You are invited to take part in an observational research study (also known as a non-interventional study) using your medical data. You were selected as a possible participant in this study because you were diagnosed with multiple sclerosis. To allow you to make an informed decision as to whether or not you want to allow your medical data to be used in this observational research study, this document describes the purpose of the study and how your data will be used. Please take your time to read the following information carefully.

This observational research study is also called a medical chart review study. This means that the study looks at medical data that has already been collected and kept in your medical records from routine medical care. No new medical data about you will be collected in this study.

The purpose of this observational research study is to better understand standards of care for patients in the United States with multiple sclerosis.

This study will be one of several studies that combines data sources to gain a deeper understanding of multiple sclerosis in order to advance research to improve patient care. You may receive information about these other studies in the future.

This research study is being financed by Genentech and conducted in the United States. The study is under the direction of PicnicHealth, a digital health company that helps patients retrieve and manage their medical records. Genentech is providing financial support to PicnicHealth to cover the cost of retrieving medical data for this study.   

This study has been reviewed by IntegReview IRB, an organization that is responsible for protecting the rights, safety, and well-being of patients who take part in research studies.

Approximately 5000 men and women, 18 years of age and older, diagnosed with multiple sclerosis will take part in this study.

It will take approximately 10-15 minutes to finish signing up for this study.

If you agree to participate in this study, you will be asked to:

• Authorize PicnicHealth to collect your medical records on your behalf.
• List information about your healthcare providers (doctors, hospitals, and/or clinics) and insurance provider.
• Allow PicnicHealth to re-contact you in the future with new information about this study or other multiple sclerosis studies like this one. These studies will also be sponsored by Genentech and be IRB-approved. You will be asked to review those study offers and decide whether you would like to participate. If you choose to participate, you will sign a new Informed Consent Form for any of these other studies. PicnicHealth will then link the data from this study to the data from these other studies.
• Allow PicnicHealth to re-contact you in the future with information about new research initiatives like participating in digital platform(s) and/or using digital device(s). You will be asked to review those offers and decide whether you would like to participate. If you choose to participate, PicnicHealth will then link the data from these research initiatives to the data from this study.
  

You will be asked to sign this Informed Consent Form. Only then will data from your medical records be extracted and analyzed as part of this study. This data is already kept in your medical records, whether or not you participate in this study.

You will receive PicnicHealth’s medical record retrieval and management services for 5 years. This is a benefit for you; it is not a part of the research study procedures. Genentech will pay for PicnicHealth’s services as long as you participate in this study. Neither you nor your insurance company will be billed for PicnicHealth’s services. As part of these services, PicnicHealth will:

• Collect your medical records on your behalf from the healthcare providers that you authorize
• Digitize your medical records so that you can access all of them online through your PicnicHealth timeline
• Enable you to electronically share your medical records with your doctors, care givers, and family
• Collect your ongoing medical records on your behalf from the doctors who continue to provide care for you for up to a 5-year period.

After 5 years or if you choose to stop participating in this study (whichever happens first), you can continue to access your existing medical records through your PicnicHealth account. No new records will be added as part of this study. You can request that your data is deleted from thePicnicHealth service at that time, or at any time before or after.  You can also continue to use PicnicHealth at your own expense to collect new records.

To learn more about PicnicHealth’s services, you can visit https://flywheel.ms.

You may be re-contacted in the future with information about this study or new multiple sclerosis studies or research initiatives. If you decide to participate in these studies or initiatives, you may continue to receive PicnicHealth’s services free of charge for the duration of those studies.

Personally identifying information, such as your name, will be removed before your data is used for this study. The data without your personally identifying information is referred to as “de-identified data.”  

Your de-identified data will be shared with Genentech to better understand multiple sclerosis. For this purpose, your de-identified data will be aggregated with those of the other study participants.

