F. What are the possible benefits to you in this research study?
The information which is obtained may be useful scientifically and possibly helpful to others. The benefit to you or your family member, which may be expected from participating in this study, includes learning more information about the possible cause of PHACE syndrome and similar syndromes involving large hemangiomas, but this is not guaranteed. If you agree to participate in this study, there will not be direct medical benefit to you. We hope the information learned from this study will benefit other patients with this skin condition in the future.
G. What are the financial risks to you in this research study?
You (and/or your insurance company) will not be expected to pay for any of the procedures or tests that are required as part of your participation in this research study. All the procedures described above are paid for by other funds which may include internal funding or grants from outside sources.
You or your insurance company will still be responsible for the cost of your usual ongoing medical care, including procedures and/or non-study medications that your study doctor or regular doctor requires during this study as part of your usual medical care. If you have any questions, please ask the study doctor or a member of the study staff.
H. Will you be paid for taking part in the research study?
You will not be paid for basic enrollment in this study. However, patients who contribute tissue from surgical excision or biopsies to the registry will receive $50.00 in the form of Target Gift Cards. In addition, patients who contribute a blood sample will receive $10.00 in the form of Target Gift Cards, and families (patient, mother, and father) who donate blood samples will receive $50.00 in the form of Target Gift Cards. As soon as your sample is received by the research team, the gift cards will be sent to you by mail at the address you give to us for study communication. If you complete online consent forms for this study, you will receive a $20 Target Gift Card. This card will be mailed to the address provided during the online consent process.
I. Do you have to participate in this research study?
You do not have to participate in this study. You are free to withdraw at any time. Your decision to withdraw will not change the quality of care that you receive from the medical staff. However, if you decide to stop participating in the study, we encourage you to talk to the researcher and your regular doctor first.
Your genetic material will be labeled with a code so that no one will know it came from you. Your genetic material may be stored in the laboratory for up to 20 years. During that time, only Drs. Siegel, Drolet, Broeckel and personnel working in collaboration with them will have access to this material. De-identified DNA samples may be shared with other investigators studying PHACE syndrome and other similar associations. You may withdraw from the study at any time. You may request that your genetic material be destroyed or that all personal identification be removed from the stored samples.
If the researchers continue additional interactions or interventions after you turn 18 years old, they will need to seek written consent and HIPAA authorization from you at that time.