1EDICAL RECORD 
INCLUSION OF HIV TESTING IN CONSENT TO 
PARTICIPATE IN A CLINICAL RESEARCH STUDY 
page 
20 
of_21 
pages 
As part of your participation in this study, it will be necessary to test your blood for the presence of 
jantibodies to the Human Immunodeficiency Virus (HIV), the virus that causes Acquired Immune 
Deficiency Syndrome (AIDS). In order to perform the test, a small amount of blood (approximately 2 
teaspoons) will be withdrawn from one of your arms with a needle. You may experience some slight 
I discomfort at the needle entry site and there may be some bruising. In addition, there is a very small 
risk of your fainting or of infection at the needle entry site. If your test results are found to be 
(positive, or if you are otherwise diagnosed as having AIDS, you should be aware of the following 
! Clinical Center HIV Testing Policy: 
j 
1. Your physician will notify you promptly of the HIV test results. 
1 1 
2. Your physician and/or the Clinical Center HIV counselor will offer you, and any current and/or 
ongoing sexual partners) (spouses are generally considered to be current or ongoing sexual 
partners) or needle-sharing partners) you identify, information on the meaning of the test 
results and how to prevent the spread of the infection. 
j 3. Because the virus may be transmitted in several ways, it is important that you inform sexual 
and/or needle-sharing partners) that any, or all, of them may have been exposed to the HIV 
virus and encourage them to be tested. If you request it, staff at the Clinical Center will assist 
you in notifying your partners) and arrange counseling for them through an HIV counselor. 
The results of your HIV test and/or documentation of the diagnosis of AIDS will become a 
part of your Clinical Center medical record and, as such, will be protected from unauthorized 
disclosure by the Federal Privacy Act of 1974. In general, access to your medical record will 
be restricted to those health care professionals directly involved in your care or in the 
conduct of ongoing biomedical research, and information is not usually released to other third 
parties without your permission or that of your designated representative. However, there are 
some particular routine uses of such information of which you should be aware. 
a. If you are unwilling or unable to notify your partner(s), the Clinical Center is responsible for 
attempting to contact and inform them of their possible exposure to the virus. Reasonable 
attempts will be made to protect your identity including withholding your name when 
notifying any partner(s) of their possible exposure. Some notification or counseling of 
current and/or ongoing partners may be carried out through arrangements with, or referral 
to, local public health agencies. 
b. A summary of your care at the Clinical Center will be sent to the physician who referred 
you here for treatment. 
c. The Clinical Center may report certain communicable diseases, including AIDS and 
symptomatic HIV infection, to appropriate State and Federal government agencies. 
If you have any questions regarding the HIV testing or the information provided above, you are 
encouraged to discuss them with your physician and/or a Clinical Center HIV counselor (496-2381). 
ent Identification 
INCLUSION OF HIV TESTING IN CONSENT TO 
'PARTICIPATE IN A CLINICAL RESEARCH STUDY 
NIH-2514-3 (2-90) 
Recombinant DNA Research, Volume 16 
[791] 
