MEMORANDUM 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 
PUBUC HEALTH SERVICE 
NATIONAL miTTTUTU OT HEALTH 
TO 
FROM 
iDlrecCor, Office of Recombinant DNA Activities 
National Institutes of Health 
Building 31, Room AA52 
Bethesda, MD 20205 
Thru: Director, NIDR/ Chief, 
:Bruce M. Chassy, LMI/N^^^ Q 
DATE: January 20, 1982 
SUBJECT: Proposed revisions of NIH guidelines for research Involving recombinant DNA. 
A careful review of the proposals described In the December 4th and December 7 th 
Federal Registers has resulted In a distinct preference for the proposal described 
In the Dec. 4 Register. The major advantages seem to be: 
1. The voluntary nature of the new guidelines. The past few years have 
demonstrated the research communities' awareness of potential biohazards 
and willingness to adhere to guidelines. Notice Is taken of the virtual 
unenforceablllty of mandatory guidelines; guidelines, to be effective, rely 
on ethical compliance, whether voluntary or mandatory. 
2. The downgrading of certain experiments from P. and P. to P^ containment 
levels seems justified by the vast experience gained with recombinant DNA 
since the original guidelines were developed. 
3. The principle of prior review should be abandoned. It Is needlessly 
expensive and time-consuming given a properly designed set of guidelines. 
4. Both prior review and the mandatory nature of the guidelines have 
required NIH to act as a Regulatory body. The Institute has responded 
very well and has established a clear course and policy that makes It 
unneccessary to require further direct control by NIH. 
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