14 
Dr. Anderson said he was amused by Dr. Miller's comment that the working group 
should be supplemented with additional specialists in the fields of molecular 
biology, pharmacology, medical chemistry, and medicine since Dr. Miller had 
driven one such specialist frcm the working group and almost succeeded in 
driving out a second. 
Dr. Gottesman thought the working group could utilize ad hoc expert consultants 
for reviews of specific proposals and circulate the first proposals broadly. 
Dr. Anderson thought this suggestion a good one; a panel of ad hoc advisors 
could be selected and individuals from that panel could be asked to participate 
in reviews of specific proposals. Dr. Gottesman thought the proposals might 
be circulated to selected panel members during the period prior to the working 
group meeting but after anncunconent in the Federal Register . 
Dr. Gartland said the review process now appears to require protocols be submitted 
for review at least five months prior to a RAC meeting. He questioned whether 
the review time could be shortened. 
Dr . Gottesman suggested one Federal Register announcenent might be used to 
announce both working group and RAC review; this could save seme lead time. 
Dr. Mar ray did not feel the review process should be curtailed; he felt re/iew 
is part of an educational process. Car. Anderson said the review process would 
not be curtailed if the announcements were combined; only the lead time would 
be shortened. 
Dr. Anderson thought investigators will first submit trial balloon proposals 
since they wall probably expect additional requirements may be placed on the 
proposal by the Working Group on Human Gene Therapy or the RAC. 
Dr. Murray asked whether a resubmitted proposal could receive expedited review. 
Dr. Gottesman said in the past RAC has taken a full vote on proposals. However, 
in some cases if explicit questions which would not affect safety in a major 
way had not been answered, the RAC has authorized a working group to lock at 
the data and reccmmend approval, if warranted, to the NIH Director. 
Dr. Walters called the attention of the subworking group to the comments offered 
by Ms. Goldberg. Ms. Goldberg said the Committee for Responsible Genetics 
recommends RAC expand the points to consider document to include questions on 
the hazards and general desirability of proceeding with the design of gene 
delivery systems using currently available technology. She also suggested: a 
risk asses snent conference on the use of retroviruses as vectors in human 
scmatic cell gene therapy be convened; the Working Group on Human Gene Therapy 
involve a larger number of public representatives; the working group urge 
full public disclosure of the results of all human somatic cell gene therapy 
risk assessment experiments; and the working group investigate the number of 
private institutions interested in or planning to engage in research involving 
human somatic cell gene therapy. 
[ 14 ] 
