3 
Dr. Walters called the meeting of the Working Group on Human Gene Therapy 
to order at 9:05 a. m. on April 1, 1985. He introduced Dr. Temin, the virology 
consultant, to the working group. 
Dr. Walters said the purpose of the meeting was to continue to develop the 
document "Points to Consider in the Design and Submission of Human Somatic-Cell 
Gene Therapy Protocols." He said the document had appeared in the January 22, 
1985, Federal Register (Attachment II) and had been widely distributed for 
comments. Seme comments on this announcement had been received (Attachment III) 
and a subworking group addressed these comments at a meeting on March 15, 1985. 
The document before the working group was the result of that siioworking group 
meeting (Attachment IV) . 
Dr. Walters noted that Dr. Grobstein (Attachment V) had provided alternative 
versions of several sections of the points to consider document. Dr. Grobstein 
had drafted alternative language for a paragraph of the introduction and for 
Section I-B-4, Public health considerations . 
Dr. Motulsky suggested the working group begin by discussing in general terms 
the issues which run though a nurrtoer of the carments . The working group agreed 
to this approach . 
Dr. Childress said many of the comments had addressed social issues; the subworking 
group had determined that several of the questions in Part II of the document 
should be moved to the introduction of the document. With these issues new in the 
introduction, the working group can indicate it will consider these types of 
issues, but investigators will not be personally required to address these 
issues. 
Dr. Grobstein felt investigators should not be required to address these issues 
generically but should be asked to address them for the specific protocol. 
He indicated that his proposed substitute language rephrased these issues 
along these lines (Attachment V) . 
Dr. Gorovitz said the points to consider document now implicitly indicates the 
working group wall address these issues. He agreed that investigators might, 
however, have specific information to offer concerning their proposals. 
Dr. Rich thought asking investigators to address these issues indicates the 
working group is seriously considering these issues. 
Dr. Gottesman did not feel the points to consider document should require 
investigators to address social issues; rather the working group should address 
these issues. 
Mr. Capron also felt the working group should not require investigators to address 
social issues. The document might explicitly state these issues are important 
considerations, but investigators will not be required specifically to 
address these issues. 
[ 88 ] 
