Research

Food Allergy Patient & Family Registry Frequently Asked Questions

1. What is the Food Allergy Patient & Family Registry?

The Food Allergy Patient & Family Registry is a new project that invites you, as a person who has food allergies or a caregiver of someone who has food allergies, to share opinions, experiences and other information about living with food allergies. The information you share is stored in a secure database sponsored by the Asthma and Allergy Foundation of America (AAFA).

You can sign up to participate in the Registry for yourself and for one or more family members, such as minor children. If you have food allergies and wish to participate, sign up and describe your own experiences by completing a survey questionnaire. If you have one or more children with food allergies, please add a new profile to your account for each child, and then fill out a new survey for them.

Adult participants (age 18 and older) should complete their own surveys.

In this patient registry, you manage and control your own data. Most importantly, all patient data from the Registry that is used for research is de-identified prior to being used by researchers. This means that your name and other identifying information are not shared with anyone.

The information you share in the Food Allergy Patient & Family Registry will help us be able to:

  • Advance research.
  • Create knowledge that can benefit patients with food allergies.
  • Help improve care and treatment for people with food allergies.
  • Understand what is most important to people with food allergies.
  • Learn more about how food allergies affect people in their daily lives.
  • Help researchers better understand and improve treatments, and find out more about which ones are most effective.
  • Improve quality of life for people living with food allergies.
  • Contribute to research that will ultimately find a cure for food allergies.

By joining the Registry, you can also help influence the type and focus of research studies conducted, so that they are on the health topics most important to you and your family.

2. How can I take part?

If you are of legal age (at least 18 years old in most states), just sign up. Otherwise, a parent, legal guardian or custodian can create a profile for a child under 18 and enter the information. You may create multiple profiles for different individuals. For example, as a parent, you may create a profile for yourself, and another for a young daughter. Once the minor child reaches legal age, they may take charge of their own profile. Please contact us for help transferring profiles.

To participate, you will need access to a desktop computer and the internet. We recommend browsers such as Firefox, Chrome or Safari. At this time, Internet Explorer or Edge are not compatible with our portal.

3. Do I have to participate?

No. It is up to you if you want to join. And even if you join, you may withdraw from the Food Allergy Patient & Family Registry at any time. For more information on how to withdraw, please see Question 15.

4. What’s expected of me after I join?

You will be asked to complete an initial questionnaire. After this, you will periodically receive requests to take other surveys. We will ask you how you are doing and other questions related to food allergies. The surveys will usually be brief (20 to 30 minutes). You can finish the surveys in more than one sitting, if needed.

5. Who can access my data and how?

This will be up to you. By controlling your health information and contact information, you will tell us who can access your data. You will use a customized control panel (or dashboard) to state your sharing, privacy and data access wishes. These can be updated at any time.

6. How will the Food Allergy Patient & Family Registry use my data?

You choose how your data may be shared. Use of the data is restricted according to your personal privacy settings.

You will customize these settings when you make your Food Allergy Patient & Family Registry account. You decide how much information you share with AAFA when you create your account. AAFA sponsors and manages the registry. AAFA will use your data to conduct food allergy research that is patient-centered. Our Food Allergy Patient & Family Registry team will analyze these data on its own and in partnership with researchers and clinicians.

You may also choose to share your data with independent researchers working on patient-centered research projects approved by AAFA. We call these researchers “recommended researchers.”

The Food Allergy Patient & Family Registry team plans to provide feedback to participants about data collected via newsletters, reports or emails. The team may also participate in writing articles in peer-reviewed journal publications or presentations. Any presentations or publications will never include any information that could identify you, even if you agree to share contact information with us. In addition, AAFA may reach out to you in the future, such as for other studies or surveys.

7. What about clinical trials?

From time to time, researchers might contact AAFA to recruit patients for studies or clinical trials (such as testing new treatments).

AAFA’s Registry committee will review these requests to confirm that the proposed research meets our research criteria. If outside researchers meet these criteria, then they may be able to act as “recommended researchers.” AAFA will identify all recommended researchers so that participants know that AAFA has reviewed and approved their research study(ies). AAFA will provide a list of recommended researchers upon request. All studies will need Institutional Review Board (IRB) review and approval.

Researchers will be able to contact you about one of these pre-approved research projects only if you have set your privacy settings in the Food Allergy Patient & Family Registry to allow them to do so.

There are three options, depending on your privacy setting:

  • “Allow” means you agreed to share contact information with recommended researchers. They can contact you about the proposed study right away.
  • “Ask Me” means the Registry will let you know about the study through your account. You can decide whether you want to provide your contact information to the researcher.
  • “Deny” means none of them may contact you.

Please note: by default, everyone using the registry starts out with “Allow” as their default setting for sharing contact information with recommended researchers. You can change this at any time by visiting your privacy settings.

8. What is patient-centered research?

Patient-centered research is research from the patient’s perspective. This type of research is intended to improve the quality of life for patients or to increase our understanding of disease using insights from patients.

New information and internet technologies allow patients to combine their data for research. We can begin to see important patterns about food allergies when we combine the data of hundreds or thousands of patients.

Your data will not include your name or other identifiers. But when we combine your data with others, our analysis can help begin to answer important questions about the course of food allergies, illness and factors that affect everyone with food allergies.

9. What about clinical trials?

From time to time, researchers might contact AAFA to recruit patients for studies or clinical trials (such as testing new treatments).

AAFA’s Registry committee will review these requests to confirm that the proposed research meets our research criteria. If outside researchers meet these criteria, then they may be able to act as “recommended researchers.” AAFA will identify all recommended researchers so that participants know that AAFA has reviewed and approved their research study(ies). AAFA will provide a list of recommended researchers upon request. All studies will need Institutional Review Board (IRB) review and approval.

