Baltimore VA Informed Consent Form - For review only

Baltimore VA Informed Consent Form - For Review Only

TITLE: Confirmatory Trial for Alleviating FatiguE in Multiple Sclerosis
(CAFE-MS)

PROTOCOL NO.: ACP-CAFE-MS-001

WCG IRB Protocol #20240782

SPONSOR: Accelerated Cure Project, Inc.

INVESTIGATOR: Mitchell Wallin, MD, MPH
10 N Greene St
Baltimore, Maryland 21201
United States
STUDY-RELATED
PHONE NUMBER(S): 202-745-8146
703-963-1103 (24 hours)

Taking part in this research is voluntary. You may decide not to participate, or you may leave
the study at any time. Your decision will not result in any penalty or loss of benefits to which
you are otherwise entitled.

If you have any questions, concerns, or complaints or think this research has hurt you, talk to the
research team at the phone number(s) listed in this document.

RESEARCH CONSENT SUMMARY

You are being invited to take part in a research study at the VA Maryland Health Care System
(VAMHCS). This document provides a concise summary of this research. It describes the key
information that we believe most people need to decide whether to take part in this research.
Later sections of this document will provide all relevant details. At the end of the document, you
will be asked if you consent to take part in the study if you qualify.

How long will I be in this research?

We expect that your taking part in this research will last a total of 12 months.

Why is this research being done?

The purpose of this research is to test two different experimental online programs as potential
treatments for fatigue in individuals diagnosed with multiple sclerosis (MS). These programs
both contain potentially useful information on MS and fatigue. Experimental means the online
programs have not been approved by the U.S. Food and Drug Administration (FDA) for the
treatment of fatigue in individuals with MS.

What happens to me if I agree to take part in this research?

If you decide to take part in this research study and are eligible to participate, the general
procedures include being assigned to one of three experimental groups, using one or both of the
experimental online programs, and submitting responses to online questionnaires through the
secure study website. Your involvement in the study is expected to last for approximately 12
months.

Could being in this research hurt me?

The most important risks or discomforts that you may expect from taking part in this research
include the possible loss of privacy or breach of confidentiality. We will take steps to reduce this
risk, such as assigning a de-identified study code to your data that is collected during the course
of this study.

Any psychological risks involved are believed to be minimal; however, you may experience
some momentary frustration when attempting to perform tasks during which you experience
difficulty. The researchers will try to minimize any frustration that may occur.
Using the online programs associated with this study and/or completing the outcome
questionnaires may worsen your fatigue.

There may be some unanticipated discomforts or risks in addition to those specified above,

but every precaution will be taken to assure your personal safety and to minimize any discomforts.

Will being in this research benefit me?

We cannot promise any benefits to you or others from your taking part in this research. However,
a possible benefit to you is that you may experience a reduction in your fatigue symptoms from
participating in this study.

What other choices do I have instead of taking part in this research?

Your alternative is to not take part in the research. If you decide not to participate, you can
review treatment options with your doctor. Other treatment options for fatigue in MS include
medications or other fatigue management programs. If you consent to participate, you may
withdraw at any time. If you choose to withdraw, it will have no effect on your future
participation in research studies conducted by Accelerated Cure Project for MS or the
Department of Veterans Affairs.

DETAILED RESEARCH CONSENT

You are being invited to take part in a research study. A person who takes part in a research
study is called a study participant.

Why is this research being done?

Fatigue is commonly experienced by people with multiple sclerosis (MS) but there are few
treatments available to help with this symptom. The experimental online programs in this study
for fatigue in MS are being evaluated as possible treatment options. These online programs both
contain potentially useful information on MS and fatigue. They differ in some aspects, but both
are intended to provide information that could help you understand and manage any fatigue
symptoms you are experiencing. Neither of these programs has been approved as a treatment by
the Food and Drug Administration (FDA) in the United States.

How long will I be in this research?

You will be in this study for a total of 12 months. We will enroll 2000 participants in this study.

What happens to me if I agree to take part in this research?

