5 
a. Certification for the physical and biological containment 
standards in the guidelines. Under the NIH guidelines 
local institutional biohazards committees and the appropriate 
study sections at the NIH will ensure that the research 
protocol meets the standards set in the guidelines. Thus, 
the NIH guidelines provide for local review plus independent 
national review by NIH study sections. Further, an appellate 
mechanism is provided for an appeal from decisions by either 
the biohazards committee or study section. Under the NIH 
guidelines the Recombinant Advisory Committee will review 
such appeals. 
b. Oversight of the investigators must be provided to ensure 
strict compliance with safety standards, training, and 
accidents. In the NIH guidelines, the institutional bio- 
hazards committee must certify safety standards, training, and 
accidents. Under the NIH guidelines, the institutional 
biohazards committee must certify annually that the researcher 
is ensuring appropriate attention to required safety 
practices, programs, and procedures. Further, there is a 
requirement of notification locally and to the NIH of certain 
accidents or new safety developments. 
c. There must also be oversight of the institution provided. 
The NIH study sections are responsible for that function as 
well as the Office of Recombinant DNA Activities. The latter 
will monitor the operations of the institutional biohazards 
committee and the selection of representatives to serve on that 
committee. 
d. There must be programs for safety education and training for 
those who work in the laboratory. The NIH has undertaken to 
develop a program under the direction of Dr. W. Emmett Barkley, 
Director, Office of Research Safety, NCI, which will be available 
to NIH scientists on campus and to those supported by grants 
or contracts. Under the guidelines, the NIH also has the 
responsibility to certify all maximum physical containment 
facilities before research work can proceed. 
e. There must be a mechanism to provide hosts,' vectors, and other 
materials necessary to conduct the experiments. The NIH has 
undertaken to develop support in this area for its grantees 
and contractors. 
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