Dr. D. Frederickson 
- 2 - 
April 14, 1978 
Protection from Research Risks (OPRR) exercises surveillance over local 
committees but does not itself approve individual protocols. This process 
of strong reliance upon local review has been endorsed by the National 
Commission for Protection of Human Subjects of Biomedical and Behavioral 
Research . 
We would like to recommend that the procedural mechanism for monitoring 
and approving recombinant DNA experiments should be delegated to individual 
institutional Biosafety committees, just as the authority for human research 
and radioisotope use is delegated. This would allow administration of 
federally-funded projects by the Same method as non-federally-funded projects, 
i.e., ensure that physical and biological containment levels proposed by 
investigators are accurate and that the vectors and host cells to be used 
are certified. At that point local approval should be sufficient for 
experiments to proceed forthwith. 
At present the requirement to send MUAs to Washington for every experiment 
involving recombinant DNA involves two to six months delay from the conception 
of the experiment to receiving approval to execute it. With the requirement 
for annual update of an MUA this means that some investigators will lose a 
quarter to a half of each year waiting for a response from ORDA. The suggestion 
to delegate real authority on individual MUAs to local committee would make 
the Washington Office of Recombinant DNA Activities into one involved with 
setting national policy, certification of approved vectors and host cells, and 
other national issues pertinent to recombinant DNA. It could also monitor 
the record of local committees to ascertain compliance with the appropriate 
regulations and guidelines. 
Specific points at which we wish to raise criticism of the procedures 
set out in the NIH Guide for Grants and Contracts are as follows ; 
Page 8 , part 4 - approval of MUAs : It is stated that the local committee 
only produces a proposed MUA and that recombxiant DNA research is not funded 
until MUAs are approved by NIH. This centralizes the system and runs contrary 
to the concept of peer review and of delegation of authority for self- 
regulation. It puts undue power into the centralized system by which 
individual experiments are approved by a small number of people in Washington. 
We see no reason why individual institutional Biosafety committees should not 
have the power to approve MUAs consistent with the guidelines set by NIH. 
The need for centralized approval runs contrary to both the spirit of 
scientific research and to policies of NIH. 
Page 9, footnotes 1, 2, and 3 : If local Committees are expected to 
control the expenditure of funds as prescribed by these footnotes to grant 
awards according to approved MUAs an expensive monitoring system would be 
required to correlate expenditures on each biological and chemical item 
to approved MUAs, Also, these footnotes imply that it should be possible 
to identify those reagents which are used for recombinant DNA and those 
which are not, The implications of these footnotes are quite unrealistic, 
especially when investigators have multiple grants and the definition of each 
type of expenditure and its correlation with MUAs requires a purchasing system 
wchich this and other institutions do not possess. 
[Appendix A — 277] 
