or dialogue specifically addressing considerations for care related to populations of devalued social identities (e.g. people of color, LGBTQIA2S+, accommodations for people with disabilities). | Trial # NCT05604794 (Field Trip Health): No Trial # NCT02876172 (MAPS): No Trial # NCT02102802 (MAPS): No Trial # NCT00920387 (MAPS): No Trial # NCT00353938 (MAPS): No Trial # NCT01458327 (MAPS): No Trial # NCT03537014 (MAPS): No Trial # NCT03485287 (MAPS): No Trial # NCT03282123 (MAPS): No Trial # NCT02427568 (MAPS): No Trial # NCT02008396 (MAPS): No Trial # NCT01793610 (MAPS): No Trial # NCT01689740 (MAPS): No Trial # NCT01211405 (MAPS): No Trial # NCT00090064 (MAPS): No Trial # NCT05065294 (UCSF): No Trial # NCT04932434 (UCSF): No Trial # NCT02950467 (UCSF): No Trial # NCT05317689 (UCSF): No |
*Yes: IC Form directly addresses ethical challenges. No: IC form does not mention or have indirect mention of ethical challenge. Partial: IC form made an acknowledgment of importance, or an indirect, or brief mention of ethical challenge.
Considerations related to risks
Diminished autonomy and decision-making
One risk associated with P-AT trials is the length of time involved in a high-dose session and the lack of complete autonomy to choose when and how to leave a psychedelic dosing session. Each study reviewed here required two or more six-to-eight-hour visits, with some requiring an overnight stay in a private room in the research unit and included study staff retrieving participant belongings to store in a secure location. Although this part of the protocol was intended as a safety measure and the FDA mandates participant supervision until the effects of the psychedelic dose have subsided, this regulation also limits the ability of the participant to leave in the event of harm by a clinician, potentially leading to feelings of being trapped or disempowered. Conversely, participants may end up in significant danger if allowed to leave a treatment session into an unsupervised environment mid-session on a high dose of psychedelics.
Some studies did not provide specific guidelines for early exit, though several studies addresed this risk by requiring participants to identify a trusted support person who could be called upon in the case of early termination. Though trusted supports are ideal, many participants in P-AT trials may be socially under-resourced which could impact their ability to identify available support persons. Given that social isolation is common within mental health diagnoses being investigated like PTSD and depression, this requirement could feel unrealistic to some. Even those who are well resourced socially may want to keep their study participation private, feeling uncomfortable sharing their participation with others potentially due to stigma of seeking help for mental health or seeking treatment using a psychedelic substance.
For the trials that did not offer the additional safety measure of a support person, it was noted that a therapy team member would be available on site until psychedelic effects had subsided. In some cases, site support involved potentially admitting participants to the hospital if they are at risk of harming themself or others. Depending on the participant's past experiences with medical care and rapport built among the participant, therapist team, and staff, this protocol may or may not feel secure or comforting to the participant. Conversely, if the participant is at risk of harming themselves, it is the responsibility of the trial to assess this risk and ensure safety. Identifying the potential for risk and considering the potential impact of risks are different considerations for a participant and a research team to evaluate.
Abuse of power
There is an inherent power differential that exists between practitioner and participant (Nimmon & Stenfors-Hayes, 2016) and this differential is likely to be more pronounced in P-AT trials given the altered state of consciousness experienced by the participant. Power differentials are heightened by the decreased decision-making capacity of participants over long periods of time and states of enhanced suggestibility and openness. For participants without any experience with therapy, research, or psychedelics, the relevant signs of an abuse of power may be unknown or misunderstood. The boundaries between therapist and participant aren't always clearly defined even without the influence of a substance like MDMA, which is known for increasing sociability and fostering feelings of deep connection and trust (Regan, Margolis, de Wit, & Lyubomirsky, 2021). These blurred boundaries could complicate issues related to power and influence (McNamee et al., 2023). It is the responsibility of the clinicians and investigators to protect participants from harm by making the ethical practice and codes of conduct explicit to those who enroll in the trial (McNamee et al., 2023). A useful addition to clinical trial documents to address these issues would be providing a professional disclosure statement alongside an ICF addressing the scope of practice of therapists, the boundaries and risks of therapeutic relationship, a client bill of rights, and a no tolerance statement for abuse or discrimination.
Sexual misconduct and the use of touch
MDMA is considered an ‘empathogenic’ drug. This means people who use it may experience increased empathy and sociability. After taking the study drug, you may feel more emotionally open, friendly, extroverted, or talkative. You may also feel closer to your therapists or more trusting of them, or you may even feel love and sexual feelings toward your therapist(s). This can happen with any psychotherapy but may be heightened by MDMA. Your therapists are aware of the effects of the drug. They have been through training on how to appropriately care for someone who has taken MDMA and on a code of ethics that prohibits any sexual relations between therapists and participants, including after participation in the study has ended.
It should be noted that this form was found in the first round of investigation but was replaced on the clinicaltrials.gov record by a different form that did not have the enhanced section during the second review. Nevertheless, such statements should be provided to participants across all clinical trials in order to ensure proper informed consent.
