D. PARTICIPANT INFORMED CONSENT FOR HIV TESTING – TEMPLATE
Protocol No._____________________________________
Protocol Title._________________________________________________
Participant No: ___________________________________
Name of Investigator: _________________________________________
Dear Participant
As part of the above research study, you are being asked to undergo an HIV test. Before agreeing to
participate in this research study, it is important that you read and understand the following
explanation of the HIV testing. You may not participate in the study if you decide you do not want the
have the HIV test performed. However, the result of this test will not only determine whether you are
suitable to continue with the research study, but could also have an important influence on your health
and lifestyle.
All costs associated with the HIV test, as well as the pre-test and first post-test counseling will be paid
for by the sponsor.
PURPOSE
This test is performed to exclude any participants who are HIV positive because these participants are
more likely to have abnormal laboratory tests, and side effects because of their HIV infection. This
may interfere with assessment of the study medication, which would make accurate analysis of the
information gathered during the study impossible. In addition, the taking of new and experimental
medication may pose additional risks to your health if you were suffering from an underlying disease
of which the study doctors are not aware.
HIV (Human Immunodeficiency Virus) infection is a serious medical condition that leads to AIDS
(Acquired Immune Deficiency Syndrome). HIV is spread by sexual contact with an HIV infected
partner, exposure to infected blood (such as sharing needles during injection drug use) and from an
HIV-infected mother to a child during pregnancy, delivery or breastfeeding. Persons who may be at
high risk for infection include people who are having unprotected sex with an HIV infected partner,
men who have sex with other men, injection drug users and their sexual partners, persons who
received blood transfusions between 1978 and 1985 and persons who have had unprotected sex with
multiple partners.
PROCEDURE
You will receive counseling both before and after you have taken the test.
The HIV test will be done on a sample of your blood. The test can detect antibodies that your immune
system makes when HIV is present. The HIV/AIDS antibody test is used to determine if you have
been infected with HIV. An HIV test is extremely accurate if performed three months after exposure to
HIV/.
A negative test means that it is extremely unlikely that you are infected with HIV. If you had a recent
expose (less than three months), an HIV test will need to be repeated to confirm that you are not in
the “window” period of HIV infection before the antibodies are present.
Standard Operating Procedures
Author: M. Haskins Approved by: C Duvenage, E Hammann
Final Version: 1 November 2010
Page 1 of 4
A confirmed positive test means that it is very likely that you have been infected with HIV. This test
does not determine how advanced the illness is and is it not a test for AIDS. Medical care and
additional testing will be needed to help plan treatment. If you test is positive, you may not continue as
a participant in the study. You will be referred to a specialist clinic for further testing and counseling.
This clinic can provide counseling and treatment that conforms to the national standard of care for
HIV prevention and treatment.
If you test positive, you will not have any recourse to the Sponsor or study site for
compensation or treatment.
ADVANTAGES AND DISADVANTAGES OF HIV TESTING
Advantages may include:
-
Making yourself available to healthcare and counseling for HIV which has many benefits
Preventing the transmission of HIV to your sexual partners
Informing your partner so he/she can also prevent the spread of HIV
Avoiding blood donations
Preventing mother to child HIV transmission
Disadvantages may include:
-
Emotional stress, depression and despair
Stigmatisaion
Discrimination
Rejection by family, friends, sexual partners and / or spouse
These advantages and disadvantages should be carefully considered before signing the consent
form.
RISKS
Possible side effects from drawing blood include feeling faint, inflammation of the vein, pain, bruising
or bleeding at the site of puncture.
CONFIDENTIALITY
Your HIV testing information and test results cannot be released to anyone without your written
consent. A general consent for health care and information release does not cover HIV-related
information. If you are found to be HIV-infected, you are not required to personally tell anyone about
this diagnosis. However, it is very important to notify your sexual partners and those that might have
been exposed to your blood.
CONSENT STATEMENT
1. I hereby agree to have blood drawn in order to undergo the HIV tests as described before in
order to determine my suitability for participation in a clinical study. I understand that until all
pre-dose checks have been carried out and reviewed by the study doctor before the first
dosing day, may participation in the study is not guaranteed.
2. I confirm that I have read and understood the above information leaflet and that I have been
informed by the study personnel about the nature, conduct, potential benefits and risks of HIV
testing and have had the opportunity to ask questions.
3. I do not consider myself to be in a high risk group for contracting HIV and have no reason to
believe that I have been previously exposed.
4. I understand I will be informed of the results of the test in confidence, and that I will be
advised regarding further counseling and care, should the result be positive.
Standard Operating Procedures
Author: M. Haskins Approved by: C Duvenage, E Hammann
Final Version: 1 November 2010
Page 2 of 4
5. I understand that should I be tested and found to be HIV positive during the screening period,
I cannot hold the SPONSOR of the study liable for my treatment or care
6. I will receive a signed copy of the Patient Information Leaflet and Consent Form.
Printed Name of Participant
________________________________________
Participant Signature
__________________
Date
*Printed Name of Legally Acceptable Representative
_______________________________________
*Signature of Legally Acceptable Representative
__________________
Date
___________________________________________
Relationship to study participant
Printed Name of Person Conducting Consent
(if other than investigator)
________________________________________
Signature of Person Conducting Consent (if other
than investigator)
________________
Date
Printed Name of Investigator
_________________________________________
Signature of Investigator
__________________
Date
I hereby verify that verbal consent was obtained from the above participant. The participant has been
informed about the risks and the benefits of the research, understands such risks and benefits and is
able to give consent to participation, without coercion, undue influence or inappropriate incentives.
Standard Operating Procedures
Author: M. Haskins Approved by: C Duvenage, E Hammann
Final Version: 1 November 2010
Page 3 of 4
*Printed Name of Witness
_________________________________________
*Signature of Witness
________________
Date
*Where applicable (See Main PIC template for explanation)
Standard Operating Procedures
Author: M. Haskins Approved by: C Duvenage, E Hammann
Final Version: 1 November 2010
Page 4 of 4