Informed Consent Form
Project Title: Online Survey of Parents of Infants with Food Protein-Induced Enterocolitis Syndrome
Principal Investigator: Alix McLaughlin, MS, Eastern Michigan University
Co-Investigator: Renée Lajiness-O'Neill, PhD, Eastern Michigan University
Invitation to participate in research
You are invited to participate in a research study. In order to participate, you must have a child (age 0-18 months) who has been diagnosed with food protein-induced enterocolitis syndrome (FPIES) by a medical provider, be at least 18 years old, live within the United States, and be conversational in the English language. Participation in research is voluntary. Please ask any questions you have about participation in this study by emailing the co-PIs at amclaug7@emich.edu or rlajines@emich.edu.
Important information about this study
• The purpose of the study is to explore patterns of parental psychosocial functioning and infant neurodevelopment
• Participation in this study involves completing a brief screener survey to determine eligibility, then completing a series of questionnaires through an online survey. These questionnaires may take 70-100 minutes, but you may pause and return within 1 week if needed.
• Risks of this study include feeling uncomfortable. If a question makes you
• uncomfortable, you can just skip it and go to the next question.
• The investigator will protect your confidentiality by storing data in the secure REDCap server and de-identifying data downloads. Identifying information is obtained in a separate dataset from your responses.
• Participation in this research is voluntary. You do not have to participate, and if you decide to participate, you can stop at any time.
What is this study about?
The purpose of the study is to explore patterns of parental psychosocial functioning and infant neurodevelopment. We aim to better understand parents' experiences of having a child diagnosed with FPIES, and assess feeding and developmental patterns for these infants to help build interventions and supports for families.
What will happen if I participate in this study?
Participation in this study involves
• Completing a screener survey in REDCap that confirms your eligibility. Please note, your responses will need to be generated within 30 days of your child becoming 2, 4, 6, 9, 12, 15, or 18 months of age. If your child's age does not fit this range, we may wait to email you until they fit these time points. Identifiable responses on this survey will be kept separate from your responses on the primary survey.
• Completing a series of questionnaires about your experience of having a young child with FPIES, and about your child's growth, feeding, and development in addition to demographic and allergy information.
• The full questionnaire may take 70-100 minutes, but you can take breaks and complete it within 1 week of starting.
What types of data will be collected?
We will collect data about demographic information (e.g., race, ethnicity, sex, age) and allergy characteristics (e.g., food triggers, safe foods) and its management. We will also ask parents to complete information about their child's growth, feeding, and developmental abilities. Parents will report on their own adjustment to their child's diagnosis as well as symptoms of psychological functioning.
What are the expected risks for participation?
Some of the survey questions are personal and may make you feel uncomfortable. You do not have to answer any questions that make you uncomfortable or that you do not want to answer. If you are upset, please see the resources listed on the final page of the survey.
Are there any benefits to participating?
You will not directly benefit from participating in this research. Benefits to society include better understanding of infant neurodevelopment and parents' experiences with FPIES, and may support long-term development of supports and interventions.
How will my information be kept confidential?
We plan to publish the results of this study. We will not publish any information that can identify you.
We will keep your information confidential by using a code to label data with the code linked to identifiable information in a key stored separately from the data. Your information will be stored in a secure service called REDCap, and all data downloads will be de-identified. We will store your information for at least five years after this project ends, but we may store your information indefinitely.
We will make every effort to keep your information confidential, however, we cannot guarantee confidentiality. The principal investigator and the research team will have access to the information you provide for research purposes only. Other groups may have access to your research information for quality control or safety purposes. These groups include the University Human Subjects Review Committee, the Office of Research Development, the sponsor of the research, or federal and state agencies that oversee the review of research, including the Office for Human Research Protections and the Food and Drug Administration. The University Human Subjects Review Committee reviews research for the safety and protection of people who participate in research studies.
Storing study information for future use
We will store your information to study in the future. Your information will be labeled with a code and not your name. Your information will be stored in a password-protected or locked file and will be stored indefinitely.
We may share your information with other researchers without asking for your permission, but the shared information will never contain information that could identify you. We will send your de-identified information by email and only upon request.
What are the alternatives to participation?
The alternative is not to participate.
Are there any costs to participation?
Participation will not cost you anything.
Will I be paid for participation?
If you complete at least 50% of the requested surveys, you will be eligible for a $5 gift card as compensation for participating in this research study. If you have not completed 50% of the survey, we will notify you (either via email, or as a pop-up box if you try to leave the survey) and you will have an opportunity to complete more items to become eligible for this compensation.
Study contact information
If you have any questions about the research, you can contact the Principal Investigators, Alix McLaughlin (amclaug7@emich.edu) and Renée Lajiness-O'Neill (rlajines@emich.edu) or by phone at (734) 487-1155.
For questions about your rights as a research subject, contact the Eastern Michigan University Human Subjects Review Committee at human.subjects@emich.edu or by phone at 734-487-3090.
Voluntary participation
Participation in this research study is your choice. You may refuse to participate at any time, even after signing this form, without repercussion. You may choose to leave the study at any time without repercussion. If you leave the study, the information you provided will be kept confidential. You may request, in writing, that your identifiable information be destroyed. However, we cannot destroy any information that has already been published.