8 
Dr. Gottesman called the attention of the subworking group to Dr. Miller's c em- 
inent on Section I-B-2-c- ( 2 ) . Dr. Miller had suggested the following question 
be included in this section: "How long have animals - especially those in vhich 
the desired gene is retained and/or expressed - been followed after treatment?" 
Dr. Anderson felt investigators wauld supply this type of information, but agreed 
the question could be explicitly stated in the document. 
Dr. Walters called the attention of the subworking group to Dr. Miller's next 
comment. Dr. Miller had suggested the first sentence of Section I-B-3-e is 
sufficient to convey the intent; the other two sentences require extremely 
complex speculation of the investigator and should be deleted. 
Dr. Anderson said every clinician performs this type of complex speculation 
everyday; there is nothing unusual in this request. Dr. waiters said the working 
group would like an indication that investigators had considered contingencies 
should the procedures not produce the expected results. 
Dr. Walters then called the attention of the subworking group to the comment of 
Dr. Robert McKinney of the National Institutes of Health. Dr. McKinney suggested 
Sections I-B-3-f, I-B-3-g, and I-B-3-h should be placed in a separate section 
entitled "Reporting Requirements." 
The subworking group agreed this was a reasonable suggestion. 
Dr. Walters then asked the siiawcrking group for its cpinion on Cr . McKinney's 
suggestion that the words "are to" should be substituted for the word "should" 
in the current Sections I-B-3-f and I-B-3-g (Attachment II). Dr. McKinney felt 
the words "are to" are more forceful them the word "should." 
Ms. Areen and Dr. Gottesman felt the word "should" was sufficiently forceful. 
Although the subworking group did not disagree with Dr. McKinney's suggestion, 
they did not feel substitution of the words "are to" would increase the force 
of the statement. 
Dr. Walters then asked the subworking group for their cpinion concerning 
Dr. McKinney' s comment on Section I-B-3-h. Dr. McKinney had suggested this 
section be amended to require the submittal of autopsy findings as a separate 
report. 
Dr. Murray said an autopsy is generally considered the final report and usually 
verifies the diagnosis. He felt the working group would definitely wish to 
receive the autopsy report. Dr. Walters felt autopsy results would influence 
future decisions of the working group and the RAC. 
Dr. Gottesman agreed the intent of current Section I-B-3-h as written is not clear. 
She suggested information requests dealing with autopsies be posed in two differ- 
ent sections of the points to consider document: (1) the section dealing with 
research design, and (2) the section on reporting requirements. 
[ 8 ] 
