appendix e 
Sample Informed Consents 
Informed Consent 
MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
® Adult Patient or °Parent, for Minor Patient 
NPTrm/TE- NIAID 
\ 
.ml JDY NUMBER 
PRINCIPAL INVESTIGATOR: Robert Waker. M D 
.qa JDY TITLE: A Phase l/ll Pilot Sludv of the Safety of the Adoolive Transfer of Cytotoxic Synoeneic l.ymohocytes 
in HIV Irfficted Identcal Twins 
DONOR 
9/21/93 
INTRODUCTION 
We invite you (or your child) to take part in a research study at the National Institutes of Health. It is important that you read 
and understand several general principles that apply to all who take part in our studies; (a) taking part in the study is entirely 
voluntary; (b) personal benefit may not result from taking part in the study, but knowledge may be gained that will benefit 
others; (c) you may withdraw from the study at any time without penalty or toss of any benefits to which you are otherwise 
entitled. The nature of the study, the risks, inconvenierrces, discomforts. ar>d other pertinent information about the study 
are discussed below. You are urged to discuss any questions you have about this study with the staff members who 
explain it to you 
OBJECTIVE OF THE STUDY 
You are invited to participate in a study to evaluate the safety and side effects of administering 
genetically modified white blood cells (lymphocytes) to individuals with HIV-1 infection. You are 
j invited to participate in this study because you have an identical twin who is infected with HIV-1 and 
! because you test negative for HIV. 
! This study has been designed to evaluate the safety and tolerance of administering lymphocytes 
: that have been removed from your blood, marked (or labeled) with a new gene in the lab, stimulated 
to grow to large numbers of cells in cell cultures, and then Infused into your twin. We hope to learn 
not only about the safety of such cell transfers, but whether the gene we are introducing will help 
your twin clear HIV from his/her body. The potential benefit of participating in this'study is that you 
, may be contributing to the improved treatment of your identical twin by his/her receiving genetically 
i modified, activated lymphocytes. The potential benefit to others would be the development of further 
knowledge about the use and side effects of this approach for treating HIV-infected patients, and 
possibly the development of a new strategy for treating HIV infection. 
DESCRIPTION OF THE STUDY 
After you and your twin have had screening blood tests, a tetanus booster injection, and a complete 
history and physical examination performed at the NIH, you will be scheduled to have a fraction of 
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