23 
Dr. We ns ink said the issues cure clear cut and we 11 -described. He thought 
clearly defined potential benefits have been enumerated and are cppoeed by 
unsupported, mythical fears of risks. 
Dr. Bowman said gene transfer may be the only feasible way of curing a dis- 
ease such as cystic fibrosis. She said to even consider stopping the gene 
transfer research needed to address this disease is out of the question. 
Dr. McKinney said he wished to point out that in addition to proposing 
modifications to the NIH Guidelines, Mr. Rifkin has chosen to interpret 
hew the NIH should apply the proposed modifications; Mr. Rifkin contends 
the NIH should extend its purview to commercial companies engaged in recom- 
binant DNA research under a licensing agreement with an NIH funded institu- 
tion which cited the NIH Guidelines in the licensing agreement. Dr. McKinney 
said Mr. Rifkin was atte m p t ing to involve the NIH, vhich is not a regulatory 
agency, in an area where it has no authority. Dr. McKinney urged the RAC 
to reject Mr. Rifkin 's proposal. 
Dr. MoGarrity said Mr. Rifkin' s statement that RAC ignores the public is 
false. Public members have long been part of RAC's composition, and RAC has 
actively sought to include the public in its deliberations. Dr. MoGarrity 
said Mr. Rifkin underestimates the intelligence and knowledge of the public. 
Dr. MoGarrity stated that Mr. Rifkin 's contention RAC would be saying there 
are no ethical problems if Mr. Rifkin 's proposals are not approved is utter 
nonsense. Dr. MoGarrity said major points of concern exist, but the scien- 
tific approach examines the data and bases a decision on a case-by-case 
review. 
Dr. Walters responded to Mr. Rifkin' s implication that RAC has always given 
permission to proceed. Dr. Walters noted that until recently NIH procedures 
permitted the local IBCs and IRBs to approve human gene therapy protocols 
without RAC review and NIH approval. The NIH Guidelines ware revised to 
require the much more rigorous process of national review. 
Dr. Walters said transfer of genes into the human germline would involve 
the use of in vitro fertilization (IVF) . NIH funded IVF research is cur- 
rently under a de facto moratorium; national review by an Ethics Advisory 
Board is required, and at present, such a board does not exist. 
Dr. Walters said animal welfare, either in the laboratory or in aniiml 
husbandry, is a real issue. RAC, however, is not the appropriate group to 
address this issue. Seme states have animal welfare rules and the NIH 
Office for Protection frem Research Risks is participating in the process 
of revising existing Public Health Service animal welfare guidelines. 
Dr. Walters felt local review ccmmittees charged with animal welfare sue 
the appropriate bodies to deal with this issue. Dr. Walters suggested RAC 
reject Mr. Rifkin 's proposal in light of the potential benefits gene trans- 
fer research might provide. 
Dr. Fax thought public support of gene transfer research is based on fear 
of death and suffering. He said Aristotle's original meaning of "telos" 
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