22 
(2) Section III-B-4-b of Section III-B-4, Itecorobinant ENA Experiments 
imals or Plants , would be footnoted. Section 
"III-B-4-b. For all experiments involving whole animals and 
plants and not covered by III-B-4-a, the appropriate contain- 
ment will be determined by the IBC." 
(3) A footnote concerning Section III-B-4-b of Section III-B-4, 
Reoombinant ENA Experiments Involving Whole Animals or Plants would 
be added to Section V, Footnotes and Reference of Sections I~IV , 
as follows: 
"For recombinant ENA experiments involving human subjects, 
see Section III-A-4." 
In addition, the Working Group on Social and Ethical Issues suggested that 
a working group composed of 9 members (including Chair) be formed to 
conduct initial review of proposals submitted to the RAC. Individuals 
with expertise in basic science, clinical medicine, law, and ethics would 
be appointed to the working group. Liaison members from the FDA and the 
Office of Protection from Research Risks would also be appointed. The 
working group might use as resource material reports such as "Splicing 
Life" prepared by the President's Commission for the Study of Ethical 
Problems in Medicine and Biomedical and Behavioral Research. 
Dr. Walters said the phrase "or DNA derived from recombinant DNA" was 
included in the proposed Section III-A-4 to keep coverage under this sec- 
tion of the Guidelines even if the DNA to be introduced into the human 
subject is first cleaved from the vector and, therefore, no longer "recom- 
binant DNA." Dr. Walters said the working group supports the concept that 
meetings dealing with these proposals be open to the public. No detailed 
list of guidelines or regulations would be developed for these proposals; 
rather specific proposals would be reviewed on a case-by-case basis. 
Dr. McGarrity reviewed for RAC some additional discussion points of the 
working group. He pointed out that the mission of IRBs is to protect the 
human subject; the IRB does not consider long term effects of the proposed 
experiments on society. Dr. McGarrity said FDA has statutory responsi- 
bilities in the area of administration of drugs and biologies to human sub- 
jects. Mr.. Max Marsh of Eli Lilly and Company explained that under FDA 
procedures, if the investigator does not receive a reply from FDA within 
thirty days he may proceed. If FDA has any questions about the proposal, 
they may prolong the review period indefinitely. He added that IRBs operate 
under strict rules of conf Identiality in order to protect the patient's 
rights. Dr. McGarrity added that other aspects of the new genetics which 
may have societal impacts such as in vitro fertilization are not reviewed 
by RAC under its charter. Dr. McGarrity moved that the proposed language 
for revision of the Guidelines developed by the Working Group on Social 
and Ethical Issues be accepted by the RAC. 
follows: 
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