Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 333 - PSILOCYBIN › Section 333-333-5040 - Informed Consent

Current through Register Vol. 63, No. 7, July 1, 2024
(1) A
			 facilitator or service center must provide every client a copy of the following
			 informed consent document during the client's preparation session or prior to
			 the preparation session upon a client's request:
Introduction
:
In the State of Oregon, psilocybin services include a
				preparation session, administration session, and integration session. You
				should receive this informed consent form prior to or during your preparation
				session. During the preparation session, your facilitator will review and
				discuss this form with you. Please make sure you read and understand every
				section because you must sign the form before the administration session
				begins. If you do not understand any part of this document, please ask your
				facilitator for clarification before signing.
I have been informed of and understand the
				following:
(Please initial each item below)
1.
____ I have reviewed the
			 Psilocybin Services Client Bill of Rights, my facilitator has explained it to
			 me, and I understand my rights as a client.
2.
____ I understand that psilocybin
			 services do not require medical diagnosis or referral and that psilocybin
			 services are not a medical or clinical treatment.
3.
____ I understand that psilocybin
			 has not been approved by the Food and Drug Administration and the federal
			 government currently classifies psilocybin as a Schedule I controlled substance
			 under the Controlled Substances Act.
a.
Federal law prohibits the
			 manufacture, distribution, and possession of psilocybin even in cities and
			 states that have adopted laws to allow its possession or
			 use.
b.
Despite
			 its federal Schedule I status, research suggests that psilocybin is very
			 unlikely to be addictive. Additionally, research and other information suggests
			 that psilocybin may improve symptoms of depression, anxiety, end of life
			 distress, various forms of trauma, and problematic substance
			 use.
4.
____ I understand that the risks, benefits, and drug interactions of psilocybin
			 are not fully understood, and individual results may vary.
5.
____ I understand that some
			 people have found psilocybin administration sessions to be challenging or
			 uncomfortable. Common potential side effects include nausea, mild headache,
			 fatigue, anxiety, confusion, increased blood pressure, elevated heart rate,
			 paranoia, perceptual changes, altered thought patterns, reduced inhibitions,
			 recovery of repressed memories and past traumas, and altered perception of time
			 and one's surroundings. If they occur, these side effects are usually mild and
			 temporary. Because the potential risks and benefits of psilocybin
			 administration are not fully understood, there may be unanticipated side
			 effects.
6.
____
			 I understand that if I am taking prescription medications or have a medical
			 condition or mental health condition, I should consider consulting with a
			 medical or clinical provider before participating in an administration
			 session.
7.
____
			 I understand that psilocybin is derived from fungi. If I have a known mushroom
			 allergy, I should consult with a medical or clinical provider before
			 participating in an administration session.
8.
____ I understand that the risks
			 of consuming psilocybin while pregnant or feeding with breast milk are
			 unknown.
9.
____
			 I understand that facilitators may not use touch while providing psilocybin
			 services without my prior written consent. My facilitator and I have discussed
			 acceptable types of supportive touch and the requirement to provide prior
			 written consent prior to the start of my administration
			 session.
10.
____
			 I understand that facilitators may be mandatory reporters of abuse. If my
			 facilitator is a mandatory reporter, they have shared this information with me
			 and explained their legal obligations to report abuse.
11.
___I understand that
			 facilitators have a duty to report misconduct that harms or endangers a client
			 to the Oregon Health Authority. If the misconduct presents an immediate risk to
			 health and safety, facilitators have a duty to contact emergency
			 services.
12.
____ I agree to follow my agreed upon transportation plan. I understand that a
			 facilitator may contact emergency services if failure to follow my
			 transportation plan presents a risk to my safety or the safety of
			 others.
13.
____
			 I understand that consuming psilocybin is completely voluntary and I may decide
			 not to consume psilocybin at any time.
14.
___ I understand that I have the
			 right to update my client information form prior to beginning an administration
			 session and I have the right to receive a copy of my client information form
			 upon request.
15.
____ I understand that if de-identified data collected by facilitators and
			 service centers is shared with people and institutions outside of the
			 facilitator or psilocybin service center, I must be provided with a disclosure
			 form that describes who will receive the data and how it will be used, and that
			 I have the opportunity to opt-out of having my de-identified data provided to
			 third parties.
16.
____I understand data that may be used to identify me as a client will
			 only be shared to the extent permitted or required by law. Specifically, ORS
			 475A.450 allows disclosure in
			 the following circumstances:
(1)
When the client or a person authorized to act on behalf of the client
			 gives consent to the disclosure;
(2)
When the client initiates legal
			 action or makes a complaint against the psilocybin service center operator, the
			 psilocybin service facilitator, or the employee;
(3)
When the communication reveals
			 the intent to commit a crime harmful to the client or
			 others;
(4)
When
			 the communication reveals that a minor may have been a victim of a crime or
			 physical, sexual or emotional abuse or neglect; or
(5)
When responding to an inquiry by
			 the Oregon Health Authority made during the course of an investigation into the
			 conduct of the psilocybin service center operator, the psilocybin service
			 facilitator, or the employee under ORS
			 475A.210 to
			 475A.722.
17.
____I understand that my
			 facilitator may take short restroom breaks during my administration
			 session.
18.
____
			 I understand that for my own safety, leaving a psilocybin service center during
			 an administration session once it has begun is strongly discouraged. Doing so
			 could lead to safety and legal risks.
19.
____ I understand and have been
			 informed of the potential benefits, risks, and complications of psilocybin
			 services with my facilitator to the extent that they are
			 known.
20.
____
			 My facilitator has shared locations of client restrooms and protocols for use
			 of restrooms during an administration session.
21.
____My facilitator has shared
			 information regarding verification of license status and process for making
			 complaints to the Oregon Health Authority.
22.
____ I have had the opportunity
			 to ask questions regarding anything I may not understand or that I believe
			 should be made clear.
23.
____ If participating in a group administration session, I understand
			 that I will be experiencing the effects of psilocybin in the presence of other
			 clients who are also experiencing the effects of psilocybin and may be reacting
			 to the experience in a different manner.
24.
____I understand that activation
			 times for psilocybin products are variable and cannot be accurately predicted.
25.
____I
			 acknowledge that the risks and benefits of consuming doses greater than 35 mg
			 of psilocybin analyte are unknown.
26.
____If consuming whole fungi
			 during an administration session, I understand that psilocybin content can vary
			 between individual fruiting bodies.
27.
____I understand that the risks
			 and benefits of repeated psilocybin use are unknown.
28.
____I understand that a
			 facilitator has a duty to call emergency services if required and a client
			 assumes responsibility for costs of emergency services.
29.
____I understand that I will be
			 required to identify an emergency contact and a facilitator or service center
			 may contact this person in the event of a medical or other
			 emergency.
30.
____ I understand that I may be charged a cancellation fee if I cancel a
			 scheduled preparation, administration or integration
			 session.
31.
____I understand that I have the right to choose my facilitator and
if a facilitator has supervisory, evaluative, or other authority over
			 me, I will be provided an opportunity to receive psilocybin services from
			 another facilitator.
32.
____I understand that service center licensee representatives may be
			 present during my administration session to assist licensed facilitators with
			 operations.
____________________
Name (Print)
________________________
				________________________
Signature Date