report of the working group of the human gene therapy 
SUBCOMMITTEE ON A GENERAL INFORMATION DOCUMENT 
RAC Meeting February 2, 1987 
The Working Group of the Human Gene Therapy Subcommittee 
has taken on the job of putting together a brief explanatory 
document for the benefit of the general public. 
The purpose of the document is to afford the non-scient i f ic 
public an understanding of Human Gene Therapy. The document is 
largely based on "Points to Consider in the Design and Submission 
of Human Somatic-cell Gene Therapy Protocols". 
On January 9th. the following people met at the HIH: 
Dr. LeRoy Walters-- of the Center for Bioethics, 
Georgetown University, and Chairman of the Human Gene Therapy 
Subcommittee . 
Dr. Maurice Mahoney -- of the Department of Genetics 
at Yale University. 
Dr. Robert Rich -- of the Institute of Government 
Public Affairs at the University of Illinois. 
Attorney Judith Areen -- of the Georgetown University 
Law Center. 
Dr. William Gartland -- Executive Secretary of RAC. 
Dr. Henry Miller -- of the Food and Drug Administration. 
Dr. Robert Wieder -- of the Heart, Lung and Blood Institute, 
and I, Anne Witherby -- public representative. 
We discussed the scope of the project which was to write what 
was originally referred to as a "Lay Summary" of the "Points to 
Consider". The following are a few of our conclusions: 
We will make an effort to limit the document to two or three 
pages which could be attached to the "Points to Consider". 
We think the two or three sheets document could also be 
mailed separately and that it might, at some future time, be 
enlarged and elaborated into material for a broad variety of educa- 
tional purposes. 
> We suggest the title of; OVERSIGHT OF RESEARCH INVOLVING 
GENE THERAPY FOR HUMAN PATIENTS - GENERAL INFORMATION, 
We plan to divide the paper into four sections. 
The first, an Introduction , will include an explanation of 
Human Gene Therapy using non-hereditary cells. This section will 
also describe the purpose of the therapy, why it is different from 
other medical treatment and make the distiction between somatic- 
cell and germ-line gene therapy. Drs. Mahoney and Wieder have 
taken on this section of the GENERAL INFORMATION document. 
The second section of the document will refer more specifi- 
cally to the "Points to Consider" and is subtitled Governmental 
and Public Oversight . Attorney Judith Areen and I are working on 
this section. 
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