35 
Dr. Cavalieri’s concern also focused upon the perception that time is 
of the essence in moving on into DNA recombinant research. He 
suggested that a more thoughtful consideration of the long-range 
implications of this area of research might produce a more conserva- 
tive attitude about its value. He referred to the problems which he 
thinks were produced by a precipitous rush into research and develop- 
ment in the field of the nuclear sciences. In this regard, he reempha- 
sized his belief that there is a need for a significant change in the atti- 
tude of scientists about their social responsibilities. 
Dr. Char ache 
Critics of the scientists who developed the guidelines have had a 
number of objections to the technical writing process. One criticism 
which has been voiced frequently is that there was a failure to include 
individuals with long experience with epidemiology, the study of 
infectious disease, or with the conduct of work within a hospital 
laboratory working with infectious organisms In order to gain the 
points of view of such individuals, the subcommittee asked Patricia 
Charache, Johns Hopkins University Hospital and Samuel Formal, 
Chief, Department of Bacterial Disease, Walter Reed Army In- 
stitute of Research to discuss the risks which they envision with 
regard to DNA recombinant research. 
Dr. Charache is a member of a Biohazards Safety Committee which 
has the responsibility for the safety of DNA research at Johns Hop- 
kins. Before commenting on the specific issue of DNA recombinant 
research, Dr. Charache pointed out that bacteria differ in the degree 
of hazard posed in working with them. Some infect directly, others 
produce toxic substances which may poison an individual. As she 
pointed out, the NIH guidelines are predicated upon a knowledge 
of these differences in hazard and prescribe either a prohibition of 
recombinant molecule research with certain types or require varying 
degrees of biological and physical containment. Dr. Charache men- 
tioned as pertinent to the evaluation of risk the fact that the condition 
of the person at the time of exposure may determine the reaction to 
the infection. It is for this reason that the guidelines caution against 
the conduct of research with recombinant molecules by individuals 
who are on antibiotic therapy, for example. 
Dr. Charache also pointed out that the prescription of genetic recom- 
binant standards for experimental organisms is not new and that long 
ago it had been determmed that semipurified DNA could pass genetic 
characteristics between organisms. At that same time, experimenters 
had learned to use genetic markers to insure safety. It was recognized 
that bacteria exchanged genetic information under natural conditions 
including the transfer of antibiotic resistance traits. At Johns Hopkins, 
about 20 DNA recombinant molecule research projects have been 
reviewed thus far. All proposals are reviewed annually or more fre- 
quently if changes are proposed. The guidelines have been implemented 
without difficulty and their committee considers work with E. coli to 
be a relatively nonhazardous task. They currently have six labora- 
tories doing this type of research and have the capability to conduct 
investigations requiring P3 levels of confinement. 
[Appendix B — 84] 
