FOX INSIGHT INFORMATION SHEET
(Online Research Participants)
Study Title: Fox Insight
Sponsor: The Michael J. Fox Foundation for Parkinson's Research (MJFF)
Thank you for expressing an interest in participating in the Fox Insight research study, sponsored by The Michael J. Fox Foundation for Parkinson's Research (MJFF).
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.
What is the purpose of this study?
The purpose of the Fox Insight study is to collect self-reported health information indefinitely from up to 500,000 study participants. Participants will include patients with Parkinson's disease (PD), their caregivers, people at-risk of developing PD, and members of the general community that do not have PD. To investigate participants lived experience, the study will collect a variety of information from study volunteers including observational and other health-related forms of information with the ultimate goal of informing future therapeutic studies. This study is being done to help improve our understanding of PD, such as how the disease impacts health and quality of life over time and whether there are connections between family neurological history, general health, environmental risk factors and PD. We are also interested in the symptoms leading up to PD in those people at-risk and the experience of care-partners for people with PD.
Participation in the study is entirely voluntary. No medical treatments, medical advice or medical interventions will be provided to you as part of this study.
What will you be asked to do in this study?
If you decide to take part in this study, you will be asked to participate in the following activities:
- Create a user name (your email address) and a password of your choice to access the study website.
- Complete a series of questionnaires on the study website over time. 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 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.
The information you share will be collected, de-identified (stripped of personal information such as your name and date of birth to help protect your privacy) and stored in the Fox Insight data repository to be made available to qualified researchers, who may be employed by non-profit organizations, companies, and/or government entities, for future research on PD and other disorders.
If you agree to participate, 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, Fox Insight includes the option to receive messages about study updates and other studies that may be developed in the future. You will be able to reply and participate using the same system, but you have no obligation to reply at all. You may report unwelcome or inappropriate emails to the sponsor. If participation in a related study conducted and communicated through Fox Insight (sub-study) becomes available, you will receive a separate description of that sub-study and be requested to review the corresponding Information Sheet to participate in the sub-study.
Are there any risks to being in this study?
This study involves collecting and storing personal, identifiable information about you, so there is a potential for invasion of privacy or breach in confidentiality. To minimize these risks, we will not store any directly identifiable information about you with your self-reported health-related questionnaire responses or sub-study data. Your information will be assigned a unique code number and stored in a secure manner. Information shared with researchers through the Fox Insight data repository will only include the code number. No personal, identifiable information will be shared outside the study team.
Even with removal of identifying information, in some circumstances it may be possible to re-identify individuals, given the type and amount of data provided. Therefore, we cannot guarantee that your identity will never become known.
Are there any benefits to being in this study?
There are no expected benefits for you to participate in this study.
Will you be paid to participate in this study?
You will not be paid to participate in this study.
Are there any costs to being in this study?
There will be no cost to you for participating in this study.
What happens to your data?
MJFF, based in the United States of America, makes reasonable efforts to keep the information collected from you private, protected and secure. MJFF may contract with other entities to conduct the study, store your data or ready it for use. In doing so, it will require such other entities to keep private, protect and secure your data. Before your health information is made available to other researchers through the Fox Insight data repository, 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 your information with the information provided by other volunteers in the study before it is made available for research purposes to qualified researchers. Qualified researchers must agree to certain terms and conditions in order to receive and use the information for research purposes. However, your health information may be stored or used in any country, including the United States, and other countries including the United States may not employ the same privacy and security standards as the one in which you live.
Your permission to use the health information provided to Fox Insight will not expire. You may choose to withdraw from the study at any time by not sharing additional information. If you choose to withdraw from the study, we will keep the information we have already collected about you indefinitely. Any de-identified data that has already been shared with the Fox Insight data repository prior to your withdrawal will not be removed.
What happens if you do not wish to participate in this study?
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. You may send an email to firstname.lastname@example.org to withdraw your participation in the study or you can simply opt to not share any additional information. Your decision will not result in any penalty.
For employees of 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.
Who do you contact if you have questions?
For more information or questions about this research, you may email email@example.com.
If you have any questions about your rights as a research subject, you may contact:
New England IRB at 1-800-232-9570.
After you have read this form and the Fox Insight website Terms and Conditions, you will be asked to check a box to indicate if you agree to participate in this study.
By checking the box, you are confirming that you have reviewed and agree to 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 allow use of your data by MJFF, its contractors, and researchers.