COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Thirteen 
nomination process will further enhance the public perception 
of these committees as truly representing and protecting the 
public interest. Many government agencies follow this nomi- 
nation procedure for Federal advisory committees today. 
In general, present FDA regulations governing ad- 
visory committees, in 21 C.F.R. Part 14, could be used as a 
model for the provisions in the Guidelines governing local 
biohazards committees. 
5. The Guidelines presently do not include pro- 
visions relating to inspection in order to assure compliance 
of research conducted with NIH funds with the requirements 
of the Guidelines. The Guidelines should make clear that 
NIH representatives or other employees of the Department of 
HEW may, at any time, upon a proper showing of credentials, 
inspect any NIH-funded research on recombinant DNA molecules 
to assure that it is being conducted in accordance with the 
Guidelines. Once again, this will create greater public 
confidence that the Guidelines are not just paper provisions 
but in fact are being enforced with adequate inspection. 
6. In order to emphasize that the Guidelines will 
in fact be enforced, specific penalties should be stated. 
The Guidelines should make clear that non-compliance with 
the Guidelines may result in termination of the grant and, 
depending upon the circumstances, termination of other NIK 
research grants involving the investigator and the institu- 
tion. The specific penalty will, of course, depend upon all 
the facts of the situation. Deliberate violation of the 
Guidelines by an investigator or by an institution should, 
however, clearly be stated to be a serious offense that will 
carry with it serious penalties. 
7. During the December 1977 meeting, it was 
charged that one private company had financed research on 
recombinant DNA molecules at one or more private university 
laboratories not in compliance with the Guidelines. Subse- 
quently, it was learned that this has not in fact happened, 
and that the company and the institutions do not intend to 
undertake any research that is not in compliance with the 
Guidelines . 
The question arises, nonetheless, whether the Guide- 
lines could be revised to broaden their reach. Although I 
have not undertaken any legal research on the matter, it 
[Appendix A — 251] 
