Patient and Caregiver Diversity in FDA Patient Engagement Activities - Interviews (OC)

OMB Control No: 0910-0697

Expiration Date: 12/31/2023

Patient/Caregiver Recruitment Email

Invitation to participate in research study on patient engagement in food allergy drug development

MONTH DAY, YEAR

Dear Ms./Mrs./Mr. XXXX,

Our PATIENTS Program at University of Maryland research team is working on a research project in collaboration with the National Health Council and the U.S. Food and Drug Administration (FDA) to better understand patient and caregiver, and patient organization involvement in food allergy therapeutics development.

As part of this project, we are interviewing different stakeholders to better understand patient engagement practices within food allergy to promote strategic engagement with diverse patients and caregivers.

Your participation is completely voluntary, and you may withdraw at any time. If you agree to participate in this study, I want to schedule a videoconference interview with a member of our research team. The interview will take approximately 90 minutes and will be recorded. To thank you for your participation, we will provide you with a gift card in the amount of $75.

If you have any questions or concerns, please don’t hesitate to contact the study team:

• Principal Investigator: Joey Mattingly (Email: jmattingly@rx.umaryland.edu; Phone: 410-706-8068)

• Primary Research Contact: Andrea Melgar Castillo (Email: amelgarcastillo@rx.umaryland.edu; Phone: 410-706- 1753)

If you would like to participate, we ask that you review before the interview our short survey that ensures our participants are eligible to participate along with some demographic information. All responses are anonymous and will never be shared with any person or entity outside our research team.

The survey can be accessed via this link: https://umaryland.az1.qualtrics.com/jfe/form/SV_brPdxfsXfud2Q06

We would appreciate your response to this invitation by MONTH DAY, YEAR. Please include in your response your availability for the interview through MONTH DAY, YEAR.

Thanks,

RESEARCH TEAM MEMBER NAME.