policy, the true name of the child either would or would not be used in public. 
Since confidentiality is a mode of management of private information, the 
limits of confidentiality would depend on the parents' choice. For example, if 
the parents prefer that a casename be used for the child, this name would 
appear on the medical record. Special precautions would, however, be taken to 
protect the medical and research records from unauthorized third parties. 
Records would be kept in a locked file for an extended period, and only the 
attending physician, specific members of the research team, and key 
administrative personnel (In the case of emergency) would have keys. 
II. Special Issues 
Although the following Issues are beyond the normal purview of local IRBs. 
the RAC and Its working group request that Investigators respond to 
questions A and B below. 
A. What steps will be taken, consistent with point I-E above, to ensure 
that accurate Information Is made available to the public with respect 
to such public concerns as may arise from the proposed study? 
Within the provisions of Section I.E., all aspects of the research leading 
up to the gene therapy procedure and all aspects of the procedure itself would 
be explained to the press in the degree of detail requested. Personal aspects 
that are not relevant to the public's need-to-know would be shielded by 
patient-physician confidential ity. 
B. Do you or your funding sources Intend to protect under patent or trade 
secret laws either the products or the procedures developed in the 
proposed study? If so. what steps will be taken to permit as full 
connunl cation as possible among Investigators and clinicians 
concerning research methods and results? 
No aspects of the work will be kept secret. A full and open communication 
will be maintained with other investigators and clinicians. 
Recombinant DNA Research, Volume 12 
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