All study activities will take place online. You will create an account on the CAFE-MS trial
website for participation in this study. If you consent to participate in this study and are eligible,
you will be randomly assigned (like drawing straws) to one of three experimental groups. You
may also be invited to create an account on the website of a company called GAIA, where the
two online programs will take place. You will complete study questionnaires on the CAFE-MS
website at various timepoints throughout the study.

Screening procedures

You will be asked to complete an online questionnaire to determine whether you are eligible for
this study. This questionnaire will collect information about your MS, demographics (such as age
and state of residence) and fatigue.

We may also need to obtain documentation of your MS diagnosis. If this is the case, we will ask
for your permission to have access to your medical records. Any records collected will be
retained behind a secure VA firewall.

There are rules to protect your private information. Federal and state laws and the federal
medical Privacy Rule also protect your privacy. By signing this form, you provide your
permission, called your ‘authorization,’ for the use and disclosure of information protected by
the Privacy Rule.

The research team working on the study will collect information about you. This includes things
learned from the procedures described in this consent form. The research team may also collect
other information including your name, date of birth, and information from your medical records.

Questionnaires

You will be asked to complete a set of online questionnaires at the beginning of the study
(baseline), and/or at 1 months, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months and
12 months. These questionnaires will include the following:

• Questionnaires about your demographics (e.g., sex, race/ethnicity) and MS history
(baseline only)
• Questionnaires about your fatigue level (all timepoints)
• Questionnaires about your MS symptoms and quality of life (all timepoints)
• A questionnaire about any other fatigue treatment you are receiving (baseline, 3 months,
6 months and 12 months)
• A questionnaire asking whether, in the 4 weeks prior to answering the questionnaire, you
started a new medicine for your MS, experienced or were treated with a steroid (3
months, 6 months and 12 months)
• A questionnaire about your ability to carry out daily activities (baseline, 3 months, 6
months and 12 months)
• A questionnaire about your satisfaction with the program (6 months and 12 months)
You can expect to spend from 10 to 60 minutes at any given timepoint completing these
questionnaires.

Experimental Phase (12 months in duration)

After completing the baseline questionnaires, you will be randomly assigned by the study portal
to one of three experimental groups. It is important for you to understand what may happen as
a result of assignment to an experimental group before deciding to participate. This random
assignment helps ensure that the study results are unbiased and scientifically valid. Neither you
nor the research team will have control over which group you are assigned to. You will not know
whether you are in Fatigue Program A group or in Fatigue Program B group but participants
in will be aware if they are assigned to Treatment-As-Usual group.

All study participants will continue to receive their usual treatment for their MS prescribed by
their doctors throughout this study. This includes medications and other types of treatment. You
can keep using any treatments for fatigue that you are already using.

The following list describes the three experimental groups you may be assigned to.

1. During the initial 6-month period of the study, you will be provided access to an online
fatigue program (A), in addition to continuing to receive your usual treatment for MS as
prescribed by your physician (Fatigue Program A group). You will be asked to
complete questionnaires every month for 6 months.

2. During the initial 6-month period of the study, you will be provided access to an online
fatigue program (B), in addition to continuing to receive your usual treatment for MS as
prescribed by your physician (Fatigue Program B group). You will be asked to
complete questionnaires every month for 6 months.

Note: Online fatigue program A is distinct from online fatigue program B.

3. You will continue to receive your usual treatment for your MS as prescribed by your
physician during the initial 6-month period of the study (Treatment-As-Usual group).
You will be asked to complete questionnaires every month for 6 months.

For participants in Fatigue Program A group or Fatigue Program B group:
• Modules from the programs (A or B) can take between 15 minutes to one hour to review.
• You will be asked to access the program once or twice per week, with the entire program
to be completed over a 6-month period.
• At the end of the 6-months, you may be offered the other online fatigue program for 6
months. Whether you are offered another online fatigue program or not, you will
continue your usual treatment for your MS and will complete questionnaires every 3
months for the remainder of the study.

For participants in the Treatment-As-Usual group:
• At the end of the 6 months, you will be offered a choice between the two experimental
online fatigue programs (A or B) for 6 months in addition to your usual treatment for
your MS and will complete questionnaires every 3 months for the remainder of the study.
• Modules from the programs (A or B) can take between 15 minutes to one hour to review.

