Attachment VII - Page 3 
NATIONAL INNTTTinTS CF HEALTH 
POINTS 'TO CONSIDER IN THE DESIGN AND SUBMISSION CF HUMAN 
SCMATIC-CEIh GENE THERAPY PROTOCOLS 
Applicability - These "Points to Consider" apply only to research conducted at or 
sponsored by an institution that receives any support for 
reccmbinant PNA research frcm the National Institutes of Health 
(NIH) . This includes research performed by NIH directly. 
Introduction 
(1) Experiments in which reccmbinant ENA 1 2 is introduced into cells of a human 
subject with the intent of stably modifying the subject's gencme are ccvered 
by Section III-A-4 of the NIH Guidelines for Research Involving Reccmbinant 
DMA Molecules (49 Federal Register 46266). Section III-A-4 requires such 
experiments to be reviewed by the NIH Reccmbinant DNA Advisory Ccrrmittee 
(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 ccmment, 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 apprcve 
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 reccmbinant 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 [joint. 
1 Section III -A— 4 applies berth to reccmbinant DNA as well as to DNA derived 
frem reccmbinant DNA. 
[ 364 ] 
September 2 3, 1985 
