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Let’s Discover Your Gene Expression

EndocannaHealth, Ethan Russo, MD and Associates are undertaking a research project to investigate the relationship of cannabis usage to various diseases.
If you are over 18 years of age, you may assist us in gathering data that may be helpful in screening patients for susceptibility to such diseases.
Those who successfully complete the following questionnaire may be eligible for free DNA testing using a painless oral swab.
You will remain anonymous throughout, and no one but you will have access to your confidential results.
It is estimated to take 7-10 minutes to complete.
Let’s begin!

CONSENT TO PARTICIPATE IN A RESEARCH STUDY


TITLE:                                     Summary of Cannabinoid Hyperemesis Syndrome Study

PROTOCOL NO.:                 None
                                                                WIRB® Protocol #20192689

SPONSOR:                            EndoCannaHealth/International Cannabis and Cannabinoids Institute (ICCI)

INVESTIGATOR:                  Ethan Budd Russo, MD
                                                 20402 81st Avenue SW
                                                 Vashon, Washington 98070
                                                 United States

STUDY-RELATED
PHONE NUMBER(S):          206-304-4344
                                                 206-304-4344 (24 hours)

Study Title: CANNABINOID HYPEREMESIS STUDY

This is a medical research study. This document will explain this study to you.

Medical research studies include only people who choose to take part. Take your time to make your decision about participating. You may discuss your decision with your family and friends and with your health care team.  If you have any questions, you may ask your study doctor, Ethan Russo, MD: ethanrusso@comcast.net

You are being asked to take part in this study because you:
  1. Have been diagnosed as having cannabinoid hyperemesis syndrome, or
  2. Have symptoms that suggest that you might have this syndrome, or
  3. Have other reasons to have your genome (DNA) tested.

Why is this study being done?


Over the past 15 years, increasing numbers of patients have reported a combination of symptoms after using cannabis (marijuana) in which they develop vomiting and abdominal (stomach) pain, and may take hot baths or showers to reduce symptoms. The cause of this problem is currently unknown. We would like to find out if people who are susceptible to this problem may have changes in their DNA (genetic structure) that might help explain the problem. If this proves true, it would allow the development of a test for the problem that might save a great deal of time and money now required to rule out other explanations (in the form of medical tests such as scans, colonoscopy, barium enema, etc.)  The test is experimental and no results about this test will be returned to you.

The study is sponsored by EndocannaHealth https://www.endocannahealth.com/ and the International Cannabis and Cannabinoids Institute (ICCI) https://www.icci.science

How many people will take part in this study?

About 100 people will take part in this study.

What will happen if I take part in this research study?
 
Before you begin the main part of the study
 
  • First, you will read this informed consent explaining the pros and cons of participating in the study. By continuing on and completing the questionnaires, you are agreeing to participate.
  • Next, you will need to fill out a questionnaire to ensure that you are at least 18 years of age and answer various questions about symptoms and medicines and your past treatment.
  • You should have all of your current medications with you so that they can be listed.
  • You will be asked questions about your medical history as it relates to the study.
During the main part of the study

You will be sent a DNA test kit with simple diagramed instructions. After swabbing the inside of your cheek, the sample will be returned postage-free for analysis. You will remain anonymous throughout the procedure and no one will have access to your results without a special online key that you will receive when your DNA results are finished.  Your results will be compared to others in the study to see if important patterns are present. 

How long will I be in the study?
The study will involve only completion of the informed consent, completing the questionnaire and taking the DNA sample. 

Can I stop being in the study?
Yes.  You can decide to stop at any time.  Tell the study doctor or EndocannaHealth if you are thinking about stopping or decide to stop.  He or she will tell you how to stop your participation.

The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.

What side effects or risks can I expect from being in the study?
We expect no side effects while on the study. The DNA swab is not painful or irritating, and resembles a cotton swab. 

Are there benefits to taking part in the study?
Taking part in this study will not make your health better. We hope that the study may make identification of cannabinoid hyperemesis syndrome easier.

What other choices do I have if I do not take part in this study?
Your alternative is to not participate. 

Will my medical information be kept private?
Participation in research may involve a loss of privacy, but information about you will be handled as confidentially as possible. A medical record will be created because of your participation in this study. Your consent form and some of your research test results will be included in this record. Therefore, your other people involved in the research may become aware of your participation. Federal regulations require that all health care providers treat information in medical records confidentially.

