3 
outside of the U.S. The government can now exert only limited influence on the 
application of the technology as no public funds were used in developing it. 
Dr. Gorovitz said seme segments of the public are deeply frightened by the 
prospect of human gene therapy. He offered the example of the lawsuit recently 
filed by the Foundation on Economic Trends and the Humane Society of the United 
States against the U.S. Department of Agriculture (USDA) concerning the project 
involving introducing the human growth hormone gene into sheep and pigs. He 
thought the preamble proposed by Dr. Gottesman should suggest that investigators 
may have sane responsibility to educate the public and to dispel fears. 
Dr. Miller said investigators have two primary responsibilities: to respect 
medical ethics and to respect medical science. He did not think investigators 
should be responsible for educating the public. Dr. Childress said although it 
might be politically advantageous to educate the public, investigators have no 
responsibility to do so. 
Dr. McCarthy felt the subgroup draft document (Attachment II) did not give 
sufficient attention to certain informed consent issues such as confidentiality. 
He said the Recombinant CNA Advisory Committee (RAC) and the working group 
might attempt to ensure the patient's privacy but cannot guarantee the actions 
of the courts and the press. Dr. McCarthy felt the media would show a great 
deal of interest in human gene therapy; he reminded the group that in the 
Martin Cline case the media invaded the patients' privacy. He said public 
interest in human gene therapy may alter the traditional balance between the 
individual's privacy rights and the public's right to knew. 
Dr. Grobstein said the working group in protecting the patient's rights also 
protects the public interest. 
Dr. Childress said a distinction can be made between public curiosity and the 
public's right to know. He said the draft document should address issues such 
as whether RAC or working group meetings at which protocols will be reviewed 
are open to the public. 
Ms. Areen felt the draft document (Attachment II) did not sufficiently deal 
with issues of informed consent for children. She said the regulations for 
children differ from those for adults; the regulations for children emphasize 
the concept of the child receiving direct benefit from the procedure. If it is 
not obvious that the child will directly benefit, the approval of the Secretary, 
Health and Human Services (HHS), must be sought and obtained. Ms. Areen said 
the working group document should clearly state and reinforce existing federal 
regulations . 
Mr. Capron said the weight the working group document gives to various informed 
consent issues depends on the mechanisms of the review process, particularly 
the respective roles of RAC and the Institutional Review Boards (IRBs). He 
thought the subgroup based the draft document (Attachment II) on the premise 
that the IRBs are fully competent to address informed consent issues, and RAC's 
review would not overlap with these IRB responsibilities. 
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