Informed Consent

Teaches how to obtain and maintain valid informed consent through clear disclosure, comprehension checks, capacity support, voluntariness, non-coercion, and respect for refusal or withdrawal. The competency also covers consent for screening procedures, recordings, collateral contact, rescue interventions, and documentation of the consent process.

8 care stages · 59 guidelines · 0 courses · 0 providers

Clinicians and research staff must clearly educate participants about study procedures, risks, side effects, restrictions, and possible benefits, and obtain written informed consent before screening and study participation. Ethical delivery depends on transparent communication and opportunities for questions.

6 care stages · 5 guidelines · 0 courses · 0 providers

Cluster covering 2 related competencies including: Psilocybin psychoeducation, Psychedelic psychoeducation and expectation management.

6 care stages · 4 guidelines · 0 courses · 0 providers

Understand how treatment expectations can influence treatment response and study interpretation. Facilitation must avoid inadvertently shaping expectations in a biased or misleading way.

3 care stages · 3 guidelines · 0 courses · 0 providers

Therapists/facilitators must support ethically valid informed consent by ensuring participants understand the intervention, expectations, risks, and logistics. They also provide anticipatory guidance before ketamine sessions and discharge information after dosing.

3 care stages · 3 guidelines · 0 courses · 0 providers

Facilitators are responsible for ensuring that participants have provided informed consent before receiving MDMA-assisted therapy. This reflects an ethical and regulatory duty central to work with investigational treatments.

4 care stages · 3 guidelines · 0 courses · 0 providers

The therapist is responsible for giving truthful, individualized preparation and reassurance about the experience, including likely sensations, risks of resistance, and expectations for conduct. The preparation aims to reduce fear, improve cooperation, and support voluntary participation.

4 care stages · 3 guidelines · 0 courses · 0 providers

Therapists must understand MDMA’s expected subjective, interpersonal, and physiological effects and prepare participants accordingly. This knowledge supports normalization, reassurance, and effective use of the medicine within therapy.

4 care stages · 3 guidelines · 0 courses · 0 providers

The handbook explicitly states that the experience should be fully explained and that the subject should accept it voluntarily. Coercion is framed as both unethical and therapeutically counterproductive.

4 care stages · 3 guidelines · 0 courses · 0 providers

Use physical contact only when necessary, explicitly permitted, and minimal. The facilitator must respect participant autonomy and avoid any contact that is not justified for safety or grounding.

2 care stages · 1 guidelines · 0 courses · 0 providers

The investigator/therapist has ethical responsibility to explain study goals, course, expected effects, possible advantages and disadvantages, risks, and alternative treatments in verbal and written form. This includes ensuring participant questions are answered satisfactorily and that there is enough time for decision-making.

1 care stage · 1 guidelines · 0 courses · 0 providers

Therapists should prepare participants by describing common psychological and physiological effects of MDMA and emphasizing variability of response.

1 care stage · 1 guidelines · 0 courses · 0 providers

Investigators have a continuing duty to inform participants about new findings regarding LSD or LSD-assisted therapy that emerge during the study. This reflects an ongoing consent responsibility rather than a one-time disclosure.

2 care stages · 1 guidelines · 0 courses · 0 providers

Therapists/facilitators must ensure participants are properly informed using approved consent materials before participation in MDMA-assisted psychotherapy research.

2 care stages · 1 guidelines · 0 courses · 0 providers

Use ibogaine only after a careful discussion of uncertain efficacy, limited research, and known risks. Ethical practice requires transparent communication about the experimental nature of treatment and the absence of robust clinical standards.

3 care stages · 1 guidelines · 0 courses · 0 providers

Clearly explain the investigational nature of ibogaine treatment and its known serious risks before treatment begins. Ethical practice requires that patients understand both uncertain benefits and significant safety concerns.

2 care stages · 1 guidelines · 0 courses · 0 providers

Study personnel involved with participants must understand informed consent responsibilities and boundaries. Consent is an ongoing process, and appropriately trained staff without an existing clinical relationship obtain consent, not the PI.

2 care stages · 1 guidelines · 0 courses · 0 providers

Clinicians need working knowledge of the potential risks and benefits of MDMA-assisted therapy as the research is designed to explore both. This knowledge supports informed consent, clinical judgment, and participant monitoring.

2 care stages · 1 guidelines · 0 courses · 0 providers

Treat consent as a continuing process rather than a one-time event. Patients must understand the treatment and retain the ability to revoke consent, with special procedures during the medication session for safety.

5 care stages · 1 guidelines · 0 courses · 0 providers

Clinicians should present the intervention accurately as ketamine- or midazolam-augmented PE within a research protocol, with clear explanation of purpose and expectations. Ethical practice includes avoiding overstatement of benefit and framing treatment as investigational augmentation of an established therapy.

3 care stages · 1 guidelines · 0 courses · 0 providers

Can explain common, psychological, and severe risks of KAP in understandable terms. Sets realistic expectations that outcomes may vary and are not guaranteed.

2 care stages · 1 guidelines · 0 courses · 0 providers

Teaches how to maintain clear relational and physical boundaries in emotionally vulnerable treatment settings. This includes professional conduct, rapport without overreach, explicit consent for touch, the right to revoke consent, and strict prohibition of sexual or erotic contact.

