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Federal Register / Vol. 50, No. 14 / Tuesday. January 22, 1905 / Notices 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Request 
for Public Comment on "Points to 
Consider In the Design and 
Submission of Human Somatic-Celt 
Gene Therapy Protocols" 
agency: National Institutes of Health. 
PHS, DHHS. 
ACTION: Request for public comment. 
SUMMARY: This notice publishes for 
public comment "Points to Consider in 
the Design and Submission of Human 
Somatic-Cell Gene Therapy Protocols" 
which was prepared by the Working 
Group on Human Gene Therapy of the 
National Institutes of Health (NIH) 
Recombinant DNA Advisory Committee 
(RAC). 
dates: Comments must be received by 
February 21, 1985. 
address: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombinant 
DNA Activities, Building 31, Room 3B10, 
National Institutes of Health. Bethesda. 
Maryland 20205. All comments received 
in timely response to this notice will be 
considered and will be available for 
public inspection in the above office on 
weekdays between the hours of 8:30 
a.m. and 5:00 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Background information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities, Building 
31, Room 3B10, National Institutes of 
Health, Bethesda, Maryland 20205 (301) 
496-6051. 
SUPPLEMENTARY INFORMATION: 
Background 
At its April 11, 1983, meeting, the NIH 
Recombinant DNA Advisory Committee 
(RAC) endorsed a proposal to form a 
working group to comment and report to 
RAC on the "Report on the Social and 
Ethical Issues of Genetic Engineering 
with Human Beings" issued by the 
President's Commission for the Study of 
Ethical Problems in Medicine and 
Biomedical and Behavioral Research. 
The President's Commission began its 
study in September 1980 ir. response to a 
request of the President's Science 
Advisor. Concern had been expressed 
earlier that year by the Nation’s three 
major religious associations that no 
governmental body was “exercising 
adequate oversight or control, nor 
addressing the fundamental ethical 
questions in a major way." The 
Commission’s report, issued in 
November 1982, concluded that 
continuing oversight of the field is 
desirable and suggested that one 
possible oversight mechanism could be 
revising RAC's responsibilities. 
The RAC Working Group for 
Development of Response to President's 
Commission's Report on Social and 
Ethical Issues met at the NIH on June 24. 
1983, and prepared a proposal for 
consideration by the full RAC at its 
September 19, 1983, meeting. 
The working group's primary 
recommendations were that: 
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 DNA technology in humans 
by the Institutional Review Boards 
(IRBs), the Office for Protection from 
Research Risks (OPRR), the Food and 
Drug Administration (FDA), the 
Institutional Biosafety Committees 
(IBCs), the Office of Recombinant DNA 
Activities (ORDA), and the 
Recombinant DNA Advisory Committee 
(RAC). 
3. The NIH Guidelines for Research 
Involving Recombinant DNA 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 were 
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 
would 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 recommendations. The 
RAC Working Group on Social and 
Ethical Issues (formerly called the RAC 
Working Group for Development of 
Response to President's Commissions' 
Report on Social and Ethical Issues) met 
at the NIH on December 13. 1983. The' 
working group requested that the 
following modifications to the 
Guidelines be published for comment 
and be considered by the RAC at its 
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 
IRC Approval Before Initiation, of the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules: 
III— A — 4. Deliberate transfer of recombinant 
DNA or DNA derived from recombinant DNA 
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 proposal should be completed before 
subission to NIH. 
2. Section III— B — 4— b of Section III— B — 4. 
Recombinant DNA Experiments 
Involving Whole Animals or Plants, 
would be footnoted. Section III— B — 4— b 
reads as follows: 
III— B— 4— b. For all experiments involving 
whole animals and plants and not covered by 
III-B-4-a, the appropiate containment will be 
determined by the IBC. 
3. A footnote concerning Section III— 
B-4-b of Section III— B— 4, Recombinant 
DNA Experiments Involving Whole 
Animals of Plants would be added to 
Section V, Footnotes and References of 
Sections 1-lV, as follows: 
For recombinant DNA 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 for 
experiments involving human subjects 
submitted to the RAC. Individuals w*ith 
expertise in basic science, clinical 
medicine, law, and ethics would be 
appointed to the working group. Liaison 
members from the Food and Drug 
Administration and the Office for 
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. 
The working group proposal was 
published in the January 5. 1984, Federal 
Register (49 FR 696). No comments were 
received during the comment period. 
The RAC discussed this proposal at 
its February 6. 1984, meeting. It was 
pointed out that the phrase “or DNA 
derived from recombinant DNA” was 
included in the proposed Section III— A — 4 
to keep coverage under this Section of 
the Guidelines even if the DNA to be 
introduced into the human subject is 
first cleaved from the vector and, 
therefore, no longer "recombinant 
DNA." 
By a vote of fifteen in favor, none 
opposed, and two abstentions, the RAC 
recommended that the changes in the 
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