Registration
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Welcome to the FARE Patient Registry

Your Food Allergy Story Drives Research Forward

Join if you are an adult with a physician-diagnosed food allergy – or represent a food-allergic child – and can provide informed medical consent (permission).

Step 1

Sign up and create a secure profile

5 Mins

Step 2

Complete our surveys

5-10 Mins

Step 3

Return occasionally to log food allergy reactions or take new surveys

Review FAQ to learn how your personal data is protected, and more.

Asterisk (*) means questions are required

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Information for: Your Relationship to Participant : <p><span style="color: #000000; font-family: Arial; font-size: 15px; font-style: normal; font-weight: 400; letter-spacing: normal; text-align: left; text-indent: 0px; text-transform: none; white-space: pre-wrap; word-spacing: 0px; background-color: #ffffff; float: none;">The participant is the person with diagnosed food allergies.</span>
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Study Information and Consent

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Sponsor / Study Title:

Food Allergy Research & Education (FARE) / "A Registry for the Food Allergy Community"
Protocol # Pro00022715
Principal Investigator:
(Study Doctor)
Thomas B. Casale, MD
Telephone:
1-800-929-4040
Address: Food Allergy Research & Education (FARE)
7901 Jones Branch Drive, Suite 240
McLean, VA 22102

 

This form is for people aged 18 years or older.

 

This form gives information about the Food Allergy Research and Education (FARE) Registry.  It explains what you will be asked to do if you join and explains the risks and possible benefits.  Please read this form carefully.  If you have questions, there is a list of people you can ask at the end of this form. 

 

Why am I being invited to join the FARE Registry?

 

You (or your child) are invited to take part in the FARE Registry, which is a research study about food allergy.  We are inviting you because you (or your child) had an allergic reaction to food. 

 

The purpose of this consent and authorization form is to give you information to help you decide whether to be in the study.  It also explains how health information will be used for this study and for other research in the future.  This form is also for you to give your permission for your health information to be used in research.  You can ask questions about anything in this form that is not clear (scroll down to see how to contact us to ask questions).  If you want to talk to your family and friends before making your decision, you can.  When all of your questions have been answered, you can decide if you want to be in the study. 

 

What is the FARE Registry?  

 

The FARE Registry is a research study funded by Food Allergy Research & Education, Inc.  The purpose of this study is to gather information from real people with food allergies.  We are doing this research to understand how many people are affected by food allergies, what foods they are allergic to, what it feels like to have an allergic reaction, and how food allergy affects a person’s life.  If you join, we will gather data about you and combine it with data from other people who join the study.  This information will help researchers understand who is at risk for developing a food allergy, how food allergies may be prevented in the future, and discovering new ways to diagnose and treat food allergy. 

     

This study is being done at more than 50 places in the United States.  More than 12,000 volunteers have already joined the study.  Our goal is to collect data on more than 32,000 people with food allergy.

 

What will happen in this study?  What will you ask me to do if I join?

If you decide to participate in this study, we will gather information about you. 

  1. Basic Data

We will ask you for information like your name, date of birth, and contact information. 

   2. Survey Data

We will ask you to complete one or more surveys about your food allergy.  Each survey may take up to 15 minutes to complete.  You may skip any question that you do not wish to answer.

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

 

What will you do with my data?

 

We will store your data securely, along with the data from all the other people who take part in the FARE Registry.  Researchers will use the data to make discoveries. 

 

There is a public database on the FARE website where participants can compare their survey answers with other members of the food allergy community who have selected to participate in the FARE Registry.  The data in the public database is about all volunteers in the group.  It does not include data about individual people.  It does not include your name or other data that directly identifies you. 

 

We have also created a scientific database.  The scientific database will have individual-level data.  Access to this database is controlled.  Researchers have to be approved by FARE to receive deidentified data (that is, data that has had names and other information that could be used to identify individuals removed).  These researchers may be from anywhere in the world. 

 

Except if you withdraw or “quit” or there are limits imposed by law, there is no limit on the length of time we will store your data.  Researchers will use your data for research long into the future.

 

What else will you ask me to do?

 

We may ask if you want to hear about chances to take part in other food allergy studies.  You can say yes or no to taking part in other studies.  You can say no and still take part in the FARE Registry. 

 

Are there any risks to joining the FARE Registry?

 

There is a risk that if people other than the researchers get your medical information, they could misuse it.  FARE has strict privacy and confidentiality protection rules to prevent this from happening so the chance is very small.  To help prevent others from finding out anything about you, your name and other information that directly identifies you will not be included with your survey information.

 

The main risk of taking part in the FARE Registry is your privacy.  A data breach is when someone sees or uses data without permission.  If there is a data breach, someone could see or use the data we gather about you.  Even without your name, there is a chance someone could figure out who you are.  They could misuse your data.  We believe the chance of this is very small, but it is not zero. 

 

Taking part in the FARE Registry may have risks that we do not know about yet.  We will tell you if we learn anything that might change your decision to take part.

 

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

 

As part of this research, health information about you will be collected.   We will do our best to keep your personal information private and confidential. However, we cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law.