Extension Phase after 180 days for certain program groups
After completion of 180 days of treatment in any of the three assigned groups, you may receive
an email notification with an offer to use a different online program but you will not be aware of
its exact identity for another 180 days. The purpose of the Extension phase is to examine longer
term stability effects of experimental on-line programs. Your study doctor will discuss your
options before transition to Extension phase after 180 days.

Participation is voluntary, and you may refuse to participate or leave the study at any time.

What are my responsibilities if I take part in this research?

If you consent to participate in this study and are eligible, you will be assigned to one of three
experimental groups. You may also be invited to create an account on the website of a company
called GAIA, where the two online programs will take place. All data you enter into the online
programs will be stored by GAIA in a de-identified manner. This means any study information
you provide will not be linked to you and will be kept in a secured database. You will be
responsible for completing the online programs that you are assigned to. The goal of the study is
to evaluate how helpful these programs might be in treating fatigue in people with MS. It is
important that you use the program regularly over the course of the study.

You will also be responsible for completing a set of online questionnaires at the beginning of the
study (baseline), and/or at 1 months, 2 months, 3 months, 4 months, 5 months, 6 months, 9
months and 12 months.

You are also responsible for reporting any events or symptoms occurring during the study that
cause you to think that this research may have hurt you or made you sick. These events should be
reported to the research team at the phone number(s) listed at the beginning of this document.

Could being in this research hurt me?

Identifiable Private Information
The risks of this study include the possible loss of privacy or breach of confidentiality. We will
take steps to reduce this risk, such as assigning a de-identified study code to your data that is
collected during the course of this study.

Psychological Discomfort
Any psychological risks involved are minimal; however, you may experience some momentary
frustration when attempting to perform tasks during which you experience difficulty. The
researchers will try to minimize any frustration that may occur.

Using the online programs and/or completing the outcome questionnaires may worsen your
fatigue.

There may be some unanticipated discomforts or risks in addition to those specified above, but
precautions will be taken to ensure your personal safety and to minimize any discomforts.

In addition to these risks, taking part in this research may harm you in unknown ways.

The risks to an embryo, fetus or infant from exposure to the study procedures are unknown.
Will it cost me money to take part in this research?

There will be no cost to you for participating in this study, other than the cost of your usual
treatment. All study-related online programs are offered at no charge to you.

If you are a VA study participant, you or your insurance will not be charged for any treatments
or procedures that are part of this study. If you usually pay co-payments for VA care and
medications, these co-payment requirements will continue to apply to medical care and services
provided by the VA that are not part of the study.

Will being in this research benefit me?

What other choices do I have instead of taking part in this research?

This research is not designed to diagnose, treat or prevent any disease. Your alternative is to not
take part in the research. If you consent to participate, you may withdraw at any time. If you
choose to withdraw, it will have no effect on your future participation in research studies
conducted by Accelerated Cure Project for MS or the VA.

Health Insurance Portability and Accountability Act (HIPAA) authorization
for the collection, use, and sharing of your private health information:

There are rules to protect your private health information. Federal and state laws and the federal
medical law, known as the HIPAA Privacy Rule, also protect your privacy. By signing this form,
you provide your permission, called your ‘authorization,’ for the use and disclosure of
information protected by the HIPAA Privacy Rule.

The research team working on the study will collect information about you. This includes things
learned from the procedures described in this consent form. The study team may also collect
other information including your name, address, date of birth, and information from your
medical records such as HIV status, drug, alcohol or STD treatment, genetic test results or
mental health treatment.

The research team may also need to disclose the information to others as part of the study
progress and regulatory oversight. Others may include the following: The Food and Drug
Administration (FDA), Office of Human Research Protections (OHRP), the VA Office of
Research Oversight (ORO), the Government Accountability Office (GAO), Department of
Defense (DoD), Accelerated Cure Project, Inc, Holland Research LLC, the Institutional Review
Board, and the local VA medical facility Human Research Protections Program.