Challenges related to the ethical use of touch have been at the heart of the conversation about the consent process in P-AT trials (Smith & Sisti, 2020). Touch is considered by some practitioners working with psychedelics to be integral to their work; others have stated that “the omission of touch may limit the types of healing that can occur” (Brennan, Jackson, MacLean, & Ponterotto, 2021). While this implies an acceptance of touch in P-AT broadly, touch remains a topic of ongoing debate and the need for touch in P-AT has yet to be empirically evaluated. None of the ICFs reviewed in this study included any language about the use of touch during a psychedelic session. Because many P-AT trials allow for the use of ‘therapeutic’ or ‘nurturing’ touch (McClane, Hutchison, Wikler, Howell, & Knighton, 2021), clinicians are challenged to determine how to assess whether and in what cognitive state consent should be obtained and honored (Devenot et al., 2022). Addressing the safety and risk related to the use of touch, and determining what is or is not appropriate touch, should be clearly outlined both in the ICF and through dynamic and continuous consent throughout the trial. Clear boundaries asserting sexual and non-sexual touch are essential to safety and understanding what is and is not appropriate or expected.
The use of touch has been controversial in traditional psychotherapy settings as well (Novak, 2023; Zur & Nordmarken, 2021); most traditional training programs for psychotherapists do not offer coursework discussing the specifics of ethical use of touch or somatic practice, thereby making the use of touch potentially out of their comfort zone as practitioners and therefore outside their scope of practice/competence (Love, 2022). Ethical codes of conduct governing the varying types of psychotherapists (e.g., family therapists) determine that treating, diagnosing, or advising on problems outside the recognized boundaries of their competencies is an ethical violation (AAMFT Code of Ethics, 3.6s, 2015). Touch in the therapeutic relationship between participant and clinician can lead to increased relational ethical risk relative to talk therapy (Brennan et al., 2021). The current prevailing narrative in the psychedelic research community is that the consent for touch should be led by the participant; however, this does not account for what happens when touch initiated by the participant may be out of the scope of practice or comfort zone of the practitioner. This issue is compounded by the vulnerable state of the participant in an altered state of consciousness that calls their decision-making capacity into question, thereby impairing client autonomy (Brennan et al., 2021; Smith & Sisti, 2020). It is through touch that the boundaries between therapist and participant may be blurred, and the door left open for the exploitation of the participant's vulnerability. Power differentials are particularly amplified in MDMA-assisted therapy; this approach requires extra caution on touch and boundaries and demands a clearly defined protocol to communicate to participants in the ICF and throughout the trial.
Short- and/or long-term personality changes
Although experiences involving changes to personality are discussed in the literature on psilocybin (Weiss, Nygart, Pommerencke, Carhart-Harris, & Erritzoe, 2021), changes to personality have also been associated with trials involving MDMA (Lear, Smith, Pilecki, Stauffer, & Luoma, 2023) and LSD (Schmid & Liechti, 2017). While some ICFs reviewed for this study mention experiential or feeling changes that may occur during the high dose session of psychedelic medicine, none of the ICFs reviewed for this study described such changes post-treatment. Not only are changes to personality possibly a life-altering experience to an individual's internal experience, but they can also be disruptive in their professional or personal relationships. As with other informed consent processes for research, the P-AT consent process should provide participants with a better understanding of this form of risk and a chance to gauge their comfort level with every aspect of the intervention.
Considerations related to benefits
Communicating benefits
In general, ICFs examined here offered minimal discussion of benefits and focused primarily on risks and safety. As most psychedelic research remains experimental, benefits have yet to be fully established. Thus far there is scant literature on the benefits perceived by participants in these trials and how potential benefits are communicated in ICFs. Communicating benefits can vary depending on the positionality of the person responsible for communicating such information. Similarly, perceived benefits experienced by participants in research may be variable dependent on the lived experience and contextual factors of the participant and the treatment they are seeking. Future trials could benefit from participant experience research to generate data that will insight into areas of improvement of the informed consent process for future participants. Multiple perspectives are needed, especially from the lens of the participant, to capture the ethical issues (including benefits) that are specific to engaging in trauma and P-AT research.
Considerations related to safety and accountabilty
Although the ICFs reviewed here alluded to a process for accountability, they offered little detail about how one might initiate a complaint related to abuse or discrimination. Participants were directed to contact the principal investigator or the IRB directly if they experienced discomfort or perceived abuse. However, in the event of abuse during a trial, participants might not feel comfortable reporting to those in positions of power within the trial. A formalized process for reporting misconduct and abuse should be listed on ICFs to ensure clearer communication to participants about the process of reporting safety concerns and the measures taken once a complaint is filed. Also noteworthy is that psychedelic research teams are often interdisciplinary, with several state boards and ethics codes overseeing their respective licensure; participants may not know all of the bodies of accountability they can report abuse or harm to beyond the IRB or principal investigator listed.
