This is a text copy of the informed consent. All participants complete an official informed consent upon registration.
INFORMATION AND CONSENT FORM
For the Cavernous Malformation Registry (CCM Registry)
Protocol Title: The Cavernous Malformation (CCM) Registry: For the Collection of Natural History and Clinical Information to Facilitate Research and Clinical Trials
Sponsor: Angioma Alliance d/b/a Alliance to Cure Cavernous Malformation
Principal Investigators: Jianbo Hu, Ph.D.
Cornelia Lee, Psy.D
Alliance to Cure Cavernous Malformation
977 Seminole Trail, Box 367, Charlottesville, VA 22901
Telephone Number: 434-207-8335
This Information and Consent Form is for the Cavernous Malformation (CCM) Registry. You also may choose to participate in the Alliance to Cure Cavernous Malformation Biobank. The Biobank requires a separate information and consent form that you can access at https://www.alliancetocure.org/research-clinical-trials/participate-in-research/CCM-Biobank.
ABOUT THE CCM REGISTRY
The purpose of the CCM Registry is to allow individuals, families, and medical and research providers to report their history with cavernous malformations (CCM) and other medical information (Medical Information). This form gives you information to help you decide if you want to participate.
If you have questions about something in this form, you should ask the principal investigators or their study staff. From now on, they will be referred to as Project Staff in this document. You may discuss this form with anyone to help you understand your options better. Do not sign this form unless the Project Staff has answered your questions and you decide that you want to participate.
When reading this form, please note that “you” and “your” refer to individuals with one or more confirmed CCM. A parent’s or legally authorized representative’s permission is required for a child to participate. Once the child reaches adulthood, the Project Staff will contact the child. The Project Staff will explain the purpose of the CCM Registry and obtain their consent to continue participation. Legally authorized representatives may also provide consent for adult CCM patients who cannot read or understand their involvement. Parents or legally authorized representatives may also provide consent for an individual who passed away. The consent process will be entirely online, and no physical signature will be collected.
Why am I asked to REGISTER?
You or a family member has one or more cavernous malformations. These abnormal blood vessels are also known as cavernous angioma or cavernoma. In this document, we will refer to them as CCM.
To help CCM research, Project Staff are asking you to provide Medical Information. Researchers want to use your Medical Information to find treatments for CCM. The Alliance to Cure Cavernous Malformation will not use your Medical Information for anything not mentioned in the form without your permission. The Alliance will not share your name or other identifying information with researchers. You may enroll in different research projects separately if you like.
It is up to you to decide if you want to participate. No matter what you choose to do, it will not affect your health care through your regular providers. You can change your mind and withdraw your consent and participation anytime. Please read the rest of this form to help you make your informed decision.
WHAT IS MY ALTERNATIVE TO PARTICIPATING?
Your alternative is not to participate.
WHO IS PAYING FOR THE CCM REGISTRY?
Individual donations, foundation grants, corporate grants, and user fees fund the CCM Registry.
WILL IT COST ANYTHING TO PARTICIPATE?
You do not have to pay to participate. While you are enrolled, you should continue your regular medical care. You and your health care payer will pay your standard medical care costs.
HOW LONG WILL I BE IN THE CCM REGISTRY?
Scientific research to find CCM treatments may take a long time. If you decide to register, the Project Staff would like you to participate indefinitely. However, you can still register if you do not want to participate indefinitely.
After you enroll, you can expect to spend anywhere from thirty minutes to one hour filling out information and answering surveys. After this, the Project Staff may contact you once a year for a short follow-up interview and may contact you periodically to fill out additional surveys.
WHAT WILL HAPPEN IF I DECIDE TO ENROLL?
If you want to enroll, you should:
- Register, and create an account username and password on the secure HIPAA-compliant CCM Registry platform.
- Review and sign this informed consent document. A copy will be stored in your registration profile, accessible to you anytime.
- Provide demographic, health, and genetic test result data, if available. The CCM Registry stores your identifying personal information in a separate and secure database.
- Periodically log into your account to update changes to your demographic, health, or genetic data. The Project Staff may remind you to update your
- Complete surveys
• Survey questions are about your experiences with CCM.
• The Project Staff may remind you to finish incomplete surveys or start a new survey periodically.
- Upload or link your electronic health records
• Sharing data from your medical records is an optional part of participating in the CCM Registry. Researchers will have the most information about CCM if all participants share their medical information.
• There are two ways to share your medical records. You can share your medical records in one or both ways.
1. Upload PDFs. You can upload PDFs (or scans) of any medical records, such as clinical notes, imaging and genetic test reports, and lab results.
2. Link your electronic health records. You may be able to connect your online records from your care provider to the CCM Registry. Your records may include imaging, like MRI and CT scans.
• If needed, the Project Staff will provide instructions to upload or link your records.
- Participate in forums
• The CCM Registry includes an interactive, web-based platform for all participants to communicate.
• You have the option to post questions and interact with all members of the community if you like.
• Other participants on the CCM Registry will see your forum username. You decide whether or not to use your identifiable name on the forum.
WILL BEING IN THE CCM REGISTRY HELP ME?
Being in the CCM Registry might not bring a direct benefit to you. The CCM Registry might accelerate the discovery of new tests or medications to help you and others in the future. Project Staff will not tell you how researchers used your de-identified information. From time to time, Alliance to Cure Cavernous Malformation provides information in its newsletter, website, and annual meetings about research studies supported by the CCM Registry.
HOW WILL YOU KEEP MY INFORMATION PRIVATE?
