UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Study Title: The Open MS Bioscreen Study
Research Project Director: Riley Bove, M.D., Assistant Professor of Neurology. University of California, San Francisco
Study Questions: firstname.lastname@example.org
This is a research study about new tools designed to visualize the disease course of Multiple Sclerosis in a new, dynamic manner. The study researchers, Dr. Stephen L. Hauser and Dr. Riley Bove, from the University of California, San Francisco, Department of Neurology, are leading this study.
Research studies include only people who choose to take part. Please take your time to make your decision about participating, and discuss your decision with your family or friends if you wish. If you have any questions, you may ask the researchers.
You are being asked to take part in this study because you have a diagnosis of multiple sclerosis or clinically isolated syndrome, and/or you are a caregiver or a provider of someone who carries the above diagnosis.
Why is this study being done?
The purpose of this study is to explore a new, interactive, digital health solution that will be integrated into an informational tool that can be accessed globally. We will learn more about the satisfaction and outcomes of how people choose to view their data in this original visualization.
This study is being funded by the Hilton Foundation.
How many people will take part in this study?
This study will enroll as many individuals that wish to take part. This study is open access and available to anyone who can access the world wide web.
What will happen if I take part in this research study?
If you agree, the following procedures will occur:
First, you will make a unique profile, and input various MS information including:
- Date of birth
- Age of onset
- MS Type
- Spinal tap
- Lab: oligoclonal bands
- Lab: IGG index
Study location: All these procedures will be done wherever you access the website.
How long will I be in the study?
Participants can browse the website for as long as they feel appropriate. Filling out the profile and associated MS information can take anywhere from 2-30 minutes.
Can I stop being in the study?
Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you wish to stop being in the study.
Also, the study researcher may stop you from taking part in this study at any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.
What side effects or risks can I expect from being in the study?
It is possible that you are uncomfortable with the way the information is presented. We do not think that this is very likely.
Although every reasonable effort has been taken, confidentiality during Internet communication procedures cannot be guaranteed and it is possible that additional information beyond that collected for research purposes may be captured and used by others not associated with this study.
The Open MS BioScreen tool is limited in what it can track and display. It may not cover all the aspects of MS that are important to you. The tool does not offer new information about your MS. It just gives you a new way to see and understand your data.
The Open MS BioScreen cannot:
- Predict how your MS will progress.
- Compare you directly to another person with MS
Seeing your information on the Open MS BioScreen may make you feel:
- Confused about how your MS is progressing.
- Emotional after seeing your MS data in one place and how others are doing.
- Tired from looking at data on the screen.
For more information about risks and side effects, ask one of the researchers.
Are there benefits to taking part in the study?
There will be no direct benefit to you from participating in this study.
What other choices do I have if I do not take part in this study?
You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.
Will information about me be kept private?
We will do our best to make sure that the personal information gathered for this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.
The Open MS BioScreen currently utilizes 256-bit secure socket layer (SSL) protocol which protects all data transmission.
The OMSB Team endeavors to protect the privacy of the Personal Information that the OMSB Team holds in its records, but cannot guarantee complete security. Unauthorized entry or use, hardware or software failure, and other factors, may compromise the security of your Personal Information at any time.
Please note that all information collected by the Site will be processed in the United States, and this may be done by another entity under contract with UCSF. During the Study, only UCSF and its sub-contractors engaged by UCSF will be able to compile data you generate or provide through or with the Site. You should only transmit data for the Study if you are in the United States and US territories at the time you transmit such data. If you transmit data for the Study while you are outside of the United States and US territories, then laws in the United States and US territories may not protect your privacy to the same extent as the laws in the country from which you have transmitted data to the Site. For this reason, we strongly discourage you from transmitting data when you are outside the United States and US territories, and in that regard you must know that you may not have the same privacy protections as when you transmit data within the United States.
As part of your participation in the Study, the OMSB Team may share your coded study data (data without personal identifiers) with researchers outside of UCSF under criteria established by UCSF.
The information collected by the Site will not be shared with or sold for advertising purposes.
The OMSB Team reserves the right to disclose information collected through the Site as required by law, when the OMSB Team believes disclosure is necessary to comply with a regulatory requirement, judicial proceeding, court order, or legal process served on us. The OMSB Team may also be required by law to disclose information to protect the safety, rights, or property of UCSF or the public.
Please note, this Site may also automatically receive technical information relating to your usage of the Site such as your operating system, device, features used, content viewed and downloaded, the dates and times of your interactions with the Site and other information. The OMSB Team may use this information to understand, customize, and improve user experience with the Site and the Study.
Are there any costs to me for taking part in this study?
No. The sponsor has agreed to pay for all items associated with this research study; you will not be billed.
Will I be paid for taking part in this study?
You will not be paid for taking part in this study.
What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.
Who can answer my questions about the study?
You may be able to add, update, or delete certain information as explained above. When you update or delete information, the OMSB Team may maintain a copy of the unrevised information