Document text
090177e197264d6f.docxCONSENT DOCUMENT COVER LETTER
TITLE:
HERO Together: A post -Emergency Use Authorization observational cohort study to evaluate
the safet y of the Pfizer -BioNTech COVID -19 vaccine in US healthcare workers
PROTOCOL NO.:
C4591008
IRB Protocol #20204110
SPONSOR:
Pfizer, I nc
INVESTIGATOR:
Emily O'Brien, PhD
200 Morris Street
Durham, North Carolina 27701
United States
STUDY -RELATED PHONE NUMBER(S):
1-844-846-6747
Dear Sir or Madam,
Thank y ou for taki ng the time to consider joining this study . This consent can help y ou make
your decision by explaining what you can expect to happen during this study , also known as a
research stud y.
Your participation in this study is completely voluntary (your choice) .Take as long as you
need to make your decision. You also can choose to take part in the stud y now, and then change
your mind later at an y time.
We encourage you to speak with your family, caregivers, doctors, and the study team about
taking part in this study and whether it is right for y ou. The study team at the Duke Clinical
Research Institute (DCRI) will work with y ou to answer an y questions that you may have about
the study . If y ou choose to participate, you will be asked to sign this consent form be fore
starting the study. You will also be asked to allow the study sponsor to review your relevant
(or important) health records if you experience certain health events .
If you agree to participate, a cop y of this signed consent will be available to you t hrough the
online portal.
We appreciate that you are thinking of taking part in this study .
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090177e197264d6f.docxSincerel y,
The HERO -Together Study Team
Key Study Information and Contact Information
Members of the HERO -Together stud y team will answer an y questions, concerns or complaints
you may have before, during and after y ou complete the study . The study team includes the
principal investigator, call center staff and others who work with the principal investigator.
If you have concerns about your participation, you may contact Dr. Emily O'Brien and the DCRI
HERO- Together research team at 1-844-846-6747 or HERO- [email protected] .
If you have concerns about your privacy, or your rights when you are in the study , you may
contact WCG I RB. The IRB is a group of people who review the research to protect y our rights
as a participant. You can reach WCG IRB at 1-855-818 -2289 or [email protected] .
Name of Stud y: Healthcare Worker Exposure Response and Outcomes (HERO) -Together
Sponsor Consent Version Number (Study /Country/Site): 1.0
Sponsor Study Number: C4591008
Name of Compan y Sponsoring the Stud y:Pfizer, Inc
Name of Principal Investigator: Dr. Emily O'Brien
Study Team Contact Information
Contact Person: Emily O'Brien, P hD
Address: Duke Clinical Research Institute, Department of Population Health Sciences, 215
Morris Street, Suite 210, Durham, NC 27701
Phone Number: 1-844-846-6747 (Mon.- Sat.: 9am-11pm ET, Sun. 12pm- 11pm ET )
Email address: HERO [email protected]
Institutional Review Board Contact Information:
Address: 1019 39th Avenue SE Suite 120 Puyallup, Washington 98374 -2115
Email: [email protected]
Phone Number: 1-855-818-2289
Brief Summary of this Study
This study will collect information about how you feel after receiving a vaccine to prevent
COVID -19 infection in order to monitor (or check) the effects of the vaccine.
You are being asked to take part in a stud y that is sponsored b y Pfizer (the " Sponsor "). The
Sponsor is pay ing to support this study , including the online platform oper ated b y a compan y
called Verily and all study activities overseen by the Duke Clinical Research I nstitute (DCRI)
Coordinating Center.
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090177e197264d6f.docxYou are being asked to take part in this study because y ou previousl y enrolled in the HERO
Registry or in the Project Baseline Community Study , are 18 years or older and living in the
United States, and have received the first dose of a vaccine to prevent COVID -19 infection
within the last 60 day s. Both the HERO Registry and the Project Baseline Community Study use
theBase line Platform by Verily . The HERO Registry is managed by DCRI ; the Project Baseline
Community Study is managed by Verily .
You will be asked to take part in the study for about 2 y ears. If you agree to participate, this
study will involve regular responses to survey s about y our health. If you report experiencing
certain health events, the study team may collect medical records or bills related to the event
from y ou or y our healthcare provider.
This study does not involve an y change in your usual healthcare and is for research purposes
only. There is no direct benefit to y ou from taking part, but information learned from the study
may help other people in the future.
