7 
thought either RAC or a RAC working group might effect NIH review, but she 
preferred the concept of prior review by a working group as a working group 
can be more flexible. Dr. Walters agreed with Dr. Gottesman. 
Dr. Nightingale asked if the first recommendation of the Working Group for 
Development of Response made at the June 24, 1983, meeting was being acted 
upon. Ihe recommendation reads as follows: 
"The membership of the RAC be modified to include adequate 
representation to deal credibly with these issues." 
Dr. Milewski replied that it was. She pointed out, however, that members can 
easily be appointed to a working group. 
Dr. Mitchell asked whether meetings of the preposed working group would be 
open to the public. Dr. Gottesman thought these meetings should be open, but 
she felt the working group would be more flexible if their meetings did not 
have to be announced in the Federal Register . She reasoned that RAC would 
offer a recommendation on the proposal, and RAC meetings are open to the public 
and announced in the Federal Register 30 days prior to the meeting. Any 
principles, structures, or questions evolved by a working group could be published 
in the Federal Register prior to the RAC meeting. 
Dr. Littlefield asked how experiments involving use of recombinant DNA tech- 
nology in humans would be forwarded to RAC for review. Dr. Gottesman replied 
that the Guidelines should specify which proposals are to come to the NIH. 
She thought the IRBs or the principal investigators might forward these types 
of proposals to RAC. Dr. Walters asked Ms. Porter if the IRBs would review 
all proposals in this category. Ms. Porter replied that if an institution has 
an Assurance of Compliance (in accordance with 45 CFR 46) with HHS, proposals 
involving human subjects and recombinant DNA must be reviewed by an IRB. 
However, if the institution has no HHS assurance and will not be receiving HHS 
funds for the project, it is conceivable that an IRB would not review this type 
of project. 
Dr. McGarrity asked Dr. Miller to describe the time scale for FDA review of 
proposals of this type. Dr. Miller said the FDA has 30 days to review the 
proposal . Unless the proposed studies are specifically interdicted by FDA the 
investigator can automatically proceed. Dr. Miller pointed out two concerns 
the working group should consider: (1) proposals frequently involve negotiations 
between FDA and the investigator; a working group should be prepared to perform 
these types of negotiations; and (2) questions of confidentiality. He noted 
that the FDA does not even admit to receiving an application in order to protect 
the proprietary interests of the submitter. Dr. Gottesman felt the NIH would 
not deal with questions of confidentiality as she did not feel issues relevant 
to confidentiality would be relevant to the working group. Mr. Mitchell agreed 
saying the first such proposals of this type will not be processed on a "fast 
track. " 
[2231 
