NATIONAL INSTITUTES OF HEALTH 
POINTS TO CONSIDER IN THE DESIGN AND SUBMISSION OF HUMAN 
SOMATIC-CELL GENE THERAPY PROTOCOLS 
Applicability - These "Points to Consider" apply only to research conducted at or 
sponsored' by an institution that receives any support for 
recombinant DNA research from the National Institutes of Health 
(NIH). This includes research performed by NIH directly. 
Introduction 
(1) Experiments in which recombinant DNA^- is introduced into oells of a human 
subject with the intent of stably modifying the subject's genome are covered 
by Section III-A-4 of the NIH Guidelines for Research Involving Recombinant 
DNA Molecules (49 Federal Register 46266). Section III-A-4 requires such 
experiments to be reviewed by the NIH Recombinant DNA Advisory Carmittee 
(RAC) and approved by the NIH. RAC consideration of each proposal will 
be on a case-by-case basis and will follow publication of a precis of the 
proposal in the Federal Register , an opportunity for public oamment, and a 
review of the proposal by the working group of the RAC. RAC recommendations 
on each proposal will be forwarded to the NIH Director for a decision 
which will then be published in the Federal Register . In accordance with 
Section IV-C-l-b of the NIH Guidelines, the NIH Director may approve 
proposals only if he finds that they present "no significant risk to 
health or the environment." 
(2) In general, it is expected that somatic-cell gene therapy protocols will not 
present a risk to the environment as the recombinant DNA is expected to be 
confined to the human subject. Nevertheless, Section I-R-4-b of the "Points to 
Consider" document asks the researchers to address specif ically this point. 
1 Sect ion III-A-4 applies both to recombinant DNA and to Dt& or RLA derived 
from recombinant DNA. . „ ,_ n/ . 
September 29, 1986 
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