Hagedorn Research Laboratory 
Niels Steensensvej 6 • DK-2820 Gentofte, Denmark • Tel. (1) 68 08 60 
Janxxary 25 , 1982 
Director 
Office of Reoanbinant DNA activities 
National Institutes of Health 
Building 31/ Rdcti 4A52 
Bethesda 
Maryland 20205 
U.S.A. 
Subject; Proposed Revision of NIH Guidelines for Research Involving 
Reconbinant DNA Molecules 
Ihe revisions suggested by the Reocribinant ENA Advisory Ccranittee (RAC) 
vrith respect to siitplifying the oontainment levels ^jpear sound and 
advisable. We also agree that the Guidelines are most suitable as a 
standard for proper laboratory vrork. 
It wsuld/ however/ not be sensible to abandon the practice of having 
an Institutional Biosafety Catmittee (IBC) or an Institutional Review 
Board (IRB) made mandatory. Althou^ Recombinant ENA research in the 
US is well advance it still has a lower volrrae in Europe. The respon- 
sibilil^ of the scientists to ke^ the public infonoed and the sharing 
of responsibility for their activities would be best served by enforc- 
ing institutions to register planned eaqaeriments with the IRB/IBC. 
It is likely that slirply a revision of the guidelines will not alter 
the public opinion about Recombinant ENA activities. We believe that 
this aspect has not been properly dealt with in the revised guidelines/ 
especially from the point of view that the NIH decision will certainly 
be guiding decisions in countries j\ast noW/ perhaps less critically/ 
entering this field of research. 
It IS our intention to report planned Recombinant ENA experiments to 
the IRB of the foundation Nordisk Insul ini aboratorium. 
[694] 
