We are conducting a survey of children with food allergies and their parents/guardians to understand the impact of school/daycare food allergy policies on psychological well-being.

In this research study, we are asking parents/guardians and their children (if age-appropriate) to complete a survey. If you have more than one child with food allergy, please pick one child to answer the survey questions about and have that same child complete the child response sections (with parent/guardian help, if needed). It will probably take about 20 minutes to complete the survey.

To be eligible to participate in this research study:

  • Your child must currently have an IgE-mediated food allergy
  • Your child must be between the ages of 0-17 years old
  • You and your child must live in the same household

What do I have to do if I participate in this research study?

If you decide to be part of this research study, you will be asked to complete an online survey about your child’s food allergies, food allergy policies at your child’s school/daycare, and the psychological well-being of you and your child. If your child is age 8 years or older and also agrees to be part of this survey, they will also be asked to complete questionnaires about their psychological well-being. It is absolutely fine if the parent/guardian chooses to participate but the child does not.

What are the risks and benefits of this research study?

There is no financial cost or benefit of participating. Benefits to society include helping us learn more about how school/daycare food allergy policies impact families so that healthcare teams and communities can develop better policies and provide better support.

What will happen to the information obtained as part of this research study?

The information that you provide in the survey will be handled as confidentially as possible. Your answers to survey questions will be identified by a code number and not linked to you or your child’s name. Information will be kept confidential in a secure location and will not be released to researchers outside of the study team.

If I do not want to take part in this research study, what are the other choices?

Participation in this research study is voluntary. You can choose not to answer any survey questions, or stop participation at any time. If you decide not to participate in this study, your decision will not affect the medical care that your child receives now or in the future.

Who should I contact if I have questions?

If you have general questions about this research, please contact Dr. Lisa Bartnikas (Principal Investigator) at lisa.bartnikas@childrens.harvard.edu. If you have questions about your rights as a research subject, any research-related concerns or complaints, or if you want to speak with someone other than the researchers, you can call the IRB Office at (617) 355-7052.

What should you know about HIPAA and confidentiality?

Your health information is protected by a law called the Health Information Portability and Accountability Act (HIPAA). In general, anyone who is involved in this research, including those funding and regulating the study, may see the data, including information about you. For example, the following people might see information about you:

  • Research staff at Boston Children’s Hospital involved in this study;
  • Medical staff at Boston Children’s Hospital directly involved in your care that is related to the research or arises from it;
  • Other researchers and centers that are a part of this study, including people who oversee research at that hospital;
  • People at Boston Children’s Hospital who oversee, advise, and evaluate research and care. This includes the ethics board and quality improvement program;
  • People from agencies and organizations that provide accreditation and oversight of research;
  • People that oversee the study information, such as data safety monitoring boards, clinical research organizations, data coordinating centers, and others;
  • Sponsors or others who fund the research, including the government or private sponsors.
  • Companies that manufacture drugs or devices used in this research;
  • Federal and state agencies that oversee or review research information, such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health, and public health and safety authorities;
  • People or groups that are hired to provide services related to this research or research at Boston Children’s Hospital, including services providers, such as laboratories and others;
  • And/or your health insurer, for portions of the research and related care that are considered billable.

If some law or court requires us to share the information, we would have to follow that law or final ruling.

Some people or groups who get your health information might not have to follow the same privacy rules. Once your information is shared outside of Boston Children’s Hospital, we cannot promise that it will remain private. If you decide to share private information with anyone not involved in the study, the federal law designed to protect privacy may no longer apply to this information. Other laws may or may not protect sharing of private health information. If you have a question about this, you may contact the Boston Children’s Hospital Privacy Officer at (857) 218-4680, which is set up to help you understand privacy and confidentiality.

Because research is ongoing, we cannot give you an exact time when we will destroy this information. Researchers continue to use data for many years, so it is not possible to know when they will be done.

We will also create a code for the research information we collect about you so identifying information will not remain with the data and will be kept separately. The results of this research may be published in a medical book or journal or be used for teaching purposes. However, your name or identifying information will not be used without your specific permission.

Instructions

The following sections are to be completed by the parent/guardian of the child with food allergies.

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You have selected an option that triggers this survey to end right now. To save your responses and end the survey, click the button below to do so. If you have selected the wrong option by accident and do not wish to leave the survey, you may click the other button below to continue, which will also remove the value of the option you just selected to allow you to enter it again and continue the survey.
The response has now been removed for the last question for which you selected a value. You may now enter a new response for that question and continue the survey.