20 
ing to William Rutter, the system is now tighter and more business- 
like. Be that as it may, the researchers who conducted the experi- 
ments neglected to confirm the rumor of pBR322 approval and them 
delayed correcting their error in the hope that the obvious remedy 
would not be necessary. The acting principal investigator, the bio- 
hazards committee, and other permanent members of the department 
exercised so little supervision that they did not discover the use of the 
uncertified vector by their colleagues. Director Fredrickson left the 
subcommittee with no doubt that this lack of action was contrary to 
the intent of the NIH guidelines. 
The guidelines themselves, however, are deficient. They require 
grantees to report accidental equipment failures and problems of 
operation and implementation of safety procedures but make no pro- 
vision for reporting or investigating violations. Only an unusual set 
of circumstances, not monitoring by the institutional biohazards 
committee or NIH, brought the incident to light after the researchers 
had decided to keep it to themselves. It is not at all clear, as Fred- 
rickson maintained, that the institutional committee is the proper 
body to investigate allegations of a violation. In the absence of any 
standard procedure, both the local committee and the Office of Re- 
combinant DNA activities failed to conduct a thorough inquiry and 
relied instead on statements by the principals. Finally, the episode 
demonstrates the inadequacy of the guidelines’ enforcement mech- 
anisms; NIH has little recourse other than to withdraw the grant of 
the principal investigator, who seemingly bears less responsibility 
in this matter than other members of the department and the bio- 
hazards committee. 
Appropriate legislation and reasonable regulations can formally 
correct these deficiencies but will not have universal acceptance. Not 
the least disturbing testimony in the affair was William Rutter’s ra- 
tionale for secrecy — the researchers’ presumption of safety and fear 
of exacerbating public controversy. First, he said, “the Recombinant 
DNA Committee had voted to approve the plasmid as an EK2 vec- 
tor. The DNA insert was placed in a region of the plasmid such that 
it was unlikely it could be read or expressed. The experiment had 
been carried out with no ill effect.” Second, an “inflamed social and 
political climate * * * existed with respect to recombinant DNA 
technology. * * * The press, among others, had sometimes fanned 
the flames of controversy. * * * Repressive and punitive legislation 
was being considered.” This assumption of superior judgment 
threatens not only regulation but also productive scientific inquiry. 
If even a few scientists ignore the common ground rules of research, 
they undermine the basis of healthy scientific competition. If they 
are discovered, they undermine public confidence in their enterprise. 
It is clearly in the interest of the scientific community to cultivate a 
willingness to comply with the guidelines. No enforcement system 
can ever fully substitute for a' spirit of good faith observance among 
investigators. 
Regulation of commercial applications 
As previously mentioned, the subcommittee heard several predic- 
tions that practical commercial applications of recombinant DNA 
technology will be feasible within a few years, much earlier than 
[Appendix B — 280] 
