This form describes a research study that is being sponsored and conducted by the Michael J. Fox Foundation for Parkinson's Research.
You may print a copy of this form to think about or discuss with family or friends before making your decision to participate in FOX INSIGHT.
The purpose of this study is to collect self-reported health information over time (about 5 years) from patients with Parkinson's disease (PD) and from people that do not have PD (controls). This is being done to help improve our understanding of PD. The information collected will be stored in a database (data repository) so that other researchers can use the information to develop future research to study PD and other disorders.
If you decide to take part in this study, you will be asked to do the following activities:
Create a user name (your email address) and a password of your choice to access the study website.
Complete your first set of questionnaires on the study website. These questionnaires will collect information about your medical history, family neurological history, and other health related information. It will take about 20 – 40 minutes to complete this information.
About every 3 months you will be receive an email from the study website asking you to update your health information. New questionnaires may be added during your participation in the study. You will be notified about new questionnaires and asked to provide the new information at the same time you are providing updates to information previously collected.
If you agree to participate as a patient with PD, you have 3 ways to give us your information:
Enter information yourself, without any assistance from someone else.
Enter information with the help of an informant. An informant is someone that knows you well enough to answer questions about you. This may be your spouse/significant other, child, friend or anyone else that you are comfortable with that can answer health questions about you.
Enter information using your informant only.
In addition to the procedures described above, the study includes the option to receive messages about Fox Insight updates and other studies that may be developed in the future. You will be able to reply using the same system, but you have no obligation to reply at all. You may report unwelcome or inappropriate emails to the sponsor
This study involves collecting personal, identifiable information about you, so there is a potential for invasion of privacy or breach in confidentiality. To minimize this risk, we will not store any directly identifiable information about you with your questionnaire responses. Your information will also be assigned a unique code number and stored in a secure manner. Information shared with other researchers from the data repository will only include the code number. No personal, identifiable information will be shared outside the study team.
There are no expected benefits for you to participate in this study.
You will not be paid to participate in this study.
The Michael J. Fox Foundation (“Sponsor”) makes every effort to keep the information collected from you private. In order to do so, before your health information is given to other researchers the data you provide will be de-identified, which means no personal identifiers are included (for example, your name, date of birth, or address). Also, the data repository will combine all the information provided by everyone in the study before it is made available for research purposes to qualified researchers.
Your permission to use your health information for this study will not expire unless you tell us you want to cancel it. We will keep the information we collect about you indefinitely. If you cancel your permission, you will be removed from the study. You may send email to info@foxinsight.org to cancel your permission.
Your participation in this study is voluntary. You may decide not to participate or you may leave the study at any time, for whatever reason
For employees of The Michael J. Fox Foundation for Parkinson's Research (MJFF), taking part in this research is not part of your job and choosing not to participate will not affect your job. You will not be offered or receive any special job-related consideration if you take part in this research.
For more information or questions about this research, you may email info@foxinsight.org.
If you have any questions about your rights as a research subject, you may contact:
New England IRB at 800-232-9570.
After you have read this form and the FOX INSIGHT website Terms and Conditions, you will be asked to check a box if you agree to participate in this study. By checking the box, you are confirming that you reviewed the FOX INSIGHT Information Sheet and the FOX INSIGHT website Terms and Conditions. This indicates your agreement to participate in the FOX INSIGHT study and that you agree to the FOX INSIGHT Terms and Conditions, which govern use of this website.