5 
diseases such as the evolution of antibiotic resistant bacteria, are Con- 
tinuing evidence of the natural processes at work in nature which 
threaten mankind. On the basis of the available evidence, the types 
of research currently permitted under the recombinant DNA research 
guidelines do not seem to pose significantly greater risks than natural 
diseases constantly confronting epidemiologists and pathologists all 
over the world and in many instances appear to present less risk. On 
balance, the biomedical research community has a highly credible 
record of safety although continual improvement in safety standards 
must be required. 
B. THE NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA 
MOLECULES 
The guidelines appear to be the product of a conscientious effort to 
insure the use of adequate physical and biological safeguards td pro^ 
tect the public health. There is a need to evaluate these guidelines 
continuously and insure that they are kept consistent with new data. 
Further, there appears to be a need to give more care to the legal 
procedures for implementation of the guidelines. This is particularly 
true since the Director of the National Institutes of Health has no 
desire or the manpower to play the role of a regulatory agency although 
the implementation of the guidelines will require some action of this 
nature. More attention needs to be given to improvement of the pro- 
cedures for public participation in the development of revisions oi the 
guidelines. Such participation should include a broader spectrum of 
scientific disciplines as well as ample and timely opportunities for 
public interest groups to make known their concerns and alternative 
options. 
The Subcommittee concludes that legislation should be adopted 
authorizing the extension of the NIH guidelines to regulate all re- 
combinant DNA research— Federal, State, private or commercial. The 
extension of the guidelines to non-federally funded research and to 
commercial development and production using recombinant DNA 
techniques may reauire restructuring of the Guidelines for two dis- 
tinct purposes: (1) the regulation of any research involving the use of 
this technique and (2) the regulation of commercial production utiliz- 
ing the DNA recombinant molecule technique. 
The Subcommittee believes that there are special problems which 
require further consideration before the Guidelines can be extended 
to commercial institutions. The protection of trade secrets and the 
granting of patents are of particular concern not only in this Nation 
but abroad. In Great Britain, for example, where commercial interest 
is very strong, confidentiality is one of the most difficult issues which 
is currently confronting the Genetic Manipulation Advisory Group 
set up to review the use of this technique in genetics. Similar concern 
has been voiced in this country as evidenced by the testimony re- 
ceived by the Subcommittee. This problem will require resolution if 
the public review required to assure safety and compliance is to be 
reconciled with the trade secret and patent protection needed to foster 
favorable applications of the DNA recombinant molecule technique^ 
Other obvious problems requiring attention in order to extend legislaA 
[Appendix B — 56] 
