MEDICAL RECORD 
CONTINUATION SHEET for either: - 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study 
STUDYNUMBGR; CONTINUATIQN: page 3 of 5 popes. 
: In addition to the possible risks already mentioned, you will be subjected to the risks of blood 
drawing on your initial screening visit, and again within 2 weeks before the lymphapheresis. These 
' include pain, redness, and swelling at the site of blood drawing, and rarely, fainting. Each time, 
I about 2 to 10 tablespoons (30 to 150 ml) of blood will be drawn. The amount of blood drawn will not 
I exceed 450 ml in a six-week period, which is within the guidelines set by the Clinical Center of the 
i National Institutes of Health. 
II 
I REQUIREMENTS FOR STUDY ENTRY 
I To participate in this study, your history, physical examination, and laboratory studies must show 
> that you are able to provide informed consent and that you are in good health. If you have used 
drugs or alcohol to excess in the past, or if you are currently using these substances, you must 
agree to refrain from any further use and may be asked to participate in regular substance abuse 
counseling and/or therapy. If you are a woman capable of childbearing, a pregnancy test must be 
! negative within 2 weeks prior to the lymphapheresis. 
NIH AND CLINICAL CENTER POLICIES 
There is no cost to you for the procedures associated with this study, but if you require medical care 
at other institutions or from other physicians during the course of this study, you or your insurance 
company will be charged for this care. Letters and results of tests performed at the NIH will be sent 
to your personal physician and you are encouraged to remain in close contact with your doctor. You 
must receive routine medical care from your own physician and you may not rely on the NIH for 
general medical care. 
PREMATURE TERMINATION OF THE STUDY 
In certain circumstances, some participants may need to terminate their participation in the study. 
You are free to withdraw at any time and for any reason without prejudice from the investigators. 
! Serious side effects may cause you to be removed from the study at the discretion of the principal 
'investigator. Other reasons for terminating your participation in the protocol include: 
I noncompliance with clinic visits and other terms of the protocol; termination of the study by the 
I principal investigator or the FDA; judgment of the principal investigator that it is in your best medical 
! interest to leave the study. 
1 
HIV TESTING FREQUENCY AND POLICIES 
As part of your participation in this study, it will be necessary to test your blood for the presence of 
jinfection by Human Immunodeficiency Virus. Testing of your blood for evidence of HIV infection will 
jbe performed prior to the time of lymphapheresis. Although you have been selected for this study 
jbecause of a history of being HIV-negative, you should be aware of the following Clinical Center 
jHIV Testing Policy in the event that your HIV test is found to be positive: 
I 
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