5 
determine whether the protocol is appropriate and safe, and the procedure would 
benefit the patient. The Working Group on Human Gene Therapy might help IRBs 
address specific questions, particularly if the IRB is subjected to a great 
deal of publicity. The local IBC would then review the proposal. The proposal 
would subsequently be reviewed by RAC and its working group, and the technical 
aspects of the proposal would be translated to make than understandable to the 
public. This might be accomplished in the Federal Register announcing 
the decision of the Director, National Institutes of Health (NIH) . RAC and 
its working groups might also address in the Federal Register decision document 
the issues outlined in Part II of the draft document (Attachment II). Mr. Capron 
agreed. 
Dr. Anderson felt the public should have an opportunity to participate in the 
review process; he questioned whether announcing the decision and educating the 
public in the same Federal Register would be an adequate way to permit public 
participation. Mr. Capron said although technical aspects of proposals would be 
translated into public policy in the Federal Register announcenent, the public 
would have prior opportunity to participate in the review process by responding 
to Federal Register announcements of proposals, by attending working group or 
RAC meetings, and by participating in the development of the points to consider 
document. 
Dr. Gorovitz said the working group document should state review requirements and 
rationales for requesting information. The public could then see the components 
of proposals even though these components would not be assembled into final 
form until the Federal Register announcement of the NIH Director's decision. 
Dr. Gorovitz asked if the working group agreed the group has a dual agenda. 
He said he heard two different concepts of the working group's mandate. He 
thought Dr. Miller saw the group's work as being purely technical; other members 
felt the group had to address both technical and public policy issues. He 
wished to resolve this fundamental di sag reorient before the working group 
proceeded. 
Dr. Miller said he did not think the working group should pander to the public 
by considering public opinion and attempting to formulate public policy issues. 
Dr. Grobstein said the charge to the working group clearly stated the group 
would address both technical and public policy issues. 
Dr. Varmus said public policy issues in this case are the flip-side of the 
technical issues. He said the working group must be responsive to the public. 
Dr. Mahoney said the U.S. is not a scientific aristocracy, and the working 
group must interact with and educate the public. If the public has concerns 
in the technical and public policy areas, these concerns must be addressed . 
Mr. Capron said the function of the working group and of the NIH is to protect 
the public interest. The working group must design its documents to show how 
the public interest will be protected in the review of human gene therapy 
protocols . 
[ 93 ] 
