Attachment: II - pg. H 
e. Privacy and Confidentially 
Intioducllnn 
45 CFR S 46.111 directs IRB's to determine "where 
appropriate, there are adequate provisions to protect the privacy 
of subjects and to maintain the confidentiality of data." In 
view of the likely public interest in any research involving 
human gene therapy in the near future, IRB's should understand 
there is a need to pay particular attention to this regulatory 
requirement. The same obligation should be honored by the 
Recombinant DNA Advisory Committee and any similar review bodies. 
1. IRB's should anticipate that, at least in the near 
future, there will be great public interest in research (and 
subjects) involving human gene therapy. Particular attention 
should be paid, therefore, to the requirement in 45 CFR § 46.111 
that there are to be "adequate provisions to protect the privacy 
of subjects and to maintain the confidentiality of data." The 
research plan should include provisions for honoring the wishes 
of individual subjects (and the parents or guardians of minor 
subjects) as to whether., when or how the identity of subjects is 
disclosed publicly. The IRB should further ensure that its own 
procedures for review minimize the possibility of inadvertent 
disclosure of the identity or location of subjects. 
2. Other review bodies, including the Recombinant DNA 
Advisory Committee and the Working Group on Human Gene Therapy, 
should similarly conduct their reviews in a way that minimizes 
the possibility of inadvertent disclosure of the identity or 
location of subjects, by avoiding public release of identifying 
data not crucial to the nature of the review issues. 
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