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may lead us away from these generic aspects of implementation, about the roles 
of principal investigators and institutions and then, more specifically, to 
how they might apply to different kinds of institutions. 
Dr. Ginsberg. 
DR. GINSBERG: Is your office going to set down any regulations as to 
what you mean by training? What is the local biohazard committee to do about 
training? It is not clear to us on the biohazards committee. 
DR. GARTLAND: I suspect this is more appropriate to be taken up with 
the implementation section of the Guidelines, really, rather than my office 
per se . 
DR. FREDRICKSON: I think maybe we might move now to a brief summary 
presentation from Dr. Walters, who is a member of the Recombinant Advisory 
Committee. He is Director of the Center for Bioethics at the Kennedy Insti- 
tute in Georgetown. 
Dr. Walters. 
DR. WALTERS: Part IV of the proposed revised Guidelines is quite brief. 
Even with the two paragraphs mercifully printed in large type on page 49604, 
it fills only four columns of the Federal Register . 
My comments will also be brief. I will discuss what seem to me to be 
the four most significant proposed changes in this section. First, the 
composition of institutional biohazards committees; second, the role of the 
biological safety officer; third, the certification procedure; and fourth, 
the exemption provision. 
Of these proposed changes the first two clearly represent a strength- 
ening of the previous Guidelines. The third clarifies a certification pro- 
cedure which is, in practice, more stringent than that envisioned in the 
1976 Guidelines. And the fourth allows for the possibility of a relaxation 
of specific provisions of the Guidelines in exceptional cases. 
First, the composition of institutional biohazards committees. In the 
section of Part IV entitled B, Institution, Federal Register page 49604, the 
proposed revised Guidelines have added the recommendation that institutional 
biohazards committees include persons concerned with "applicable laws, regu- 
lations, standards of practice, community attitudes, and health and environ- 
mental considerations." This recommendation is parallel to current DHEW 
regulations on research involving human subjects, which require that local 
institutional review boards include persons with similar competencies. The 
primary reason for adding this recommendation is to ensure that a variety of 
perspectives and points of view are taken into account before any research 
proposal receives approval at the local level. 
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