9 
Dr. Childress suggested the second sentence of Section I-D-3 should be deleted 
since it is not really a part of informed consent. That sentence reads as 
follows: 
"What special procedures, if any, will be followed to protect the privacy 
of patients and their families?" 
The subworking group agreed to delete this sentence. 
Dr. Walters then called the attention of the subworking group to the Sep- 
tember 13, 1985, comments (Attachment VI) of Dr. Henry Miller of the FDA. In 
his first comment. Dr. Miller suggested the points to consider should state 
that closed sessions will be available for review of human gene therapy protocols 
Dr. Gottesman said this co m ment had been considered by the Working Group on 
Human Gene Therapy at the April 1985 meeting; the points to consider document 
had been modified by the working group in response to this comment at that 
time. While the working group will not refuse to hold closed sessions, it did 
not wish to encourage closed session review; and the points to consider reflect 
this position. 
Dr. Walters said Dr. Millers's second comment was that the points to consider 
ignore that the appropriateness of medical therapies is the result of complex 
risk/benefit judgments; Dr. Miller thought the points to consider imply that 
any risk of teratogenesis is unacceptable . 
Dr. Gottesman said a complex risk/benefit judgment determines the appropriateness 
of any therapy, and this is also true of human gene therapy. In hunan gene 
therapy two potential risks exist: (1) vertical transmission of genetic material 
and (2) horizontal transmission of genetic material. Both of these potential 
risks must be considered; the examples offered by Dr. Miller do not consider 
horizontal transmission. 
Dr. Murray said the word "teratogenesis" is not appropriately used by Dr. Miller; 
Dr. Miller intends to refer to transmission of genetic information. Dr. Murray 
said transmission of genetic information is net necessarily teratogenic. 
Dr. Andersen said clinicians recognize that inadvertent transmission of 
genetic information might occur in gene therapy; however, transmission would 
not be the goal of the therapy. 
Mr. Mitchell said the working group drafted the document to allay public fears 
about germ line intervention but is aware 100% assurance against inadvertent 
transmission cannot be given. 
Dr. Chil dress asked whether the document should state explicitly that seme 
risk of inadvertent transmission to germ line cells would be acceptable. 
[338] 
