Donald S. Fredrickson, M.D. 
February 16, 1976 
Page 2 
need to make more explicit some statements in the guidelines 
that were implicit in the current version. There may even 
be the desire or need to make some substantive changes, 
or additions, in terms of review procedures to be followed 
both locally and nationally in the implementation of the 
guidelines. Although I stated at the meeting that I felt 
that you should err on the conservative side in the final 
version, I would hasten to add that I believe the persons 
responsible for developing the present guidelines had that 
in mind all along and when there was any reasonable doubt 
as to the right decision they always seemed to be overly 
conservative perhaps and go to more restrictive language. 
As important as it is to build in adequate safeguards at the 
outset, it is equally important to provide a mechanism to 
revise the guidelines, at frequent intervals if necessary, 
to take into account new information and knowledge. In that 
regard I have two specific suggestions: (1) rather than 
have the advisory committee meet "at least annually" as 
stated in the present guidelines, I would suggest meeting 
3-4 times a year. (2) To define as precisely as possible 
many of the risks about which there is such speculation and 
controversy at present, I think the NIH, by contract research 
and/or in-house research, should see that certain critical 
experiments, some of which were described by Dr. Rowert, be 
carried out as soon as possible. 
Although granted it is very much a "gut reaction" I feel 
fairly comfortable that if, indeed, investigators throughout 
the world would adhere to the guidelines as they are finally 
promulgated, there would be minimal chance of something 
going awry. One of my major concerns, probably the major 
concern, is how do we get everyone to play by the same 
ground rules. Frankly, I am not as concerned about our 
highly competitive pharmaceutical firms as I am with 
irresponsible investigators in certain countries where there 
is little or no concern within the government or the public 
regarding the hazards of such research. I do hope that your 
advisory group will give this problem area its most serious 
attention. 
Lastly, I would like to thank you and congratulate you on 
the exemplary manner in which you handled a most difficult 
assignment. May I add that those of us "in the field" are 
much gratified at the sound and vigorous leadership you are 
providing the NIH. 
Si 
Charles C. Sprague, M.D. 
President 
ccs :db 
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