Dr. Gartland 
February 3, 1984 
Page 3 
Q2. Should NIH accept for review only individual proposals funded by NIH 
or only proposals funded by the Federal government ? 
HIMA believes that RAC should continue to review studies voluntarily 
submitted by non-f ederally funded sources. 
As mentioned above, we consider the scientific community to extend 
beyond the confines of federally funded research and see no reason that 
questions raised by industry could not or should not be addressed by RAC. 
Implicit in Dr. Talbot's question No. 2 is whether voluntary compliance 
with the Guidelines by non-f ederally funded entities will continue to be a 
workable option. While NIH cannot compel such compliance, NIH and RAC should 
realize that non-f ederally funded entities will continue to come to RAC and 
to comply with the guidelines since they can secure advice from RAC which is 
unobtainable from any other source. 
Thus we feel that lack of direct NIH control over non-federally funded 
entities is not a valid reason for excluding these entities from RAC's expert 
review. 
Q3. Should all portions of all RAC meetings be open to the public ? 
HIMA believes that if RAC is to continue its important role as a public 
oversight committee, it is essential that RAC be allowed to close portions of 
its meetings to hear proposals containing proprietary information. This 
seemingly paradoxical statement follows from consideration of the alternatives 
to this procedure. Presently there has been an admirable voluntary interaction 
between industry and RAC which has been due, in part, to RAC's agreement not to 
divulge proprietary data. Members of RAC are special governmental employees 
who are bound not to divulge the contents of proprietary submissions. If this 
were not the case and if it were not possible to close portions of the RAC 
meetings, it is most unlikely that industry would be able to seek RAC's advice. 
It should be pointed out that data submissions are usually considered proprietary 
not because they involve any hazard, but because of the real investment of a 
company in what it has discovered and considers to be a marketable idea. 
We believe that both public and private interests are best served by the 
present RAC procedures. 
We are pleased to submit these comments and if further clarification of 
our association's position is desired, please do not hesitate to contact us. 
Sincerely 
Timothy J. Henry, Ph.D. 
Director, Biological Sciences, HIMA 
and Executive Secretary to the 
Biotechnology Committee 
TJH : pjm 
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