itself. There is a very slight possibility that something may happen during the study 
that will allow the virus to multiply. The effects of this event are unknown. 
However, your immune system will likely kill the virus after it has been there for 
several days to weeks. 
c) Damage to the airway cells. It is possible that the virus could injure airway 
cells that it enters. This has not been seen in the experiments that have been 
performed on animal and human cells. If this occurs, the segment of lung that is used 
for the study could be temporarily or permanently damaged. 
d) Spread of the virus. It is possible that the virus could spread from your body 
to your surroundings. The virus has been altered so that it cannot reproduce by 
itself. If, however, something should happen that the virus does spread and 
reproduce, it would likely behave no different from similar types of viruses that are 
already in the environment around us. However, if there are signs that virus is 
being spread, you may be asked to remain in the hospital longer than two weeks for 
further monitoring. 
e) Cancer. The type of virus used in these studies is not the type that inserts its 
genes into the patient's own genes. The insertion into normal genes is thought to be a 
cause of cancer in very rare instances. Because insertion of the virus gene into your 
genes is highly unlikely, the chance the virus will cause cancer is very small. 
f ) Changes in the body's eggs or sperm. There is a remote possibility that the 
virus containing the cystic fibrosis gene could change genes in the body's eggs or 
sperm. Because of your inability to have children, you would not be able to pass the 
genetic changes on to future generations. 
4. Exposure to xrays. To select the segment of lung to be used for the studies and to 
evaluate the effects of gene therapy on that segment, xrays will be taken. A total of 20 
chest xrays and 4 high resolution computed tomograms are planned over the course of the 
study. The dose of radiation is small. The chances of developing cancer because of this 
amount of radiation is very small. 
5. Withdrawing from the study. If you withdraw from the study after the gene is placed 
into your lungs, it will not be possible to evaluate fully the safety of gene therapy. Should 
complications occur, it might not be possible to detect them promptly and institute 
therapy. 
6. Loss of privacy. Gene therapy is very interesting to the general public. Although 
every effort will be made to maintain your privacy, it is possible that the news media or 
other individuals might learn your identity and spread this information, even if you do not 
want this to happen. 
Participation in multiple studies may be hazardous to you. If you already are 
participating in another study, please inform us fully. You should not participate in 
multiple studies, unless you and the investigators agree that your health and the outcome 
of the study will not be jeopardized. 
7 . Measures to be taken to minimize risks, discomforts and inconveniences 
1 . Blood tests. Pressure will be held at the sites of blood drawing to limit bruising. If 
you become light-headed, you will helped to a lying position to prevent fainting. 
Recombinant DNA Research, Volume 16 
[845] 
