Dr. Walters said that here the authors argue that human trials of genetic therapy should await results of successful 
animal tests and that in the case of successful clinical treatment for some human disorders, the research community will 
seek an expanded use of gene therapy beyond the initial range of cases where gene therapy has support of social 
consensus. And finally, the authors are urging RAC to establish in advance boundaries for "restricted zones of 
application of human somatic cell gene therapy. 
Enhancement Therapies 
Dr. Walters explained that the authors argue that use of somatic cell gene therapy to change such characteristics as 
height or skin tone would raise profound ethical problems. 
Genetic Therapy for the Prevention of Disease 
Dr. Walters presented the authors' view that it could be possible that employers might require an employee at some 
future time to undergo gene therapy for environmentally induced disease rather than the employer removing the toxic 
disease-causing material from the workplace. Limiting gene therapy to relief of life-threatening or severely disabling 
conditions would exclude such improper actions by employers. 
Genetic Manipulation of the Human Germ Line 
Dr. Walters pointed out the authors argue that genetic additions or deletions in the sperm, egg, or zygote would be 
tantamount to experimentation on future generations and would also set a direct path to programs of eugenics. 
Dr. Walters said the proposed amendment had been referred to the RAC Human Gene Therapy Subcommittee for 
consideration at its meeting of August 8, 1986. The results of the meeting can be found at tab 1271 entitled, 
Recommendation to RAC Regarding Proposal from Committee for Responsible Genetics . The subcommittee 
recommendation, explained Dr. Walters, was that the RAC not add new restrictions to Section III-A-4 of the NIH 
Guidelines. 
The Human Gene Therapy Subcommittee agreed that gene therapy should be attempted only for life-threatening or 
severely disabling conditions but believed that this matter is already covered in the "Points to Consider in the Design 
and Submission of Human Somatic -Cell Gene Therapy Protocols." The entire thrust of Part I-A of the "Points to 
Consider," which deals with objectives and rationale of gene therapy protocols, is to ask about the seriousness of the 
disease and the availability of alternative therapies. 
The subcommittee agreed that only somatic cell approaches to gene therapy should be considered at the present time. 
Indeed the title of the "Points to Consider" includes the phrase "somatic-cell gene therapy." However, the 
subcommittee was reluctant to speculate about what other approaches to gene therapy might become technically feasible 
in the future or to express a blanket disapproval of possible alternative approaches. Dr. Walters stated that the phrase, 
"At present," in paragraph 7 of the "Points to Consider" is meant to convey that current policy is not to entertain 
proposals for germ line therapy, but that the subcommittee will be willing to consider new evidence if it emerges in the 
future. 
Dr. Walters stated the subcommittee questioned the wording of the CRG's proposed NIH Guidelines change to exclude 
human genetic therapy "that could alter germ line cells." This would seem to rule out hypothetical unintended side 
effects on sperm or egg cells of a seriously ill patient despite somatic-cell gene therapy being the only reasonable 
treatment for that patient. Dr. Walters underlined that unintended side effects on reproductive cells are currently accepted 
in cases where the patient consents to having toxic chemotherapy or radiation therapy directed at certain parts of the 
body and stated that the subcommittee felt it was unwarranted to set up a different standard for possible unintended side 
effects to apply to human somatic-cell gene therapy. Dr. Walters added that the "Points to Consider" document does ask 
investigators to specifically look for germ line effects in laboratory studies on animals (pg. 13 of Points to Consider). 
Regarding in vitro experiments with sperm or egg cells. Dr. Walters noted that this concerns haploid cells only, i.e., 
separate sperm or egg cells. If the two have gotten together and fertilization has occurred, it falls under the next point 
concerning early human embryos. He pointed out that the subcommittee simply disagreed with the proposed exclusion 
of in vitro experiments that alter haploid human sperm or egg cells by means of recombinant DNA techniques. Such 
experiments are already covered in the NIH Guidelines under Section III-C. The subcommittee was concerned that such 
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Recombinant DNA Research, Volume 11 
