4 
II. Roles and Responsibilities of the Committee 
Following a short break for coffee, the Committee was reconvened to 
discuss responsibilities of the Committee. Dr. Fredrickson reviewed 
the mandate of the Committee and the prospective scope of inquiry. 
The mandate of the Conmittee was described as follows: 
1. The Committee shall review the nature and scope of Federal 
and private sector activities relating to recombinant DNA 
research. 
2. The Committee shall determine the applicability of NIH guidelines 
to govern research in the public and private sectors. 
3. The Committee shall recommend, if appropriate, legislative 
or executive actions necessary to ensure compliance with 
the standards set for this research. 
Dr. Fredrickson then reviewed functions and processes required in 
the regulation of recombinant DNA research as envisioned under the 
NIH guidelines. He asked that representatives of regulatory and 
research agencies consider their respective agencies' roles with 
regard to the following functions: 
1. Registration of Activity: An accurate record of the 
nature and scope of recombinant DNA research nationally 
must be determined. The NIH has already under way the 
the development of a registry that might possibly serve 
for the entire nation. 
2. Mechanisms to ensure that the science and safety standards 
set in the guidelines reflect the continuing development of 
knowledge in the science and safety aspects of this research 
area: For example, the NIH guidelines currently prohibit 
certain classes of experiments and prohibit the release 
of recombinants from the laboratory. Further, there is a 
limit on the size of the research experiment that can be 
conducted. Further, to ensure the best safety techniques, 
there needs to be support for research and development in 
testing biohazards and risks and the development of 
safer hosts and vectors. 
3. There are a number of roles and responsibilities in the 
implementation of the guidelines that need to be considered. 
They Include the following: 
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