presumed to be harmless 
12. Adverse publicity and loss of privacy - complete anonymity of child/family 
may not be possible because of factors discussed in next section 
E. Privacy and confidentiality 
Indicate what measures will be taken to protect the privacy of gene 
therapy patients and their families as well as to maintain the 
confidentiality of research data. 
1. What provisions will be made to honor the wishes of Individual 
patients (and the parents or guardians of pediatric or mentally 
handicapped patients) as to whether, when, or how the Identity 
of patients Is publicly disclosed? 
Problems in safeguarding the privacy of parents and families will arise In 
the first cases of human gene therapy. Medical attention will be focused upon 
them and the child. A tension might arise between protection of privacy and 
Informing the public accurately. Direct communication of the parents with the 
news media, without medical intermediaries, would be optimal. Special 
protection would be added to Insure that parents and other family members have 
prior counseling about hazards to their privacy and have consented to a plan 
designed to protect their privacy within realistic limits imposed by the public 
Interest. 
The Investigators will not promise any parents total anonymity because a) 
It would raise suspicion that the consent process had not been properly 
conducted, b) it could likely lead to unlawful invasions of the parents' 
privacy by the press, and c) It Is a promise that probably could not be kept. 
The following options regarding a privacy policy would be offered: 
A. Complete Openness 
This policy has two options: Plan A includes full disclosure by the 
hospital of all facts relating to the case, names of parents, child, hometown. 
Recombinant DNA Research, Volume 12 
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