Taking part in this study is voluntary (your choice). There is no penalt y or change to your regular
medical care if you decide not to participate. You can choose to take part in the study now, and
then change your mind later at an y time without losing an y benefits or medical care. We
encourage you to speak with your family, caregivers, health ca re providers, and the study team
about taking part in this study and whether it is right for y ou. The study team will work with y ou
to answer an y questions that y ou may have about the study .
If you agree to participate, a cop y of this signed consent will be available to y ou through the
online portal.
If you are interested in learning more about this study, please continue reading below.
What is the purpose of this study?
The HERO -Together study will collect information about people who have received a vaccine to
prevent COVID -19. You will be asked to provide some information about y ourself and y our
health after vaccination.
The Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA)
for or approval of the vaccine that has be en administered to you. The Sponsor is conducting this
study to collect additional information about the health effects of a COVID -19 vaccine when
given to healthcare workers. The stud y leverages the existing HERO Registry and Project
Baseline Community Study online platform s to streamline data collection and reporting.
How long will I participate in this study?
After enrollment, y ou will be asked to complete follow -up survey s for up to 2 y ears after first
vaccination.
How many people will take part in this study?
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090177e197264d6f.docxWe expect about 20,000 people in the United States enrolled in the HERO Registry or in the
Project Baseline Community Study will also participate in the HERO -Together study . The stud y
is being conducted remotely using an online platform.
What will happen during this study?
Before an y stud y activities begin, you will electronically sign this consent document in the
online portal . If you experience certain health events during the stud y, you’ll also be asked to
sign a medical record release form in t he online portal. The medical record release form will be
used to collect your medical records from an y hospital, office or other health care facility where
you receive care for certain health events while you are enrolled in the study.
You will also provide information for one or more alternate contacts. These contacts may be
asked to provide information about y our health and well -being if you cannot be reached during
the follow- up period.
We will ask y ou to provide the following personal information:
Your date of birth so we can confirm y our age;
Your phone number, email address, and cell phone number so we can contact y ou to see
how y ou are doing;
Your primary health care providers and any primary / secondary hospitals you may visit if
you need care;
Access to medical records so we can review an y hospitalizations or non- routine medical
visits that occur while y ou are participating in the study ; and
Contact information for a family member or friend so we can contact them if we can't
reach you. These people may be asked to provide us some information about y our health.
You will be asked to provide additional information about y our medical history , medications
(prescription and non -prescription), and pregnancy status at enrollment. This information will be
combined with information y ou provided when you enrolled in the HERO Registry or in the
Project Baseline Community Study , so that y ou don't have to provide the information multiple
times. Only the information from the HERO Registry or the Project Baseline Community Study
that is also necessary for the study will be used.
After enrollment, y ou will be asked to complete follow -up survey s using the online portal at 1
week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the first dose of your vaccination.
Thereafter, you'll be asked to complete follow -up every three months through 1 y ear after
vaccination, and every 6 months for up to 2 y ears after vaccination. The total amount of time
you'll participate in this registry is up to 2 y ears following vaccination. A map of the participant
journey can be found here.
The follow -up survey s will ask information about y our health and well -being, and about
healthcare events that required medical care. You'll receive email reminders to complete the
survey s at the nec essary time points. I f you don't complete the surveys within a specific
timeframe, or if key information is missing or inconsistent, the Call Center at the Coordinating
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090177e197264d6f.docxCenter will contact you via telephone to collect the information. The phone surveys wil l take
about 15 minutes. The Call Center may also contact y ou via text message or email to collect the
information. If you cannot be reached, the Call Center staff may contact your alternate contacts
to collect the information.
If you report a medically significant event during the study , you’ll be asked to sign a medical
record release form so that the Call Center may contact y our healthcare provider, or the hospitals
where you received care , to obtain related medical records or bills. They may also coll ect records
for care that occurred up to one y ear prior to y our vaccination, to understand how the health
event is related to your regular health status before receiving the vaccine. The Coordinating
Center will review these records to understand more deta ils about the event and whether it meets
the definition of the events of interest in this study .The Call Center may contact y ou if assistance
is needed in obtaining these records.
Once your participation in the HERO -Together study is completed, you wil l still be a member of
the larger HERO Registry or Project Baseline C ommunity Study programs , and y ou can continue
to participate in those online communit iesas long as y ou wish. You may also be contacted about
additional studies regarding the vaccine and how long it protects against COVID- 19. If y ou are
contacted about these studies, they will be explained to y ou at that time, and y ou will be asked to
provide a separate consent. You do not have to participate in an y of these studies.
