The Joseph and Rose Kennedy 
Georgetown University 
Institute lot the Study 
Washington. D C. 
o( Human Reproduction 
20057 
and Bioethics 
202. 625-2371 
Donald 5. Frederickson , M.D. 
Director, National Institutes of Health 
Bethesda, Maryland 20014 
October 11, 1977 
Dear Dr. Frederickson: 
Thank you for sending a copy of the proposed revisions of the 
NIH Guidelines on Recombinant DNA Research, as published in the 
Federal Register on Tuesday, September 27, 1977. 
I note that in the introduction to the revised Guidelines, you 
mention a December 1977 Director's Advisory Committee meeting, at 
which all comments on the proposed revisions will be discussed. The 
introduction leaves open the question whether, as in February of 
1976, the Director's Advisory Committee will be augmented by the 
appointment of additional ad hoc members and whether there will be an 
opportunity for oral public comment at the December meeting. 
I write to urge that representatives of contrasting points of 
view be included to the greatest feasible extent at the December 
meeting. There are three reasons for my making this recommendation. 
First, the breadth of representation at the February 1976 Director's 
Advisory Committee was perhaps the decisive factor in establishing 
the legitimacy of the initial set of NTH Guidelines on Recombinant 
DNA Research released in June of last year. 
Second, until now members of the public and critics of recombinant 
DNA research have not been invited to comment on proposed revisions 
of the Guidelines; indeed many well-informed persons have probably 
been unaware that the revision-process was in progress. To them, the 
chance to submit written comments within a maxi man of 60 days may seem 
like an inadequate opportunity to participate in a policymaking process 
of great national and international significance. 
Third, a review in December which includes public hearings nay 
have the important benefit of encouraging thoroughgoing, constructive 
criticism of the revised Guidelines and is unlikely to produce sensation- 
alistic fallout. I base this rather sanguine judgment on our experience 
at the February 1976 meeting (at which a large audience followed a 
technical discussion intently) and on the experience of the National 
Commission, which has held lively but instructive public hearings an 
such vo l a ti le topics as fetal research and psychosurgery. 
[Appendix A — 7] 
