-3- 
the Guidelines. The institutional Biohazards Committees and the Biological 
Safety Officers shall assure, among other things, that the laboratory 
safety procedures are rigorously followed. There is an implication that 
the staff of the NIH has a responsibility to ensure that all NIH-funded 
research conform to the Guidelines: It is indicated that a major factor 
contributing to the expectation that the Guidelines will be followed is 
"the fact that non-compliance will result in termination of funding." 
Other factors, such as peer pressure and publication review, will contrib- 
ute to the general expectation that there will be compliance. 
There are many specific questions concerning the procedures which will 
be followed by the staff and Director of the NIH in carrying out their re- 
sponsibilities. This is particularly true with respect to possible NIH 
monitoring of compliance and/or termination of funding. The general public 
and the scientific community should know in advance (a) who could bring 
charges of non-compliance, (b) how charges of non-compliance would be evalu- 
ated, (c) what opportunities the Principal Investigator and his institution 
would have to defend themselves against such charges, and (d) what proce- 
dures would be followed before termination of funding or other penalties 
are invoked. 
5. Risk-Assessment Studies ; We are generally concerned with the 
problem of conducting risk-assessment studies under the present strictures 
stated in the Guidelines. For example, how can experiments devised to 
increase our knowledge of risk be undertaken when such experiments are 
specifically forbidden under the Guidelines and may even be subject to 
legal strictures? We suggest that the Director of the NIH consider plans 
whereby risk-assessment experiments can be appropriately designed and 
carried out, and to consider the specific characteristics of control and 
containment under which such information can be safely obtained. 
[Appendix A — 126] 