What are the possible risks and discomforts of this study?
This is a non- interventional study , so there are no phy sical risks associated with taking part in
this study . This study is non- interventional because it collects information only . Your usual
health care provider will manage your care no differentl y than if you were not taking part in this
study .There may be non -physical risks such as the risk of accidental disclosure of y our personal
data (including your medical information), but we will do our best to keep your data secure.
The COVID -19 vaccine that y ou received prior to enrollment in the study may cause some side
effects, including certain risks or discomforts. These side effects were described in the
information sheet provided at the time of vaccination. I f you ex perience any side effects that are
severe or do not go away (for example, an y illness for which you are hospitalized) or become
pregnant during the study , you should inform y our healthcare provider that y ou received a
COVID -19 vaccine.
Pregnancy Follow -up
If you become pregnant during the stud y, please tell the doctor who will be taking care of you
during the pregnancy that y ou received a COVID -19 vaccine. The stud y team may ask if you are
willing to participate in a study related to the health effects of a COVID -19 vaccine during
pregnancy .
What are possible benefits of this study?
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090177e197264d6f.docxThis study is for research purposes only . While there are no direct benefits for participating in
this study because y ou will continue to receive your regular medical care, you may feel benefit
from knowing that y our participation will help researchers understand the effects of a vaccine
against COVID -19 and help other people in the future.
What other choices do I have if I do not join this study?
This study is for research purp oses only . Your alternative is to not take part in this study . If y ou
choose not to take part in the study you will continue to receive your regular medical care.
What happens if I am injured during this study?
This study collects information only , so it is unlikely that y ou will have a study -related injury .
You were vaccinated with a COVID -19 vaccine as part of y our medical care outside of this
study . Any negative reaction y ou may experience while taking part in this study will not be
considered a study -related injury .
What if I join this study and then change my mind?
If you agree to participate and then change your mind for an y reason, you are free to stop
participating at an y time. Your decision will not affect your regular medical care or an y benefits
to which y ou are entitled. Tell the study team if y ou are thinking about stopping or decide to stop
taking part.
The principal investigator or the Sponsor may decide to take y ou out of the study if:
The study is stopped by the Sponsor, the institutional review board (I RB) or independent
ethics committee (IEC) (a group of people who review the study to protect y our rights),
or by a government or regulatory agency ;
You do not agree with consent updates;
The study ends; or
The principal investigator or the team who oversees research recommends you no longer
participate.
There may be other reasons not listed here. If y our participation ends without y our permission,
the reason will be explained to y ou at that time.
The study team will give y ou a Privacy Supple ment, which is considered part of this consent
document. I t describes what happens to y our personal information and how it may be used if y ou
withdraw from the stud y.
What will I have to pay for if I take part in this study?
There are no costs to y ou to jo in the study .
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090177e197264d6f.docxThis study is collecting information only and there is no change to y our regular medical care. So,
the Sponsor will not pay for any treatments or procedures that y ou may receive during y our
participation in this study including the COVID -19 vaccine.
If you access the stud y using a mobile device, or if you receive text messages related to the
study , you will be responsible for an y data usage or other charges from your wireless service.
Will I be paid for taking part in this study?
You may rec eive up to $ 200 over the two years you participate in this study . You will be asked
to complete a form to agree (“opt -in”) to receive this reimbursement. Duke Universit y
employ ees and students will also be asked to provide their unique ID number.
The Sponsor may use information resulting from the study to develop products or processes from
which it may make a profit. There are no plans to pay you or provide y ou with any products
developed from this study. The Sponsor will own all products or processes that are developed
using information from the study .
What will happen to my personal information?
The Privacy Supplement, accessed below, is considered part of this consent document. The
Privacy Supplement tells y ou about:
What personal information may becollected from you during the study ;
How y our personal information will be used and by whom (including by the study team
and the Sponsor);
How y our personal information might be used for other research;
How y our personal information will be protected duri ng transfer;
Your data protection rights, and whom y ou may contact about these rights or any related
concerns or complaints; and
What happens to y our personal information if y ou decide to stop taking part in the study .
Where can I find additional informati on about this study or the study results?
You will not receive personal health information from this research. Research is not the same as
medical care. We may contact y ou by phone, email, or other methods with updates related to the
study . We will share t he results with y ou and others, including through publications. Any results
shared or published will be anon ymous, meaning they will not identify you in any way .
