EBCare Registry


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Registry Information Sheet


This Registry Information Sheet provides detailed information about participation in the EBCare Registry.  Please read it carefully before you consent to participate and contact your local DEBRA office with any questions that you may have. To locate your nearest DEBRA office, please visit www.debra-international.org.

What is the EBCare Registry?
The Registry is a single, online database that collects and stores information provided by participants and includes personal and clinical information provided by patients with all forms of epidermolysis bullosa (EB). This information will be kept confidential by EBCare, LLC. The Registry is a research project that collects and stores information, and makes this information available to qualified researchers and others interested in studying the disorder with a view to diagnosing, characterizing, and treating the disease.

The Registry facilitates research by all qualified investigators who wish to study patient populations that are well characterized by accepted criteria. Once established, a Registry is a research resource that can support many diverse types of investigations, including clinical trials, performed by qualified researchers to help diagnose and treat disease.

By sharing your information with the EBCare Registry, you are helping create this valuable resource that does not currently exist.

By enrolling in the Registry, you are in no way committing yourself to participate in any Registry-related research project.  Your personal and confidential information will be  protected in accordance with applicable United States and international privacy and security regulations such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the European Union Data Directive as well as applicable state or national laws. 

Why an EBCare Registry?
Research projects and clinical trials are critical to the development of effective treatments for EB. Clinical research is the way that drugs, devices or other medical treatments are tested to see if they are safe and effective.  Recruitment of patients for clinical trials can often take a long period of time, especially for rare disorders such as EB and this can slow down the development of new therapies. An up to date Registry can speed up that process. This is an important first step to accelerate clinical studies for all forms of EB.  All of the personal information you provide will be kept strictly confidential by EBCare, LLC and the Registry will be compliant with applicable privacy and security regulations. Only de-identified data will be made available to qualified researchers. No information will be used that would make it possible for anyone to identify you in any presentations or written reports that utilize data from the Registry.  If a researcher wishes to identify and contact patients or use identifiable patient information in connection with a future research project, he or she will be required to comply with legal requirements, such as obtaining your consent. 

Vision
The vision for the Registry is to establish a global resource that will ultimately serve as a repository of information gathered from people affected by all forms of EB. 

Goal
The goal of the Registry is to facilitate communication between affected individuals, clinicians involved in their treatment, members of the health care community, and scientists who strive to advance research on the diagnosis and treatment of all forms of EB.

Objectives
The objectives of the Registry are to:
1.     Characterize and describe the experiences of individuals affected by all forms of EB.
2.     Identify EB treating physicians.
3.     Assist the development of clinical care guidelines.
4.     Facilitate in the planning of clinical trials.
5.     Facilitate clinical trials by informing the EB community in a timely fashion about new EB clinical trials and research projects.

By achieving these objectives it is hoped that the Registry will accelerate the development of effective therapies for all forms of EB.

Who Maintains and Funds the Registry?
EBCare, LLC maintains and coordinates the Registry and is guided by a Board of Managers that provides oversight and includes DEBRA International and DEBRA of America. 

Who Should Participate?
Individuals of all ages affected by all forms of EB may participate in the Registry. Those over the age of 18 can register and provide their own information. A family member or caregiver can enter information on the affected individual’s behalf with that individual’s consent. Individuals younger than 18 years of age should have a parent or guardian enter information on their behalf, and if they are able, to assent to participation in the Registry. EBCare, LLC is working with EB patient groups throughout the world so their members can participate. The success of this project requires a high level of patient participation and the value of the Registry is increased by each patient who contributes his or her information to the Registry.

Individual researchers should not register to participate in the Registry. If you are a qualified researcher interested in a research project that uses data from the Registry, please email This e-mail address is being protected from spambots. You need JavaScript enabled to view it with a brief proposal that will be submitted to the Board of Managers of EBCare LLC for approval.

How Can I Participate in the Registry?
The EBCare Registry was launched in February 2012, initially in English. In the future, we plan to develop versions of the Registry in other languages to facilitate more international participation. The Registry is accessed through the Internet and to participate you must register online and complete an easy-to-use questionnaire, which will be accessible to you after you register.

After reading this Registry Information Sheet carefully and completely, you should ask any questions that you may have before you consent to participate.  You must give consent prior to participating.  After checking the consent box, you will be registered as a participant and can start the questionnaire. You may stop entering information and end your participation in the Registry at any time. You may also suspend your participation, and later re-visit the Registry using the username and password you will create when you register to continue where you left off.

If there are multiple members of the family with EB, you can create a single-family account.  Register the first individual with EB, and then you will be able to add other family members at the end of the survey by clicking on the "Add a Family Member" tab.  Each family member must provide his or her own consent and complete an informed consent form before their data may be entered into the Registry. 

To maintain the utility of the Registry over time, it is important that you keep your profile periodically updated. If you move your home, change your email address or phone number, you will need to update your profile. EBCare, LLC, the administrator of the registry, will periodically remind you to update your information.

Will My Information Be Private?
EBCare, LLC is committed and obligated by law to ensure the privacy of all individuals who choose to participate in the Registry as well as the security of participant information. The United States has stringent laws in place to protect the privacy of identifiable health information for all individuals. The Registry was built by Innolyst, Inc./PatientCrossroads, a US software company that has built 200 disease registries and the Registry data is stored in secure servers located in the USA. The Web-based software program that Innolyst/Patient Crossroads is using for the Registry has been designed in accordance with applicable provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Non-profit and qualified researchers who are interested in studying EB can request de-identified information from the Registry. De-identified information does not contain any names or personal identifiers, and can be provided by EBCare, LLC to approved qualified researchers. without having to contact Registry participants. Information that can identify you (e.g., names, dates of birth, addresses) will never be released to qualified researchers without your express, written permission unless permitted or required by law. Qualified researchers may request contact with families to obtain specific information or to request participation in a research study or clinical trial requiring the use of identifiers. In advance of any such contact, qualified researchers will have obtained approval from their institutional review board (IRB) and otherwise complied with legal requirements.

An IRB is a committee that has been formally designated to approve, monitor, and review research involving human subjects and to protect the rights and welfare of the research subjects. An IRB approves, requires modifications in planned research prior to approval, or disapproves research. An IRB also performs critical oversight functions to ensure that research conducted on human subjects is scientifically sound, ethical, and performed in accordance with human subject protection regulations.  

After IRB approval of a proposed study, if you meet inclusion criteria, you may be contacted by the EBCare Registry Program Coordinator with a request for information. You can decide for yourself if you want to contact the researcher for more information and can choose to participate in the research project or clinical trial.  Your participation in the Registry does not guarantee that you will be accepted into any clinical trial.