[Federal Register Volume 59, Number 169 (Thursday, September 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21676]
[[Page Unknown]]
[Federal Register: September 1, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Institutes of Health (NIH); Notice of Meeting of Panel
The National Institutes of Health (NIH) Human Embryo Research Panel
is scheduled to meet on Tuesday, September 27, 1994 from 9:30 a.m. to
12:30 p.m. to present publicly a report of its findings and
conclusions. The meeting will be held at the NIH, 9000 Rockville Pike,
Bethesda, Maryland, in Building 31, Conference Room 10. Copies of the
Panel's report will be available to the public at the meeting. The
Panel is a group of special consultants to the Advisory Committee to
the Director (ACD), NIH, established to consider the scientific and
ethical issues raised by research involving the ex utero
preimplantation human embryo resulting from in vitro fertilization or
other sources and to recommend guidelines for Federal funding of such
research.
The September meeting of the Panel continues the NIH effort to
enhance public understanding of the scientific and ethical issues in
this area of research and of the Panel's findings and conclusions with
respect to those issues. It is important to underscore that the Panel's
report is subject to the review and acceptance by the Advisory
Committee to the Director, NIH. The Advisory Committee members will be
reviewing the Panel report during the fall and will consider the
Panel's recommendations at a public meeting in December. After
receiving the advice and recommendations of the Advisory Committee, a
decision will be made by the NIH about which areas of research are
acceptable for Federal funding and guidelines will be formulated to
govern that research. Once the guidelines are issued, the NIH will
continue to monitor developments in this area of research.
Background
Until June 10, 1993, Federal regulations governing research on
human subjects required research involving in vitro fertilization (IVF)
to be reviewed by a Departmental Ethics Advisory Board. The one Ethics
Advisory Board that existed from 1978 to 1980 considered the ethical
issues associated with IVF and embryo transfer and concluded in a
report, after much study, consultation, and deliberation, that IVF is
acceptable from an ethical standpoint as long as certain stipulated
safeguards were followed. No action was taken based on the
recommendations from that report. Because no other Ethics Advisory
Board was chartered after 1980, Federal funding of IVF protocols has
not been possible. This so-called de facto moratorium on IVF research
funding was lifted when Congress included a provision in the NIH
Revitalization Act (Pub. L. 103-43) that rendered legally ineffective
the regulatory requirement for Ethics Advisory Board review. It is the
enactment of this law that now enables the NIH to fund IVF proposals,
as well as research involving human embryos that result from IVF or
other sources.
Although the Congress provided the authority to go forward in this
area, the NIH did not want to proceed without first broadly considering
the moral and ethical questions raised by such research and developing
guidelines for its review and conduct. With the concurrence of the
Assistant Secretary for Health, the NIH established the Human Embryo
Research Panel as a group of special consultants to the Advisory
Committee to the Director, NIH. The Panel is composed of 19 individuals
with broad expertise in the fields of basic and clinical research,
ethics, law, social science, public health, and public policy.
The Panel's charge is to consider various areas of research
involving the ex utero human embryo and provide advice as to those
areas it views to be acceptable for Federal funding, areas that warrant
additional review, and areas that are unacceptable for Federal support.
For those areas of research considered acceptable for Federal funding,
the Panel has been asked to recommend specific guidelines for the
review and conduct of this research. The Panel's charge encompasses
only research involving the extracorporeal human embryo produced by in
vitro fertilization, i.e., in the test tube, or parthenogenesis--a
process whereby activation of an ovum is initiated without sperm.
Research involving in utero human embryos or fetuses is not part of the
Panel's mandate. Guidelines for such research are embodied in current
Department of Health and Human Services regulations (45 CFR Part 46)
governing human subjects research. Research involving germ-line gene
modification also is not within the Panel's scope.
The Panel met five times previously from February through June
1994. During its meetings, all of which have been open to the public,
the Panel examined the wide range of scientific and human health
benefits that could result from governmental support of research
involving the preimplantation ex utero human embryo, and the ethical
issues that should be considered in determining appropriate boundaries
for Federally-funded research in this area. Among the potential
benefits reviewed by the Panel were advances in the understanding and
treatment of infertility, pregnancy loss, birth defects, and the
mechanisms of uncontrolled cell growth that occur in cancer. Other
possible benefits that were considered included the further development
of preimplantation diagnosis of genetic and chromosomal abnormalities,
innovations in contraception, and research on embryonic stem cells that
might in the future lead to therapeutic applications in a broad range
of areas, including bone marrow transplantation, repair of damaged
tissues, and treatment of degenerative diseases of the nervous and
muscular systems.
Among the ethical issues considered by the Panel during its
meetings were competing ethical frameworks with respect to the moral
status of the human embryo; the ethical acceptability of various areas
of research involving the ex utero preimplantation human embryo; the
relevance of any distinctions between research involving ex utero human
embryos that are intended for transfer into humans and research that
does not involve transfer; ethically acceptable sources of human
embryos or eggs; informed consent requirements; concerns regarding the
compensation of gamete providers and commercialization of human gametes
and embryos; and, the need for additional mechanisms for the review,
evaluation, and monitoring of human embryo research at local and/or
national levels.
A critical part of the Panel's process of considering the issues
involved in Federal funding of human embryo research was to gain an
understanding of the diversity of beliefs and opinions held about the
moral status of the human embryo and about Federal funding of research
involving the preimplantation ex utero human embryo. To this end, the
Panel heard 46 oral presentations during Panel meetings and, considered
the views expressed in over 18,000 written comments, letters,
petitions, and postcards received.
Additional Information
The NIH will endeavor to provide seating for all members of the
public who wish to attend the September 27 meeting. Seating in the
meeting room is limited, however. An overflow room will be available so
that the Panel's proceedings can be viewed through closed circuit
television. To help ensure that adequate seating is available for the
public, individuals interested in attending the meeting are asked to
notify the NIH by contacting Ms. Peggy Schnoor at 301-496-1454.
Individuals who require special accommodations also are asked to
contact Ms. Schnoor as is anyone who has a general question about the
meeting.
Dated: August 25, 1994.
Ruth L. Kirschstein,
Deputy Director, NIH.
[FR Doc. 94-21676 Filed 8-31-94; 8:45 am]
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