A description of this study will be available on the European Union (EU) post -authorization
study (PAS) register www.encepp.eu/encepp/studiesDatabase.jsp. This Web Site will not include
information that can identify you. At most, this Web Site will include a summary of the results.
You can search this Web Site at any time. It may be many years, ho wever, before research
results are posted.
If you need assistance understanding this Web Site, please ask the study Principal I nvestigator.
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090177e197264d6f.docxSignatures
Now it's time to sign the HERO -Together study consent!
To do so, y ou will be asked to log in to the por tal. Logging in acts as a legally binding signature,
just as y our handwritten signature, and confirms that y ou:
Are at least 18 y ears old, and live in the United States
Received the first dose of a vaccine against COVID -19 within the last 60 day s
You can r eview this consent information as man y times as y ou'd like. You can reach out to us
with questions at 1-844-846-6747 or HERO- [email protected]. After signature, you'll receive
an email confirming your enrollment, and providing access to your cop y of the signed consent in
the online portal.
I confirm I have read and understand this consent for the study described above and have
had the opportunity to ask questions. I have had enough time to review this consent. I
also have had an opportunity to ask about the details of the study and to decide whether
or not to participate.
I have read and understand the Privacy Supplement. I understand that taking part i n the
study will require the processing (including collection, use, transfer, storage, anal ysis and
reporting) of m y personal information, as explained in the Privacy Supplement. I
understand and agree to the processing of m y personal information within an d outside my
country of residence for health care, medical research and/or regulatory purposes.
I understand that taking part is voluntary and that I am free to stop taking part in this
study or to withdraw my consent to the processing of my personal infor mation at any
time. I do not need to give any reason and my regular medical care and legal rights will
not be affected. However, even if I withdraw m y consent to processing, my personal
information held at that time may be kept to comply with laws and regulations and to
maintain the integrit y of the study.
I agree to the study team accessing m y medical history, including information from
medical records and test results and an y medical treatment I receive during the course of
the study , and if necessary , contacting my doctor or any other health care providers
treating me for access to such information.
I understand that the Sponsor and/or others working with or on behalf of the Sponsor,
institutional review boards (IRBs) or independent ethics committees (I ECs), and
regulatory agencies may need access to personal information about me collected by the
study team for the study and any other research. I agree that they may have access to my
personal information.
I agree that the stud y team (or others working on behalf of the Sponsor) may send me text
messages as described above.
I do not give up an y of my legal rights b y signing this consent document. I have been told
that I will receive a signed and dated copy of this document.
I agree to take part in the stud y described in this document.
PRIVACY SUPPLEMENT
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090177e197264d6f.docxThis Privacy Supplement describes how we will collect, use, and share y our personal
information. I t also describes y our privacy rights.
You are not required to authorize the use and disclosure of your pers onal information as
described below. If you do not agree, you cannot participate in this study , but there will be no
penalty or change to y our regular medical care or pay ment for that care.
A. What personal information may we collect about you during this study?
The study team will collect or provide information about y ou, some of which is sensitive. This
information may include:
Information that directly identifies you such as your name, address, telephone number,
email address, and date of birth.
Sensitive personal information such as your medical history, data from this study,
demographics (for example, age and gender) and other sensitive information that is
needed for this study such as HIV/AIDS, tuberculosis, substance use disorders, mental
health disorders, diagnoses and treatment, race, ethnicity .
Data captured from electronic devices if you complete the consent process using an
online tablet or if you use a mobile application or other digital tool during the study. This
information may include data about your use of the eConsent application or tool, such as
the length of time it takes y ou to complete the consent process, the number of times y ou
scroll between pages or click on the hy perlinked items, and y our electronic signature.
Mobile applica tions and other digital tools used in the study may have their own privacy
policies. Those policies provide additional information about the data processing
activities performed b y the digital tools.
B. Who will use my personal information, how will they use it, and where will it be
stored?
Any personal information collected about y ou during this study will be stored by the study teams
at Veril y and DCRI. The study teams must keep your personal information private. A U.S.
privacy law called HI PAA (the He alth Insurance Portability and Accountability Act of 1996)
protects the privacy of your personal health information. DCRI and Veril y must get your
permission to use and share with others an y personal health information that could identify you.
Your person al information will likely be accessed by :
The study Principal Investigator and other stud y team members;
The Sponsor and its representatives (including its affiliated companies);
People, or organizations providing services for, or collaborating with, the Sponsor;
Any organization that obtains all or part of the Sponsor's business or rights to the product
under study ;
Government or regulatory authorities (including the U.S. Food and Drug Administration
and authorities in other countries); and
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090177e197264d6f.docxInstitutional Review Board(s) (IRB) or Independent Ethics Committee(s) (IEC)
overseeing this study .
