Consent for Participation in Research

Title: Niemann-Pick Type C Patient-Focused Drug Development Post-Meeting Survey Addendum

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) Post-Meeting Survey Addendum.  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 Addendum 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.

Purpose of the Study

This survey is an addendum to an earlier survey about experiences with Niemann-Pick Type C disease symptoms, treatments, and the impact of the disease on daily life.  This survey addendum is being used to collect additional details on those topics.  The purpose of this study is to collect additional data that will be used to inform a report on the experiences of Niemann-Pick Type C disease patients that will be shared with the U.S. Food and Drug Administration.  

What will you 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 you 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 any time. 

Will there be any compensation?

You will not receive any type of payment for participating in this study.

How will your privacy and confidentiality be protected if you participate in this research study?

Your privacy and the confidentiality of your data will be protected by the Ara Parseghian Medical Research Fund.  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 stakeholders external to the Ara Parseghian Medical Research Fund, only these identifiers will be shared.  The Ara Parseghian Medical Research Fund will not contact you about your responses.   

If it becomes necessary, the Institutional Review Board may need to review the study records.  If this happens, information that can be linked to your child will be protected to the extent permitted by law. Your research records will not be released without your consent unless required by law or a court order.

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.  

Whom to contact with questions concerning your rights as a research participant?

For questions about your rights or any dissatisfaction with any part of this study, you can contact, anonymously if you wish, the Notre Dame Research Compliance Office, at 574-631-1461 or by email at compliance@nd.edu .

Participation 

If you would like to participate, click “I consent” on the first page of the Niemann-Pick Type C PFDD Survey and then click the “Next” button at the bottom of the page.  This will be used in lieu of a signature, and completion and submission of the survey will constitute consent to participate in this research.

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