[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]
BILLING CODE 4140-01-P