39 
propriate in cases of knowing violations, but the subcommittee also 
recommends that the Secretary have authority to suspend research 
being conducted in violation of the regulations and persons from 
participating in recombinant DNA research for a specified period of 
time. With regard to both institutional and individual suspensions, the 
Secretary should be able to issue an administrative order rather than 
be obliged to seek a court injunction. The judicial route would incur 
delay and might require a showing of harm or potential harm. Never- 
theless, due process must be assured ; the more severe the penalty, the 
more rigorous should be the procedural safeguards. 
The subcommittee believes that realization of the benefits of recom- 
binant DNA technology requires some protection of the confiden- 
tiality of research ideas and procedures, but it recognizes the public’s 
right of access to information necessary to judge compliance with the 
Federal standards and their effectiveness in protecting public health 
and the environment. Unfortunately, the subcommittee has found 
no ideal balance between these competing values. Two major study 
commissions have recognized, however, that the disclosure of aca- 
demic research protocols, submitted in application for Federal 
funds, is a generic problem, not limited to research with recom- 
binant DXA. Indeed, enactment of legislation to regulate such 
research would not significantly increase the likelihood of such 
disclosures. Consequently, the legislation should not establish for 
recombinant DNA researchers a right of confidentiality which 
is not accorded to other scientists. Rather, for the time being, HEW 
should continue its present policy of refusing to disclose a grant 
application prior to funding and, after consultation with the grantee, 
of maintaining the confidentiality of potentially patentable informa- 
tion contained in a funded research protocol. In the long run, this 
policy may entail a heavy administrative burden and possibly further 
litigation. The appropriate committees of Congress should therefore 
address the general problem of protecting intellectual property rights, 
as the President’s Biomedical Research Panel and the National Com- 
mission for the Protection of Human Subjects of Biomedical and 
Behavioral Research have recommended. 
Regulation of the use of recombinant DNA techniques would expose 
the private sector to disclosure of properietary information at the be- 
ginning of research and development, whereas present Government 
regultation of products and processes is limited for the most part to 
the manufacturing and testing stages. The subcommittee believes that 
some measure of protection against this risk of disclosure should be 
provided, especially in view of the fact that recombinant DNA tech- 
niques may be only a part of a larger research project. Nevertheless, 
the concern of the pharmaceutical manufacturers and others is also 
a general one; they argue that regulatory agency and court inter- 
pretations of subsection (b) (4) of the FOIA and 18 U.S.C. 1905 fail 
to protect much trade secret information, particularly against dis- 
closure to competitors. 
The subcommittee doubts that the solution lies in attempt- 
ing to define in recombinant DNA legislation categories of informa- 
tion, some of which would remain confidential and others be subject 
to disclosure. Instead, the legislation should establish a notification 
23-S90 — 78 1 
[Appendix B — 298] 
