178 
Now it is time for the committee members to respond to my earliest sug- 
gestion — that is, that I would like to gain from them in brief terms a sense 
of their comprehension of the nature of the experiments and risk-benefit 
assessments, and what judgments, if any, they have arrived at after hearing 
all sides of the issue as presented. Your response to the proposed proce- 
dural mechanisms for implementation and monitoring the guidelines are also 
important. We have had less discussion of this that we have had of other 
issues . 
Now, before asking for your comments, I would like to review some pos- 
sible steps in how we will proceed from this meeting. I would like to 
remind all of you that there will be no vote taken. This committee is ad- 
visory to the Director, and it is from the comments of the committee as 
well as the entire record that that decision must be made. 
Let me, in very non-legal terms, explain briefly the nature of guide- 
lines and what may follow from them. 
Mr. Riseberg of the General Counsel's Office is here to amplify or an- 
swer further questions, and I know that several members of the committee, 
particularly Mr. Hutt and perhaps Judge Bazelon, will in their own comments 
clarify much of what I am about to say. But basically we are here today to 
discuss guidelines which are to determine how certain research which is 
funded by the National Institutes of Health should be carried out — the basis 
of which we would expect to award grants and to continue support for such 
research. 
Guidelines in general have little legal standing. Their enforcement is 
really up to the instituion and to the NIH, and they usually are followed 
by a manual issuance. That is, when the guidelines have been agreed upon, 
a manual is issued indicating what the guidelines are. These, then, also 
have limited legal standing in the usual case. 
What, then, can follow the issuance of a manual? Well, there are two 
possibilities. One is that we can then put the guidelines referenced in the 
manual as a notice for the Federal Register . The guidelines here are pre- 
ferred as a draft working document. This is an optional first step in de- 
veloping regulations, and it allows the public opportunity to comment before 
guidelines might be proferred as a notice of proposed rulemaking. 
The notice of proposed rulemaking is a step which can be taken after 
the manual issuance, and it can bypass the notice for the Federal Register , 
which is a more leisurely period for the development of further comment and 
experience with reference to the guidelines that have initially been 
approved. 
Now, the notice of proposed rulemaking has definite legal standing, 
and again, it offers an opportunity for comments by the public before those 
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