The monitors, auditors, the IRB, the Food and Drug Administration will be granted direct access
to your medical records for verification of the research procedures and date. By signing this
document, you are authorizing this access.

Your health information disclosed pursuant to this authorization may no longer be protected by
Federal laws or regulations and may be subject to re-disclosure by the recipient.

While this study is being conducted you will not have access to your research related health
records. This will not affect your VA healthcare, including your doctor’s ability to see your
records as part of your normal care and will not affect your right to have access to the research
records after the study is completed.

You can revoke this authorization, in writing, at any time. To revoke your authorization, you
must write to the Release of Information Office at this facility or you can ask a member of the
research team to give you a form to revoke the authorization. Your request will be valid when the
Release of Information Office receives it. If you revoke this authorization, you will not be able to
continue to participate in the study. This will not affect your rights as a VHA patient to treatment
or benefit outside of the study.

If you revoke this authorization, Dr. Mitchell Wallin and his research team can continue to use
information about you that was collected before receipt of the revocation. The research team will
not collect information about you after you revoke the authorization.

Treatment, payment, or enrollment/eligibility for benefits cannot be conditioned on you signing
this authorization. This authorization will expire at the end of the research study unless revoked
prior to that time.

What happens to the information collected for this research?

The information that is contributed to this study will be stored securely in the study’s online
database using industry-standard security controls and will be associated with a code that de-
identifies the information. Your contact details will be stored separately in the same secure
fashion in the database associated with the code and used only for communicating with you. De-
identified information will be shared with individuals and organizations that conduct or watch
over this research, including:

• The research sponsor, Accelerated Cure Project, Inc.
• Organizations collaborating with the research sponsor

• Five (5) Veterans Health Administration Medical Centers (Washington, DC;
Baltimore, MD; Seattle, WA; Portland, OR; and Nashville, TN), two (2) German
universities (Charité – Universitätsmedizin Berlin and University Medical Centre
Göttingen) and a German company (GAIA AG)
• Government agencies, such as the Food and Drug Administration and Department of
Defense (DoD)
• WCG IRB that reviewed this research. An IRB is a group of people who perform
independent review of research studies, following US Federal Government rules, to
protect rights and welfare of the people taking part in research studies.

By consenting to participate in this study, you give permission for uses and disclosures of the
information about you and your health that you or study personnel contribute to the CAFE-MS
study website. Your information will be kept as confidential as possible under local, state, and
federal law, but absolute confidentiality cannot be guaranteed.

Some of the persons or groups that receive your study information may not be required to
comply with the Health Insurance Portability and Accountability Act (HIPAA) privacy laws.

Your information may lose its federal protection if those persons or groups disclose it.

We may publish the results of this research. However, we will keep your name and other
identifying information confidential. We protect your information from disclosure to others to
the extent required by law. We cannot promise complete privacy.

Individuals from WCG IRB and Federal regulatory agencies may look at records related to this
study to make sure we are adhering to research regulations and the protocol and minimizing risks
to human subjects. The results of this research may be published or presented to others. You will
not be named in any reports of the results.

In addition, we will share study data with our collaborating organizations and may use de-
identified data (data without your name or information that can be used to directly identify you)
for future studies.

Additional informed consent will not be required for us to share your de-
identified data for future studies. Data will be transmitted via a HIPAA-approved confidential
server. Efforts will be made to limit the use and sharing of your personal research information to
people who have a need to review this information.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required
by U.S. Law. This Web site will not include information that can identify you. At most, the Web
site will include a summary of the results. You can search this Web site at any time.

Additionally, you will be able to view the research results of this study, when available, on the
Accelerated Cure Project website (www.acceleratedcure.org), the iConquerMS website
(www.iconquerms.org), and the study trial CAFE-MS website. These research results may also
be shared with other advocates and interested partners in MS.

Data collected in this research might be used for future research or distributed to another
investigator for future research without your additional consent. Neither you nor your doctors
will be informed of your individual results from these future research and future research will not
affect your current treatment in any ways.

If your data is used for commercial profit, you will not share in this commercial profit.
Who can answer my questions about this research?

