6 
Dr. Miller said the FEA must approve experiments involving introduction of a 
new substance into humans. He said FEA evaluates risk vs. benefit and reviews 
consent forms, clinical procedures, licensing, etc., but does not consider 
ethical issues. Dr. McGarrity asked Dr. Miller how FEft would review a proposal 
dealing with human genetic engineering. Eft:. Miller said the Office of Biologies 
would evaluate the following information: (1) analytic testing data to verify 
the product's identity, purity, and potency; (2) a description of the manufac- 
turing process; (3) protocols of clinical trials; (4) the qualifications of 
the principal investigators; and (5) elements of informed consent. 
Mr. Mitchell asked if the proposed working group would evaluate the societal 
impact of field testing and release into the environment of organisms contain- 
ing recombinant DNA. Drs. Nightingale and Gottesman felt a second working 
group with a different composition might be better suited to conduct such a 
review. Dr. McGarrity pointed out that the Environmental Protection Agency 
(EPA) may have statutory authority to regulate certain activities involving 
environmental release of genetically altered microorganisms. 
Dr. Fletcher said some of the earliest proposals involving introduction of ENA 
into humans will probably be attempts to correct single gene, "classic" inborn 
errors of metabolism such as Eesch-Nyhan syndrome or phenylketonuria through 
somatic cell therapy. He felt most individuals would perceive the merit in 
such attempts. He warned though that the line between desirable and undesirable 
subjective alterations is fuzzy. He thought an example of subjective changes 
would be modifications made for aesthetic purposes such as increased height 
or the modification of character traits. He questioned whether society would 
ultimately be able to distinguish between desirable and undesirable subjective 
modifications. 
Dr. Miller pointed out that aesthetic issues exist in the use of anabolic 
steroids, growth hormones, breast implants, rhinoplasty, etc. Eft:. McGarrity 
replied that these considerations only apply to a single individual. Alteration 
of the gene pool through use of recombinant DNA techniques could apply to 
society as a whole. 
Dr. Nightingale said the human subject guidelines are inadequate when applied 
to human germ line manipulations such as those involving embryos, sperm, or 
eggs. Can the human subject guidelines be applied to cells in vitro? Who 
will be protected? The cells in vitro which might become a human being? 
These types of questions will not be addressed by FDA or the IRBs. 
Dr. Gottesman said proposals should be viewed on a case-by-case basis, yet she 
pointed out the problem inherent in such an approach; the first proposals com- 
ing to RAC will probably involve somatic cell therapy to correct or ameliorate 
single gene defects. These proposals will pose simpler ethical questions than 
the proposals which will follow, yet the first proposals may set precedents. 
Eft:. Gottesman expressed her belief that proposals involving human genetic 
engineering should first be reviewed by the IRBs. Proposals which have IRB 
approval could then concurrently be reviewed by FEA and the NIH. Dr. Gottesman 
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