Recombinant DNA Advisory Committee - 09/9-10/93 
requesting that the RAC consider certain categories of vaccine protocols as "exempt" 
from the NIH Guidelines and, therefore, exempt from RAC review. 
Discussion 
Dr. Zallen said that it is not practical to have a standardized Informed Consent 
document for all different institutions and protocols. Instead, she suggested 6 essential 
elements that should be considered when developing the Informed Consent documents: 
(1) recommendations about the use of birth control, (2) financial costs to patients, (3) 
the necessity for long-term follow up, (4) a request for autopsy, (5) timing of press 
releases relating to research, and (6) how patient confidentiality will be maintained. 
In her written comments, Ms. Meyers stated that it is premature for any gene transfer 
protocols to proceed without prior RAC review. The number of patients treated to date 
is relatively small, and the issues of long-term safety and clinical benefit of gene transfer 
are largely unresolved. 
Dr. Post agreed with the working group's recommendations and suggested an additional 
three categories of protocols that could qualify for exemption from RAC review: (1) 
vaccine protocols, including those using vaccinia viruses, adenoviruses and retroviruses, 
(2) those in which transduced cells (using a RAC-approved vector) are lethally irradiated 
prior to administration to human subjects, and (3) gene marking protocols with RAC- 
approved vectors. 
Dr. Straus noted that the NIH Guidelines definition of "vaccines" as described in footnote 
21 is unclear. Footnote 21 states that: 
"Section III-A-4 covers only those experiments in which the intent is to modify 
stably the genome of cells of a human subject. Other experiments involving 
recombinant DNA in human subjects such as feeding of bacteria containing 
recombinant DNA or the administration of vaccines containing recombinant DNA 
are not covered in Section III-A-4 of the Guidelines." 
Dr. Straus explained that although vaccinia viruses do not persist in the host, other 
viruses such as herpes viruses, adenoviruses, papovaviruses, and retroviruses persist either 
through integration into the host genome, or stably within host cells. He suggested that 
a distinction should be made as to the categories of vaccines that are considered exempt 
from the NIH Guidelines and RAC review. 
Ms. Buc asked the RAC if it might consider relinquishing its purview over human gene 
transfer protocols entirely. Mr. Capron explained that the RAC should not relinquish its 
responsibilities since there are many ethical questions for the RAC to consider, i.e., 
germ-line intervention. Dr. Chase added that the RAC serves to inform the public about 
broad issues involving recombinant DNA research in an unbiased and scientifically 
informed manner. Dr. Miller noted that the Food and Drug Administration's (FDA's) 
review of protocols is not held in a public format; and at this stage of gene transfer 
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