Assent for Participation in Research
Title: Niemann-Pick Type C Patient-Focused Drug Development Meeting and Pre-Meeting Survey
Principal Investigator: Sean Kassen, Director, Ara Parseghian Medical Research Fund
Introduction:
You have been invited to participate in the Niemann-Pick Type C Patient-Focused Drug Development (PFDD) Survey. Read the information below and before deciding whether to participate, and please feel free to send any questions that you may have to skassen@nd.edu. Clicking “I consent” on the first page of the Niemann-Pick Type C PFDD Survey page will indicate that you agree to participate and have the data that you provide be used to support the PFDD initiative and other research.
What am I going to be asked to do?
If you agree to participate, you will be asked to answer a series of questions about your experiences with Niemann-Pick Type C disease. With the exception of questions about contact information and demographics, all of the survey questions are optional. The survey will likely take 30-60 minutes to complete. You may complete the survey at a time and place of your choosing using a computer, tablet, or mobile phone. Approximately 75 families have been invited to participate in this survey.
What are the risks involved in this study?
The risks involved with participation in this study are very low but some questions may cause emotional discomfort. With the exception of questions about contact and demographic information, all survey questions are optional.
What are the possible benefits of this study?
You will receive no direct benefits from this survey, but this is your opportunity to provide information on your experiences with Niemann-Pick Type C disease and to make sure that the U.S. Food and Drug Administration is made aware of these experiences via the written report that will be informed, in part, by the survey data.
Do I have to participate?
No, your participation is optional. You may decide not to participate at all or, if you start the survey, you can stop at anytime.
Will I get anything for participating?
You will not receive anything for participating in this study.
Who will know about my participation in this research study?
The records of this study will be kept private. Only the Ara Parseghian Medical Research Fund will receive your full survey responses including your name and contact information. Each survey response will be coded with a random identifier and, if the survey data is shared with the U.S. Food and Drug Administration or any other stake holders external to the Ara Parseghian Medical Research Fund, only these identifiers will be shared.
Whom to contact with questions about the study?
Before, during, or after you complete the survey, you can contact the Ara Parseghian Medical Research Fund to ask any questions: Sean Kassen, (574) 631-4689, skassen@nd.edu.
For questions about your rights or if you are unhappy with any part of this study and don’t want to talk to the researcher, you can contact, anonymously if you wish, the Notre Dame Research Compliance Office, at 574-631-1461 or by email atcompliance@nd.edu .