Informed Consent Form – Colorado

The Natural Medicine Informed Consent, listed here as the Informed Consent Form, is the Colorado document in which a participant confirms they were told about psilocybin natural medicine services, their risks, benefits and alternatives, and agrees to proceed; the licensed facilitator certifies the explanation.

Colorado Natural Medicine rules require a facilitator to obtain informed consent before providing natural medicine services, per Rule 6.5, 4 CCR 755-1. Beyond the nature of the treatment, its risks and benefits, and the alternatives (including no treatment), Colorado facilitators must disclose and obtain consent on safety planning, physical touch, the presence of other individuals, video recording, how services end, and any other decisions the facilitator considers necessary. The practice of licensed facilitators is regulated by the Office of Natural Medicine of the Department of Regulatory Agencies.

The six-page form covers:

• what psilocybin is and how the regulated market works;
• the preparation, administration and integration sessions;
• risks, contraindications and possible side effects;
• possible benefits and alternatives;
• supportive touch and touch contracts, safety health screening and the transportation plan;
• suicidal ideation, confidentiality, fees and termination of services;
• twelve numbered consent statements, the participant signature block and the Licensed Facilitator Statement.

The form refers to separate documents completed elsewhere, such as the physical touch contract, the transportation plan, the client information form and a disclosure of who may be present or have access to your information. It is not a medical or clinical treatment record.

Participants who will receive natural medicine services from a licensed facilitator or a licensed clinical facilitator review and sign this form, and the facilitator signs the Licensed Facilitator Statement. The instructions say the form should be reviewed carefully by the facilitator and the participant together, and that the facilitator must obtain informed consent before providing services.

Points the form itself makes about who should or should not proceed:

• Psilocybin administration does not require a medical diagnosis or referral (consent statement 1).
• Psilocybin therapy should not be used with participants who have active psychosis, active suicidality, pregnancy or breastfeeding, a prior hypersensitivity or negative reaction to psilocybin, or mushroom allergies.
• If you report certain behavioral or medical conditions or medications, you may be referred to a clinical facilitator or medical provider for risk review, which may add costs.
• You must accurately report prescription medications and medical or mental health conditions to your facilitator (statement 10).

The form has signature lines only for the participant and the licensed facilitator; it prints no block for a representative.

Complete and sign the form before the licensed facilitator provides any natural medicine services. Rule 6.5, 4 CCR 755-1 requires the facilitator to obtain informed consent first, and the form describes at least one preparation session that comes before any administration session, during which State required paperwork is completed.

You may withdraw your consent and stop at any time until the actual dose has been administered. After administration begins, you can still revoke consent for physical touch, but no other change can be made to the touch contract. The form sets no filing deadline with an agency, and it prints no expiration or renewal period. Update your client information form before an administration session begins (consent statement 9).

The form names no agency filing channel, no mailing address and no portal. It is completed between the participant and the licensed facilitator, and the participant keeps a signed copy: consent statement 7 says you have been given a signed copy of the informed consent form, which is yours to keep.

• Participant and facilitator: review the form together, then each signs and dates in the signature blocks. The participant also prints their name, and so does the facilitator.
• Questions or complaints: the form directs suspected violations of the standards of conduct, or malpractice, to the Director of the Natural Medicine Program, 1560 Broadway, Suite 1350, Denver, Colorado 80202, (303) 894-7800, [email protected].

FillingPDF lets you fill out and download the PDF; submission follows the channels above.