Attachment II - Page 3 
3 
NATIONAL INSTITUTES OF HEALTH 
POINTS TO CONSIDER IN THE DESIGN AND SUBMISSION CF HUMAN 
SCMAT IC-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 CNA research frcm the Ncitional Institutes of Health 
(NIH) . This includes research performed by NIH directly. 
Introduction 
(1) Experiments in vhich recombinant CNA 1 2 - is introduced into cells 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 Reccmhmant 
CNA 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 prcposail 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 comment, 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 
vhich 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 sema tic-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-B-4-b of the "Points to 
Consider" document asks the researchers to address specifically this point. 
^-Section III-A-4 applies both to recombinant DNA as well as to DNA derived 
from recombinant CNA. 
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September 23, 1985 
