3 
responsibilities without some form of IBC. I understand from the 
first NIH meeting of the IBC Chairmen that many IBC's had taken 
responsibility of the whole range of biohazard problems In those 
Institutions, and did not restrict themselves merely to recombinant 
DMA. I think that the existence of IBC's should be encouraged by 
the National Institutes of Health, and that the proposal to delete 
a requirement for them Is too negative. 
The process we use for our Guidelines Is to have a 
simple statement with each grant application covered by the guide- 
lines that the IBC has checked the faclllt’les, and found them con- 
sistent with the proposed work. The Grants Connlttees and. If 
necessary, MRC staff, can comment on these. We have no prior 
authorization on an experiment by experiment basls(Apart from case- 
by-case one^. The rest Is up to the IBC and the Investigator, thus 
putting primary responsibility where It should be. 
3. Legal Effect of Guidelines 
The issue here is voluntary or compulsory. 
The problem In a voluntary approach Is that It negates 
the likely result in the event of harm resulting from a laboratory 
accident where the research program receives NIH support but was not 
In compliance with NIH guidelines. A court would probably find fault 
with the Investigator and Institution because they did not adhere to 
a nationally recommended standard, compulsory or not, and might state 
that NIH did not act responsibly In not receiving assurance that Its 
funds would be used In accord with Its own guidelines. Parallels 
with human experimentation and the use of animals are cbvlous. 
If the guidelines reflect a national approach to safety 
In the face of reasonably anticipated hazard, then why not express 
confidence In that ludgement by requiring compliance as a condition 
of use of NTH funds: Other funding agencies can do what they like. 
The alleviation of bureaucratic nonsense Is a matter at least as much 
of the procedures used as It is of the compulsory or voluntary nature 
of the NIH guidelines, which. In the last analysis, are likely to be 
seen as the national standards. 
I look forward to hearing the results of the debate 
on February 8-9. 
Best regards. 
Francis Rolleston 
Director, Special Programs 
FSR/ct 
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