DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bathesda, Maryland 20205 
January 28, 1982 
Dr. Wllllaa Gartland 
Bldg. 31. Room 4A-S2 
NIH 
Bethesda, HD 20205 
Dear Bill: 
I have studied Che tvo published (Federal Register) proposals for revising 
the NIH Guidelines for Research Involving RecoablnanC DMA and have concluded that 
neither proposal adequately aeets the current situation. This aay be surprising 
since In April of 1981 I wrote to you In support of the Baltlaore-Canpbell pro- 
posal. However, the present version of Chat proposal differs In significant ways 
froa Che original version. In particular, the treataenC of presently prohibited 
ezperlaenCs Is auch aore lalsses-falre In the recent docuiMnt and oalts any re- 
ference Co Che deliberate release Into the envlronaenC of any organism containing 
recoablnanC DMA, a point which, I believe, should be explicitly considered. 
Furthermore, reading Che CoCCesaan proposal emphasised to ae Che value of offering 
Investigators aore detailed advice chan provided by Che very brief contalnsKnt 
recoaaendaClona In Baltlaore-Caapbell. Nevertheless, I do still support the basic 
Idea of the Baltimore -Cambell version, namely, Chat Che Guidelines should at this 
time be advisory rather chan regulatory. 
Aa a result of this analysis I would like to propose a middle ground between 
the two published proposals. This takes Che fora of an advisory set of Guidelines 
based on Che GotCesaan proposal. In other words, the Gottesaan proposal remains 
substantively Intact, but Is put In the fora of recoaaandaClons or real Guidelines, 
rather than regulations. In ay letter of last April I stated why regulations are 
no longer appropriate for recombinant DNA experiments. But I also Indicated why 
a set of standard practices remains useful. My present suggestion Is, I believe, 
consistent with ay earlier arguaents. Not only Is a set of standard practices 
provided, but a fraaework la provided for continued monitoring of chose experiments 
about which soae question remains. 
In order to give an explicit Idea of ay proposal I have gone through the 
Gottesaan version as well as Che present version of part IV of Che existing Guide- 
lines and written In suggested wording. Together, these essentially supply a com- 
plete revision. Copies of these 'corrected' documents are appended. The suggested 
changes will need careful attention should ay proposal be adopted. I am certain 
that I have not been thorough In making all the changes necessary to bring the 
[715J 
