INFORMED CONSENT FORM

Introduction

You are invited to participate in the above mentioned research registry, referred here as “the registry.” However, before you accept to take part in this registry and sign this informed consent form, please take the time to read, understand and carefully examine the following information.

Participation in the registry is completely voluntary, and you may withdraw your participation at any time. By participating you are consenting to be contacted for other studies conducted at Santé Cannabis, you are not consenting to participate in any specific study, you will be contacted about specific studies in the future and will be able to make a decision to participate at that time.

Please take your time to read this form carefully. You may ask any question, at any moment. A qualified person at Santé Cannabis will address any concern you may have regarding this registry.

Purpose Of The Registry

The purpose of this registry is to develop a list of individuals who are interested to participate in cannabis research and are willing to be contacted in the future for cannabis research studies. This may help to improve recruitment for cannabis studies. The anonymized (no longer able to be identified) data in the registry may be analysed to understand demographic information and cannabis use.

Who Can Participate?

The registry is expected to include up to 3000 subjects who will be recruited over 5 years.

To participate in the registry:

• You must be between 21 and 65 years old;
• You reside in Quebec;
• You must have no significant health condition or regular use of medications;
• You must be capable of consenting and completing online forms in English or French.

You will not be able to participate if:

• You are a pregnant or breastfeeding individual;
• You are taking cannabis for medical purposes with a medical authorization;
• You have a current or personal history of substance use disorder.

What Your Participation Involves?

This registry will be done online. If you choose to participate, you will provide your informed consent here and continue with the online forms. You will complete an online form that includes the following information about you:

• Demographics, questions such as your age, ethnic background, education, sex, gender, occupational status, and your postal code
• Social & lifestyle information such as tobacco and alcohol use
• Cannabis use history: length of cannabis use, reasons/motivations of use, makeup of product (tetrahydrocannabinol [THC]/ cannabidiol [CBD]), types of products, formulations, dosage, prevalence of negative effects
• Health information: medical condition, medication use including supplements and natural health products, height, weight
  • This information will be anonymized and linked to your contact information only when Santé Cannabis will reach out to you about a study that you may be eligible for.
  • Your contact information will be securely stored and used only to notify you of studies for which you may be eligible to participate.
  • You will be contacted by email or phone to ask if you are interested in participating in future studies.
  • You are not required to participate in any study and your information will not be shared outside Santé Cannabis unless you expressly provide your consent.

All information collected on this form will be stored anonymously, and only the Santé Cannabis research team will have access to your name and contact information to reach out for your potential participation in a study for which you may be eligible.

Length Of The Study

The online forms will take a maximum of 10-15 minutes to complete. Your contact information will be kept for a maximum of 5 years.

What Are The Risks Of Participating?

There are no direct health risks associated with being part of this registry. If you choose to join a study, health risks specific to that study will be outlined in its consent process. While every effort is made to ensure confidentiality, there is a small risk of subject identification in the registry due to a data breach or human error. To minimize this risk, we will take the steps to protect your confidentiality described in the "Confidentiality" section, below. There may be other risks that are currently unknown.

What Are The Benefits Of Participating?

Participation may contribute to advancing cannabis research. There is no intended clinical benefit from your participation in this study.

Voluntary Participation/Withdrawal From The Registry

Your participation in this registry is voluntary. Therefore, you may refuse to participate or you may withdraw from the registry without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care. If at any time, you wish to not proceed with the registry, you can do so without providing any reason, by informing a member of the research team. If you accept to take part in the registry but later change your mind, you can end your participation by contacting us via email, phone, or in person.

The Principal Investigator (PI) or the registry sponsor may put an end to your participation without your consent. This may happen if new findings or information indicate that participation is no longer in your interest, if you do not follow study instructions, or if there are administrative reasons to terminate the registry

If you withdraw or are withdrawn from the study, your data will be removed and the information already collected about you that can be identified as yours will be destroyed.

This research study is for research purposes only. The only alternative is to not participate in this study.

Privacy And Confidentiality

The information collected in the registry is strictly confidential and protected by the Act Respecting the Protection of Personal Information in the Private Sector. At no time will we share this information with anyone external to the research team. The information you provide will be securely stored and accessed only by authorized research team members at Santé Cannabis. Your personal data will not be shared outside the scope of this registry without your explicit consent unless required by law.

To make sure that the health information collected in this study is accurate, it will need to be checked from time to time against your medical records. Some persons may need to see these records in order to monitor the research and verify the accuracy of the study data, including:

• A limited number of representatives from the study sponsoring drug company (namely its monitors and auditors),
• The research ethics review board – Advarra IRB (an independent ethics committee that reviewed the ethical aspects of this study to help protect the rights and welfare of study participants),
• Government regulatory authorities including Health Canada and other foreign regulatory agencies.

You will be identified by a code number only. The key to the code linking your name to your study file will be kept by the Principal Investigator (PI) in charge of this research study.

Your personal information will be stored only for a maximum of 15 years. You have the right to access, rectify, or cancel access to your personal information at any time by contacting us via email, phone, or in person.

The study data will be stored indefinitely and may be published or shared at scientific meetings; however, it will not be possible to identify you.

While every effort will be made to protect the confidentiality of your information, absolute confidentiality cannot be guaranteed.

For auditing purposes, the research study files which could include documents that may identify you may be examined by a person mandated by the institution or the Research Ethics Board. All these individuals and organizations will have access to your personal data, but they adhere to a confidentiality policy.

Will You Be Paid For Taking Part In This Research Study?

You will be added to a draw for a gift card valued at $50 CAD. A random draw will take place every 100 subjects enrolled until completion of the registry. Future studies for which we may contact you may offer compensation.

Costs

There is no cost to you, your private medical insurance (if any), or the public health insurance plan, for study procedures. The study drug, study-related procedures, and study visits will be provided at no charge for the duration of the study

Conflicts Of Interest

Dr. Naila Debbache and Dr. Lorne Wiseblatt are contractors of Santé Cannabis. To mitigate this potential conflict of interest, this information is disclosed to you and will be mentioned at each time results from this registry are published in specialized journals, press releases, or presented in conferences and workshops.

Who Can You Contact If You Have Questions About The Study?

If you have any questions about this registry or your rights as a subject, you are welcome to contact the research team listed on the first page of this form with any concerns you have about the study.

Whom To Contact About This Study

During the study, if you have questions, concerns or complaints about the study such as:

• Payment or compensation for being in the study, if any;
• Your responsibilities as a research subject;
• Eligibility to participate in the study;
• The Principal Investigator’s or study site’s decision to withdraw you from participation;

Please contact the Principal Investigator at the telephone number listed on the first page of this consent document.

An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, contact:

Please reference the following number when contacting the Study Subject Adviser: Pro00085571.

New Findings

Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you in a timely manner.

Informed Consent

By completing and submitting the online form, you are indicating that you have read and understood to your satisfaction the information regarding participation in the registry and are agreeing to study participation.

In no way does this waive your legal rights nor release the researchers or involved institutions from their legal and professional responsibilities.

You are free to withdraw from the registry at any time, and /or refrain from answering any questions you prefer to omit, without prejudice or consequence. Your continued participation should be as informed as your initial consent, so you should feel free to ask for clarification or new information throughout your participation. A copy of this consent form can be given to you to keep for your records and reference.