Recombinant DNA Advisory Committee - 01/14/93 
Ms. Buc said that she is confident that the NIH Director will adopt the policy that she 
has proposed. 
Dr. Parkman said that under the proposed policy, the only circumstance in which a 
protocol would be reviewed outside of the RAC is when there are time constraints that 
do not permit the normal review process. Therefore, the question is: who will review - 
the protocol? Assuming that these requests are not too numerous, the NIH Director 
could choose to use RAC members as reviewers of these protocols rather than NIH staff. 
Using RAC members as reviewers would introduce consistency in the review process. 
Ms. Meyers proposed an amendment to the motion. Upon announcement of this policy, 
the NIH Director will consult (if at all possible, both legally and practically) with current, 
former, and possible future members of the RAC. 
Dr. Parkman said that one of the issues that could arise is the appropriateness of a 
protocol. There will be some protocols that, by the nature of the subject matter, are 
really not appropriate for expedited review. These decisions should closely tie to the 
procedures in effect at the IRB level. 
Ms. Buc restated the amendment. The amendment is that the RAC recommends to the 
NIH Director that when this policy is announced, the Director will announce her 
intention to consult (to the extent legally and practically feasible) with the members of 
the RAC and others who can shed scientific, ethical, and legal guidance on the issue in a 
rapid manner. Dr. Moskowitz noted that this amendment is almost identical to the 
interim policy created by Dr. Healy and reminded the RAC that an attempt was made to 
contact Dr. Walters regarding Dr. Royston's approval. Dr. Parkman reminded Dr. 
Moskowitz that an attempt had been made to notify Dr. Walters that the decision had 
already been made, not to seek advice. 
Dr. Carmen inquired about the legal standing of any vote that is taken by the RAC 
today. Dr. Walters responded that a quorum vote would be in favor of policy 
recommendation, which would go forward to the NIH Director. 
In response to concerns raised by Dr. Carmen, Ms. Buc amended the policy statement 
that the NIH Director will take into account, among other factors, the degree of 
consanguinity to previously approved protocols. The further away the protocol is from a 
previously approved protocol, the greater the likelihood that it should be brought before 
the full RAC. 
Dr. Carmen stated that the various reasons grounded in administrative law put forward 
by Dr. Healy's staff to support her decision to bypass RAC review in approving Dr. 
Royston's petition for expedited consideration were inadequate to sustain her disposition 
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