Severe Acute
Respiratory Syndrome (SARS) |
[Please send a signed copy of this form with the specimen]
The Centers for Disease Control and Prevention (CDC) and public health
laboratories are using an investigational laboratory test to test
for the virus that causes "severe acute respiratory syndrome" or (SARS).
The Food and Drug Administration (FDA) has not licensed this test.
The FDA has agreed that we can use this test as part of the public health
response to SARS. We do not know for sure if this test can find all
people who may get sick with SARS. There are no FDA approved tests that
quickly find the virus.
Your State or Local Health Department and CDC are using the results
of this test as one piece of information to help us find out if people
are sick with SARS and to limit the spread of this illness. Your (or
your child's) doctor will use other information along with this test
result to decide what is best for you (your child).
BACKGROUND
SARS is a respiratory illness that can start as fever and cough. It
may go on to pneumonia in some people. SARS seems to be spread by close
person to person contact. This can occur when a person who is sick with
SARS coughs or sneezes onto themselves, other people, or nearby surfaces.
Droplets from the cough or sneeze can travel a short distance through
the air and land on the mouth, nose, or eyes of persons who are nearby.
The virus also can spread when a person touches a surface or object with
infectious droplets and then touches his or her mouth, nose, or eye(s).
It also is possible that SARS can be spread through the air or by other
ways that we don't yet know about.
WHY SHOULD MY (MY CHILD'S) SAMPLE BE TESTED?
You (or your child) may be asked to have SARS testing done when there
are no reported cases of SARS in the world or when and if SARS returns.
It is important to test for SARS when there are no reported SARS cases
so that public health efforts could quickly identify a case and limit
its spread. The results of this test, along with other information, may
also help your (your child's) doctor take better care of you (your child).
You (or your chi ld) may be asked to be tested for the SARS virus because:
- You (or your child) are being hospitalized for symptoms like pneumonia and within
10 days of the start of symptoms you (or your child):
- Have traveled to an area that had reported SARS cases
in the past, or
- Had close contact with an ill person who just came back
from these areas, or
- Had close contact with person(s) who have pneumonia
like symptoms and have not been diagnosed, or
- Are employed in a job that may put you at risk for SARS,
such as a healthcare worker with direct patient contact or a worker
in a laboratory that has live SARS virus.
OR
2. There are reported cases of SARS in the world and you (or your child)
have symptoms which may be early symptoms of SARS, such as fever
or lower respiratory symptoms or other symptoms your doctor feels might
be SARS and :
- Recent close contact with persons thought to have SARS, or
- Recent exposure to areas (in the U.S. or outside the
U.S. ) with confirmed or suspected SARS (or close contact with ill
persons with a history of these exposures)
ARE THERE ANY BENEFITS?
There may be no direct benefits to you (or your child) from having this
test done. This test may help to find the virus in people who do not
yet have all the signs of SARS. If people with the SARS virus limit contact
with other people, this can prevent others from getting sick. By having
this test done, you may lower the chance of spreading the virus from
you (your child) to your family or others. Use of this test could also
help us to know more about this virus to help stop the spread of this
illness. The results of this test, along with other information, may
help your (your child's) doctor take better care of you (your child).
IF THIS TEST IS POSITIVE, DOES THAT MEAN I (MY CHILD) HAVE SARS
AND WHAT ARE THE RISKS OF A POSITIVE RESULT?
There is a small chance that this test may give a positive result for
the SARS virus when the virus is not there (false positive). If your
(your child's) result from this test is positive:
- You (your child) could be asked to limit contact outside the home
by not going to work, school, out-of-home childcare, church, or other
public areas. You may also be asked to use a mask at home to limit
the risk of spread of the virus. If you (your child) have had symptoms
of SARS, you might be asked to follow these limits because of these
symptoms and not because of the test results. If your (your child's)
tests are positive, there is a small chance that you (your child) may
be asked to follow these limits even if you (your child) do not seem
sick.
- There is no proven treatment for SARS at this time.
If you (your child) your child is very ill, in rare cases, you (your
child) may be advised to take an antiviral drug. If this happens, your
(your child's) doctor will discuss the risks and benefits and obtain
your consent.
- Your (or your child's) doctor may decide how to care
for you based on the test results along with other factors.
