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THE COMMITTEE ON HUMAN RESEARCH
UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES
Special Subject Populations - HIV-Infected Individuals
(From CHR Guidelines, Appendix G - revisions
in process: estimated completion date 01/04)
Individuals
who are infected with the Human Immunodeficiency Virus (HIV) are a particularly
vulnerable subject group. The fact that they suffer or may eventually
suffer from a fatal disease with no currently known cure may compromise
their ability to freely give or refuse consent to participate in research
projects. The Committee will therefore give special attention to certain
issues for these individuals, such as assessing the potential risk/benefit
balance of the study and assuring that the consent process clearly distinguishes
experimental procedures from clinical care.
Testing
for HIV-antibody, which establishes that an individual has been exposed
to the HIV virus, involves unique concerns when it is done for research
purposes. The primary concerns for the Committee revolve around two sets
of issues. One is the complex set of risks associated with a subject
learning that he or she is HIV positive, particularly if the results
are unexpected. The other issue is the risk of loss of confidentiality
of the research record which is created when such testing is done as
part of a study. Thus, if HIV-antibody testing is to be performed for
research purposes, the following should also occur:
| a. |
The appropriate box
must be checked on the CHR Application Cover Page. |
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| b. |
Both the protocol and the consent form must
state that the HIV testing is being performed for purposes of
the study |
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| c. |
The protocol must include a justification as to
why this testing is being performed. |
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| d. |
Pre- and post-test counseling of the subjects
by qualified personnel must be performed and the subjects must
be informed in person of their test results. The subjects
should be counseled as to the various risks associated with HIV
testing as well as the risks associated with being HIV positive.
If the person is HIV positive, the various options available
for treatment should be discussed.
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| e. |
The details of this counseling, where, when
and by whom it will be done, should be included in the Procedures
section of the consent form.
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| f. |
The protocol should discuss how the confidentiality
of the HIV-antibody test results will be maintained (see discussion
below). |
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California Health and Safety Code Statute
In
1985, statutory additions were made to the State Health and Safety
Code to establish certain requirements regarding mandated blood
testing, and confidentiality to protect public health. While further
revisions of the Code are now under consideration, the current
Code contains several points which must be addressed by any investigator
doing a research study which includes HIV-antibody testing.
The
statute provides for special protection of results of the AIDS
antibody test, and prescribes various penalties for the negligent
or willful disclosure of identified results, unless there is written
authorization by the subject to do so. It also specifically forbids
HIV-antibody testing without written authorization, and requires
the person giving the test to keep the written authorization unless
the test is performed at a designated alternate site, on blood
or blood products specified by the statute, or on previously stored
blood in a blood bank.
Because
the statute refers to individually identified test results, it
is assumed that none of the protections apply to research records
in which no individual is identified.
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