56 
majority's recommendations concerning' section 361 are without 
significant merit. 
Recent events, however, suggest that increased attention will be 
focused on the use of section 361 in lieu of legislation. Based on pres- 
ently available information, it would be unwise for this subcommittee 
to condone or support the use of such inadequate statutory authority, 
especially in such a delicate matter as the regulation of basic scientific 
research. If there is shown to be a need for statutory authority to 
ensure compliance with the NIH guidelines by the private sector, 
it should be accomplished by specific legislation expressing the clear 
intent of the Congress rather than unilateral action by the executive 
branch. 
SUMMARY 
I am greatly disturbed with the substance and implications of the 
majority's recommendations which results in unwarranted and exces- 
sive regulation of a field of scientific research where the risks are 
purely theoretical, inconsistent with other knowledge, and unproven. 
The consensus of the testimony presented at the subcommittee hearings 
does not support such action. 
The testimony presented at the hearings supports the position that if 
there is determined to be a need for immediate legislation it should be 
directed solely toward extending the NIH guidelines to.nonfederally 
funded research on recombinant DMA. I generally agree with that 
conclusion, although I am nevertheless concerned that we might initi- 
ate unnecessary and unreasonable restrictions on the conduct of basic 
scientific research. Even here the guidelines are already being applied 
voluntarily in the private sector. Certainly there should be only those 
minimal requirements necessary to ensure compliance with the 
guidelines. 
Based on my experience in the scientific community and the general 
level of professional responsibility demonstrated by the scientists them- 
selves, I cannot concur with the majority's conclusion that a system of 
voluntary compliance would be inadequate. I do believe that scientists 
must continue to insist on ethical compliance with the NIH guidelines 
and general principles of good research procedures. 
There is a need to further examine alternatives to a harsh and un- 
wieldy system of regulations for enforcing the guidelines. One example 
which appears promising is the use of patent withdrawal to enforce 
compliance with the guidelines. In his testimony before the subcom- 
mittee, David Newburger. assistant professor of law at Washington 
University, indicated that conditioning the grant of patents for dis- 
coveries resulting from research on recombinant DXA technology on 
a showing of compliance with the NIH guidelines would provide a 
substantial incentive for investigators to abide by the guidelines. Such 
a system would avoid the need for excessive regulatory' and licensing 
requirements. The investigator would ultimately be held accountable 
for his adherence to the guidelines and a system of monitoring could 
be incorporated. 
Uncertainties still exist with respect to the possible scope of such a 
system and whether it would reach all recombinant DXA research. 
Nevertheless, this is at least one option which deserves further exam- 
ination before we set up a major regulator}’ structure. 
[Appendix B — 315] 
