Informed Consent and Account Creation

The Sturge-Weber International Patient Registry

Informed Consent

For

Participants Age 18 and older / Parents / Guardians / Family Members

 

Sponsor: The Sturge-Weber Foundation
Protocol Number: SWF-130114-01
Principal Investigator: Karen L. Ball
Telephone: (973) 895-4445
(973) 760-9161 (24 Hour)
Registry Coordinator Additional Contact(s): Anne Howard
Address: 1240 Sussex Turnpike
Randolph, NJ 07970

 

For the purpose of this document “you” and “your” refer to the Registrant, either the individual affected by Sturge-Weber syndrome (SWS) (the patient) or the parent, guardian or family member providing the information on behalf of the patient.

Please read “Understanding Your Participation” at www.swsregistry.org and this form carefully.  If you have questions that are not answered in either document, please contact The Sturge-Weber Foundation (SWF) Registry Coordinator. Take time to ask the Principal Investigator or Registry Coordinator as many questions about the Registry as you would like.  The investigator or coordinator can explain words or information that you do not understand.  Reading “Understanding Your Participation”, reading this form and talking to the investigator or coordinator may help you decide whether to take part or not. 

INTRODUCTION to the Sturge-Weber International Patient Registry

The Sturge-Weber Foundation (SWF) is a non-profit organization that was founded in 1987 to improve the quality of life and care for people with SWS and associated port wine birthmark conditions.  The SWF provides education, research and friendly support.  Approximately 4300 patients and families are members of the SWF. The SWS website is www.sturge-weber.org.

The Sturge-Weber Foundation (SWF) has a Registry with information about individuals with Sturge-Weber syndrome (SWS). You are being asked to join this Registry because you have Sturge-Weber syndrome (SWS) or you have a port wine birthmark in the forehead and/or eye region. The Registry is a place to store detailed information about affected individuals with a specific disease or syndrome. 

Purpose of THE REGISTERY

The SWS Registry is collecting information with these goals:

  • Study why individuals have different symptoms.
  • Learn about how certain treatments work and don’t work.
  • Help medical professionals improve how they treat affected individuals with SWS.
  • Speed up research on SWS by collecting information that scientists can use.
  • Let affected individuals (or their families) know when they may be eligible for clinical research studies or clinical studies.

INFORMATION ABOUT JOINING THE REGISTERY

The Registry includes questions that can be sensitive and you may feel uncomfortable answering. You do not have to share any information you do not want to.

There is minimal risk in taking part in the Registry. There is a possible risk of breach of confidentiality. This risk is minimized by the security of the SWF computer system.

You may or may not receive any benefit from being in the Registry.We hope that others will be helped by what we learn from the Registry.

You do not have to join this Registry. Your participation in the Registry is entirely voluntary.

There is no cost to you and you will not be paid for joining the Registry.

You will be told about any new information that may affect whether you want to continue to take part in the Registry. 

If at any time you have questions about the Registry or want to talk with someone you may contact the Principal Investigator or the Registry Coordinator at the telephone number listed on the first page of this form.

If you have any questions or complaints about your rights as a participant in the Registry, you may contact Chesapeake IRB at 410-884-2900 (collect), by email at This e-mail address is being protected from spambots. You need JavaScript enabled to view it , or by mail at Study Subject Adviser, Chesapeake IRB, 7063 Columbia Gateway Drive, Suite 110, Columbia, MD 21046. Please reference the following number when contacting the Study Subject Adviser: Pro00008023.

1. Your information will be saved in the Registry using a code. The code is used so others don’t know who you are. The Registry may share your information with other registries or databases. This information may be used for research or to plan clinical studies. Do you give your permission for your information to be transferred to other registries and databases?

* This Field is required
Yes

2. If researchers learn anything interesting about your condition, do you want to be contacted by the Registry with this information?

* This Field is required

3. The Registry may get information about a clinical study that you might be eligible for. Do you want to be contacted with this information?

(Please note that even if the coordinators of a clinical study believe that you might be eligible for the study, based on the data about you stored in the Registry, it is still possible that later on it will turn out that you do not meet the study inclusion criteria (requirements) after all. Please also be aware that if we inform you about the existence of a study, this does not imply that we endorse it. In order to participate in any study, you will need to fill out a separate informed consent form.)

* This Field is required

4. It is important that the Registry information is up to date. We will contact you once a year to ask about changes in your medical condition. Periodically you will receive an email reminding you to update your profile. Do you give us permission to contact you for this information?

* This Field is required

5. Your participation in this project is entirely voluntary. Should you change your mind and wish to withdraw your data from the Registry, you will be free to do so without having to provide any explanation. Data accessed prior to your request for removal cannot be retrieved from researchers who have already accessed it. Do you understand this?

* This Field is required
Yes

6. The Registry has been fully explained to me. I understand the patient information and informed consent form. I also know how to access this document in the future if I want to review it. I have had the opportunity to ask questions of the Registry Coordinator. All my questions have been answered to my satisfaction.

* This Field is required
Yes

7. I agree to participate in The Registry.

* This Field is required
Yes

Signature:
* This Field is required
(Please type your name to indicate your 'signature')
Your Relationship to the affected person:
* This Field is required Information for: Your Relationship to the affected person : <p>
	Please tell us how you are related to the affected person.</p>
Name of Family Member with SWS:  
First Name:
* This Field is required
Last Name:
* This Field is required
Date of Signature:
* This Field is required
Your First Name:
* This Field is required
Your Last Name:
* This Field is required
Address:
* This Field is required
 
City
* This Field is required
State (USA Only):
Postal/Zip Code:
* This Field is required
Country:
* This Field is required
Primary Phone:
* This Field is required
Cellphone:
E-mail / Re-enter email:
* This Field is required Information for: Email : Please enter a valid e-mail address. A confirmation email will be sent to this address upon registration. * This Field is required Information for: Verify Email : Please enter a valid e-mail address. A confirmation email will be sent to this address upon registration.
Username:
* This Field is required Information for: Username : Please enter a valid username.  No spaces, at least 3 characters and contain 0-9,a-z,A-Z
Password / Re-enter Password:
* This Field is required Information for: Password : Please enter a valid password.  No spaces, at least 6 characters and contain lower and upper-case letters, numbers and special signs * This Field is required Information for: Verify Password : Please enter a valid password.  No spaces, at least 6 characters and contain lower and upper-case letters, numbers and special signs

Please enter the code below

Image with security code embedded in itclick here to hear the letters

* This Field is required Information for: Security Code: : Enter Security Code from image. If no image is present then try disabling your advertisement blocker and then refresh this page. Otherwise please contact the website administrator for assistance.

 
* This Field is required Required field | Information for: ? : Field description: Move mouse over icon Information: Point mouse to icon