Dr. Donald Fredrickson 
3 
January 19, 1978 
Apropos of forbidden experiments, the provisions in the 
Revised Guidelines permitting certain of these experiments to be 
performed for the purpose of risk assessment are excellent. They 
eliminate the intolerable situation in which experiments thought 
to be dangerous were not permitted to be performed by anyone to 
ascertain whether in fact they were dangerous. Furthermore, you 
should exercise this discretionary power to launch a program of 
risk assessment experiments. 
In short, the Revised Guidelines must contain not only a well 
articulated theoretical base, but a device enabling you to test the 
assumptions undergirding this base. 
Roles and Responsibilities 
The assignment of primary enforcement responsibility to in- 
stitutional or area-wide biohazards committees is clearly the best 
of the alternatives which I have heard discussed. Of particular note 
in this connection, are the portions of the Revised Guidelines which 
suggest that these committees should have members who are not 
scientists. As long as these are suggestions, I would recommend 
that some language be included encouraging these other members be 
drawn not only from the local community, but chosen after consulta- 
tion with the municipal governing authority. These authorities have 
the ultimate responsibility for public health and safety, and those 
who serve on these authorities must be comfortable about what is being 
approved by the institutional biohazard's committees. Indeed, the 
appointment of someone like a public health officer, who is responsible 
to the local governing authority, ought also to contribute sub- 
stantially to enhancing the quality of the communication between the 
researchers and the municipal governors. 
As I have said much about communication with the public earlier, 
I will only add here that this subject would be the worthy object of 
an NIH sponsored conference. Keeping members of the public accurately 
advised about scientific developments is a problem that will not go 
away and which cannot be solved by the ordinary newspaper and 
magazine coverage. 
Finally, on the subject of institutional biohazard committees, 
I wish to note that no discussion of enforcement is complete without 
mentioning sanctions. While the notion that scientists should be 
liable to pay huge fines for negligent violations of these guidelines 
is deplorable, there is no doubt that sanctions must be available. 
For NIH Grantees the withdrawal of grant funds ought to be a signifi- 
cant disincentive. Another would be the inability to publish the 
results of inappropriately conducted research in reputable journals. 
These penalties, implying the opprobrium of their peers, will always 
be coupled with the fear of legal liability for negligent conduct 
which causes harm to others. Taken together, this structure of 
sanctions makes the consequences of flagrant disobedience to the re- 
quirements of the guidelines an unattractive prospect. 
[Appendix A — 220] 
