Thank you for your interest in this study. We aim to better understand how patients are using cannabidiol (CBD) to alleviate symptoms associated with cerebral palsy. Your answers will help us provide better care to children in similar situations as your own.
Below, you will see a consent form that further describes the purpose of this study. If you would like to participate, please select "Yes" in response to the next question. Your participation would entail completing two surveys on behalf of your child, one assessing CBD use and another evaluating your child's health-related quality of life (CPCHILD).
Caregivers of patients who have not used CBD, as well as those who have, are invited to participate. Please only complete these surveys once. All responses will be kept confidential.
PURPOSE OF RESEARCH
You are invited to participate in a research study investigating the current use of cannabidiol (CBD) in children with cerebral palsy. We hope to learn about current use patterns and perceived efficacy of CBD, as well as any impact on quality of life it may have.
If you have any questions regarding the study, you should contact Dr. John Vorhies, protocol director, at 650-497-1835. You can also contact the research investigator, Ryan Seltzer (rseltzer@stanford.edu) if you have any questions or decide to terminate your participation in this study.
VOLUNTARY PARTICIPATION
Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your child's medical care. You can decide to participate now but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you or your child is entitled. You have the right to refuse to answer particular questions.
DURATION OF STUDY INVOLVEMENT
Your active participation will take approximately 15 minutes. This research study is expected to take approximately 18 months in total.
PROCEDURES
If you choose to participate, Dr. Vorhies and his research team will ask for the one-time completion of two questionnaires. The first is aimed at assessing current usage and opinions about cannabidiol (CBD), while the second is titled CPCHILD and assesses your child's health-related quality of life. Your participation is estimated to take approximately 15 minutes in total. We will use the results from these surveys to inform clinical practice and the planning of a clinical trial to investigate the efficacy of CBD in children with cerebral palsy.
FUTURE USE OF PRIVATE INFORMATION
Research using private information is an important way to try to understand human disease. You are being given this information because the investigators want to save private information for future research. Identifiers will be removed from identifiable private information and, after such removal, the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you.
PARTICIPANT RESPONSIBILITIES
As a participant, your responsibilities include:
• Follow the instructions of the Protocol Director and study staff.
• Complete questionnaires as instructed.
• Ask questions as you think of them.
• Tell the Protocol Director or research staff if you change your mind about staying in the study.
WITHDRAWAL FROM STUDY
If you first agree to participate and then change your mind, you are free to withdraw consent and discontinue participation at any time. Your decision will not affect you or your child's ability to receive medical care and you or your child will not lose any benefits to which you or he/she would otherwise be entitled. If you decide to withdraw your consent to participate in this study, you should notify Dr. Vorhies at 650-497-1835. Alternatively, you can also contact Ryan Seltzer, research investigator, at rseltzer@stanford.edu.
The Protocol Director may also withdraw you from the study without your consent for one or more of the following reasons:
•Failure to follow the instructions of the Protocol Director and study staff.
•The study is canceled.
•Other administrative reasons.
•Unanticipated circumstances.
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES
There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions.
There are no known harms associated with your participation in this research study. This study asks you to complete general questions about your child's quality of life and cannabidiol (CBD) use. All responses will be kept confidential.
POTENTIAL BENEFITS
We cannot and do not guarantee or promise that you will receive any benefits from this study. Data from completion of the CBD survey may help in quantifying usage and describing any perceived benefits of CBD. Information from this survey may lead to a future clinical trial investigating the use of CBD directly in children with cerebral palsy.
ALTERNATIVES
The alternative is not to participate. Your child will still receive the same clinical management whether or not you choose to participate in this study.
PARTICIPANT'S RIGHTS
You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction.
You will be told of any important new information that is learned during the course of this research study, which might affect your child's condition or willingness to continue participating in this study.
CONFIDENTIALITY
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your or your child's identity and/or personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified. Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.
Authorization To Use Your Health Information For Research Purposes
Because information about you and your child's health is personal and private, it generally cannot be used in this research study without your written authorization. If you agree to participate, it will provide that authorization. The form is intended to inform you and your child about how your health information will be used or disclosed in the study. You and your child's information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before agreeing to participate.
What is the purpose of this research study and how will my health information be utilized in the study?
The purpose of this study is to investigate the current use of cannabidiol (CBD) in children with cerebral palsy. We hope to learn about current use patterns and perceived efficacy of CBD, as well as quantify any impact on quality of life it may have via the CPCHILD questionnaire. This study will ask for your one-time completion of two surveys - one assessing quality of life and one assessing CBD use and opinions.
