association off american 
medical colleges 
One Dupont Circle, N.W. /Ashing ton, D.C. 20036 
September 28, 1984 
Dr. William Gartland 
Office of Recombinant DNA Activities 
National Institutes of Health 
NIAID-ORDA 
9000 Rockville Pike 
Building 31, Room 3-B10 
Bethesda, MD 20205 
Dear Dr. Gartland: 
We wish to comment on the proposed amendments to the NIH Guidelines for 
research involving recombinant DNA molecules which were published in the 
Federal Register on September 20, 1984 and will be considered at the RAC 
meeting on October 29, 1984. These two amendments proposed to prohibit, 
on philosophic grounds, any transfer of genetic traits between mammalian 
species, including man. The enactment of such amendments would constitute 
a serious limitation on entire classes of experiments which will be critical 
to achieving the maximal use of recombinant DNA technology to improve human 
heal th. 
The genomes of higher mammals are complex and much of the study of gene 
incorporation and expression must be done using these species if we are 
to realize the potential application of gene transfer therapy for human 
diseases. The proposed amendments as written exaggerate the effects of 
such gene transfer experiments by implying that a trait is transferred 
"...into the germ line of another unrelated mamalian species...". As 
the RAC members well know, in such studies a gene is transferred to the 
germ line of a single animal under experimental conditions, not 
permanently introduced into the germ line of the entire species. 
The Association of American Medical Colleges would urge the RAC not to 
unnecessarily restrict the progress of medical research by adopting these 
suggested amendments to the NIH guidelines. 
Sincerely yours, 
Ziujul firuf 
Elizabeth M. Short, M.D. 
Director, Division of Biomedical Research and 
Faculty Development 
[459] 
