Registration
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Informed Consent and HIPAA Authorization Form

Sponsor / Study Title: Jazz Pharmaceuticals, Inc. / “Nexus Narcolepsy Registry”
Principal Investigator: JeanPierre Coaquira, MPH
Principal Investigator Telephone: (650) 496-3641 (24 Hour)

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. 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. Over 1,000 participants are estimated to participate in this study.

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.

You can search for your study on the Web site using the identifier NCT02769780.

Participating in NEXUS

In order to participate in Nexus, we would like you to answer the Nexus Narcolepsy Registry 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, asking you to fill out follow-up surveys so that we can better understand the impact that the disease has on people over time. The registry platform is maintained by Invitae Corporation, a company with data processing capabilities. 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 kind of data is collected in the Nexus Narcolepsy Registry?

The questionnaire will collect health data, which includes: name, date of birth, demographics, experience with diagnosis, narcolepsy symptom severity, drug treatments, functioning, and quality of life.

What happens to the information that I put into the surveys, how is it protected and who has access to it?

As part of this research, health information about you will be collected. The Registry may share your data, but without any reference to your identity (unless you share such protected health information [PHI] within free text responses) with researchers and other databases, including the Global Rare Disease Registry and Data Repository (GRDR). 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. Study staff will read all free text answers you provide and therefore there is a risk that if any of your free text answers contain your identifying information your responses may not be confidential.

Your de-identified responses will be combined with those from other participants. The results of this study may be shown at meetings and published in journals to inform other doctors and health professionals, but your identity will be kept private. Authorized users may review or receive your identifiable health information. They will need this information to conduct the research, to assure the quality of the data, and/or to analyze the data. These authorized users include:

  • Members of the research team, including data processing partners
  • Authorized staff at Invitae Corporation
  • People from agencies and organizations that perform independent accreditation and/or oversight of research, such as the Department of Health and Human Services, Office for Human Research Protections
  • Representatives of Jazz Pharmaceuticals, Inc. who is the study sponsor funding this research
  • Representatives of Advarra IRB (a Research Ethics Review Board that reviews this study).
  • The Food and Drug Administration (FDA) and other U.S. governmental agencies.
  • Government agencies of other countries

Are there any risks to taking part in the NEXUS Narcolepsy Registry?

We will do our best to keep your personal information private and confidential. Only a unique code number will be used to identify your data. However, we cannot guarantee absolute confidentiality. Keeping the information from your survey in a secure computer database will limit risk, but does not eliminate it. Your personal information may be disclosed if required by law.

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. Additionally, contributing to the Nexus Narcolepsy Registry helps researchers better understand narcolepsy.

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. If you do not consent to the terms described by this form, you cannot participate in this research.

Do you need to give your consent in order to participate?

If you decide to participate in this study, you must consent to the terms described by this form. A copy will be available to download from the main profile page. Please consider the study time commitments and responsibilities as a research participant when making your decision about participating in this study.

What about privacy, authorization for use of Protected Health Information (PHI) and confidentiality?

By law, Invitae is required to protect your health information. The research staff will only allow access to your health information to the groups listed above. By consenting to the terms of this document, you are authorizing the Nexus Narcolepsy Registry to use your health information for this research. There is no set time for destroying the information that will be collected for this study. Researchers continue to analyze data for many years and it is not possible to know when they will be completely done. 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.

If you decide not to sign and date this form, you will not be able to take part in the study.

How long will my participation last?

We plan to follow-up with 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 writing to the investigator (coordinator@narcolepsyregistry.com). However, information that has been uploaded before canceling will remain in the database and shared with others as described in this form. You will not be penalized or lose benefits if you cancel your participation.

Additionally, the registry may stop at any time for any reason, such as if the investigator decides to stop the study.

Will I be paid for taking part in this study?

There is no cost to you to participate and you will not be paid for taking part in the registry.

Who is funding this research study?

This study is supported by Jazz Pharmaceuticals, a drug company that develops pharmacologic agents for sleep disorders and other conditions. The results of the study will be reported to Jazz Pharmaceuticals.

Will I be able to access my records?

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.

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) by contacting Invitae Corporation at the email address listed below. Invitae Corporation is the organization that maintains the NEXUS Narcolepsy Registry website platform.

Study Title: NEXUS Narcolepsy Registry
Contact Information: Invitae at
coordinator@narcolepsyregistry.com
Address: Invitae Corporation
1400 16th Street
San Francisco, CA 94103

You may contact the Nexus team at the email address listed at the bottom of this form for questions about the registry.

Whom to contact about the study

During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study, please contact the Investigator at the telephone number listed at the top of this consent document. If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.

An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, and/or concerns or complaints regarding this research study, contact:

  • By mail:

    Study Participant Adviser
    Advarra IRB
    6940 Columbia Gateway Drive, Suite 110
    Columbia, MD 21046

  • or call toll free:   877-992-4724
  • or by email:        adviser@advarra.com

Please reference the following number when contacting the Study Participant Adviser: Pro00012594.

Consent to Take Part in this Research Study and Authorization to Use and Disclose Health Information for the Research

We would now like to find out if you would like to take part in the Nexus Narcolepsy Registry. Please make your choice below. You can change your mind at any time.

Account Registration

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Permission

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By clicking the box, you agree to participate. If you change your mind and wish to stop participating, you are free to do so without having to provide any explanation. You also agree to the terms and conditions and privacy policy.


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