38 
desire to create a large Federal bureaucracy of licensing officials and 
inspectors or to impose on scientists requirements that effectively cur- 
tail productive research. On the other hand, accomplishment, prestige, 
profit, and expectation of benefits for society are positive incentives to 
proceed as rapidly as possible with the use of recombinant DNA. as 
with any other promising research technique. Some scientists are 
already convinced that it poses no significant health or environ- 
mental hazard; some may be inclined to substitute their own judg- 
ment of safety for that of a regulator. The incidents at the Univer- 
sity of California at San Francisco underscore the need for greater 
accountability. 
To support the primary role of the institution in guaranteeing the 
safe conduct of recombinant DNA research, the subcommittee rec- 
ommends that the Department of HEW certify individual universi- 
ties, corporations, private laboratories, or their autonomous divisions 
to conduct the research. Approval should be conditional upon a show- 
ing that the chief administrative officer of the institution has appointed 
a qualified biosafety review committee thoroughly familiar with the 
Federal requirements to approve projects and facilities and to provide 
for the training of investigators and laboratory personnel in proper 
physical and biological containment methods. The application should 
describe the facilities and physical containment levels at which the 
research is planned to be conducted. F urther, the institution must agree 
to monitor the health of laboratory workers and to keep such records 
and make such reports as the agency prescribes, including reports of 
any violations of the regulations. The certificate should be valid for 
the duration of the act or not more than 3 years. If the institutional 
committee fails to carry out its responsibilities, however, the Secretary 
should suspend its authority to approve recombinant DNA projects or, 
where appropriate, specific categories of experiments. 
The subcommittee believes that the Department will not have suffi- 
cient information to achieve compliance unless privately supported as 
well as federally funded projects are registered with it in advance. The 
registration should describe the proposed experiments, the physical and 
biological containment levels required, the facilities, materials, and 
procedures that will be used, and other data that the Secretary may 
prescribe. These projects should not be subject to the rigorous review 
given Federal research grant applications ; indeed it would be appro- 
priate for a project to commence unless the Department raised objec- 
tions within a brief period of time, such as 14 days. To the extent 
feasible, qualified institutional or local biosafety officers should be ap- 
pointed to advise investigators and monitor experiments ; but the Sec- 
retary should have authority to inspect research facilities and to order 
the destruction of hazardous or potentially hazardous material pre- 
pared in violation of the standards. The Secretary should consider sup- 
porting biosafety training programs for investigators and technicians, 
perhaps conducted on a regional basis. 
The suspension of an institutional committee is a severe sanction to 
be reserved for rare cases of serious dereliction on the part of the 
institutional officials or their agents. Even the withdrawal of a Fed- 
eral grant may not be an appropriate response to misconduct by an 
individual or a small group of researchers. Civil penalties may be ap- 
[Appendix B — 297] 
