12 
suggested the full reference to the booklet "Biosafety in Microbiological 
and Biomedical Laboratories" be included. Dr. McGarrity seconded the 
motion. 
The RAC recommended the motion be accepted by a vote of twenty-two in favor, 
none opposed, and no abstentions. 
VII. REPORT OF TOE WORKING GROUP ON HUMAN GENE THERAPY 
Mr. Mitchell called on Dr. Walters, the Chair of the RAC Working Group on 
Human Gene Therapy, to offer a progress report on the activities of that 
group. 
Dr. Walters said his report will describe: (1) the mandate and history of 
the working group; (2) the membership of the group; (3) the "points to 
consider" document being developed by the working group; and (4) a timetable 
for ccrrpleting the document. 
Dr. Walters said RAC at the September 19, 1983, meeting accepted responsi- 
bility in principle for reviewing human gene therapy protocols. At the 
February 6, 1984, meeting, RAC operationalized this acceptance. Language 
was added to Section III-^V of the NIH Guidelines requiring protocols 
involving human gene therapy be reviewed by RAC and approved by the IBC 
and the NIH before initiation. A Working Group on Human Gene Therapy 
comprised of members frcm the basic sciences, clinical medicine, ethics, 
and law was formed during the summer 1984 and held its first meeting on 
October 12, 1984. 
Dr. Walters said the Working Group on Human Gene Therapy is composed of 
fifteen menbers plus executive secretary (Attachment II). He categorized 
the menbers as follows: four laboratory scientists, three clinicians, three 
ethicists, three lawyers, and two public policy experts. The working group 
also has a consultant on retroviruses and representatives from the NIH 
Office of Protection frcm Research Risks (OPRR) and the FDA. 
Dr. Walters offered the RAC a draft outline (Attachment III) of the docu- 
ment being developed by the working group; that document is to be entitled 
"Points to Consider in the Design and Submission of Human Gene Therapy 
Protocols." He emphasized that the draft outline represents the current 
trend of the group's thinking and will undoubtedly be modified. 
Dr. Walters said the document's preamble will: (1) Indicate the document 
focuses on somatic cell gene therapy. The working group does not foresee 
germline gene therapy being applied to humans in the near future. (2) Note 
that the working group has based seme of the draft document on EHHS regula- 
tions involving human subjects and on the report "Splicing Life" by the 
President's Commission for the Study of Ethical Problems in Medicine and 
Biomedical and Behavioral Research. (3) Outline the review procedure for 
human gene therapy protocols. The IBC and the Institutional Review Board 
ri44] 
