Dr. DeWitt Stetten 
April 16, 1976 
Page 2 
I consider that the staff proposals for a replacement of section four 
were basically sound (although they could be simplified here and 
there), and disagree with the Committee's view that the local 
institutional role should be limited to advice and certification that 
appropriate facilities are available. Local involvement and over- 
seeing seems to me to be as essential in regard to recombinant DNA 
work as it is in the control of fire, chemical or radiological 
hazards or in the case of human experimentation. I believe that 
there must be continuing onsight appraisal by individuals other 
than the principal investigator not only of the suitability of 
facilities and training of personnel conducting the experiments 
but, in particular, to insure that the precautions that apply to a 
particular experiment are actually in use. The institution as the 
employer or sponsor of the investigator has, I believe, a legal and 
moral responsibility to concern itself with the nature and control 
of any potentially hazardous activity, and this is no exception, 
Actually, we are obligated in this state to play an active role 
under the requirements of the Washington Industrial Safety and 
Health Act, let alone under the requirements of OSHA, 
I have had some experience with another situation which involves the 
control of real or potential dangers and the need for the application 
of strict rules and standards of containment. This is the question of 
the control of hospital infections. All the experience gained over 
the last couple of decades or so indicates that to expect the problem 
to be controlled simply by requiring the application of particular 
isolation and other techniques by physicians and nurses is unrealistic 
and doesn't work. There are endless opportunities for differences in 
judgment and rationalizations, and it has been found essential for an 
institution to have an active infections committee and an epidemiologist 
with considerable authority if procedures are to be maintained and 
nosocomial infections kept down to acceptable limits. I believe there 
are parallels here with what is likely to be found in the application 
of the guidelines. 
I realize that there are many who would regard these views as applying 
excessive infringements on academic freedom and opening the door to 
local uninformed bureaucratic interference with the initiation and 
performance of important experiments. Should these views prevail, 
I urge that an investigation be undertaken to determine the degree 
of operational conformity to the guidelines as experiments begin to 
be undertaken around the country on a large scale. This should involve 
spot checks without advance notice by appropriately qualified NIH 
staff or advisors so that the level of confaga i ty -to the guidelines can 
be determined and data derived for any moidincation or further action 
that may be needed in the future. ( r — ^ 
Sincerely yours, 
John t^^^eVriivfttlJr\ 
Professor and Chairman 1 
JCS/smb 
[ 529 ] 
