any rate, I feel that it is a mistake to leave the responsibility for 
lowering containment to the Institutional biohazards Committee without 
strengthening the structure and functioning of this committee. Too often, 
these committees fail to critically investigate either the data or 
the working habits of the investigator in question. Because diversity 
of representation on these committees is not required, decisions may 
be made without paying sufficient attention to the quality or scope 
of the information submitted. 
For these reasons, I find this provision inadequate. The problems 
with it could be resolved by strengthening the Institutional Biohazards 
Committee and especially by strengthening the enforcement provisions 
and procedures. 
V. Roles and Responsibilities 
The guidelines as they are now written confer a large amount 
of responsibility for enforcement to the principal investigator and 
the institution. As the UCSF experience indicates, this is an unrealistic 
and unacceptable approach to enforcement. Procedures must be developed 
to monitor the Institutional Biohazards Committees as well as the 
Principal Investigators. One way to do this is to establish better 
communication between the IBCs and local citizens. Specifically, 
this could be achieved by requiring rather than recommending that IBCs 
include persons representing the areas of standards of practice, 
community attitudes, health and environmental concerns. 
In addition, the IBC should be required to have adequate representation 
from workers and non-ins titutionally affiliated persons. 
Another way to increase the accountability of both the IBC ana 
the labs doing recombinant DNA research would be to require that the 
majority, if not all of the meetings of the IBC be open to the public. 
Mere minutes of these meetings are not sufficient to inform the public 
and institutional employees of the extent and nature of local recombinant 
DNA research. By having open meetings, the public will be better 
informed and better able to contribute to decisions and actions aimed 
at ensuring safety and upholding the guidelines. 
As far as monitoring of Principal Investigators is concerned, 
if no legislation is forthcoming setting up a regulatory process for 
this research, the NIK staff should be fortified so that it can tackle 
the responsibility of enforcement. Relying on outside sources for 
information on violations of the guidelines indicates a gap in the en- 
forcement process. The guidelines must be made more specific so that 
each level of regulation feeds into the next. Provisions and funds 
should be made both to establish criteria for monitoring and to develop 
a process for their implementation. This could include unannounced 
bimonthly monitoring of labs by either biohazards-commi ttee members, 
a biological safety officer, or any other individual who could show 
that he or she could effectively investigate the labs following 
[Appendix A — 191] 