The results of this study may be shown at meetings and published in journals to inform other doctors and health professionals. We will keep your identity private in any publication or presentation.

 

Several people and organizations may review or receive your identifiable information. They will need this information to conduct the research, to assure the quality of the data, or to analyze the data. These groups include:

  • Members of the research team and other authorized staff at FARE;
  • 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.
  • The Data Coordinating Center at Children’s Hospital of Philadelphia

By law, FARE is required to protect your health information. The research staff will only allow access to your health information to the groups listed above.  By signing this document, you are authorizing FARE to use and/or release your health information for this research. Some of the organizations listed above may not be required to protect your information under Federal privacy laws. If permitted by law, they may be allowed to share it with others without your permission. 

 

There is no set time for destroying the information that will be collected for this study. Your permission to use and share the information and data from this study will continue until the research study ends and will not expire. Researchers continue to analyze data for many years and it is not possible to know when they will be completely done.

 

What will you do to protect my privacy? 

Your privacy is very important to us.  We will take great care to protect it.  Here are a few steps we will take:

  • Data we have about you will be stored on protected computers.  We will limit and keep track of who can see this data.
  • We will limit who is allowed to see information that could directly identify you, like your name and contact information.
  • We will tell you if there is a data breach.

Will you ever give out my name or other information that identifies me?  Who will be able to see my records?

 

FARE will not provide survey data to your family, your insurance company, your employer or others.  Research information from this study will not become part of your medical records. 

Unless required by law, health data which identify you and this consent form may be looked at and/or copied for research purposes by:

  • FARE and those working for FARE
  • The Institutional Review Board (the committee that is in charge of protecting the rights of all adults and children who take part in research studies)

All identifying information collected in this study will be kept strictly confidential, except as may be required by law or regulatory authority.  Because of the need to release information, complete confidentiality cannot be promised.  The study results may be published in medical journals or presented at medical meetings, but your identity will not be revealed.

 

There are a few times when we might need to give out your name or other information that identifies you.

  • We will give out information about you to protect your health or the health of others.  For example:
    • If we learn or suspect that you are being abused.
    • If we learn or suspect you are abusing, neglecting, or have abandoned someone who depends on you for care, like a child or dependent adult.
    • If we learn that you plan to harm yourself or someone else.
    • If we learn that you have a disease that is a risk to public health, like measles.
  • We will give out any data needed to meet U.S. research laws and regulations.  This may include information that identifies you.

Once your information is shared with the FARE Registry, it may no longer be protected by  certain patient privacy rules governing clinical data (like the Health Insurance Portability and Accountability Act, or HIPAA). 

 

However, it will still be protected by other privacy rules.  These include the rules that researchers must follow to access the FARE Registry scientific database. 

 

Will being in this study benefit or help me in any way?

You may indirectly benefit from taking part in the FARE Registry.  Being in this study may help you learn more about your condition.  However, we cannot promise this will happen.  Even if the study does not help you directly, your participation in this study may benefit other people in the future by helping researchers make discoveries that may help future generations.

 

Will being in this study cost me anything?

There are no direct costs to taking part in the FARE Registry. 

 

Will I be paid or receive anything for being in this study?

We will not pay you to complete surveys.

 

Researchers will use your data to make discoveries.  If any of their studies lead to new tests, drugs, or commercial products, you will not get any profits.  These inventions will be the property of the researchers who develop them. 

 

Do I have to take part in the FARE Registry? 

No, you do not have to be in this study. Taking part in research is voluntary.  No matter what you decide, now or in the future, it will not affect your medical care.

 

What if I say “yes” now and change my mind later?

If you decide not to take part in the study, or if you choose to leave the study, your choice will not affect any treatment relationship you have with healthcare providers or any services you receive from them.  No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights.

 

Your authorization for researchers to use your protected health information (PHI) does not have an end date.  However:

  • You can choose to take back your authorization for researchers to use your health information.  You can do this at any time before or during your participation in the research.
  • If you take back your authorization, information that was already collected may still be used and shared with others, but the researchers will no longer be able to collect NEW information about you. 
  • If you take back your authorization, you will not be able to take part in the research study.
  • To take back your authorization, you will need to tell the researchers by writing to the Lead Researcher, Dr. Thomas Casale, at 7901 Jones Branch Drive, Suite 240, McLean, VA  22102.

Who can answer my questions?

Questions about the FARE Registry

Questions about your rights as a research subject

Registry Coordinator

Food Allergy Research & Education, Inc.

7901 Jones Branch Drive, Suite 240

McLean, VA  22102

1-800-929-4040

farepatientregistry@foodallergy.org

Study Subject Advisor

Advarra Institutional Review Board (IRB)

6940 Columbia Gateway Drive, Suite 110

Columbia, MD 21046

1-877-992-4724

adviser@advarra.com

 

I have read and understand the information in this consent and authorization form.

I know and agree that:

  • My participation is voluntary.
  • This FARE Patient Registry is for research purposes only.
  • My data will be stored in the FARE database.
  • Researchers will do studies using the FARE database, and their research may be on nearly any allergy topic.
  • My contact information may be used to tell me about other studies.
  • I can withdraw (quit) at any time, and there is no penalty if I withdraw.

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