Testimony for HEW/NIH Public Hearings on Revised Guidelines for 
Recombinant DNA Research 
September 15, 1978 
Nancy Pfund, Research Associate, Division of Health Services Research, 
Stanford University School of Medicine, Stanford, California 
The introductory comments to the revised NIH guidelines by Secretary 
Califano and Dr. Frederickson make specific mention of the need to examine 
and ref ine the mechanisms for implementing and enforcing regulatory requirements 
for recombinant DNA research. In my testimony, I will address this issue as 
it relates to the local regulatory unit, namely, the Institutional Biosafety 
Committee (IBC). First, I will comment on the importance of the IBC in 
shaping a representative and efficient regulatory policy. I will then 
discuss the results of some preliminary data we have obtained on a sample 
of 30 IBCs. Finally, I will outline some plans for further research designed 
to fill gaps in current knowledge about the structure and function of IBCs. 
This research is part of a larger project of which I am a member, entitled, 
''Medical Progress and the Public: Ethical Issues in Biomedical Innovation," 
funded largely through the National Science Foundation's Program on Ethics 
and Values in Science and Technology. 
I . Introduction 
The latest version of the NIH guidelines gives major regulatory 
responsibility and decision-making power to Institutional Biosafety Committees 
(IBCs). Earlier versions of the guidelines, in contrast, focused on the 
responsibility of the IBC to implement nationally determined regulatory 
requirements and to provide the office of rDNA Activities (ORDA) with the 
information necessary for making final decisions on research proposals. 
There has since been a conscious shift toward locating more of the decision- 
making power at the local institutional level (Revised Guidelines, pp. 33045, 
[ 387 ] 