The individuals and groups listed above will use your personal information to conduct this study ,
and to comply with legal or regulatory requirements, including to:
determine if you are eligible for this study;
verify that the study is conducted correctl y and that study data are accurate;
answer questions from IRB(s), IEC(s), or government or regulatory agencies;
contact you during and after the study (if necessary);
follow-up on y our health status, including using publicly available sources should the
study team be unable to contact y ou using information held on file;
protect your vital interests or the interests of your pregnant partner (for example, a critical
medical situation, such as providing information to an emergency department of a
hospital where you are being treated); and
answer your data protection requests (if an y).
The study team will retain y our personal information for the period necessary to fulfill the
purposes outlined in the consent document(s), which could be up to 25 years after the end of the
study .
If you provide someone else's personal information (for example, an emergency contact or
details of family medical history ) you should make them aware that y ou have provided the
information to us. We will only use such personal information in accordance with this informed
consent and applicable law.
Please note the following information regarding the delivery of text messages:
The study team, or a comp any working on behalf of the Sponsor may send text messages
to remind y ou of available survey s or check -ins, or other stud y-related information. Texts
messages will be sent only to the contact telephone number that y ou have provided. The
number of messages per month may vary depending on the specific requirements of the
study .
Message and data rates may apply . Please contact y our wireless phone provider to inquire
about the details of your plan.
The messages received through this program may appear on yourmobile phone screen as
soon as they are received, even when the phone is locked. These messages could be seen
and read b y others who are near your phone when the message is received.
Text messages are not encry pted. Encry ption is a way of coding a message so that only
authorized people can access it. There is a risk that information contained in unencry pted
text messages may not be secure and could be read, used or disclosed b y people other
than the study team or the Sponsor, such as y our wireless service provider or other
unauthorized people.
For questions regarding text messages, please contact the DCRI study team at 1-844-846-
6747 .
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090177e197264d6f.docxC. What happens to my personal information that is sent outside DCRI or Verily?
DCRI and Veril y are required by HIPAA to protect your personal information. After your
information is shared with others, such as the Sponsor, it may no longer be protected by HIPAA.
Before the stud y team transfers your personal information outside, DCRI or Verily will replace
your name with a unique code and remove information that directly identifies y ou. We call this
"Coded Information ." The study team will keep the link between the code and y our personal
information confidential, and the Spons or will not have access to that link. The Sponsor's
employ ees and representatives are required to protect y our Coded Information and will not
attempt to re- identify you.
Your Coded Information will be used by the following:
The Sponsor and its representat ives (including its affiliated companies);
People and/or organizations providing services to or collaborating with the Sponsor;
Any organization that obtains all or part of the Sponsor's business or the rights to the
product under stud y;
Other researchers;
The I RB or IEC that approved this study ;
Government or regulatory authorities;
The above parties may use y our personal information for the following purposes:
Conducting the study , including:
oExamining y our response to the COVID- 19 vaccine;
oUnderstanding the study and the study results and learning more about the
COVID -19 vaccine; and
oAssessing the safet y and efficacy of the COVID -19 vaccine.
Complying with legal and regulatory duties such as:
oEnsuring the stud y is conducted according to good clinical practice;
oMaking required disclosures to I RB(s), IEC(s), or government or regulatory
authorities;
oSeeking approval from government or regulatory authorities to market the
COVID -19 vaccine (it is possible that these government or regulatory authorities
may disclose your Coded I nformation to other researchers for the conduct of
future scientific research); and
oSharing stud y data with other researchers not affiliated with the Sponsor or study
team (including through publication on the internet or other way s. However,
information that could directl y identify you will not be made available to other
researchers).
Publishing summaries of the study results in medical journals, on the internet or at
educational meetings of other researchers. You will not be directly identified in any
publication or report of the study . But, some journal representatives may need access to
your Coded Information to verify the study results and ensure the research meets the
journal's quality standards. Also, journals may require that ge netic and other information
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090177e197264d6f.docxfrom the study that does not directly identify you be made available to other researchers
for further research projects.
Improving the quality, design and safety of this study and other research studies.
The Sponsor will retain your Coded Information for the period necessary to fulfill the purposes
outlined in the consent document(s), which could be up to 25 years after the end of the stud y.
D.Can my personal information be used for other research?
