7 
Drs. Grobstein and Childress preferred any questions posed in the preamble be 
parenthetical and illustrative. 
Mr. Capron sugqested the preamble only offer a single example of the concerns 
the working group might consider and state that the IRBs will not deal with 
social and ethical issues. The working group agreed to this approach by a 
vote of eight in favor. 
Ms. Withefby felt one important consideration had been overlooked in preparing 
the document; i.e., whether treatments exist for any side effects which might 
result from the therapy. Dr. Walters suggested this consideration might be 
included in the clinical and public health consideration portion of the 
document. 
Dr. Rich felt the preamble should not pose questions on the broader implica- 
tions of the therapy such as whether this technology suggests moral, ethical, 
or philosophical problems. He thought including such questions in the pre- 
amble was in effect asking the investigator's opinion. 
Dr. Grobstein said the review process may be educational for the investigator; 
the investigator should address these considerations even if they do not bear 
on the success of the experiment. 
fir. Capron suggested the working group invite investigators to comment on these 
issues in order to aid the working group evaluation. He suggested the questions 
be turned into statements by prefacing them with the phrase "The working group 
will " 
The working group then developed two alternative draft versions of the introduction 
(Attachments IV and V). These versions would be used as a basis for redrafting 
the introduction. 
Dr. Walters then called the attention of the working group to the section of 
the working group document entitled Objectives and Rationale (Attachment VI). 
Ms. Areen suggested the informational requests of this section should be phrased 
so as to elicit descriptive information. Ms. Areen interpreted Section l-(a) 
as requesting a one page abstract. Dr. Gorcvitz asked whether an abstract had 
been requested elsewhere in the document. Mr. Capron said other sections of 
the document request a rationale for doing the experiment. He suggested an 
abstract could synthesize all pertinent information and might announce the 
proposal in the Federal Register . 
The working group agreed the working group document should require the investi- 
gator to supply an abstract of the proposal; the working group would decide the 
correct section of the document (Attachment II) in which to state this require- 
ment at a later time. 
Dr. Mahoney felt a rationale should state whether treatment was undertaken to: 
(1) prevent initial symptoms; (2) prevent progression of the disease; or (3) 
prevent imminent death. 
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