8 
Dr. Childress said a tension exists in the document between the patient's 
right to privacy and the public's right to know. He said the working group 
would give primacy to the privacy of the patient and the family; the working 
group does not care if the public is interested in the identity of the child. 
Dr. Areen suggested the portion of the points to consider referring to the right 
of the public to know should be cross referenced to the section dealing with 
privacy and confidentiality issues. 
The subworking group agreed Section II-A should read as fallows: 
"Vhat 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?" 
Dr. Walters asked whether it would be appropriate far the subworking group to 
respond to Mr. Rogers' letter. The subworking group agreed a letter to 
Mr. Rogers would be appropriate. 
Mr. Mitchell and Dr. Childress suggested a letter of commendation and thanks 
might be sent to Dr. Temin for his invaluable assistance as a consultant. 
Dr. Walters reported that Dr . Gartland had solicited the opinion (Attachment 
V) of Dr. Myron Max Levine of the Uhiversity of Maryland, a former RAC member 
and a specialist in vaccine development. Dr. Levine had written that the 
points to consider are excellent, balanced, conservative, and sensitive to 
social issues. Dr. Levine felt a willingness to cooperate in long-term follow-up 
and to permit an autopsy should be prerequisites for participation in the 
earliest clinical trials. The subworking group agreed these procedures should 
be required of the initial patients. 
Dr. Gartland said the NIH legal counsel would prefer Secrtion I-D-5 not be 
included as part of Section I-D since Section I-D-l through Section I-D-4 
are questions while Secrtion I-D-5 contains a statement. 
Dr. Childress said Section I-D inquires how the privacy of the patient wxll be 
protected; Section I-D-5 which deals with autopsy. Follow-up could be placed 
in other sections of the document as well as in Section I-D. 
Dr. Walters thought Section I-D-5 dealt with points which the working group 
considers to be particularly important in human gene therapy and which should 
be emphasized in informed consent. 
Dr. Gottesman suggested Sections I-D-4 and I-D-5 should be modified to ask 
"hew" patients will be informed. A question mark will be added to Section 
I-D-5-a . The subworking group agreed . 
[ 337 ] 
