Investigating Parentally Reported Food-Reactivity
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PURPOSE OF THIS RESEARCH STUDY
You are being invited to take part in a research study to assess parental experiences related to food reactivity in their children.
The purpose of this research study is to investigate parentally reported food reactivity to better understand the challenges and experiences of parents with food-reactive children. Despite the high prevalence of food allergies and other adverse food reactions, there is a significant gap between the number of parental-reported cases and the number of diagnoses made by healthcare providers. This gap can have serious consequences for affected individuals and their families, as undiagnosed food reactions can lead to ongoing suffering and potentially life-threatening reactions.
One potential barrier to diagnosis is the lack of diagnostic tests for non-IgE mediated allergies, such as food protein-induced enterocolitis syndrome (FPIES) and food protein-induced allergic proctocolitis (FPAIP). These conditions can be difficult to diagnose due to their widely variable symptoms and the absence of reliable diagnostic tests.
As non-IgE mediated allergies most commonly impact children under 5 years of age, this often contributes to the added complexity of navigating breast/body feeding, formula, and starting solids. Recent publications have shown that human milk contains allergenic protein fragments transferred from the lactating individuals’ diet which may elicit a response in some reactive children.
By collecting and analyzing data from parents of food-reactive children, this study aims to shed light on the experiences and challenges of these families, and to identify strategies and interventions that may help to improve diagnosis and management of food reactivity. The findings of this study may also inform the development of new diagnostic tests and treatment options for non-IgE mediated allergies.
HOW LONG WILL I BE IN THIS RESEARCH STUDY?
Your participation in this study will last as long as the single survey, estimated to take 30 minutes.
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
Before any study related procedures are performed, you will be asked to read and sign this consent form. You will then complete a participant questionnaire about your and your family’s medical history, your pregnancy, your child’s birth and labor, your child’s feeding, your child’s symptomology, and more related to their immune and gastrointestinal systems.
This Research Study is not intended to treat or diagnose and is for testing purposes only. Free to Feed will not perform any monitoring of you during or after the Research Study.
WHAT ARE THE BENEFITS OR RISKS TO ME IF I PARTICIPATE IN THIS RESEARCH STUDY?
It is not expected that you or your child will directly have any beneﬁt from this study, however you will be contributing to the scientiﬁc knowledge and research in child food reactivity. This Research Study may beneﬁt future generations of parents and children around the world.
For this study, you are only completing one questionnaire. There is no physical risk to you or your child from participating in this study. The only potential risks would be the loss of confidentiality of your or your child’s information. Free to Feed has standards in place to keep your information private and confidential.
Free to Feed does not oﬀer medical services. Our Products and Services are in no manner intended to substitute for the advice and care of a licensed professional and Free to Feed does not oﬀer any medical advice, analysis guidance, diagnosis, or treatment. If you are facing a medical emergency, please visit your nearest emergency room or dial 9-1-1.
The Research Study ﬁndings from your contribution may, one day, result in processes that may be used in association with Free to Feed’s product and service oﬀerings, which may in turn beneﬁt Free to Feed, the scientiﬁc community and the public health. You will not receive any compensation or payment for products or services that are developed from the information collected in this study.
WILL IT COST ME MONEY TO TAKE PART IN THIS RESEARCH STUDY?
No, it does not cost you anything to participate in this Research Study.
WILL I BE COMPENSATED FOR PARTICIPATING IN THIS STUDY?
You will not be compensated for completing the study questionnaire.
WHAT HAPPENS IF I PARTICIPATE IN THE RESEARCH STUDY BUT CHANGE MY MIND LATER?
Participation in this Research Study is completely voluntary. You are free to withdraw from the study at any time, without having to give a reason. You can withdraw your and/or your child’s survey answers from the study any time prior to them being analyzed for publication. There will be no penalty if you choose to withdraw.
If you decide to withdraw from the study, please contact the study team.
WHAT HAPPENS TO THE INFORMATION COLLECTED FOR THIS RESEARCH STUDY?
Information collected for this study that identifies you or your child will be kept confidential, and to the extent possible will not be made publicly available. No material, which could personally identify you or your child, will be used in any reports on this Research Study. Unique identiﬁcation IDs will be used to identify your and your child’s study questionnaire.
Your private information and your health record are very important to us. They will only be shared with individuals and organizations that conduct or watch over this Research Study, including:
Free to FeedTM
Third party service providers who work with the study sponsor (for example the hosting provider)
The Department of Health and Human Service (DHHS)
We may use your personal information in Free to Feed’s research database in order to support future research. We may share aggregated, de-identiﬁed information (for example, aggregated trends) publicly and with our partners (this information will not include any personally identiﬁable information). We may author publications using de-identiﬁed information, either on our own or in collaboration with academic or commercial third parties (these publications may include, for example, blinded pedigree diagrams or de-identiﬁed family history).
WHO CAN ANSWER MY QUESTIONS ABOUT THIS RESEARCH STUDY?
If you have questions, concerns or complaints about the research study, please contact:
Trillitye Paullin, Ph.D., CEO & Co-Founder of Free to Feed
This research study has been reviewed and approved for exemption from IRB review determination by the institutional review board at Sterling IRB. This means that the study has been deemed to involve minimal risk to participants and meets the criteria for exemption as outlined by federal regulations. If you have any concerns or questions about the ethical review of this study, please contact the principal investigator or the institutional review board at Sterling IRB.
Statement of Consent and Authorization
I have had a fair opportunity to discuss this Form, ask questions about it, and seek counsel in connection with it. I have the full capacity to provide consent, and I was not subject to any duress or undue inﬂuence in the course of reviewing this Form or deciding to click below.
By consenting, I give permission to take part in this study by Free to Feed.