Your de-identified data may be shared with select researchers outside of Genentech. This data-access program is designed to ensure that the data extracted through this Genentech-sponsored study is also made available to qualified researchers working to advance MS-research for the public good. Data access will be through an application process managed by PicnicHealth and limited to researchers working with recognized academic or research organizations. Their research is not considered part of this Genentech-sponsored study.

If it is available from your existing medical records in the past 7 or more years or during the duration of your participation in this study, the following information will be extracted:

• Demographics (gender, date of birth, etc.)
• Visits to healthcare providers (date, care site, etc.)
• Date of multiple sclerosis diagnosis
• Data about multiple sclerosis (severity, relapse, etc.)
• Medical history (other diseases you may have or have had)
• Results of physical examinations
• Vital signs (heart rate, body temperature, etc.)
• Blood tests and other laboratory tests
• Procedures (imaging, surgeries, etc.)
• Medications
• Doctor’s notes
  

There is no direct medical benefit to you from being in this study. The information gained from this study may help scientists and doctors to learn more about the treatment of multiple sclerosis in general. You and other patients with multiple sclerosis or a similar condition may benefit from results of such research in the future.

However, as long as you participate in this study, you will benefit from free access to PicnicHealth’s medical record collection and management services for a 5-year period. As part of these services, PicnicHealth will:

• Collect your medical records on your behalf from the healthcare providers that you authorize
• Digitize your medical records so that you can access all of them online through your PicnicHealth timeline
• Enable you to electronically share your medical records with your doctors, care givers, and family
• Collect your ongoing medical records on your behalf from the doctors who continue to provide care for you

To learn more about PicnicHealth’s services, you can visit https://flywheel.ms.

Your alternative is to not agree that your medical data can be used, and you will not take part in this study. If you choose not to participate in this study, you will not receive PicnicHealth’s service free of charge. This will not affect in any way the regular care you receive from your doctors.

For Employees of Genentech, Inc. or F.Hoffmann-La Roche Ltd:

You are allowed to participate in this study. If you are an employee:

• The decision to participate or not will not affect your performance evaluation.
• The decision to participate or not will not affect possible promotions.
• The decision to participate or not will not affect your pay.

You will not be paid for taking part in this study. However, as long as you participate in this study, you will receive PicnicHealth’s medical record retrieval and management services for free for up to 5 years. PicnicHealth will collect and digitize your medical records and make the records available to you through the PicnicHealth timeline. You will be able to view your medical records data (e.g., lab results, prescriptions, and imaging files), download copies of records, and share your records with your doctors. After 5 years or if you choose to stop participating in the study (whichever happens first), you can continue to access your existing medical records through your PicnicHealth account but no new records will be added unless this study is extended or you choose to subscribe to the PicnicHealth service at your own expense. You can request that your data be deleted from the PicnicHealth service at that time, or at any time before or after, but your data cannot be deleted from the study once it has been collected.  

To learn more about PicnicHealth’s services, you can visit https://flywheel.ms.

There are no physical risks from participating in this study. There may be privacy and confidentiality risks. Despite best efforts, it is not possible to guarantee that your personally identifiable information (e.g., name, date of birth) will never become known. For example, data may be vulnerable in transit or servers may be accessed by unauthorized individuals. However, the risk for such a confidentiality breach is considered low.

Your doctor has collected medical and personal information about you as part of routine clinical practice. As part of this study, data will be extracted from your medical records in a way to ensure that your medical and personal information is kept confidential. Your medical and personal information and copies of your medical records will be held by PicnicHealth.

You will be assigned a unique patient identification number. The medical data used for this study will be labeled with this identification number; the data will not be labeled with your name, picture, or any other personally identifying information. The de-identified data will be kept in data warehouses within Genentech. 

National applicable laws and regulations to protect the personalized data in your medical records will be strictly followed. The confidentiality of your personal information will be protected throughout the study and thereafter. It will be kept confidential; your medical and personal information may be revealed only if required by law. National health authorities, regulatory bodies, or other overseeing agencies may want to examine your data within the scope of an inspection according to national law to ensure that the observational study is done properly.

