190 
The four non-scientists from leaders of areas of public concern such as 
bioethics, law, sociology, medical history, et cetera. 
Each institution receiving NIH funds will be required to appoint a 
local committee on biohazards, which will be expected to become famililar 
with the recombinant DNA safety regulations promulgated by the NIH technical 
committee and approved by the advisory council. No research grant or con- 
tract will be considered by NIH in the area of recombinant DNA unless the 
local committee certifies to the satisfaction of the technical committee 
or its designee that the principal investigator and the local institution 
meet the safety regulations. If the grant is awarded, the local committee 
will periodically inspect the laboratory of the principal investigator and 
submit an annual report of these inspections of NIH to assure that the reg- 
ulations are being carried out. 
Except when the technical committee is considering applications for 
research grants, its meetings shall be open to the public. Time will be 
provided to hear the opinions of scientists and non-scientists who feel that 
the regulations should be modified. These discussions will be summarized 
and evaluated by the technical committee for consideration by the policy- 
making advisory council. 
DR. FREDRICKSON: Thank you. Dr. Melnick. You are going to send the 
details of your suggestions to me in writing, aren't you? 
Dr. Walters? 
DR. WALTERS: Up to this point the field of ethics has dealt primarily 
with ethical problems arising from clinical medicine and in research involv- 
ing human subjects. So it is quite a new area for the field of ethics to be 
looking at problems arising in basic research. 
One way of looking at the current proposed guidelines is to compare 
the guidelines with the letter of the committee on recombinant DNA molecules 
published in Science in 1974. There, two kinds of experiments were to be 
deferred — type one, having to do with antibiotic resistance or toxin forma- 
tion, and type two, the use of foreign DNA from oncogenic or other animal 
viruses. 
It seems that what has happened at the Asilomar meeting and now in the 
various versions of the guidelines is that there has been a sifting process, 
and that these two types of experiments have been graded into levels of risk. 
Still deferred are experiments that would form toxins. Secondly, the use of 
foreign DNA from oncogenic or other animal viruses is permitted, but under 
very stringent safeguards. And thirdly, antibiotic resistance: experiments 
involving antibiotic resistance are allowed to go forward under stringent, 
but somewhat less stringent safeguards. 
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