22 
members of the IBC who are not themselves DNA researchers; and finally we 
require that votes to approve MUAs be by an extraordinary majority, in 
order to signify to the general public that a substantial proportion of the 
membership of the IBC believes in the safety and efficacy of the proposal 
at issue. I urge that the NIH incorporate such rules as requirements for 
the functioning of all IBCs. 
(3) Other insufficiencies and inconsistencies . The Guidelines correctly 
reflect a concern for the due process rights of researchers and investigators. 
They are remiss in not similarly reflecting a concern for the due process 
requirements that laboratory workers and the general public have the right 
to expect from this regulatory process. 
Although the Guidelines are quite elaborate, the section on sanctions 
are rather terse and slender (section IV-D-1, FR 33087). I believe that 
administrative law has developed a nuch more wide-ranging set of possible 
sanctions which should be considered by the NIH for possible use in- regard 
to violations of the Guidelines. My concern here is that the sanctions 
provided in the revised Guidelines are neither flexible enough nor credible 
enough to achieve the aims of compliance and smooth operation. 
The guidelines should require that practices within institutional 
laboratories comply with OSHA standards, and the standards of any state 
agencies concerning occupational health and safety. Although it is true 
that this is not legally necessary, having note of it in the Guidelines 
would perform the salutary functions of (1) acknowledging that NIH is 
seriously concerned about the health and safety of laboratory technical 
personnel in this whole matter, and (2) reminding the principal investi- 
gators (if not the institutions) who might be unaware that their activities 
fall within the perview of the OSHA rules that this is in fact the case. 
[ 335 ] 
