MASSACHUSETTS INSTITUTE OF TECHNOLOGY 
77 MASSACHUSETTS AVENUE 
CAMBRIDGE, MASSACHUSETTS 02139 
DEPARTMENT OF BIOLOGY March 14, 19 7 8 PHONE: (617) 253-1000 
Room 56-721 
Dr. Wallace P. Rowe 
Laboratory of Viral Diseases 
Bldg. 7, Rm. 304 
National Institutes of Health 
Bethesda, MD 20014 
Dear Wally: 
In the course of my dealings with the Office of Recombinant DNA 
Activities (ORDA) I have become concerned about the way in which that 
office interacts with the active workers in the field. In accord 
with the revision of the guidelines now in progress, I think that 
feedback from the active researchers in the field to -the Recombinant 
DNA Committee might be in order, so that the "Roles and Responsibilitie 
section of the Guidelines might also be updated to maximize research 
efficiency and minimize senseless bureaucracy while still ensuring 
safe practice in the research. What I propose is a meeting of your 
Committee with Biohazard Officers and Principal Investigators at 
universities where recombinant DNA research is actively being pursued. 
Our experience at M.I.T. suggests the following: 
1. The principle of primary oversight by the local biohazard 
committee is being steadily eroded by pre-emption of decision power 
by ORDA. A typical instance is approval by the University Committee 
of a proposal followed by months of delay at N.I.H., leaving the 
researcher in limbo. The power of the local committee to approve 
research is clearly stated in the current Guidelines as written, 
but the ORDA seems to behave as formal approval is required from 
them even for obvious cases and for minor variances such as change 
of vector or protocol. I believe that the local committees should 
be encouraged to take responsibility; if they are robbed of all their 
authority, they will quickly become useless. The precedent of Human 
Experimentation seems a good one - N.I.H. should have ultimate say, 
but the local approval should suffice in the absence of ambiguities. 
2. Off-the-cuff opinions given by people in ORDA are inadver- 
tantly inhabiting research. A good example of this is the yeast 
host situation: instead of going ahead and approving the decision of 
the local committee or seeking a determination from the Committee, 
applications were held up. Only a clever bureaucratic strategem 
[Appendix A — 267] 
