a prohibition would impede potentially valuable research on haploid cells. 
Dr. Walters then stated that the final type of experiment covered in the CRG's proposed NIH Guidelines change 
involves in vitro recombinant DNA experiments with early human embryos. Such experiments, if ever proposed, 
would be governed by Department of Health and Human Services regulations on human in vitro fertilization. Dr. 
Walters said that at the time of the August 8th subcommittee meeting, the members of the subcommittee believed that 
the Health Research Extension Act of 1985, PX. 99-158, had placed a 3-year moratorium on research with human 
embryos. A closer reading of the statute suggests, however, that it applies only to implanted or formerly implanted 
embryos and fetuses and not to pre-implantation embryos. Therefore, alternative wording to the second sentence of 
point 2 on page 2 of the subommittee recommendations (tab 1271) has been worked out and should read as follows: 
’The subcommittee understands that human germ line 
cells would be covered by provisions for cells in tissue culture 
in the NIH Guidelines for Research Involving Recombinant DNA 
Molecules, and that HHS support for research involving human 
in vitro fertilization is precluded by regulation unless reviewed 
by an Ethical Advisory Board which must render advice as to 
the acceptability of the procedures." 
Dr. Walters explained that this language is contained in tab 1278, which was distributed to the members of the RAC at 
today's meeting. He further noted that this language had been circulated on September 19 to all subcommittee 
members. Comments were solicited from subcommittee members but no objections had been received from any of 
them. Dr. Walters further stated that even though the subcommittee ultimately decided not to recommend a change in 
the NIH Guidelines, its members believe that open discussion of these issues in a public forum, such as the RAC, is 
essential to the formulation of a sound public policy on human gene therapy. Dr. Walters added that at the appropriate 
moment he would move the recommendation of the Human Gene Therapy Subcommittee, as amended, be accepted by 
the RAC. Mr. Mitchell thanked Dr. Walters and called upon Dr. Epstein for his comments as a secondary reviewer. 
Dr. Epstein stated that in general he concurred with the subcommittee’s position. One of the major concerns he had 
with the CRG’s requested changes was that in several places the language was so vague that it might lead to great 
difficulty in interpretation of what types of research should or should not be done. In particular, he pointed to the terms 
"life-threatening" and "severely disabling" and said putting such words into the NIH Guidelines would lead to 
interminable arguments as to what constitutes "life-threatening" or "severely disabling" conditions. He said there is no 
way of making a dichotomy between conditions that clearly will warrant therapy of this sort and conditions that clearly 
will not warrant therapy of this sort by the use of terms such as "life-threatening" or "severely disabling." As time 
goes on, if these therapies prove successful, we may wish to change, on a case-by-case basis, the types of conditions 
that arc treated. In the accompanying rationale from the CRG, the term "enhancement therapies" is used apparently in 
an attempt to try to clearly discriminate these types of approaches from those which are "life-threatening” or "severely 
disabling." If one thinks about the broad range of therapeutic maneuvers that are used medically, this kind of dichotomy 
is not clearly establishablc. We today, in many ways, already use what would fall within the definition of 
"enhancement therapies" for legitimate medical needs. 
Concerning the CRG’s proposed addition to the NIH Guidelines of the words ’’that could alter germ line cells," Dr. 
Epstein said that "could" is a very broad and difficult word to deal with. Dr. Epstein said that there may be legitimate 
reasons for doing in vitro experiments on sperm or egg cells. Precluding such experimentation would not serve any 
useful goal and might inhibit possible work in the future that could be of tremendous benefit. Dr. Epstein said that 
there is an implicit assumption in the CRG proposal that any type of germ line therapy one might envision in the 
future is on the face of it a bad thing. Yet there may be some serious genetic disorders where that may be a better 
approach than today's approaches involving prenatal diagnosis and abortion. Therefore, whereas he concurred with 
recommendations that at the present time there not be any attempts to alter the germ line or the genetic constitution of 
early embryos, he could not be sure that at some time in the future there might not be a clearly beneficial reason to do 
so. 
Mr. Mitchell called on Nachama Wilker, Executive Director of the CRG. She read from a prepared statement which 
was distributed to the RAC which is attached to these minutes as Attachment n. 
After Ms. Wilker's statement, Mr. Mitchell called on Dr. Stuart Newman. Dr. Newman stated he is a molecular 
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