(4) 
opportuntiy for input before the decisions are made. 
III. Responsibilities of the NIH 
Due Process Considerations 
1. The reference to "shifting the burden of proof" should be 
stricken from the guidelines. As discussed earlier, it is clearly 
premature. For an excellent discussion of where the burden of proof 
lies, refer to Peter Hutt's letter (March 3, 1978) to Dr. Fredrick- 
son , p . 2 . 
2. "Appropriate notice and opportunity for public comment" 
is an inadequate public participation mechanism. By that point, 
the important decisions have already been made. Our comments in 
the past have too often been ignored. For example, one commentator 
at the Director's Advisory Committee (DAC) meeting in December did 
an extended critique of the probability analysis used to justify 
the safety of recombinant DNA research, particularly pointing out 
the fallacies in the work of Robin Holliday. Holliday relied on 
fault tree analysis, the use of which was initially discredited 
during the space program, and more recently widely criticized in 
the Rasmussen report. Nevertheless, Dr. Fredrickson refers to his 
work as "noteworthy" and makes no mention of the critique delivered 
before him in December. 
The public perspective must be introduced at a much earlier 
stage in the decision-making. 
3. In that regard, the Director's Advisory Committee (DAC) 
does not adequately substitute for public involvement on the 
Recombinant DNA Advisory Committee (RAC) . Once again the decisions 
are made by the time the "public" gets input. It may be possible 
to change the details, but the basics are set in concrete. It is 
this kind of public participation that has led to distrust of the 
policies of the NIH. 
4. Public membership must be substantially increased on the 
RAC. As the Stevenson subcommittee concluded, "the technical and 
social policy aspects of even physical and biological containment 
standards or host-vector approval cannot be readily distinguished." 
Scientific decisions cannot and should not be separated from their 
social and political context. In attempting to do so, the NIH has 
insured that the decisions were simply made in a less representa- 
tive social and political context. 
Recombinant DNA Advisory Committ ee 
The RAC has turned out to be much less conservative than the 
Director, NIH. In many cases, they went further in the PRG-RAC 
than the Director finally allowed in the PRG-NIH. Advisory Com- 
mittees have often been expected to counter balance internal con- 
flicts of interest, and in this case ensure that the public health 
and safety is being considered adequately. Unfortunately, the RAC 
does not seem to be fulfilling that function. 
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