Attachment II - Pg. 10 
C . I nformed Consent 
All procedures for IRB approval set forth in 45 C.F.R. 46 
will apply. In particular, because it is likely that the first 
protocols will involve children, the additional protections set 
forth in 45 CFR 46.401 to 46.409 will apply, including the 
requirement of soliciting the permission of each child's parents 
or guardians and the assent of each child. Two matters of 
special concern are addressed here: privacy and disclosure of 
certain low probability risks. 
1. The IRB shall ensure that as part of the process of 
obtaining informed consent, each subject (and the parents or 
guardians if the subject is a minor) is informed that the 
innovative nature of the therapy involved may lead to great 
interest in the research and in all the subjects by the media on 
behalf of the public. If special procedures will be followed to 
protect the privacy of subjects and their families, those 
procedures should be explained in detail. 
2. The IRB shall interpret broadly the requirement that a 
"description of any reasonably forseeable risks or discomforts to 
the subject" be provided to each subject as part of the process 
of obtaining informed consent. A risk of activating ocogenic 
activity, for example, even if judged of small probability on the 
basis of animal tests, should be disclosed unless there is 
sufficient experience in human subjects to confirm that the risk 
is indeed insignificant. 
D. Data Monitoring: Recommendation Is To Omit. 
(On the assumption that special requirements for reporting 
adverse reactions of subjects will be covered in Section A 
(Research Design) , no special requirements for data monitoring 
appear needed at this time, in view of the fact that is is 
unlikely that the first protocols will involve more than a 
limited number of subjects.) 
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