The study data will be recorded, analyzed, and published. No patient will be identified in any report or publication from this study.

To make sure the study is being done properly or to check the quality of the data, the following people and groups of people will be granted direct access to copies of your medical records (i.e. they may look at your medical and personal information) without violating the confidentiality of your data:

●        PicnicHealth personnel directly involved with the medical data retrieval processes and, if applicable, study auditors from Roche.

●        The Institutional Review Board responsible for protecting the rights and safety of the patients who take part in research studies

●        Regulatory health authorities (government agencies involved in keeping research safe for people)

If you sign this consent form, you give permission to PicnicHealth to use or disclose (share) your health information that could identify you only for the purposes of this research study and for research directly related to multiple sclerosis.  You do not have to sign this consent form, but if you do not, you may not take part in this research study.

The health information for which you are giving permission to be used and shared includes all health information about you in the medical records that PicnicHealth retrieves.
 
No names or personally identifying information will be disclosed to Genentech or to researchers outside of Genentech. However, de-identified health information and data may be analyzed in any country worldwide.
 
Health information that identifies you may be disclosed to the Institutional Review Board, and representatives of the U.S. Food and Drug Administration (FDA) or other national and local health authorities.  
 
You have the right to see and get a copy of your medical records kept by PicnicHealth.  Your authorization (permission) to use and disclose (share) your health information does not have an expiration date, but that use and sharing will only be for the purposes described in this consent form.
 
You are free at any time to limit PicnicHealth’s use and sharing of your health information, without penalty or other consequence. However, you may not be allowed to take part or continue to take part in this study if at any time you choose to limit PicnicHealth’s use and sharing of your health information that is necessary for the completion of this study.
 
You may change your mind and revoke (take back) this authorization at any time.  If you revoke this authorization, no additional health information will be retrieved about you.  However, any data that has already been retrieved, up until the time you notify PicnicHealth to revoke your authorization, will remain accessible to Genentech. This data will not include your name or personally identifying information.
 
If you leave the study, you can choose to pay to continue using PicnicHealth’s medical record collection and management services, independent of the study. If you use PicnicHealth independent of the study, you can authorize PicnicHealth to collect your medical records for your personal use and care coordination.

Yes, you will receive the published results of this study. The results will be made available to you online on the study website or through email sent by PicnicHealth.

This study is one of several studies to better understand multiple sclerosis. It is possible that the results of this study will be linked to the outcome of other studies, or data derived from digital platform(s)/devices(s). If this is the case, you will receive these results as well.

You will not lose any of your legal rights by signing this consent form.

You can contact PicnicHealth for any questions.

Email:  flywheelms@picnichealth.com

Phone: 1-415-801-0572

If you do not want to talk to PicnicHealth, or if you have concerns or complaints about the research, or if you want to ask about your rights, you may contact IntegReview.  IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review to: 

Mailing Address:

integreview@integreview.com

Chairperson

IntegReview IRB 

3815 S. Capital of Texas Highway 

Suite 320 

Austin, Texas 78704  

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If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact IntegReview’s office at:

Phone: 1-512-326-3001 or toll free at 1-877-562-1589 (between 8 a.m. and 5 p.m. Central Time)

IntegReview has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IntegReview has approved your being in the study.  You must consider the information in this consent form for yourself and decide if you want to be in this study.

It is your choice if you want to be in the study. No one can force you to be in the study. You may not want to be in this study or you may leave the study at any time without penalty or loss of benefits to which you are otherwise entitled. If you want to stop participating in this study, you should email PicnicHealth at flywheelms@picnichealth.com

PicnicHealth,Genentech, or IntegReview may take you out of the study without your permission, at any time, for the following reasons:

• If you do not follow the investigator’s instructions
• If we find out you should not be in the study
• If the study is stopped