8 
Dr. Littlefield said genetic engineering experiments utilizing recombinant DNA 
techniques are currently being performed with animals. He asked if the Guide- 
lines adequately cover this research. Dr. Gottesman replied that Section 
III-B-4-b of the Guidelines specifies that these types of experiments be reviewed 
by the IBCs Dr. Littlefield asked if RAC would want to review experiments which 
genetically modify animals through use of recombinant DNA. Dr. Harvin thought 
experiments involving animals should be reviewed. Dr. Gottesman said many such 
experiments are currently being performed, but only a small subgroup of these 
experiments would present a concern. Dr. Gottesman added that the animals 
used in these experiments would be contained as specified by the Guidelines. 
Humans cannot be "contained." She felt that the proposed working group should 
deal only with human applications. If necessary, a second working group could 
be formed to deal with animal issues. 
Dr. Walters asked if RAC will review gene therapy experiments which do not uti- 
lize recombinant DNA techniques. Dr. Gottesman said the Guidelines do not cover 
those types of experiments. She offered the example of the Martin Cline case. 
If Dr. Cline had used a restriction nuclease to cut the DNA from its vector, the 
experiment would not have fallen under the Guidelines. Dr. Walters said Guide- 
lines which deal only with a specific type of experiment set up incentives to 
perform manipulations in certain ways. Dr. Gottesman pointed out that in the 
Cline case the IRB had not approved the experiments. Dr. Walters said he was 
concerned about the public's perception that some research in this area will 
not be reviewed. Dr. Walters asked if the Guidelines could be rewritten to 
require procedures such as Dr. Cline's experiments to be reviewed by RAC. 
Dr. Gottesman said language to specify review for these types of experiments 
might be developed. 
Dr. Walters asked if the RAC charter could be modified to give RAC a larger 
purview. Mr. Mitchell thought perhaps the charter could be reviewed. 
Dr. Gottesman suggested that a new Section III-A-4 be added to Section III-A, 
"Experiments that Require RAC Review and NIH and IBC Approval Before Initiation." 
Proposed Section III-tA- 4 would specify that recombinant DNA experiments involving 
humans should be reviewed by IRBs, IBCs, and RAC. Dr. Walters said such language 
would not meet his concerns about RAC's purview. Dr. Gottesman said the more 
sophisticated techniques, those most likely to work, will use recombinant DNA 
to effect the introduction of recombinant DNA into humans ; and these experiments 
will be reviewed by RAC. 
After some discussion of definitions, the working group developed the following 
language for a new Section III-A-4: 
"III-A-4. Deliberate transfer of recombinant DNA or DNA derived 
from recombinant DNA into human subjects." 
Dr. Miller asked that language be added indicating that this review would not 
preempt FDA and IRB review. Dr. Gottesman agreed and suggested that such 
language might be added to Section V of the Guidelines, "Footnotes and References 
of Sections I-IV. " A footnote might read as follows: 
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