Recombinant DNA Advisory Committee - 06/7-8/93 
Review-Dr. Post 
Dr. Post stated that he originally considered this request to be reasonable since the PI 
proposed the introduction of an antibiotic resistant gene in an attenuated strain of 
Rickettsia. Since Dr. Krogstad (an infectious disease expert) has raised many serious 
concerns about this experiment, Dr. Post recommended that the RAC defer approval of 
this proposal. 
Other Comments 
Dr. Haselkom noted that an outside expert, Dr. David O. Wood of Department of 
Microbiology and Immunology, University of South Alabama, Mobile, Alabama, 
submitted a review of this request. Dr. Wood states that introduction of an antibiotic 
resistance gene into a Class 3 pathogen poses major concerns. Dr. Haselkom questioned 
whether the PI has explored the use of other antibiotics that would be useful in cell 
culture but that are not critical for the treatment of human infection. 
Committee Motion 
A motion was made by Dr. Post and seconded by Dr. Straus to defer approval of the 
request. The motion to defer approval passed by a vote of 20 in favor, 0 opposed and 
no abstentions. The request was deferred until the investigator submits the following 
data for full RAC review: (1) data demonstrating that the construct is safe and useful, 
and (2) in vitro data demonstrating the selective advantage of chloramphenicol resistance 
over other selectable markers. 
XVII. AMENDMENT TO SECTION III-A-4 OF THE POINTS TO CONSIDER REGARDING 
THE TERM SUBJECTS/DR. PARKMAN 
Dr. Parkman proposed an amendment to the NIH Guidelines regarding the use of the 
term "subjects". To close a potential loophole that could conceivably allow investigators 
to bypass RAC review for single patient protocols, he proposed that the current language 
should be revised to cover single or multiple patient protocols. 
Section III-A-4 currently reads: 
"III-A-4. Deliberate transfer of recombinant DNA or DNA or RNA derived from 
recombinant DNA into human subjects [21]..." 
Throughout the Points to Consider document the term "subject" and "subjects" are used. 
Section III-A-4 will be amended to read: 
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Recombinant DNA Research, Volume 17 
