Page Two 
Letter to Dr. Fredrickson 
concerning risks, the ability to destroy or contain altered genes, as well as encouraging 
the further development of safer vector/host systems. 
4) A communication system must be established worldwide that will permit almost 
instantaneous alerting in the event of experimental misadventure, the intent being to prevent 
repetition, as well as to bring all minds to bear on developing a solution to the problem created 
5) All individuals involved in this variety of experimentation must understand the 
dangers of that involvement. Informed consent is essential, particularly as it relates to 
individuals of less than scientific background who through ignorance may not understand 
the gravity of their working conditions. 
6) An appropriate Appellate Mechanism must be established to allow for individual 
requests for variances from established guidelines. The granting authority, however, must 
be broadly representative of knowledgeable peers in genetic engineering and any decision 
to grant a variance should be a unanimous opinion of all members of the granting council. 
Variances should apply only to a single individual and not an entire laboratory or system, 
and should be public knowledge to all investigators so that they are aware of who is doing what 
7) There must be an ascending pyramid of review and comment on policy, planning 
and implementation with both local and national involvement. The review must be on a 
consumer, as well as scientific level. It is essential that control of the scientific process 
remain within the fraternity of investigators and they must act always in the best interest 
of the public, less the Congress mandate that review authority be delegated elsewhere. 
8) Probably the most important issue is that of appropriate control to prevent 
intentional abuse of this newly discovered power. I feel it is essential that a governmental 
mandate authorize control, within this nation, to a council of superscientists of many 
disciplines within the genetic engineering spectrum. There must be provision for full 
disclosure to this group of the types of ongoing experimentation, as well as for unannounced 
peer sight surveys and inspection with the explicit intent of ensuring compliance. There 
must be a deterrent gradation of sanctions, quantified with a degree of safety breach, and 
applied to all parties concerned, including, but not necessarily limited to, the primary 
investigator, his associates and the involved institution. 
This, then, concludes my observations concerning the proposed guidelines for 
Recombinant DNA Research. May I again thank you for the opportunity of participating in 
a meeting that mentally stimulated me far beyond any that I have been associated with in 
recent years. 
erely. 
oseph J . Dodels, M.D. 
Member, Advisory Committee to the Director 
National Institutes of Health 
JJD/jc 
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