Registration
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Account Registration

PatientCrossroads collects health information in a way that protects your privacy and allows you to control access to your information. To register, you must meet one of the following:

  • Have or be at risk to develop a food allergy be, age 18 or older and be able to make your own medical decisions
  • Represent a child or dependent who has or is at risk to develop a health condition and for whom you can legally make medical decisions

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Account Holder

The person entering the data
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Information for: Your Relationship to Participant : <p>Please tell us how you are related to the participant.</p>
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Sponsor / Study Title:

Food Allergy Research & Education (FARE) / “The FARE Patient Registry: A Registry for Patients with Food Allergy”
Principal Investigator:
Study Doctor
James Baker, MD
Telephone: (646) 559-6226 (24 Hours)
Additional Contacts:
(Study Staff)
Luis Garcia
Jonathan Spergel, MD
Stephen Tilles, MD
Address: Food Allergy Research & Education (FARE)
7925 Jones Branch Drive, Suite 1100
McLean, VA 22102

 

Review the Informed Consent Form for Adult Subject / Parent / Legal Guardian / Legally Authorized Representative / Participant Turning 18 Years Old

Information about the FARE Patient Registry
Before you agree to participate in the FARE Patient Registry, it is important that you understand what is involved and what will be done with the information you provide. This form provides information about the FARE Patient Registry.

This form is for use in a research study that may involve adult participants who may or may not have the capacity to consent to take part in the study. Accordingly, when the participant cannot legally consent to take part, pronouns "you" and "your" should be read as referring to the participant rather than the person (legally authorized representative) who is signing this form for the participant.  Please read this form carefully. Reading this form and talking to the Investigator or registry staff may help you decide whether to take part or not.  Take time to ask the Investigator or registry staff as many questions about the FARE Patient Registry as you would like. The Investigator or registry staff can answer as many questions about the FARE Patient Registry as you would like.  

If you are the parent or legal guardian of a child who may take part in this study, your permission and the permission of your child will be needed.  When “you” appears in this form, it may refer to you or your child.  

For questions about the goals of the FARE Patient Registry, contact the Investigator at patientregistry@foodallergy.org.  For all other questions, contact the FARE Patient Registry Coordinator at fare.coordinator@altavoice.com.

We suggest that you print a copy of this form for your records. A copy of the information in this form will also be available to you via your website account. Additional information about this study is available in the FARE Patient Registry FAQ.

Purpose of the FARE Patient Registry
The FARE Patient Registry was created in order to help characterize the extent of the food allergy problem, including allergies to specific foods.  The registry aims to accomplish this by creating a food allergy reporting system and storing detailed health and other basic information about people with food allergies and encourage open sharing of de-identified data (no personal identifiable information is shared).  A registry keeps information in one place making it easier for researchers to share and study information, while still protecting the privacy of those who take part.

The objectives of the FARE Patient Registry are to:

  • Develop an online reporting system to capture real-time data on food allergy reactions.
  • Facilitate demographic studies to understand the epidemiology of food allergy. Epidemiology studies the health of a large number of people.
  • Help in the development of diagnostic tests, biomarkers (proteins) and therapies by increasing participation in clinical trials and research studies for patients with food allergy.
  • Identify psychosocial determinants that influence food allergy reactions. Psychosocial studies the effect of the environment on the behavior of a person.
  • Study the natural history of food allergy and how it impacts the quality of life of patients
  • Understand the frequency of food allergy reactions and under what conditions they occur.

Participating in the FARE Patient Registry
The registry already contains information from over 1500 patients with food allergies, and does not have a limit to the number of people who may join.  Your participation in this study is completely voluntary.  In order to participate in the FARE Patient Registry, you will be asked to provide demographic information such as your name, date of birth, gender and location of residence.  You will also be asked to complete online surveys, of varying lengths or otherwise enter information about yourself such as healthcare providers, family members, and medical records into the FARE Patient Registry website. Each survey will take approximately 15-20 minutes to complete.  Additional surveys will be added based on information that you provide and your participation is ongoing. You will be asked to provide copies of medical evaluations and assessments, including serum IgE blood test (an allergy lab test), skin prick tests and genetic test results, as indicated by the study.

Your doctor may update the registry database with information obtained from electronic health records including changes in your condition, diagnostic tests or treatments.  Reminders will be sent to participants via email and website/app notifications when surveys or other tasks are due or missing. FARE Patient Registry staff will contact participants for clarification regarding incomplete or missing assessments.

Additional optional surveys may be added in the future to better understand the impact that food allergies and its treatment have on patients over time.  The FARE Patient Registry program staff will notify you at the time when additional surveys are available.

Giving consent below means that you agree to let the FARE Patient Registry use the information that you provide to the registry for research.  Self-reported information also includes previously entered data that was submitted to and collected by the registry prior to giving consent to participate in this study including answers and other data collected in the food allergy initial survey.  You do not have to enter information you do not feel comfortable with and you may choose to complete all, some, or none of the surveys.  Finally, participants will be provided the option to take part and opt-in to future studies conducted by the FARE Patient Registry and FARE.