If you have questions about your rights as a study participant, or you want to make sure this is a
valid VA study, you may contact the local VAMHCS Research Protections Officer (RPO). You
may call them at 443-421-5602 if you have questions, complaints, or concerns about the study or
if you would like to obtain information or offer input.

If you want to speak to someone who is not a member of the study to discuss problems, ask
questions or voice concern, you can call 443-421-5602. Please contact Dr. Wallin or VAMHCS
staff if you have any questions.

DURING THE DAY:
Dr. Mitchell Wallin, phone: 202-745-8146
24 HOURS:
Dr. Mitchell Wallin, phone: 703-963-1103

What if I am injured because of taking part in this research?

If you are a VA study participant, the VA (not you or your insurance) will provide necessary
medical treatment should you be injured by being in this study. You will be treated for the injury
at no cost to you. This care may be provided by the VAMHCS or arrangements may be made for
contracted care at another facility. You have not released this institution from liability for
negligence. In case of research related injury resulting from this study, you should contact your
study team. If you have questions about compensation and medical treatment for any study
related injuries, you can call the medical administration service at the Baltimore VA Medical
Center at 410-605-7000.

If you want to speak to someone who is not a member of the study to discuss problems, ask
questions or voice concerns, you can call the VAMHCS Research Protections Officer (RPO) at
443-421-5602.

You do not give up any legal rights by signing this form.

Can I be removed from this research without my approval?

The person in charge of this research can remove you from this research without your approval.
Possible reasons for removal include:
• You have an event or symptom that requires stopping the research
• You need a treatment not allowed in this research
• The research is canceled by the FDA, IRB, DoD, or the sponsor

We will tell you about any new information that may affect your health, welfare, or choice to
stay in this research.

What happens if I agree to be in this research, but I change my mind later?

Your participation in this study is voluntary. You do not have to take part in this research. You
are free to withdraw your consent at any time. Refusal to take part or stopping your participation
in the study will involve no penalty or loss of benefits to which you are otherwise entitled. Your
participation will not affect the way you now pay for medical care at the VAMHCS.

If you decide to stop taking part, if you have questions, concerns, or complaints, or if you need to
report a medical injury related to the research, please contact the investigator, Dr. Mitchell
Wallin, at 202-745-8146.

If you withdraw from this study, already collected data may not be removed from the study
database. You will be asked whether the investigator can collect data from your routine medical
care. If you agree, this data will be handled the same as research data.

The authorization to use and disclose your health information collected during your participation
in this study will expire at the end of study unless you withdraw your permission prior to that
time. You may withdraw or take back your permission to use and share your health information
at any time. If you want to cancel permission to use your health information, you must submit
the request in writing to the Release of Information Office at this facility.

If you cancel permission to use your health information, the research team will stop collecting
any additional information about you and you will not be able to stay in this study. Please note
that the research team may use and disclose information that was gathered before they received
your cancellation. However, to join this study you must sign this form to allow use and
disclosure of your health information.

Will I be paid for taking part in this research?

If you are eligible for the study, you will be compensated $15 (paid via a digital or physical gift
card) for completing the baseline screening and subsequent health surveys at each of the 8 time-
points for a maximum of $120. You will receive a total of $120 if you complete all the
questionnaires.

In order to process payments for stipends or reimbursements, information about you is needed by
Accelerated Cure Project, Inc. By signing this form and providing HIPAA authorization you
consent to the release of personally identifying information about you including your: Name,
Address, Date of Birth and Social Security Number in order to mail or email compensation.

Statement of Consent:

Your signature indicates that the research team member obtaining consent has explained the
research study to you. You have been told of the risks or discomforts and possible benefits of the
study. You have been told of other choices of treatment available to you. You have been given
the chance to ask questions and obtain answers.

Furthermore, by signing this document below, you voluntarily consent to participate in this study
and authorize the use and disclosure of your health information for this study. You also confirm
that you have read this consent, or it has been read to you. You will receive a copy of this consent
after you sign it.

Attachment

VA Baltimore Informed Consent Form - FOR REVIEW ONLY.pdf