IF THIS TEST IS NEGATIVE, DOES THAT MEAN I (MY CHILD) DO NOT
HAVE SARS?
This test may give a negative result when you (or your child) actually
have the virus (false negative). A false negative result should not have
an effect on your (or your child's) care. CDC has told doctors that a
negative test does not prove that a person does or does not have the
SARS virus. No changes in your medical care or how you interact with
people around you should be based on a negative result.
ARE THERE ANY RISKS FROM TAKING MY (MY CHILD'S) SAMPLES?
To do this test, extra blood samples may be taken that are like samples
that are normally taken for testing when you are sick. Your (your child's)
doctor may also ask to take more blood samples in the future.
To do this test, we need a minimum of ¼ teaspoon of blood from
children and 1 to 2 teaspoons of blood from adults. This blood may be
taken by putting a needle into a vein in your (or your child's) arm.
This test may also be done on blood that is left over after other tests
for your (your child's) care are done.
We may also ask for a second blood sample more than 28 days after you
(your child) became sick. We may ask for this second sample in order
to test for SARS. This is because this test looks for evidence that the
body is fighting the infection (antibodies), and sometimes it takes time
for the body to make antibodies to fight the virus.
When we take you (your child's) blood, the needle poke may pinch or
sting or cause a bruise.
ARE THERE OTHER CHOICES?
There are no rapid laboratory tests approved by FDA that can be used
to tell if you (or your child) have the virus believed to be causing
SARS.
WHAT ABOUT PRIVACY?
We will keep all facts about you (your child) as private as the law
allows. CDC, FDA the Local/State Health Department staff, and the person(s)
who ordered your test (such as your doctor) may see your/your child's
results. When we present or publish papers about these tests, neither
you (nor your child) will be named.
WHAT ARE THE COSTS?
The test will be done by CDC or your health department at no cost. You,
your insurer, Medicare or Medicaid will need to pay for other costs related
to the testing, such as doctor's visits.
WHAT HAPPENS IF YOU (YOUR CHILD) ARE HARMED?
If you (your child) are harmed as a result of taking the samples, CDC
will not pay the costs for hospital and medical care. You, your insurer,
Medicare or Medicaid will need to pay those costs. You (or your child)
do not give up any legal rights that otherwise would be available to
you (or your child).
RIGHT TO REFUSE
It is your choice to have this testing done on you (your child). If
you refuse to have the testing done, you (or your child) will not lose
the right to get health care because of not having results from these
tests.
WHO TO CALL IF YOU HAVE QUESTIONS
Please call your doctor if you have any questions about this testing.
If you have questions about your (or your child's) rights as a participant
in this testing program or if you feel you have been harmed or injured
by taking part in the program, please call the CDC Associate Director
for Science at 1-800-584-8814. Leave a message including your (or your
child's) name, phone number and that the protocol # is 3918. Someone
will call you back as soon as possible.
CONSENT STATEMENT
I agree
that this investigational laboratory testing can be done on samples collected
from me (my child).
I have read
the above and have had my questions answered by ______________.
Print
Patient's Name: |
__________________________ |
|
|
|
Patient's/Parent's
Signature: |
__________________________ |
Date: |
__________ |
|
Legally Authorized Representative Signature:: |
__________________________ |
Date: |
__________ |
|
|
|
|
Witness
to signature: |
__________________________ |
Date: |
__________ |
|
Witness to signature:
(required by FDA) |
__________________________ |
Date: |
__________ |
CONSENT FOR SAMPLE STORAGE
Thank you for agreeing for you (or your child) to be in this program.
We are asking for your consent to store any remainders of your (your
child's) samples used for SARS virus testing at CDC for future SARS-related
research. If the results of any future tests are important for your medical
care we will make every effort to notify your doctor.
We will not do human genetic testing or HIV testing unless we contact
you and ask for your consent. If you agree to storage and change your
mind later please call Dr. Lia Haynes at 404-639-4004.
Print
Patient's Name: |
__________________________ |
|
|
|
Patient's/Parent's
Signature: |
__________________________ |
Date: |
__________ |
|
|
|
|
Legally Authorized Representative Signature: |
__________________________ |
Date: |
__________ |
NOTE: PLEASE INCLUDE A SIGNED COPY OF THIS FORM WITH THE SPECIMEN
AND PROVIDE A COPY TO THE PATIENT.
|