25 
New Ethical Factors 
Dr. Fredrickson indicated his belief that biomedical research is 
entering a new era in its relations with society. The DNA recombinant 
molecule research issue has highlighted the public concern in this 
new era. In his view, biomedical research is moving from an area of 
privacy and autonomy to new ethical, legal and social imperatives 
involving a need for scrutiny. The response of NIH has been to form 
review boards to oversee experimentation with human subjects, 
promulgation of animal care regulations, and the new emphasis of 
public involvement in the DNA recombinant molecule issue. He con- 
jectured that similar bodies may soon have to oversee other hazardous 
laboratory research. Dr. Fredrickson believes that this new involve- 
ment of the public in science policy determination is an adjustment 
to the need for insuring the public that such research is being con- 
ducted safely and for the public good, but also that care must be taken 
to insure that successful research is not impeded or creativity ham- 
pered. 
Dr. Fredrickson stated that he does not believe that we could make 
a really useful technology assessment on DNA recombinant research 
at this time beyond imagining various scenarios for examination. There 
is not enough evidence now to adequately assess this new technology. 
Control of Research 
With regard to the guidelines, both Dr. Wald and Ur. Curtiss indi- 
cated considerable concern about factors related to but not a specific 
part of the proposals to extend the guidelines to all DNA recombinant 
research. Dr. Wald summarized his view that a general application 
of the guidelines to all DNA recombinant research is being viewed 
by some scientists as a foot in the door to regulation and control of 
ail biological research. His discussion suggested a fear on the part of 
some scientists that an expanded regulation of such research would 
have a harmful effect on the spirit of free inquiry. [He suggested ap- 
plying the guidelines only to the P2-P4 cateogories of risky research 
and limiting this research to a few national laboratories in order to 
avoid excessive regulation of all laboratories.] Dr. Curtiss suggested 
that the guidelines may actually be "overkill” in their protective 
specifications and that the recognition of an “excessive” conservatism 
by scientists might cause the guidelines to be treated in a cavalier 
fashion in much the same way that other sorts of laws which are 
unnecessary or unrealistic are frequently disobeyed by individuals 
who view the law in this fashion. He seemed concerned that overly 
restrictive regulation might produce contempt and a refusal of co- 
operation. 
Dr. Nathans 
During his discussions of the potential risks which might be hy- 
pothesized for DNA recombinant research, Daniel Nathans, Johns 
Hopkins University School of Medicine, emphasized his opinion that 
the NIH guidelines are conservative. However, he supports this 
conservative approach until such time as evidence is accumulated to 
further reduce any of the uncertainties causing concern about safety. 
Dr. Baltimore 
Dr. Baltimore indicated that he would prefer to see Federal regu- 
lation of DNA recombinant research in a uniform fashion rather than 
[Appendix B — 74] 