Do I have to agree to participate?
You and your child do not have to agree to participate in this study. Agreeing to participate is not a condition for receiving any medical care.
If I agree to participate, can I revoke it or withdraw from the research later?
If you and your child decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain the integrity of research). If you or your child wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to:
Dr. John S. Vorhies, MD
Edwards Building, R107
300 Pasteur Dr.
Stanford, CA 94305
What Personal Information Will Be Obtained, Used or Disclosed?
You and your child's health information that may be used or disclosed in connection with this research study includes, but is not limited to, demographic information, dates more precise than year only, clinical narratives or reports, prescriptions or medications, questionnaire results, and other unique identifying numbers, characteristics, or codes.
Who May Use or Disclose the Information?
The following parties are authorized to use and/or disclose you and your child's health information in connection with this research study:
•The Protocol Director: Dr. John Vorhies
•The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary
•Research Staff
Who May Receive or Use the Information?
The parties listed in the preceding paragraph may disclose you and your child's health information to the following persons and organizations for their use in connection with this research study:
•The Office for Human Research Protections in the U.S. Department of Health and Human Services
You and your child's information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.
When will my authorization expire?
You and your child's authorization for the use and/or disclosure of your health information will end January 1, 2035 from the date of your agreement or when the research project ends, whichever is earlier.
FINANCIAL CONSIDERATIONS
Payment/Reimbursement: You and your child will not be paid to participate in this research study.
Costs: There is no cost to you and your child for participating in this study, other than the personal time it will take to complete the questionnaires.
CONTACT INFORMATION
Questions, Concerns, or Complaints: If you or your child have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should ask the Protocol Director, Dr. John Vorhies, by calling him at 650-497-1835. You should also contact him at any time if you feel you or your child has been hurt by being a part of this study.
Independent Contact: If you or your child are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at (650)-723-5244 or toll-free at 1-866-680-2906. You can also write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306.
Alternate Contact: If you or your child cannot reach the Protocol Director, please contact Ryan Seltzer, the research investigator, at (650) 464-2111 or Katie Hastings, research manager, at (650) 725-5339.
If you agree to participate in this research, please indicate this by selecting the option below.
Do you consent to participating?
* must provide value
Yes No
The following questions are intended to acquire clinical and demographic data about your child.
Has your child been diagnosed with cerebral palsy?
* must provide value
Yes
No
What is the sex of your child?
Male Female Other
What is your child's race/ethnicity? Check all that apply.
What country does your child live in? If located in the United States, please specify the state of residence too.
What is your child's most recent weight (in pounds)?
What is your child's height (in inches)?
What is your child's GMFCS score (Gross Motor Function Classification System)? This is usually reported as an integer ranging from 1 to 5, with higher scores implying more significant functional impairment. Please leave blank if unsure.
Does your child require a tracheostomy tube for breathing?
Yes
No
Does your child require a feeding tube (i.e., G or GJ tube) for nutrition?
Yes
No
Does your child experience seizures?
Yes
No
Does your child require a breathing machine (e.g., a ventilator or positive airway pressure)?
Yes
No
Has your child been afflicted by developmental delay or cognitive impairment?
Yes
No
Has your child ever used or been given cannabidiol (CBD) for the treatment of their cerebral palsy or related symptoms?
* must provide value
Yes No
Why did your child start taking CBD? Mark all that apply.
Has your child undergone surgery in the past two years?
Yes
No
In what form has your child taken cannabidiol (CBD)? Mark all that apply.
On average, what dose (amount) of CBD has your child used? Please include units (e.g., milligrams or mg) or leave blank if unsure.
How often does your child use CBD in an average week?
Two times or less per week Three to five times per week Six to eight times per week Nine to eleven times per week Twelve to fourteen times per week Fifteen or more times per week Unsure
For how long has your child used CBD?
Less than 6 months Between 6 months and 1 year Between 1 year and 1.5 years Between 1.5 years and 2 years Greater than 2 years Unsure
How did you initially learn about cannabidiol (CBD)? Mark all that apply.
From where do you obtain the cannabidiol (CBD)? Mark all that apply.
Has CBD affected any of the other medications that your child is taking?
Yes No
Please explain which medication(s) and what happened or leave blank if unsure.
Please mark any of the following side effects your child may have experienced while using cannabidiol (CBD).