220 • Impacts of Applied Genetics— Micro-Organisms, Piants, and Animals 
sight. Penalties are based on NIH’s power to re- 
strict or terminate its funding. 
The initial responsibility for compliance lies 
with the scientist doing the experiments. A re- 
searcher’s attitude toward the risks of rDNA 
techniques and the necessity for the Guidelines 
appear to be an influential factor in the degree 
of compliance. A science writer who worked for 
3 months in a university lab in 1976 noted slop- 
py procedures and a cavalier attitude, stating: 
“Among the young graduate students and post- 
doctorates it seemed almost chic not to know 
the NIH rules. On the other hand, in the case 
of a recent violation of the Guidelines, it appears 
as if the investigator’s graduate students were 
the first to raise questions. Competitiveness 
is another important factor. Novice scientists 
must establish reputations, secure tenure in a 
tight job market, and obtain scarce research 
funds; established researchers still compete for 
grants and certainly for peer recognition. This 
competitive pressure could provide strong in- 
centives to bend the Guidelines; on the other 
hand, it might be channeled to encourage com- 
pliance if it is believed that NIH will in fact 
penalize violations by restricting or terminating 
funding. 
The first level of actual oversight occurs at 
the institution. An argument can be made that 
reliance on the PI and an IBC (that might be 
composed mostly of the Pi’s colleagues) provides 
too great an opportunity for lax enforcement or 
coverups. On the other hand, spreading respon- 
sibility among the institution, the PI, the IBC, 
and, in the case of more hazardous experi- 
ments, the Biological Safety Officer might re- 
duce the chance of violations being overlooked 
or condoned. This responsibility is enhanced by 
the reporting requirements borne by each of 
these parties, designed so that ORDA learns of 
“significant’’ problems, accidents, violations, and 
illnesses. What is “significant” is not defined. 
Public involvement at the local level acts as an 
additional safeguard. Twenty percent of the 
“Janet L. Hopson, "Recombinant Lab for DNA and My 95 Days 
in It," Smithsonian, vol. 8, June 1977, p. 62. 
“D. Dickson, "Another Violation of NIH Guidelines," Nature vol. 
286, Aug. 14, 1980, p. 649. 
“D. Dickson, "DNA Recombination Forces Resignation," Nature 
vol. 287, Sept. 18, 1980, p. 179. 
IBCs members must be unaffiliated with the in- 
stitution. IBC documents, including minutes of 
meetings, are publicly available, but meetings 
are not required to be held in public. On the 
other hand, the probable inability of the mem- 
bers who represent the public to understand 
the technical matters might limit their effective- 
ness. 
How successful has compliance been? Three 
known violations have occurred. In each, no 
threat to health and the environment existed. In 
each, there was some confusion as to why the 
violations occurred. NIH is presently in\est- 
igating the third violation. For the first two, it 
accepted explanations of misunderstandings 
and misinterpretations of the Guidelines. How- 
ever, a Senate oversight report concluded:*® 
While undoubtedly most researchers ha\e 
observed the guidelines conscientiously, it is 
equally clear that others have substituted their 
own judgments of safety for those of NIH. 
No firm conclusions can be drawn on the (jues- 
tion of compliance. The reporting of only a few 
violations could be evidence that the compliance 
mechanism embodied in tbe Guidelines has 
been working well. Or it could mean that some 
violations are not being discovered or reported. 
Tbe November 1980 amendments to the 
Guidelines substantially cbanged procedure's 
designed to monitor compliance by abolishing a 
document called a Memorandum of I'nder- 
standing and Agreement (MllA). It had been re'- 
quired for 15 to 20 percent of all e'xperime'nts, 
those thought to Ije potentially most risk\’. I'he* 
MUA, which was to be filed with ()MI).\ by an 
institution, provided information about each e.\- 
periment, and it was the institution's certifica- 
tion to NIH that the experiment complie'd w ith 
the Guidelines. By having the Ml'.Xs, OBD.A 
could monitor for inconsistencies in interpret- 
ing the Guidelines, actual non{'om[)liance, and 
the consistency and (luality with which IB(!s 
functioned nationwide. The amendments con- 
tinued a trend begun in January 1!)80, when ap- 
proximately 80 percent of the experiments. 
^’"Recombinant DNA Rt'.searcli and Its Vppla ations n\rr\ifihl 
Report, Siihcommitlee on Sciencr, I cchnoliigv and Spati- ol ibe 
Senate Committee on Commerce, Science and 1 1 anN|«>i tation 
Aug. 1978, p. 17. 
