15 
willing to turn a blind eye to the risks because of the great need; he thought 
in this case the family might be better told of lew probability risks. He 
felt families too hopeful of the outcome might be devastated by the results. 
Dr. Varmus suggested this issue be left to the judgment of the clinician. 
Dr. Gorovitz said the question facing the working group is vhether the working 
group wishes to ensure that clinicians give explicit attention to these types 
of considerations even though the probability of certain risks may be very lew. 
Dr. Gottesman wondered if data indicating lew risk probabilities should be part 
of the informed consent form. Dr. McCarthy said his personal feeling is that 
while the working group might wish to consider this type of information, it 
should not be part of an informed consent document. He said most IRBs include 
a general disclaimer for lew probability risk. 
Dr. Anderson said different IRBs follow different procedures; he thought the 
issue of how an IRB explains the protocol to the patient is a valid concern for 
the working group to discuss at a later date. 
Dr. Gorcvitz felt the preamble of the working group document should simply 
state that in seme cases risk cannot be quantitated. 
Dr. Walters asked if Section I-D, Data Monitoring , should be part of the draft 
document. Mr. Capron said that Section I-D should be part of the document; he 
suggested , however, that an ongoing data feedback reporting requirement be 
included in this section. Dr. Anderson suggested language describing reporting 
requirements be included in the preamble to this section. Ms. Areen asked 
whether data would be reported back to the working group. Dr. Gottesman replied 
that the data would be reported to the Office of Recombinant ENA Activities 
(ORDA). This procedure has been followed under the NIH Guidelines. The NIH 
Guidelines also contain language requiring accidents, untoward, or unexpected 
consequences be reported to ORDA. 
Mr. Capron said the working group might also ask the IRBs to indicate their 
reporting requirements. Dr. Gottesman said language requesting such information 
might be included in the preamble to Section I-D. 
Dr. Walters called the working group's attention to Section I-E, Privacy and 
Confidentiality , of the draft document. He asked if any other information 
should be included in Section I-E. 
Dr. Childress suggested the language in this section of the working group 
document (Attachment II) admonishing parents to protect their children should 
be modified. 
Dr. Childress said protocol review should not expose the patient and family to 
the public. Dr. Gottesman said RAC and the working group should review proposals 
in public session, but the patient's identity should not be revealed. Dr. Mir ray 
thought only the city and the name of the institution need be revealed. 
Dr. Mot ul sky thought re/ealing the institution may reveal the name of the 
patient as there will not be many potential candidates for gene therapy, and the 
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