13 
about effects on gametes should be not greater than apprehension for effects on 
other critical tissues. 
Dr. Walters said to ignore this issue is to ignore a source of public appre- 
hension. Ms. Areen said Dr. Miller had offered this comment to the working 
group in April 1985; the working group had substituted the word "particularly" 
for the word " specif ically" in Section I-B-2-c-( 2 ) . 
Dr. Anderson said Dr. Miller was expressing a private opinion in this comment. 
Dr. Anderson thought germ line effects are legitimate public concerns. The 
sufcvorking group agreed. 
Dr. Walters then called the attention of the subworking group to Dr. Miller's 
ninth comment. Dr. Miller had suggested the first sentence in Section 
I-B-2-c-( l)-(e) would be more clear if revised to read: "Describe animal 
experiments completed or in progress employing protocols similar to that 
proposed . " 
Dr. Anderson said the working group had also previously considered this comment 
and had elected not to modify the language of the points to consider document. 
The working group specifically wished to request data gathered from primate 
testing. Dr. Anderson said the experience of his research team emphasizes the 
importance of testing gene therapy protocols in large animals such as primates. 
Dr. Anderson asked whether Section I-B-2 should include a statement on testing 
in "a large animal." 
Dr. Gottesman said a statement on animal testing is included in Section I-B-2. 
She suggested the word "laboratory" be deleted from this section since the 
phrase "laboratory animal" to most people suggests mice or rats. Deleting 
this word might meet part of Dr. Anderson's concern. The subworking group 
agreed with this proposal. 
Dr. Gottesman noted that Dr. Miller had suggested the term "in progress" be 
added to the language of Section I-B-2-c-(l )-(e) . She questioned whether 
Dr. Miller's proposed language would suggest review would be deferred to await 
the results of "in progress" experiments. 
Ms. Areen suggested the language of the section was correct as currently 
written. The subworking group agreed the language as written was appropriate. 
Dr. Walters said Dr. Miller's tenth comment was that "selection of subjects" 
should be included in Section I-B-3 rather than be a separate Section I-C. 
Mr. Mitchell said the working group disagreed with Dr. Miller on the emphasis 
which should be given this topic. 
Dr. Vfalters said the working group also wished to include ideas of fairness 
and equity and for this reason made "selection of subjects" a separate section. 
[342] 