8 care stages · 24 guidelines · 4 courses · 3 providers

Cluster covering 11 related competencies including: Preparation support, Psilocybin preparation, Therapeutic preparation.

8 care stages · 16 guidelines · 6 courses · 5 providers

Teaches structured pre-dose preparation and post-dose integration as the therapeutic frame for psychedelic-assisted psychotherapy. The therapist supports rapport, intention clarification, meaning-making, emotional processing, and consolidation of insights after dosing.

8 care stages · 13 guidelines · 2 courses · 2 providers

Support decision-making about ongoing treatment after trial completion, particularly for participants who received escitalopram. The clinician helps participants consider whether to continue, taper, or return to usual care.

5 care stages · 7 guidelines · 0 courses · 0 providers

Therapists may record sessions only with explicit participant consent and must handle recordings for training and research within protocol limits. Recording is part of the therapeutic and scientific framework, not routine clinical use.

5 care stages · 6 guidelines · 0 courses · 0 providers

Teaches counseling and monitoring around contraception, reproductive restrictions, pregnancy risk, and pregnancy-related discontinuation rules. Learners are trained to explain requirements clearly and respond promptly when pregnancy or reproductive-safety concerns arise.

5 care stages · 6 guidelines · 0 courses · 0 providers

Teaches clear communication of behavioral requirements before dosing sessions so conditions are standardized and preventable risks are reduced. Staff confirm that participants understand and follow pre-session instructions.

4 care stages · 4 guidelines · 0 courses · 0 providers

Help the patient identify personally meaningful, positive intentions to guide the session and future change. Intentions should be active, concrete, and framed toward desired gains rather than avoidance.

2 care stages · 3 guidelines · 0 courses · 0 providers

Teaches practitioners to identify and apply relevant legal, regulatory, ethical, and institutional requirements, including documentation, consent, reporting, controlled-substance, and jurisdiction-specific obligations.

7 care stages · 2 guidelines · 2 courses · 2 providers

Staff must ensure participants can understand and engage with the protocol in the site’s recognized language and can participate in a way that preserves safety and informed consent. This is part of the practical knowledge needed for ethical facilitation.

2 care stages · 2 guidelines · 0 courses · 0 providers

A major therapist competency is preparing patients extensively for the ketamine session, including the nature of the special state of consciousness and possible ego dissolution or separation from the body. Preparation is both educational and psychotherapeutic.

3 care stages · 2 guidelines · 0 courses · 0 providers

Collaborates with patients, medical practitioners, and referring providers to support individualized care. Helps patients consider alternatives and coordinate ongoing treatment needs.

4 care stages · 2 guidelines · 0 courses · 0 providers

Teaches psychoactive substance pharmacology, expected drug effects, contraindications, and relevant drug-interaction risks. The competency supports safer screening, medication review, participant education, and clinical decision-making.

4 care stages · 1 guidelines · 2 courses · 2 providers

Understand the transition from blinded randomized treatment to open-label MDMA-assisted therapy for eligible participants. This includes separate consent, revised scheduling, and altered assessment timing.

3 care stages · 1 guidelines · 0 courses · 0 providers

Clinicians should be able to evaluate and support treatment acceptability from both participant and clinician perspectives. The pilot reported high acceptability ratings by participants and study clinicians.

1 care stage · 1 guidelines · 0 courses · 0 providers

Manage optional future-contact procedures ethically and separately from current study participation. Participants may choose whether to authorize future contact without affecting present enrollment decisions.

2 care stages · 1 guidelines · 0 courses · 0 providers

Communicates the experimental and unregulated nature of ibogaine treatment honestly. The source highlights an ibogaine subculture offering unregulated preparations, which creates an ethical duty to disclose uncertainty and risks.

2 care stages · 1 guidelines · 0 courses · 0 providers

Uses publicly available trial information responsibly and within its intended scope. Respects that registry content is not a substitute for clinical judgment, consent procedures, or study-specific training.

1 care stage · 1 guidelines · 0 courses · 0 providers

Therapists must protect voluntariness when potential participants are also their patients. Independent evaluation should be used to reduce pressure or perceived coercion in recruitment and consent.

3 care stages · 1 guidelines · 0 courses · 0 providers

Therapists must prepare participants psychologically and practically for ketamine dosing through rapport-building, psychoeducation, expectation-setting, and intention development. Preparation is emphasized because of trauma burden, psychiatric comorbidity, and instability in the target population.

3 care stages · 1 guidelines · 0 courses · 0 providers

Expectation that study personnel are trained in research ethics and responsible conduct of research. This underpins appropriate consent, confidentiality, and participant safety practices.

2 care stages · 1 guidelines · 0 courses · 0 providers

Because the protocol compares single versus repeated KPT, therapists must be able to prepare patients for sequential sessions and maintain continuity across a month-spaced treatment course. This includes pre-session counseling and repeated integration work.

2 care stages · 1 guidelines · 0 courses · 0 providers

Cluster covering 4 related competencies including: Ethical practice, Ethics in psychedelic care, Ethics and ethical practice.

8 care stages · 0 guidelines · 4 courses · 3 providers