Researchers will be able to contact you about one of these pre-approved research projects only if you have set your privacy settings in the Food Allergy Patient & Family Registry to allow them to do so.

There are three options, depending on your privacy setting:

  • “Allow” means you agreed to share contact information with recommended researchers. They can contact you about the proposed study right away.
  • “Ask Me” means the Registry will let you know about the study through your account. You can decide whether you want to provide your contact information to the researcher.
  • “Deny” means none of them may contact you.

Please note: by default, everyone using the registry starts out with “Allow” as their default setting for sharing contact information with recommended researchers. You can change this at any time by visiting your privacy settings.

10. Is my information secure?

Yes, your information will be kept in a secure database. To protect your confidentiality we will use only secure computers and secure ways of moving your information.

11. What about privacy?

We take privacy VERY seriously. We have partnered with experts in the field of online protection and privacy to protect your information and keep it secure (see Question 6 and 10 for more details). Private Access, an award-winning consent management and access control technology developer, is the technology partner for the Food Allergy Patient & Family Registry. Their PrivacyLayer® system ensures that your wishes for sharing your health information and/or contact information is carried out exactly as expressed in your privacy settings.

AAFA and other researchers will only have access to your health and/or contact information if you allow it. And, even if you do choose to share your contact information with us, AAFA will only share your health information (and not your name or contact information) in AAFA research projects. We also require recommended researchers to do the same: to ensure that your contact information and name will never be publicly shared.

Joining this Registry is also entirely voluntary. You do not have to share any information you do not want to. With few exceptions, you can skip questions you prefer not to answer. You are free to withdraw from the Registry at any time, without having to provide any explanation, as well. (See Question 17 for more information about privacy.)

12. Are there any risks from participating in the Food Allergy Patient & Family Registry?

The risks associated with taking part in the Food Allergy Patient & Family Registry are minimal. You may be uncomfortable answering some questions in the surveys. However, you do not need to share any information unless you want to. As described in the privacy question above, there are strong safeguards in place to avoid a security breach. Should this unlikely event occur, we will notify everyone.

13. Is there an Institutional Review Board (IRB) approval for this registry, and if so by what Board?

Yes – actually there are several. An IRB is a committee that reviews and approves research studies involving people as subjects. The overall technology platform for this registry is called the Platform for Engaging Everyone Responsibly, or PEER. The Western Institutional Review Board (WIRB) initially reviewed and approved PEER in June 2014, and granted a renewal in June 2016. We note the WIRB approval in a Prospective Participant Informational Notice included in the verification email we send to anyone signing up for the Registry.

In addition to WIRB, the Genetic Alliance IRB has also reviewed the questionnaire and marketing materials for the Food Allergy Patient & Family Registry, as well as other details. The Genetic Alliance Ethics Team also oversees this work. The team has been instrumental in creating PEER and its approach to privacy. PEER technology lets people set detailed privacy and access settings for their data. This data can be easily updated at any time.

14. Who owns the data in the Food Allergy Patient & Family Registry?

The individual participant owns his or her data in the Registry. Privacy and sharing settings allow each person to choose how much of their health data, and with whom, to share. Data will only be shared according to these instructions.

15. How can I withdraw from the Registry?

There are two ways in which you may withdraw from the Registry. You may remove your health information. Or, if you prefer, you may contact us to delete your account. This will delete your contact information as well.

To remove your health data (or the health data of a profile that you are entering information for):

  • Select the profile for which you’d like to remove health information.
  • From your profile menu (accessed through the menu dropdown in the top-left corner of the registry screen), click on “Erase Health Data.”
  • Confirm that you wish to remove health data from the profile in question.
  • Once you erase this information, it cannot be retrieved.

To delete your account and contact information:

Please contact the Food Allergy Patient & Family Registry if you have been entering information for yourself, and would like to delete both your profile and account. Remember that accounts are separate from profiles: one account can contain multiple profiles. For instance, you could have an account with a profile for yourself as a caregiver of a son with food allergies, and a separate profile for your son.

If you have been entering information for someone else, you can choose to just delete that particular profile. Or you can choose to delete the whole account, which would delete all profiles linked to that account.

To delete a single profile, open up the profile menu for the profile in question (use the menu dropdown in the top left corner of the registry screen) and click on “Delete Profile”.

This cannot be undone once you have deleted a profile.

To delete your whole account, please contact the FoodAllergyRegistry.

16. Who are the financial sponsors of the registry?

This project is supported by a grant from the Genetic Alliance (GA) and the Robert Wood Johnson Foundation (RWJF). AAFA received a grant to use technology developed by the GA. The technology is called the Platform for Engaging Everyone Responsibly (PEER). AAFA is providing organizational staffing and other resources to operate and maintain the Registry.

17. Where can I find the privacy policy and security guidelines on the Registry site?

These are available in the public links to the Privacy Policy or Terms of Service located at the bottom of the Registry screens. After clicking on either link, you will bring up a pop-up with details about the platform’s End-User License Agreement, Privacy Policy, Privacy Statement and Terms of Service.

18. Where will the project/Registry/survey’s data be stored?

The PEER system (the registry platform that the Food Allergy Patient & Family Registry uses) has a number of databases associated with it, all managed on security-compliant servers. All data is secured using enterprise-standard security and privacy systems developed by Private Access, a company with expertise in novel internet security platforms.

19. Who can I contact if I have questions about the Food Allergy Patient & Family Registry?

If you have difficulty signing up. If you have any questions or concerns about your rights as a participant, contact us at FoodAllergyRegistry@aafa.org