21 
(1) the membership of the RAC be modified to include adequate 
representation to deal credibly with these issues; 
(2) procedures should be developed for the coordinate consideration of 
experiments involving the use of recombinant ENA technology in 
humans by Institutional Review Boards (IRBs) , the Office of Protec- 
tion from Research Risks (OPRR) , the Pood and Drug Aininistration 
(FE&), Institutional Biosafety Committees (EBCs) , the Office of 
Recombinant ENA Activities (ORDA) , and the Reconbinant ENA Advisory 
Ccnmittee (RAC); and 
(3) the NIH Guidelines for Research Involving Recombinant ENA Molecules 
should be reviewed for their adequacy and clarity in dealing with 
human experimentation. 
The RAC discussed this proposal at its September 19, 1983, meeting. It was 
noted that the recommendations are based on several premises. These are: 
(1) there is currently no other national body that deals with ethical 
issues in the biomedical field; 
(2) RAC's expertise could be supplemented by adding experts in the 
ethical issues of using human subjects; and 
(3) RAC would review proposals on a case-by-case basis in response to 
investigator- initiated research. RAC's review would supplement 
review by IBCs and IRBs . 
The RAC unanimously accepted the working group's recommendation. Questions 
such as vhether the language of the Guidelines as currently written is 
adequate or how the review procedure would function were to be discussed 
at subsequent meetings of the working group. 
The Working Group on Social and Ethical Issues (formerly the Working Group 
for Development of Response to President's Commission's Report on Ethical 
and Social Issues) met at the NIH on December 13, 1983. The working group 
requested that the following modifications to the Guidelines be published 
for Garment and be considered by the RAC at their February 1984 meeting. 
(1) A new Section III-A-4 would be added to Section III-A, Experiments 
that Require RAC Review and NIH and IBC Approval Before Initiation , 
of the Guidelines: 
"III-A-4* Deliberate transfer of recombinant ENA or ENA derived 
from recombinant ENA into human subjects. The requirement for 
RAC review should not be considered to preempt any other required 
review of experiments with human subjects. IRB review of the 
proposed should be completed before submission to NIH." 
[266] 
