antibiotics that are not inactivated will be available and effective in 
treating any potential bacterial infections. 
We emphasize that this gene has never been used before in human 
patients. Because this procedure is new, it is possible that despite our 
extensive efforts, other unforeseen problems may arise, including the very 
remote possibility that death may occur. Blood and possibly tissue 
specimens will be taken where possible to follow the duration and effects 
of Rev M10 gene expression. 
Follow-Up 
After you receive the treatment, you will be discharged from the 
hospital if you have no other significant medical problems. You will be 
required to return to the University of Michigan Medical Center for 
follow-up studies described above. Tests used to decide if you have 
responded to the therapy will be similar to those you had before beginning 
the therapy. If your disease progresses during treatment in this 
protocol, you will be eligible for other protocols and will receive 
treatment as indicated by your disease or referred elsewhere for such 
treatment. Because this form of therapy is new, unanticipated side 
effects that may cause your condition to deteriorate could be encountered. 
You will be closely monitored for such side effects. 
Treatment will continue as long as there is sufficient possibility of 
response to warrant the risks and side effects encountered. Your 
physicians feel that the risks of your disease are much greater than the 
risks of the treatment as outlined above. Furthermore, your physicians 
have considered your individual situation and have concluded that, at this 
time, no other therapeutic approaches, such as drug treatments, are 
clinically indicated as being more effective. At some later time, should 
these alternatives be clinically indicated, they will be discussed with 
you because this study does not preclude their use. 
Other Pertinent Information 
1. Confidentiality. When results of a study such as this are reported in 
medical journals or at meetings, the identification of those taking 
part is withheld. Medical records are maintained according to current 
legal requirements, and are made available for review, as required by 
the Food and Drug Administration or other authorized users, only under 
the guidelines established by the Federal Privacy Act. A qualified 
representative of the National Institutes of Health may inspect 
patient and study records. This procedure may attract attention from 
the media. We will make every effort to protect your confidentiality. 
Because of media interest, however, there is a significant chance that 
information concerning you and your treatment will appear publicly 
without your consent. 
2. Policy regarding research-related injuries. In the unlikely event of 
physical injury resulting from research procedures, the University 
will provide first-aid medical treatment. Treatment of injuries or 
side effects directly related to this experimental treatment will be 
provided at no cost to you. Additional medical treatment will be 
provided in accordance with the determination by the University of its 
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Recombinant DNA Research, Volume 18 