Your Medical Information will only contain your unique ID number. The Project Staff will store your identifiable personal information separately from your medical history form, any images, and medical records in the secure HIPAA-compliant online data storage platform. The Project Staff will remove your name and medical record number from individual MRI images and other medical records you upload. Only you, the Project Staff, the service provider for the data storage platform, and North Star Review Board (see below) have access to your identifiable personal information. Your name or other facts that might identify you will not appear in any study findings. Nobody will publish results using your identifiable information without your written permission.
ARE THERE RISKS TO ME IF I AM IN THE CCM REGISTRY?
Your Medical Information is private. The Project Staff will remove all your identifying information from your medical history. However, it is still possible that others may be able to identify you through your de-identified Medical Information. The Alliance to Cure Cavernous Malformation will make every effort to make sure only those people or companies you read about in this form have access to your test results.
If you choose to link your electronic medical records to your CCM Registry, you might surprisingly learn some of your medical information that you are not aware of previously. This might be a concern for you.
WILL I GET PAYMENT?
There is no payment to you for being in this collection. Researchers may make money from a discovery based on your Medical Information. The rights to any money from this belong to the researcher who makes the discovery. You will not get any payment for providing your Medical Information.
From time to time, we may inform you about opportunities to participate in studies that offer compensation. These opportunities will require separate consent.
WILL MY MEDICAL INFORMATION BE USED FOR ANYTHING ELSE?
The purpose of the CCM Registry is to promote research about CCM. However, researchers studying other diseases related to CCM may find the CCM Registry valuable to their area of research. Their work may eventually benefit patients with CCM or other patient populations. You may choose to allow us to share your information with researchers studying diseases related to CCM. You may also decline.
DO I HAVE TO BE IN THE REGISTRY?
Your decision to be in the CCM Registry is voluntary. You can change your mind at any time. Your decision to participate will not affect your healthcare or the services that Alliance to Cure Cavernous Malformation offers you at any time.
You may change your mind about participation at any time and for any reason by simply clicking the “withdraw” button on your CCM Registry account page. Participants’ identifiable information will be removed after withdrawal. However, participants’ data collected before withdrawing may remain part of the CCM Registry database and may not be removed.
The CCM Registry also has an associated biological sample collection program called the CCM Biobank housed at Texas Heart Institute. The CCM Biobank can store blood, CCM tissue, saliva, urine, and fecal samples. If you are interested in providing your biological samples to the CCM Biobank, please read and sign the CCM Biobank consent form on the CCM Registry website.
Please let the Project Staff know if you are scheduled for a future procedure or surgery. The Project Staff may help coordinate biological sample collection. This may be the best time to provide a biological sample. For example, if you have a scheduled future CCM lesion removal, the Project Staff can help ensure a sample also goes to the CCM Biobank.
Your participation in the CCM Biobank is voluntary. You may participate in the CCM Registry even if you do not share biological samples.
WHOM CAN I TALK TO ABOUT THE STUDY?
You can email or call the Project Staff using the contact information on page 1 of this form if you have any questions, concerns, or complaints.
An institutional review board has reviewed the CCM Registry to ensure it meets ethical and regulatory standards for protecting your rights. An institutional review board is an independent group that reviews research protocols to ensure they adequately protect participants. For questions about those protections and your rights as a participant, please contact North Star Review Board at 877-673-8439 or firstname.lastname@example.org. You may want to contact North Star Review Board if:
• You have concerns or complaints that the Project Staff will not address.
• You are not getting answers to your questions from the Project Staff.
• You cannot reach the Project Staff.
• You want to talk to someone else about the CCM Registry.
• You have questions about your rights as a participant.
WHO WILL USE AND SHARE MY INFORMATION IN THE CCM REGISTRY?
Your Medical Information can reveal personal things about you. This section explains who will use and share your Medical Information. The Project Staff will store and analyze the Medical Information you share with us. Your records also will include other identifying information about you, such as your name and address.
If you sign this form, you allow Alliance to Cure Cavernous Malformation to:
- Store your Medical Information in the CCM Registry.
- Use and allow researchers, including those planning clinical trials, to use facts you have shared with us. Those facts might appear in books, magazines, journals, and scientific meetings. No one will use your name or other identifying information if this happens. Almost all research publications combine facts from many people using statistics. Typically, researchers do not report information about just one person without speaking to them directly.
- Share your records without identifying information with government agencies, including the FDA, National Institutes of Health, and the Center for Disease Control.
- Share this signed consent form and all your records with the North Star Review Board. North Star Review Board may use your records to check the CCM Registry information. They may also check how the Project Staff protects participants’ rights and safety.
Project Staff will follow applicable laws to protect the privacy of your Medical Information. However, you do not have a guarantee of absolute privacy because of the need to share your information as described above.
You have the right to see and save your records.
Please save or print a signed copy of this form for your records.
DO YOU WANT TO BE IN THE CCM REGISTRY?
I have read this form and asked all of my questions about the CCM Registry. The Project Staff has answered all my questions, if any. I voluntarily agree to be in the CCM Registry.
By signing this form, I have not given up my legal rights as a research participant. I will save or print a signed copy of this consent form for my records.
Please check next to each statement below if you give your permission:
Required for Enrollment:
- I agree that Alliance to Cure Cavernous Malformation may store, use, and share my Medical Information in the CCM Registry described above.
- I give Project Staff permission to contact me for updated Medical Information or to participate in more research.
- I permit using my Medical Information in research for other CCM-related diseases.
Name of Participant (Print) Date of Birth
Signature of Participant (if age 18+) Date
If the participant could not read English or does not have the legal capacity to consent to their participation:
I certify that I am the parent or hold legal power of attorney for the participant named above under state law. I am authorized to sign this consent for their participation in the CCM Registry described above.
Name of Parent/Legal Representative (Print) Relationship to Participant
Signature of Parent/Legal Representative Date