Recombinant DNA Advisory Committee - 12/3-4/92 
administration of these viruses. However, the possible clinical result of a recombinant 
virus is unknown. 
Ms. Meyers provided a list of changes that should be incorporated into the informed 
consent document: (1) the phrase, CF symptoms should read CF lung symptoms ; (2) 
paragraph 1(b) should be modified such that the patient is informed that he/she will be 
monitored closely for 8 weeks following the procedure; however, there will be long-term 
follow up for many years; (3) the patient should be informed that data derived from 
animal experiments does not guarantee that the virus will produce the same effects in 
humans; (4) the statement, To learn whether the experimental virus can correct cystic 
fibrosis abnormalities ..., should be expanded to read, To learn whether the experimental 
virus can correct cystic fibrosis airway abnormalities, (5) the following sentence should be 
added, You will not be allowed to participate if you are planning to become pregnant, (6) 
the patient should be clearly informed that if their insurance company does not provide 
payment for costs, the individual will be expected to pay all costs; (7) the sentence that 
describes the request for autopsy should be modified to read, In the unlikely event of 
death, an autopsy would be expected ; (8) a statement regarding protection from the media 
should be included in the confidentiality section; and (9) the disclosure of information 
section should be expanded to include NIH among the list of parties that may have 
access to the patient's records. Dr. Welsh deferred to the RAC regarding the proposed 
changes in the consent form. Dr. Murray suggested that the requirement to exclude 
women if they are planning to become pregnant should be changed to a suggestion that 
they should not become pregnant. Dr. Parkman said that the expectation of researchers 
involved in human gene therapy is that they will be following patients long term. Long- 
term follow-up should be indicated without any specific definition about the time period. 
Dr. Walters complemented the investigators on their detailed responses to the Points to 
Consider. 
Committee Motion 
A motion was made by Dr. Post and seconded by Dr. Carmen to approve the protocol 
with the following stipulations: (1) removal of the requirement for the Ela negative 
assay, (2) removal of the requirement for the rat-1 transformation assay, (3) 
incorporation of the informed consent changes suggested by Dr. Walters and Ms. Meyers, 
and (4) submission of a 3Vz inch diskette with the entire vector sequence in ASCII 
format. 
Dr. D. Miller said that he wanted to make the statement, for the record, that he does 
not think that there will be any untoward consequences as a result of the release of 
CFTR adenovirus into the environment. Dr. Ginsberg agreed with the statement made 
by Dr. D. Miller and added that is extremely unlikely that if a recombinant occurred, 
that it will contain the CFTR gene. Data indicates that the inserted gene is always lost 
Recombinant DNA Research, Volume 16 
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