Your Coded Information may be used to advance scientific research and public health in other
projects that will occur in the future. At this time, we do not know the specific details of these
future research projects. This other research may be conducted (1) in combination with dat a from
other sources , (2) for additional scientific research purposes beyond objectives of this study ,
and (3) subject to specific safeguards.
Other sources : Coded Information may be combined with data from other sources that
are taken from outside t ypica l research settings. These sources may include: coded
electronic health records, claims and health care cost and pay ment data or databases,
product and disease registries, data gathered through your phone, tablet, or other devices
and mobile applications, social media, pharmacy data, biobanks, or patient engagement
programs.
Additional scientific research: Coded Information may be used to understand how to
make new medicines, devices, diagnostic products, tools and/or other therapies that treat
diseases and to improve future research. It may also be used to inform value, cost -
effectiveness and pricing, and to optimize access to medicines.
Specific safeguards will be used to protect your Coded I nformation, which may include:
oLimiting access to Coded I nformati on to specific individuals who will be
obligated to keep this information confidential and will be prohibited from
attempting to re -identify your Coded Information.
oUsing securit y measures to avoid data alteration, loss and unauthorized access.
oAnony mizin g the data b y removing and/or replacing information from the Coded
Information and/or destroy ing the link to the Coded Information.
oAssessing data protection sy stems to identify and mitigate privacy risks, if any ,
associated to each additional scientific research purpose.
oWhen required b y applicable law, ensuring that the scientific research has the
approval of IECs, IRBs, or other similar review groups.
E. How will my personal information be protected when transferred from DCRI to the
Sponsor?
Your personal information will be treated in compliance with applicable data protection laws,
including requiring people and/or organizations providing services to or collaborating with the
Sponsor to use appropriate measures to protect the confidentiality and security of your personal
information. Some of the people using your personal information, including your Coded
Information, may be based in countries other than y our country . Data privacy laws may be
different in these countries. If your personal inf ormation is transferred by the Sponsor to other
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090177e197264d6f.docxcountries, the Sponsor, and people working with the Sponsor, will take steps to maintain the
confidentiality of your personal information.
F. What are my data protection rights? Whom may I contact about th ese rights or any
concerns or complaints?
You have the right to access y our personal information that is held about you by the study team.
To ensure the integrity of the study, you will not be able to review some of the data until after the
study has been completed.
If you wish to exercise this right, or have concerns about how your personal information is being
handled, it is best to contact the DCRI study team and not the Sponsor. Generall y, the Sponsor
will not know who y ou are (b y name) because the Sp onsor usually holds only your Coded
Information, which does not include y our name or other information that can easily identify you.
To contact a stud y team representative, please see the contact information at the beginning of
the consent document.
G. What happens if I do not wish to continue with the study?
As noted in the main consent document, y ou are free to stop taking part in this study at any time
by telling the study team. Your authorization for the study team to disclose y our personal
informa tion does not expire unless y ou withdraw y our authorization.
If you stop taking part in the study and you do not tell the study team, your contact information
may be used by the study team to contact y ou and check whether you wish to continue in the
study . If the study team is unable to reach y ou, the Sponsor may use publicly available records
about y our health to monitor the long -term safet y of the vaccine. This will only be done if
allowed b y the law.
If you stop taking part in the study but do not withdraw your consent, your personal information
will continue to be used in accordance with this Privacy Supplement and applicable law. No new
information will be collected about you or from you by the stud y team, unless you have agreed to
provide them.
If you decide to withdraw your consent:
You will no longer be able to participate in the study ;
No new information will be collected about y ou or from y ou by the study team;
The study team may still need to report any safet y event that you may have experienced
due to y our participation in the study to the Sponsor;
Your personal information, including Coded Information, that has alread y been collected
up to the time of your withdrawal will be kept and used by the Sponsor to guarantee the
integrit y of the st udy, to determine the safet y effects of the COVID -19 vaccine, to satisfy
legal or regulatory requirements, and/or for an y other purposes permitted under
applicable data protection and privacy laws;
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090177e197264d6f.docxYour personal information (including Coded Information) wi ll not be used for further
scientific research. However, if your personal information has been anon ymized so that
the information does not identify you personall y, that information may continue to be
used for further scientific research (as described in Se ction E of this Privacy
Supplement), as permitted by applicable law.
I acknowledge that the name below is my legal name and I adopt the signature below as the
electronic representation of my name and initials. I agree and acknowledge that the signature
below is my legal, binding signature just as my handwritten name and initials.
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