Tell me more about how the Registry protects the confidentiality of participants.
Your account will be protected by the username and password you select in setting up your account. The Registry has to follow rules to protect information about you. Federal and state laws also protect your privacy. Only the Registry director, Registry coordinators, and key staff at PatientCrossroads have the ability to see your personal information.
Upon registering, the Registry will assign you a unique numeric identifier. This number will be used in place of your identifying or personal information when researchers access the Registry. Any information that could identify you and your family members will not be shared without your approval. As previously noted, a subset of de-identified information collected from each registrant profile may be shared with certain other databases (including databases maintained by the National Institutes of Health) in order to develop global knowledge that may lead to new research studies, clinical trials, and clinical treatments.
What is the process I’ll go through if I choose to participate in the Registry?
- If you are an adult registering a child who is between the ages of 10 and 18, you must get the child’s assent to participate (their verbal permission), unless the child is unable to provide assent.
- If you are an adult acting on behalf of an individual who is 18 years or older who cannot make decisions for him/herself, you should have documentation of your authority to do so, for example, a court-appointed guardianship or advance directive.
- If you are an adult who is physically unable to enter your own data, you can appoint someone to enter data on your behalf with your input.
- You will indicate that you agree to participate in the Registry by providing your name, and contact information on the Account Registration page.
- You will be asked to print the signed consent form to keep a copy for yourself.
- You will be asked to provide basic contact information and to create a username and password to access the online Registry. A confirmation email will be sent to you.
- When you log into the Registry, you will be asked to complete three or more surveys. These include questions about clinical information, diagnoses, and experiences with Duchenne/Becker.
- You may take as much time as you need to complete the surveys. You can complete them at your own pace and can save what you have completed so that you can return to complete remaining questions at a later time.
- You will be asked to upload attachments to the Registry or otherwise allow us to access some pieces of information from your medical records. These may include genetic reports, medications, and heart and lung tests. We will provide you with more information on how you can obtain this information for the Registry after you have agreed to participate.
- The Registration process generally takes at least one hour to complete. You do not have to enter all of the information at once and we are here to help you. To help us obtain information with less work on your part, if your healthcare provider/system uses an electronic medical record system, DuchenneConnect may ask you to allow us to access some electronic information from your records to put into DuchenneConnect. We would provide you with a release form that you would have to sign before we could access your information.
What if I register myself/my child in more than one registry/database?
You may participate in more than one registry. DuchenneConnect explores and pursues opportunities to coordinate efforts with other registries. To identify registrants participating in more than one registry and to ensure effective coordination, DuchenneConnect uses certain checks and safeguards and always seeks to ensure the protection of your personal information
As a parent/guardian, how deeply should I involve my child in the registration process?
Every participant in this Registry should be well informed about the Registry, its purposes, and about the benefits and risks of participation. As previously noted, if you are a parent or legal guardian of a child who is between 10 and 18 years of age, you should ask for the child’s assent to participate in this registry. We recommend that any individual over the age of 18 register for himself, unless the parent or guardian maintains legal guardianship. Adult individuals with Duchenne/Becker muscular dystrophy may still need help completing the registration and answering the questions; there is no problem with another adult providing that help.
Will I be expected to provide the Registry with additional information in the future?
Yes. The Registry is most valuable for scientific research when it includes data important to emerging research questions, and when the data are kept up-to-date. Therefore, you will be asked to update your information from time to time. DuchenneConnect will send out notifications during the course of the year to remind you to add to and update your information. The Registry can also be updated whenever there is a change to a Registry question, such as a gain or loss of skill, change in medications, or new symptom.
Will I receive compensation for participating in the Registry?
You do not usually get compensation (money or gifts) for participating in the DuchenneConnect Registry. For some IRB-approved research studies, reasonable compensation may be provided to families for time spent completing additional questionnaires or uploading information to the Registry. In addition, DuchenneConnect conducts raffles where individuals who register, complete particular surveys, or share particular reports may be eligible to win a non-monetary prize or a gift card.
Will it cost me anything to participate in this Registry?
How is DuchenneConnect financially supported?
DuchenneConnect is a program of Parent Project Muscular Dystrophy. DuchenneConnect is supported by PPMD and by grants and awards. In addition, there is a fee for some data access and recruitment services that helps offset part of the cost of running the Registry. DuchenneConnect accepts donations to the Registry (please visit our homepage for information on making a donation).
I want to be involved in a clinical trial. If I register, is this guaranteed?
One of the main goals of the Registry is to make it easier for patients to participate in research, but there is no guarantee that that you or your family member will be eligible for a trial.
Some important notes:
- Even if the researchers believe that you might be eligible for the study, based on the data about you stored in the Registry, it is still possible that at a later date you may no longer meet the inclusion criteria.
- Also, you may appear not to be eligible for a study even when you are, if the answers to your Profile Survey are not up-to-date (genetic test results, mobility, and steroid use questions are particularly important).
- Even if DuchenneConnect informs you about the existence of a research 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 as part of that study.
I don’t want to be involved in a clinical trial. Should I still register?
Absolutely. We hope that you will still be willing to register, even if you don’t want to take part in a trial. Your information will still be useful to researchers who are trying to learn more about people with Duchenne or Becker muscular dystrophy and how to best manage symptoms over time.
Why is the consent document so long?
Ideally, informed consent is obtained in person after a conversation with a researcher or healthcare professional. Since we cannot meet with each potential registrant in person, we have written a document that explains the purpose of the registry, highlights the benefits and risks of participating, and tries to address all possible questions and concerns.
Who should I contact if I have any questions?