INFORMED CONSENT 
UAB 9405 
March 16, 1994 
We emphasize that this procedure of administering genes directly into muscle cells is new and 
has not been done in humans previously. Because it is new and despite our extensive efforts to 
assure its safety, other unforeseen problems may arise including the very remote possibility that 
death could occur. 
POTENTIAL BENEFITS 
The therapy is not guaranteed to work, nor is it considered a cure. The possible benefit to me 
might be that my immune system is stimulated by the vaccine and develops anti-CEA immunity 
that can be monitored by special tests. Whether and how this effect translates to a clinical benefit 
is not yet known. The hope is that the development of anti-CEA immunity would be useful in 
my immune system’s fight against CEA bearing colon cancer cells. Development of anti-CEA 
immunity might benefit me by causing tumor shrinkage with reduction of symptoms and 
prolongation of life. However, no such effects are known to occur. While I may not personally 
benefit from this research study, knowledge may be gained that will benefit others. 
ALTERNATIVE TO PARTICIPATION 
At the present time, there is no proven method to improve my survival and alternate 
chemotherapy programs have modest benefit. I may choose not to voluntarily participate in this 
study and be followed routinely by my physician. Alternatively, I could seek other alternate 
experimental therapy using investigational chemotherapy or immune therapy studies. 
CONFIDENTIALITY 
I understand that the results of my treatment, including laboratory tests and x-rays, may be 
published for scientific purposes. However, my identity is not revealed and confidentiality will 
be maintained as provided by state and federal law. 
In addition, I understand that representatives from the Food and Drug Administration may 
monitor the trial records and that the individual conducting the review will see my name in the 
file folder. A qualified representative of the National Institutes of Health may inspect patient and 
study records. This procedure may attract the attention of the media. Every effort will be made 
to protect your confidentiality. Because of media interest, however, there is a significant chance 
that information concerning me and my treatment will appear publicly without my consent. 
WITHDRAWAL WITHOUT PREJUDICE 
I understand that my participation is voluntary and I am free to withdraw my consent and to 
discontinue participation in this project at any time without prejudice against future medical care 
I may receive at this institution. I also understand that my physician may discontinue this 
program if further treatment is felt to be dangerous or unwarranted. I understand I will be 
informed of any new findings that could influence my desire to continue with this treatment. 
Patient’s Initials 
Recombinant DNA Research, Volume 19 
[419] 