In this study you will be asked about drug use and other possibly illegal activities. The researchers will keep your information as confidential as possible, but complete confidentiality cannot be guaranteed. You will be identified by a code. You will not be personally identified in any publication about this study. However, records may be reviewed for research, quality assurance, and data analysis, under guidelines of the Federal Privacy Act, by the following organizations:
      • U.S. Food and Drug Administration (FDA)
      • EndocannaHealth
      • ICCI
      • The IRB
What are the costs of taking part in this study?
You will not be charged for any of the study activities.

Will I be paid for taking part in this study?
No, however, you will receive information about your DNA results from EndocannaHealth. 

What happens if I am injured because I took part in this study?
We do not expect any danger to you from this study. It is important that you tell Dr. Ethan Russo, if you feel that you have been injured because of taking part in this study. You can the doctor at ethanrusso@comcast.net

What are my rights if I take part in this study?
Taking part in this study is your choice.  You may choose either to take part or not to take part in the study.  If you decide to take part in this study, you may leave the study at any time.  No matter what decision you make, there will be no penalty to you, and you will not lose any of your otherwise-entitled benefits. Leaving the study will not affect your medical care. You can still get your medical care from your usual caregivers.

We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.

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.

Who can answer my questions about the study?
You can write to Dr. Ethan Russo: ethanrusso@comcast.net or call 206-304-4344 (24 hours) if you have any questions, concerns, or complaints.

This research is being overseen by an Institutional Review Board (“IRB”). An IRB is a group of people who perform independent review of research studies. You may talk to them at (800) 562-4789, help@wirb.com if:
    • You have questions, concerns, or complaints that are not being answered by the research team.
    • You are not getting answers from the research team.
    • You cannot reach the research team.
    • You want to talk to someone else about the research.
    • You have questions about your rights as a research subject.

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Please note: This section of the informed consent form concerns the use of your left-over DNAsamples for future research studies. You can say “yes” or “no” to this proposed use of your samples. You can still participate in the study even if you say “no.”

About Using Biological Specimens for Research

Research Samples

With your permission, the DNA that is left over after testing for biomarkers will be preserved for future research.  The specimens will only be used by EndocannaHealth.

Information from these samples will not be shared with you or your health care provider. Information from these samples will not be part of your medical record and will not be given to your insurance provider or employer.

If you agree now for your samples to be used for future research, you can decide at any point later on to have your samples destroyed by contacting EndocannaHealth https://www.endocannahealth.com/

If you decide to have your samples destroyed, any data or analysis done before your request will not be removed; however, no further analysis will be done and your remaining samples will be destroyed.

Things to Think About

The choice to let us use your samples for future research is up to you.  No matter what you decide, it will not affect your care.

Benefits: The future research will not benefit you directly, but it may help scientists better understand genetics.

Risks: There is some risk from a breach in confidentiality.  We will do our best to ensure that your personal information is kept private. The chance that this information will be given to anyone else is very small.  If this information were released, it could potentially be misused. Such misuse could cause psychological distress and/or affect your ability to get a job or insurance. The types of information that could be collected include your previous medical history, laboratory results, and information about use or abuse of controlled substances.

In order to minimize this risk, all research information obtained for your DNA samples will be kept as confidential as possible. Your samples will be labeled with a code number, not your name. Only Dr. Russo and study staff will be able to identify you based on the code.  Your samples will be kept in locked storage.

Making Your Choice

You will not be charged, and you will not receive any payment or financial benefit from any products, tests, or discoveries. You may be asked in the future about participating in other research studies.  You will not be told the results of any future research involving your samples.

Please read the sentence below and think about your choice.  After reading the sentence, insert your initials in the space next to the “Yes” or the “No.” If you have any questions, please contact Dr. Ethan Russo ethanrusso@comcast.net

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CONSENT

You have been given copies of this consent form and the Experimental Subject's Bill of Rights to keep.

PARTICIPATION IN RESEARCH IS VOLUNTARY.  You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.
Cannabis/CBD Use (Why are we asking this?)
It is important to understand how you have used cannabis and CBD products in the past.  This helps us understand your history of  dosage, along with consideration of your metabolic predisposition.
2. Are you 18 years of age or older? You must be 18 or older to take this survey! *This question is required.
4. Gender: *This question is required.
If you qualify for a free DNA testing using a painless oral swab, how may we contact you?