Training and competency
Though some research sponsors have their own P-AT training programs, there are many P-AT trials that may or may not be employing clinicians with specific training for P-AT practice, though presumably they have their own supervision and training within their teams. Nevertheless, the risks associated with P-AT necessitate an explicit statement regarding the training, theoretical orientations, and accountability systems for study therapists. Specific statements about these topics could be communicated clearly in the ICF and participant-onboarding process. Further, future studies should provide brief education about the types of touch and therapeutic interventions that are considered appropriate or inappropriate.
Culturally responsive informed consent
Calls for greater inclusion of more diverse ethnoracial groups in empirically supported P-AT research have emphasized how little diversity exists among participants in past and current P-AT trials (Grau et al., 2022). Increasing these numbers will not only require more effective recruitment strategies (Smith et al., 2022), but will also require systemic changes to prevent participants of color and other marginalized identities from being further harmed (Strauss, de la Salle, Sloshower, & Williams, 2021). For example, in a methodological search of psychedelic studies from 1993 to 2017, Michaels, Purdon, Collins, and Williams (2018) found that in the 18 studies meeting their criteria (n = 282 participants), 82.3% of participants were non-Hispanic White; the remaining breakdown included 2.5% African American, 2.1% of Latino origin, 1.8% Asian origin, 4.6% Indigenous origin, 4.6% mixed race, 1.8% identifying as “other,” and 8.2% of participants were of unknown ethnicity. If researchers are to address this issue by including a greater diversity of participants in P-AT trials, particularly non-White and other participants of socially marginalized identities, the investigators and therapists themselves must be equally diligent in ensuring the emotional and physical safety of those participants (Kruk & Matsick, 2021).
The ramifications of ethnoculturally insensitive care in P-AT research are too great to dismiss, especially in consideration of the presence of trauma. Disregarding participants' contextual factors leads to negative outcomes, including higher risks for communities of color to have challenging drug experiences, poorer long-term outcomes, and less trust for future participants and stakeholders in P-AT (Fogg et al., 2021). To create safe environments for socially marginalized identities in the US, it must be acknowledged that participants in those populations are at higher risk of harms like discrimination (Diop et al., 2021).
Psychedelic research has almost exclusively been conducted on White populations in North America and Western Europe (Fogg et al., 2021; Smith et al., 2022). Missing from the ICFs reviewed for this study was mention about the cultural competency of the investigators or clinical trial therapists. Further, the ICFs examined in this study do not address the potential risks of unconscious bias, microaggressions, or other forms of discrimination, and they do not offer explicit reporting protocols and supportive structures for participants in the event of racial harm. Statements from the research study on the ICF acknowledging the risk of discrimination and asserting a no tolerance policy and protocol for reporting discrimination should be implemented.
Limitations
Results from this inquiry illuminated that very few ICFs are posted on clinicaltrials.gov. Although this is not unique to trials related to P-AT, this reveals a major challenge for assessing the current state of consent practices and limits the ability to generalize findings from this review to all P-AT trials. Furthermore, although additional efforts were made to request ICFs from principal investigators of studies that would be eligible for review, none of these requests received a response. Without a response, it was difficult to determine whether these omissions were due to limited bandwidth for responding to inquiries or an unwillingness to share these materials. Additionally, it is possible that some ICF documents omitted information on safety and logistics that was provided elsewhere, such as in study protocols, therapy manuals, and other participant-facing materials. However, even if these materials provide a more holistic picture of the entirety of the experience of consent and communication of risk, safety, benefits, and accountability, this information should be available to participants at the outset of the consent process.
Conclusion
Risk of harm is inherent to many clinical research trials, and ICF requirements were created to ensure that participants have the ability to choose to participate with full understanding of what their participation will entail. Although the ICFs for P-AT trials that were examined for this study covered several important areas related to risk, benefits, safety, and accountability, as required by federal regulations in the US, there were also several unique risks and ethical considerations for P-AT that were largely missing from these forms. These omissions limit the ability of participants to provide full consent to P-AT trials. When consent is fully realized, it is a “communicative act that alters moral relations, authorizing activities that would otherwise be forbidden” (Koenig, 2014). Yet mounting evidence suggests that there are large disparities between the ideal of consent and its actual practice (Koenig, 2014). In the cases of historical and current P-AT trials, the protection of participants will require more than reading and agreeing to risks outlined in an ICF. Given the discrepancy between what it takes to be considered “federally compliant” and what should be considered adequate information to consent to psychedelic therapy, it is worth asking whether the rules (as constructed) are up to the task of protecting participants from harm driven by the ethical complexities involved in P-AT. Including relevant information in future ICF practices for P-AT clinical trials would begin to close some of the important gaps identified in this review. However, developing a culture of consent and accountability in P-AT research will require moving beyond a system that emphasizes checkboxes of consent rather than truly informed understanding. Because of the unique risks posed by the forced vulnerability associated with P-AT, a more robust informed consent process should be considered a primary focus of future research.
Acknowledgement
There was no funding received for this study. The primary research was performed while affiliated with Duke University and was finished once affiliated with University of Ottawa. The onset of this review took place while affiliated with Duke University for the completion of a Master of Arts in Bioethics and Science Policy.
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