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 
STUDY NUMBER: 
CONTINUATION: page of page: 
this has not already been done. The bone marrow biopsies and biopsies of tumor will be done 
with local anesthesia. The risks associated with these procedures are pain, bleeding and local 
infection. On occassion, it may be necessary to obtain a biopsy of tumor under general anesthesia 
to prove that your breast cancer has spread. The risks of this procedure include pain, bleeding, 
infection, risks of general anesthesis and risks associated with the specific area undergoing 
surgery. These risks will be individually explained to you at the time of surgery. If you develop 
any damage to your nerves ffrom the bone marrow transplant (see below) you will have nerve 
conduction studies performed. This test is done by placing small needles in several nerves and 
testing their function. In order to undergo bone marrow transplant, you will have to have a 
Hickman catheter placed. This is a semi -permanent catheter (fine tubing) which is placed under 
the skin of your chest wall and into a major vein in your chest. This catheter is necessary for 
infusion of chemotherapy and drawing of blood during transplant. The catheter is inserted by a 
surgeon in the operating room under local anesthesia. The risks associated with the procedure 
include pain, bleeding and infection. The long term risks of the catheter include infection and 
clotting of your veins. If these occur, it may be necessary to remove the catheter. These risks 
will be explained to you in more detail at the time of insertion. This catheter can be removed 
after you have recovered fully from bone marrow transplantation. 
As part of your participation in this study, it will be necessary to test your blood for the 
presence of antibodies to the Human Immunodeficiency Virus (HTV), the virus that causes 
Acquired Immune Deficiency Syndrome (AIDS). If you are found to carry the AIDS virus, it 
will not be possible to treat you with bone marrow transplantation on this study because the risks 
to your health are felt to be too great. 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(approximately 2 teaspoons) will be withdrawn from one of your arms with a needle.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 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: 
1. Your physician will notify you promptly of the HTV test results. 
2. Your physician and/or the Clinical Center HTV 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 partner(s) you identify. Information on the meaning of thetest 
results and how to prevent the spread of the infection. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-251 4-1 (10-84) 
NIH-251 4-2 (10-84) P.A.: 
09-25-0099 
Recombinant DNA Research, Volume 16 
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