6 
Hr. Miller felt rrany agencies might potentially review various aspects of human 
aene therapy. He suggested the working group consider mechanisms to avoid 
redundant reviews. 
Dr. Orobstein did not think the working group should unnecessarily complicate 
an investigator's life by requiring investigators to avoid redundant or over- 
lappinq review; an investigator would probably not be avare of the complex 
interactions between federal agencies. 
Dr. Harmison agreed investigators probably would net be aware of the complex- 
ities of aqency interactions; he thought the working group document (Attachment 
II) should simply ask the investigator to identify the agencies to which the 
protocol has been submitted. 
Dr. Milewski said Dr. Temin had telephoned the Office of Recombinant ENA Activ- 
ities (ORDA) with cements on the working group document (Attachment II). 
Dr. Temin had questioned whether the preamble should refer to "reexmbinant ENA." 
Dr. Milewski said the vectors most likely to be used in human gene therapy are 
the RdA containing retroviruses. She said Dr. Temin had suggested the term 
"nucleic acid" be substituted for "recombinant DNA." Dr. Gottesman suggested 
the text of the document should refer to "recombinant ENA," but a footnote 
might indicate the document applies to "recombinant RNA" as well. 
Dr. Witherby suggested the word "interested" be deleted from the preamble 
statement indicating one important function of the review process should be 
educating the "interested" public' on the meaning and implications of the techni- 
cal aspects of the proposal. Mr. Capron felt the concept of educating the 
public was very important and should be clearly stated . He agreed the word 
"interested" could be deleted. 
Mr. Capron suggested the last paragraph of the preamble (Attachment II) vhich 
indicates the document is to be a submission outline may be redundant. 
Dr. Gottesman agreed and suggested the working group delete the first sentence 
of this paragraph. The second sentence vhich suggests the initial experiments 
will involve bone marrew cells could be moved to another portion of the document, j 
Dr. Nightingale felt the preamble should specifically list the questions vhich 
the working group vould address. Dr. Gottesman disagreed; she felt the document b 
cannot contain an exhaustive list of questions as all important questions 
cannot be foreseen at this time. 
5 
Dr. Gorovitz thought the preamble should not refer illustratively to issues 
such as vhether the proposed experiments pose a risk to the patient or how the 
benefits compare to the risks. He said illustrative preamble language describing 
qeneral issues on vhich the working group will be focusing could be misleading 
because the illustrative points might be taken for points vhich must be 
addressed in every case. 
Dr . Gottesman said she had included these examples in the preamble because she 
felt the public would more likely read the preamble than the body of the document. 
J 
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