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<center>INFORMED CONSENT DOCUMENT FOR AN OBSERVATIONAL COVID-19 RESEARCH STUDY:<br> IDCRP-085: <u>Ep</u>idemiology, <u>I</u>mmunology, and <u>C</u>linical <u>C</u>haracteristics of Emerging Infectious Diseases with Pandemic Potential
(EPICC)</center><br>
<font size="2">
<font style="font-style:normal; font-weight: 100;">Thank you for your interest in learning more about this study. Please read the following information to ensure that you would like to participate. The Department of Defense has
sponsored this research study, led by the Infectious Disease Clinical Research Program (IDCRP) at the Uniformed Services University of the Health Sciences (the military's medical school), to better understand risks and illness
caused by the novel Coronavirus disease (<font style="font-style:normal; font-weight: bold;">COVID-19<font style="font-style:normal; font-weight: 100;">).<br>
<br> The COVID-19 pandemic is a global public health emergency. If you agree to participate, we are asking you to complete online questionnaires about your health history, possible exposures, symptoms and health care visits and
to collect small blood samples using a simple in-home kit to look for immunity (antibodies against the virus). Your medical records in the military health system will be reviewed now and in the future for information related to
COVID-19 risks, treatments, and health outcomes.<br>
<br>
<font style="font-style:normal; font-weight: bold;"><u>Who can participate?</u><br>
<font style="font-style:normal; font-weight: 100;">The EPICC study is available to DoD beneficiaries of all ages who have confirmed COVID-19, or who meet current Centers for Disease Control and Prevention (CDC) criteria for
testing for the virus that causes COVID-19, or received a vaccine for COVID-19. You are eligible to participate even if you have received a negative test result.<br> This online-only section of the study is available to
adults who are able to send/receive email and complete online questionnaires.<br>
<br>
<table style="width:100%" border="1px solid black">
<tbody>
<tr>
<td>
<font style="font-style:normal; font-weight: bold;"><u>KEY INFORMATION</u>
<font style="font-style:normal; font-weight: 100;">
<ul>
<li>This is an observational study meaning we will look at your medical records and collect data and samples from you <i>but we will not give you any medicine or treatment</i>. <font
style="font-style:normal; font-weight: bold;">Any questions about your treatment or vaccination for COVID-19 should be directed to your doctor<font style="font-style:normal; font-weight: 100;">.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">Your participation is voluntary, your decision will not affect your care or any other benefits to which you are entitled. Your alternative to volunteering
is to not participate.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">Your participation will last about 1 year. We will continue to follow your medical records for up to 5 years.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">You may end your participation at any time without any consequences.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">There is no cost for participating.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">All information and samples you provide will be handled securely and in confidence. Only those involved in conducting this study will know you are
enrolled.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">The information collected about you is for research purposes only. This information will not be used to guide your medical care.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">You may not personally benefit from this study. The information gained from this study may not be available in time to affect your care. The information we
learn may help in caring for other future patients with COVID-19 or similar illnesses.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">Potential risks in participating include the following:</font>
</font>
</li>
<ul>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">Blood draws can cause a risk of pain, bruising, bleeding, and rarely fainting or infection.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">There may also be unforeseen risks associated with this study.</font>
</font>
</li>
</ul>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">If you are pregnant, there are no additional risks to you or your fetus.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">Once your identifying information has been removed from the collected data and specimens, additional consent will not be sought for future studies. This
also applies if you withdraw from the study. Leftover samples will be stored and may be shared for future analyses related to COVID-19 or other infections.</font>
</font>
</li>
<li>
<font style="font-style:normal; font-weight: bold;">
<font style="font-style:normal; font-weight: 100;">Volunteering for this study does not limit your ability to participate in another study of an experimental drug or vaccine. That decision would be made in
discussion with your doctor and the other study's investigators and is separate from this study. We may ask to collect additional blood to assess the new drug's effects.</font>
</font>
</li>
</ul>
</font>
</font>
</td>
</tr>
</tbody>
</table>
</font>
</font>
</font>
</font>
</font>
</font>
</font>
</td>
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mRHLdiBCvYf5dVBKGBfcNfkQvpVnXrk
ELECTRONIC CONSENT FORM
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Please read through the consent document. If you are interested in participating
please print your name, date and sign the end of the consent form. Thank you.
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CRF Version
INFORMED CONSENT DOCUMENT FOR AN OBSERVATIONAL COVID-19 RESEARCH STUDY:
IDCRP-085: Epidemiology, Immunology, and Clinical Characteristics of Emerging
Infectious Diseases with Pandemic Potential (EPICC)
Thank you for your interest in learning more about this study. Please read the
following information to ensure that you would like to participate. The
Department of Defense has sponsored this research study, led by the Infectious
Disease Clinical Research Program (IDCRP) at the Uniformed Services University
of the Health Sciences (the military's medical school), to better understand
risks and illness caused by the novel Coronavirus disease (COVID-19).
The COVID-19 pandemic is a global public health emergency. If you agree to
participate, we are asking you to complete online questionnaires about your
health history, possible exposures, symptoms and health care visits and to
collect small blood samples using a simple in-home kit to look for immunity
(antibodies against the virus). Your medical records in the military health
system will be reviewed now and in the future for information related to
COVID-19 risks, treatments, and health outcomes.
Who can participate?
The EPICC study is available to DoD beneficiaries of all ages who have confirmed
COVID-19, or who meet current Centers for Disease Control and Prevention (CDC)
criteria for testing for the virus that causes COVID-19, or received a vaccine
for COVID-19. You are eligible to participate even if you have received a
negative test result.
This online-only section of the study is available to adults who are able to
send/receive email and complete online questionnaires.
KEY INFORMATION
* This is an observational study meaning we will look at your medical records
and collect data and samples from you but we will not give you any medicine
or treatment. Any questions about your treatment or vaccination for COVID-19
should be directed to your doctor.
* Your participation is voluntary, your decision will not affect your care or
any other benefits to which you are entitled. Your alternative to
volunteering is to not participate.
* Your participation will last about 1 year. We will continue to follow your
medical records for up to 5 years.
* You may end your participation at any time without any consequences.
* There is no cost for participating.
* All information and samples you provide will be handled securely and in
confidence. Only those involved in conducting this study will know you are
enrolled.
* The information collected about you is for research purposes only. This
information will not be used to guide your medical care.
* You may not personally benefit from this study. The information gained from
this study may not be available in time to affect your care. The information
we learn may help in caring for other future patients with COVID-19 or
similar illnesses.
* Potential risks in participating include the following:
* Blood draws can cause a risk of pain, bruising, bleeding, and rarely
fainting or infection.
* There may also be unforeseen risks associated with this study.
* If you are pregnant, there are no additional risks to you or your fetus.
* Once your identifying information has been removed from the collected data
and specimens, additional consent will not be sought for future studies. This
also applies if you withdraw from the study. Leftover samples will be stored
and may be shared for future analyses related to COVID-19 or other
infections.
* Volunteering for this study does not limit your ability to participate in
another study of an experimental drug or vaccine. That decision would be made
in discussion with your doctor and the other study's investigators and is
separate from this study. We may ask to collect additional blood to assess
the new drug's effects.
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