4 
Dr. Walters then called the attention of the subworking group to canments 
on the August 1985 version of the points to consider document offered by 
Dr. Howard Temin, a consultant to the Working Group on Hunan Gene Therapy. 
Dr. Walters said Dr. Temin had once again pointed out that the vectors most 
likely to be used in hurran gene therapy protocols are retroviruses. The 
genetic material of these viruses is RNA. Dr. Temin suggested sane mention af 
recombinant RNA should be made in the first footnote of the points to consider 
document. 
Mr. Mitchell said RAC at the May 3, 1985, meeting had discussed the possibility 
of modifying the NTH Guidelines to explicitly cover recombinant RNA. The 
subworking group agreed that until such action is taken the first footnote 
should refer only to recombinant DNA. 
Dr. Walters said Dr. Temin had also suggested Section I-B-l-a-(l) should be 
modified to read as follows: 
"Describe the gene (genanic or cDNA) , the bacterial plasmid or phage vector, 
and the delivery vector (if any) . Provide complete nucleotide sequence 
analysis or a detailed restriction enzyme cleavage site map of the total 
construct . " 
Dr. Gottesman said the section as written contains scientific jargon; she 
thought Dr. Temin's suggested language was more specific. Dr. Walters agreed 
Dr. Temin's suggested language was more specific but thought it used rrany 
nouns as adjectives. 
Dr. Anderson suggested the subworking group accept most of Or. Temin's suggested 
language but not the words "cleavage site." The language would then be more 
precise but not use so marry nouns as adjectives. The subworking group agreed 
to this modification. 
Dr. Walters said Dr. Temin had suggested the last sentence of Section I-B-l-b-( 2) 
should read as follows: 
"What steps are being taken (and assays used with their sensitivity) to 
detect and eliminate any contaminating materials (nucleic acids, proteins, 
etc.) or contaminating viruses or other organisns in the cells or serum 
used for preparation of the virus stock?" 
The subworking group agreed to this suggested clarification. 
Dr. Walters said Dr. Temin had suggested the word "added" be substituted for 
the word "inserted" in Section I-B-2-a-( 2) , Section I-B-2-a-(4) , Section I-B-2-b, 
and Section I-B—4-b. 
[ 333 ] 
