- 2 - 
Attachment II - Pg. 3 
An important purpose of the consideration and decision process should be the 
education of the interested public on the meaning and implications of the 
technical aspects of the proposal, what is unique about the experiments, or, 
if the technique is analogous to currently used technologies, the reasons for 
considering them analogous. Some consideration of these issues by the 
submitters may help facilitate the review process. 
The special attention required by the NIK Recombinant DNA guidelines for 
experiments utilizing recombinant DNA for human gene therapy should focus on 
tvo general issues: 
1} Risk 
Does the proposed experiment pose a risk to the patient, other people, or 
the environment by virtue of the use of recombinant DNA? Is the risk 
different in kind from those posed by other forms of treatment? How do the 
anticipated benefits compare to these risks? How certain are the benefits? 
{•lost of the specific "Points to Consider" in this document are directed 
cowards evaluating risk and benefit. 
2) Broader Implications 
Does the use of this technology in this particular way suggest moral, 
ethical, or philosophical problems, either directly from the proposed experiment 
or indicectly? Should this affect the approval of th experiment? Is 
a public discussion of the implications of the experiment necessary? 
The "Points to Consider" are meant to serve as an outline for submitters 
planning to use recombinant DNA in human subjects. Because it seems likely 
that initial experiments of this sort will involve introduction of DNA 
into bone marrow cells, some of the specific scientific questions are based 
on the use of bone marrow. 
[ 234 ] 
