Informed Consent Form
Nexus Narcolepsy Registry
Please read this form carefully so that you may decide whether or not to take part.
What is the NEXUS Narcolepsy Registry?
Nexus is a registry for individuals who have been diagnosed with narcolepsy by a doctor. It is part of a larger series of CONNECT rare disease registries. The purpose of the Nexus Registry is to collect information directly from people with narcolepsy in order to better understand their experience with the condition. The registry plans to enroll approximately 1,000 participants.
A description of this registry will be available on http://www.ClinicalTrials.gov, as required by U.S Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Participating in NEXUS
In order to participate in Nexus, we would like you to answer the Narcolepsy Survey, which will probably take you about 45-60 minutes to complete. You may complete the survey in more than one sitting. The registry study staff would then contact you via email every six months for 3 years, asking you to fill out follow-up surveys so that we can better understand the impact that the disease has on people over time. You can take part in as much or as little of the study as you want, and you can change your mind at any time.
What if I am already in a study at my doctor’s institution?
You will not be eligible to register if you are participating in a clinical trial in which you do not know (i.e., you are blinded to) what medication you are taking.
What happens to the information that I put in my profile, and who has access to it?
Only trained registry managers will have access to your identifying information. PatientCrossroads will store your study data in a secure database. All personal identifiers, such as your name or email address, are removed before your survey answers are shared. To advance the understanding of various health conditions, we ask you to contribute your de-identified survey answers (no personal identity is shared) into the pool of other participant answers. Because all CONNECT rare disease registries share survey answers, the information, in the form of standard reports and graphs that incorporate all of the participants’ data together, is available to the greater medical community. In addition, your survey answers without any of your personal information will be used together with the data from other respondents in the Nexus Registry by narcolepsy researchers (e.g., non-profit organizations, doctors, research scientists, medical investigators, pharmaceutical, biotech, and biomedical companies) and may be available to regulatory agencies such as the Food and Drug Administration (FDA) and Chesapeake IRB.
Are there any risks to taking part in the NEXUS study?
Although we will take every precaution to protect your personal information, there is a risk that your privacy may be compromised. This risk is minimized by protections described in the Confidentiality section below. Keeping the information from your survey in a secure computer database will limit that risk, but does not eliminate it.
Are there benefits to participating?
You may not receive a direct benefit if you agree to participate. You may receive information that you find helpful, such as seeing how your survey answers compare to the rest of the group in the database.
You will not be compensated for participating in the registry.
What happens if I don’t participate?
Taking part in the study is completely voluntary. You may choose not to participate. You will not be penalized or lose benefits if you do not take part or if you start the study and then decide to stop.
Sharing de-identified data and confidentiality
The Registry may share your data, but without any reference to your identity, with researchers and other databases, including the Global Rare Disease Registry and Data Repository (GRDR). No personal information, such as your name, phone number, email or other contact information will be shared. Everything possible will be done to protect your privacy at all times. A code will be used instead of your name. All of your study data will be kept in a secure location.
The sponsor, the sponsor’s representatives, the Food and Drug Administration (FDA), and Chesapeake IRB may have access to the study data.
How long will my participation last?
We plan to follow you and other registry participants every 6 months for as long as you are willing to participate or until the study is closed. Your permission for contact and use of your registry data will not end unless you cancel it. You may cancel it by sending written notice to PatientCrossroads at the email address listed below. However, information that has been uploaded before canceling will remain in the database. You will not be penalized or lose benefits if you cancel your participation.
Your part in the registry may stop at any time for any reason, such as the investigator decides to stop the study. If this happens you will be given the reason at that time.
You will be told about any new information found during the study that may affect whether you want to continue to take part.
There is no cost to you and you will not be paid for taking part in the registry.
Authorization to disclose health information
If you decide to be in this study, the investigator and study staff will use and share health data about you to conduct the study. Health data may include:
- Your name
- Date of birth
- Medical History
- Answers to the Narcolepsy Survey
Health data may come from your study records, your questionnaire responses or from the sleep studies that you may choose to upload to the NEXUS Web site.
For this study, the research team may share health data about you with authorized users. Authorized users may include:
- Representatives of Jazz Pharmaceuticals, Inc.
- Representatives of Chesapeake IRB (a Research Ethics Review Board that reviews this study).
- The Food and Drug Administration (FDA) and other US governmental agencies.
- Government agencies to whom certain diseases (like HIV, hepatitis, and STDs) must be reported.
- Governmental agencies of other countries.
- Labs working with the sponsor on this study.
- Other authorized users.
The sponsor and those working for the sponsor may use the health data sent to them.
- The purpose of the Nexus Registry is to collect information directly from people with narcolepsy in order to better understand their experience with the condition.
Once your health data has been shared with authorized users, it may no longer be protected by federal privacy law.
Your permission to use and share health data about you will not end unless required by state law. If state law applies, your permission to use and share health data about you will end on December 31, 2065.
You may take back your permission to use and share health data about you at any time by writing to the investigator. If you do this, you will not be able to stay in this study. No new health data that identifies you will be gathered after your written request is received. However, health data about you that has already been gathered may still be used and given to others as described in this form.
Your right to access your health data in the study records will be suspended during the study to keep from changing the study results. When the study is over, you can access your study health data.
If you decide not to sign this form, you will not be able to take part in the study.
Who may I contact if I have questions about participating?
You can ask questions about this consent form or the study (before you decide to start the study or at any time during the study). Questions may include:
- Your rights and your responsibilities as a study subject.
- Other questions.
You may contact the Nexus team at the email address listed at the bottom of this form for questions about the registry. If you have any questions or complaints about your rights as a research subject, contact:
Please reference the following number when contacting the Study Subject Adviser: Pro00012594.
An IRB is a group of people who review research studies to protect the rights and welfare of research participants.
For other questions, please contact PatientCrossroads at the email address listed below. PatientCrossroads is the organization that maintains the NEXUS Narcolepsy Registry website.
||NEXUS Narcolepsy Registry
4225 Executive Square
La Jolla, CA 92037