osu 
The Ohio State University 
Graduate School 
University Hall 
230 North Oval Mall 
Columbus, Ohio 43210 
21 September 1978 
Phone 614 422-6031 
Donald S. Fredrickson, Director 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
We wish to respond to proposed revised guidelines for recombinant DNA 
research as published in the Federal Register , Vol. 43, No. 146, July 28, 
1978. 
The proposed revised guidelines are viewed on this campus as a reasonable 
relaxation of current guidelines brought about by the failure to demonstrate 
the hazards that have been improperly attributed to experiments involving 
recombinant DNA. Tangible results will be felt at The Ohio State University 
should the proposed revision advance to final promulgation. Several experi- 
ments now conducted at lower levels of containment will be exempt from guide- 
lines, and the containment level for one project will drop from P3 to P2. Thus, 
for at least one group of researchers, the requirements for regulation and 
monitoring would decline and no new facilities would be needed to conduct any 
of the research they propose with recombinant DNA. We applaud NIH for its con- 
tinuing evaluation of the need for the close surveillance affiliated with re- 
combinant DNA research and urge on-going consideration for further reductions 
in regulation and containment levels. 
While we accept the need for NIH to maintain a registry of NIH-supported 
recombinant DNA research via the filing of Memoranda of Understanding and Agree- 
ment (MUA) , we question the need to extend the registration process to non-NIH 
projects, especially at the PI and P2 level. It is not clear that there need be 
the kind of monitoring of recombinant DNA research at lower hazard levels that would 
include the submission of a non-NIH MUA to NIH, review by ORDA and follow-up with 
the submitting institution should a protocol for non-NIH supported activities not 
conform to standards contained in the proposed revised guidelines. 
A more acceptable approach would be to develop an institutional assurance 
program, of the kind used by DHEW for research involving human subjects, one 
component of which would be that institutions qualifying for a "general RDNA 
assurance" would review, administer and monitor all research involving recombinant 
DNA according to NIH standards articulated in the proposed revised guidelines. 
MUA's would be forwarded to NIH for federally funded projects and perhaps for 
activities at the P4 containment level supported by non-federal sponsors. Records 
of Institutional Biosafety Committees (IBC) would be available for periodic in- 
spection by NIH as a method for insuring IBC compliance with terms of general 
RDNA assurances. Institutions unwilling or unable to qualify for general assur- 
ances would be required to submit information to NIH for all research activities 
involving recombinant DNA as described in the proposed revised guidelines. 
[A-224] 