Your “de-identified” or “de-coded” information will be labeled with a unique code number to protect your privacy.
If available in the future, you may choose to share de-identified information with other databases, such as the National Institute of Health (NIH) or the National Center for Biotechnology Information (NCBI), which may help to expand research on food allergies.  In the event of any publication or presentation resulting from the study, no personally identifiable information will be shared.
During your participation in the registry, you may be asked if you are willing to be contacted by the
FARE or other parties and provide identifying information at that time. In addition, your identifying information may be shared to the extent required by law. You may also learn of other research opportunities through this food allergy registry, and may have the opportunity to contact other researchers. Any information that you share with anyone outside of the FARE Patient Registry is your choice and not covered by the steps the FARE Patient Registry takes to de-identify information.

What are the potential benefits of participating?
You may not benefit directly from participating in the FARE Patient Registry. You may receive information that you find helpful, such as information about the FARE Patient Registry study or food allergies.  The information collected by the FARE Patient Registry may help researchers gain a better understanding of food allergies and may lead to better diagnostic tests and treatments.  By taking surveys you may learn about FARE Patient Registry research findings, including how your answers compare with those of other food allergy patients and new discoveries made by FARE research programs.
 
What are the potential risks of participating?
There are no major risks associated with participation in this study.  None of the surveys or tools used in the FARE Patient Registry study are interventional, invasive or experimental and involve minimal risk as described hereafter.  Although we will take every precaution to protect your personal information, there is a risk that your privacy may be compromised. In the unlikely situation where this happens, you will be notified right away. Keeping the information from your survey in a secure computer database will limit that risk, but does not eliminate it. FARE Patient Registry staff are trained on how to work with human research participants.   If you share your login and password with others, they may be able to access your account and self-reported survey answers.  There may be other risks that are currently unknown.

There may be risks of loss of privacy and confidentiality if the PDF copy of this consent form is viewed and/or stored on a personal electronic device (PED), especially if that PED is shared with other users or is lost, hacked, or subject to a search warrant or subpoena.
If you change your mind and no longer want to be part of the FARE Patient Registry, you may contact the FARE Patient Registry Coordinator by e-mail at fare.coordinator@altavoice.com. Your account will be deleted; however, data previously collected and de-identified before you decided to withdraw from the FARE Patient Registry cannot be retrieved.  The FARE Patient registry cannot retract the use of de-identified data from studies prior to the date you decided to opt-out.  In the event this study is terminated, FARE will maintain your participant data according to the terms of our Privacy Statement.
You may decide to not participate or you may leave the Registry at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled.
This Registry is for research purposes only. The only alternative is to not participate in this Registry.
There is no cost to you for taking part in this Registry.
You will be told about any new information found during your participation in the Registry that may affect whether you want to continue to take part.  

Who do I contact if I have any questions?
Dial 911 immediately in the event of an emergency.  If you have any questions about the FARE Patient Registry or about your rights as a participant, you may contact the FARE Patient Registry Coordinator by e-mail at fare.coordinator@altavoice.com. If you have any questions or complaints about your rights as a research subject, contact: the Chesapeake Institutional Review Board:

  • By mail:
         Study Subject Adviser
         Chesapeake Research Review, Inc.
         7063 Columbia Gateway Drive, Suite 110
         Columbia, MD 21046
  • or call collect: 410-884-2900
  • or by email: adviser@irbinfo.com

Please reference the following number when contacting the Study Subject Adviser: Pro00022715.

Health data may come from your medical records and assessments, your questionnaire responses or any additional information that you may choose to provide to the FARE Patient Registry. The FARE Patient Registry study investigators, study staff and doctors may access and use the health data, including identifiable data that you provide to the registry.

The FARE Patient Registry may share de-identified health data about you with authorized users. Authorized users may include:

  • The sponsor (FARE) and those working for the sponsor.
  • Representatives of Chesapeake Institutional Review Board (IRB, an ethics board that reviews the FARE Patient Registry).
  • The Food and Drug Administration (FDA) and other US governmental agencies.
  • Governmental agencies of other countries.
  • Labs working with the sponsor on this study.
  • Other authorized users.

 

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) protects the privacy and security of individual health information. In compliance with these regulations, the FARE Patient Registry has multiple levels of security. These safeguards include data elements (for example, restricted access to fields), user access (for example, a password is needed to enter the FARE Patient Registry), application (for example, role-based access to features, access audit trails), and hosting services (for example, firewall, secure sockets layer). These safety features help to make sure that private health information is protected from those who should not have access to it.

Your participation in this research will be kept private to the extent permitted by law. However, it is possible that other people may become aware of your participation in the FARE Patient Registry. We might have to release your private information in a few specific situations—if it is required by the any of the following:

  • Food and Drug Administration (FDA) or representatives from regulatory agencies in other countries.
  • Chesapeake Institutional Review Board.
  • Law enforcement officials.

 

Once your health data has been shared with authorized users, it may no longer be protected by federal privacy law.

The sponsor and those working for the sponsor may use the health data sent to them:

  • To help characterize the extent of the food allergy problem, including allergies to specific foods.

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, 2067.

You may take back your permission to use and share health data about you at any time by contacting the FARE Patient Registry Coordinator by email at fare.coordinator@altavoice.com. If you do this, you will not be able to stay in the FARE Patient Registry. 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. If you decide not to agree to sharing your health data, you will not be able to take part in the Registry.

If you are the parent, guardian or legally authorized representative of a person with food allergies, you may provide informed consent on behalf of the person if you agree to have the person’s information included in the FARE Patient Registry. The Legally Authorized Representative is the person legally responsible for the care of an adult person with food allergies.

Please agree to the statements below if you would like to join the FARE Patient Registry.

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