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D. No Guidelines but NIH Consideration of Each 
Proposed Project on an Individual Basis 
Before Funding - 
With this alternative, individual investigators requesting NIH 
funds for projects involving recombinant DNA research would bring 
plans for proposed experiments to an NIH committee that would, without 
the use of formal guidelines, recommend suitable containment measures. 
Depending on the criteria used by the committee, this might result 
in lower or higher containment levels than the Guidelines currently 
impose. The advantages of such a procedure would include constant 
reevaluation of potential hazards and containment measures, and 
up-to-date information for investigators. The disadvantages include 
the enormous time and resources required for review, given the size 
of the biological research enterprise in the United States, the problem 
of finding knowledgeable individuals to serve on such a committee 
(essentially a full-time occupation), the opportunity for arbitrary 
decisions, and the bypassing of local input in assessment of hazards. 
It should be pointed out that under the present NIH Guidelines, local 
institutional biohazards committees must consider proposed research 
projects on an individual basis and may impose more stringent safeguards 
than the Guidelines require. The judgments of the investigator and his 
local committee will be reevaluated by the NIH Study Section reviewing 
the scientific merit of the proposal. 
E. General Federal Regulation of All Such Research 
The NIH Guidelines are only binding for recombinant DNA research 
supported by NIH. Nevertheless, NIH has assumed responsibility to 
work toward the promulgation of safety measures for all such research. 
NIH conducted a series of meetings with representatives of other Federal 
agencies and private industry to insure as wide an application of the 
NIH Guidelines as possible. As a research agency, however, NIH does 
not have regulatory responsibility, and therefore, general Federal 
regulation was beyond its purview. Thus, the Secretary of HEW, with 
the approval of the President, established in October 1976 an Interagency 
Committee on Recombinant DNA Research, chaired by the Director of 
NIH. The Committee was chartered to review the nature and scope of 
Federal and private -sector activities related to recombinant DNA 
research, to determine the applicability of the NIH Guidelines to govern 
research in these sectors, and if necessary, to recommend appropriate 
legislative or executive action. The Committee consists of all Federal 
Departments and agencies that support and conduct such research and 
all regulatory agencies that may have potential authority over it. 
