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: email@example.com
This is a research study about new tools designed to visualize the disease course of Multiple Sclerosis in a new, dynamic manner. The study researcher, Dr. Riley Bove, from the University of California, San Francisco, Department of Neurology, is 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.
What do I need to know?
You understand and agree that nothing accessed through this Site constitutes professional medical advice. UCSF disclaims any representation or warranty, expressed or implied, concerning the accuracy or completeness of the information contained on the Site. In no event shall UCSF be liable for any special, indirect or consequential damages or damages of any kind whatsoever, resulting from or arising out of or in connection with the use of this Site.
UCSF and The University of California, San Francisco are trademarks of The Regents of the University of California, San Francisco or its licensors.
You understand that nothing accessed through this [application, website, etc.] constitutes professional medical advice. This app is provided for general informational purposes only and is not intended as, nor should it be considered a substitute for, professional medical advice. Do not use the information on this [App, website, etc.] for diagnosing or treating any medical or health condition. If you have or suspect you have a medical problem, promptly contact your professional healthcare provider. UCSF disclaims any representation or warranty, expressed or implied, concerning the accuracy or completeness of the information contained on the [App, website, etc.]. UCSF and The University of California, San Francisco are trademarks of The Regents of the University of California, San Francisco or its licensors.
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:
You will sign up for an OpenMSB profile by providing your
and creating a
for your account.
You will then be given the option to provide information about your background and demographics (e.g. date of birth, gender, race, ethnicity, etc.), as well as aspects of your MS history (e.g. date of symptom onset, medications, etc.). These data may be used to personalize and appropriately label OpenMSB tools. You can opt to input as much information in your profile as you choose, though certain features may be non-functional if you do not provide the necessary data to populate the tool. For example, a visualization tool that can display a timeline of your MS history with superimposed medication changes (if applicable) and changes to disability scores (if provided) will not work without providing information about the date of disease onset – data needed to scale the timeline through present day. Upon building a OpenMSB profile and inputting selected information, you will be allowed to visualize your MS course in a graphical representation and can compare your course to the cohort, as determined by UCSF OpenBioscreen team (ongoing additions and updates to the cohort to reflect represenatative data).
If you would like, you can answer a 23-item questionnaire called the "patient reported expanded disability status scale" referred to as PR-EDSS. (iteration of Goodin 1998). This questionnaire will ask questions about symptoms relating to your vision, cognition, mood, bowel & bladder, strength, coordination, spasticity, hearing, and walking abilities. The survey will output a number between 0 and 9 based on the Neurostatus Expanded Disability Status Scale (EDSS). You can use this output to be a part of your MS course visualization. This is an optional tool. This aspect of the website will be recorded and kept for future analysis by the reasearch team.
If you would like, you can answer a 18-item questionnaire called "MS Vibes". This questionnaire will vibrate your mobile device and ask questions pertaining to how well you can feel the vibrations in your index fingers and big toes. The survey will output a number between 0 and 3 for each digit. You can use this output to be a part of your MS course visualization. This is an optional tool. This aspect of the website will be recorded and kept for future analysis by the research team.
If you would like, you can answer a 7-item questionnaire called the "Assessing Relapse in Multiple Sclerosis Questionnaire" referred to as ARMS, a previously published survey. This questionnaire will ask questions about your new or worsening symptoms, previous relapses and treatments for those relapses. You can use this output to be part of their MS course visualization. This is an optional tool, and this aspect of the website will be recorded and kept for future analysis by the research team.
If you would like, you can answer a 12-item questionnaire called the "Symptoms MS Survey". This survey was previously published as "symptoMScreen" and is being added as an instrument in the study application. This questionnaire will ask questions about the your MS symptom severity across multiple domains. This is an optional tool, and this aspect of the website will be recorded and kept for future analysis by the research team.
FOR EPIC PARTICIPANTS ONLY:
*Participants of the EPIC research study have the opportunity to visualize the data, that they have been contributing to the EPIC study, on the OpenMSB platform. If you are an EPIC participant, you can check an additional box, stating "I am an EPIC participant". If you wish to view your EPIC data on the MSB platform, you can check a box stating: “I understand and consent that by checking this box, I am agreeing to visualize my EPIC research data. This includes medications, relapses, and neurological assessments by the research doctor (EDSS) for every year that I came in for an EPIC research study visit." Your profile will then be marked as an "EPIC" subject, and a button will appear on the visualization page saying "Link my EPIC data" with a field to enter in your EPIC ID number.
This is completely voluntary and does not enhance the OpenMSB experience in anyway. As an EPIC participant, you have been contributing clinical information longitudinally and we have provided an opportunity to link this data instead of self-entering it.
As an EPIC participant, you have signed a consent form (yearly) when participating in the EPIC study, that you can view your own research data if you choose to.
An EPIC participant does not have an advantage to a non-EPIC Open MSB user.
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, if you are assigned to a visit where your doctor uses the new tools, 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.
If you choose to answer the MS Vibes questionnaire within Open MS BioScreen, you may be prompted to download a third-party application. This is only necessary if you do not have a compatible device. If you download the third-party application, it is possible that additional information beyond that collected for research purposes may be captured and used by others not associated with this study. However, this is unlikely, as the third-party application does not prompt you to enter any personal information.
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.
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.
Organizations that may look at and/or copy your research records for research, quality assurance, and data analysis include:
- The University of California
What are the costs of taking part in this study?
You will not be charged for accessing this website.
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.
Who can answer my questions about the study?
You can talk to the researcher(s) about any questions, concerns, or complaints you have about this study by contacting the UCSF Department of Neurology.
If you wish to ask questions about the study or your rights as a research participant to someone other than the researchers or if you wish to voice any problems or concerns you may have about the study, please call the Office of the Committee on Human Research at 415-476-1814.
You have been explained the purpose of this study and you understand all the information hereby thereafter is completely research based.
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to be in this study, or to withdraw from it at any point without penalty or loss of benefits to which you are otherwise entitled.
If you wish to participate in this study, you can proceed to the website.