[Federal Register Volume 74, Number 77 (Thursday, April 23, 2009)]
[Notices]
[Pages 18578-18580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft National Institutes of Health Guidelines for Human Stem 
Cell Research Notice

SUMMARY: The National Institutes of Health (NIH) is requesting public 
comment on draft guidelines entitled ``National Institutes of Health 
Guidelines for Human Stem Cell Research'' (Guidelines).
    The purpose of these draft Guidelines is to implement Executive 
Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-
funded research, to establish policy and procedures under which NIH 
will fund research in this area, and to help ensure that NIH-funded 
research in this area is ethically responsible, scientifically worthy, 
and conducted in accordance with applicable law. Internal NIH 
procedures, consistent with Executive Order 13505 and these Guidelines, 
will govern the conduct of intramural NIH research involving human stem 
cells.
    These draft Guidelines would allow funding for research using human 
embryonic stem cells that were derived from embryos created by in vitro 
fertilization (IVF) for reproductive purposes and were no longer needed 
for that purpose. Funding will continue to be allowed for human stem 
cell research using adult stem cells and induced pluripotent stem 
cells. Specifically, these Guidelines describe the conditions and 
informed consent procedures that would have been required during the 
derivation of human embryonic stem cells for research using these cells 
to be funded by the NIH. NIH funding for research using human embryonic 
stem cells derived from other sources, including somatic cell nuclear 
transfer, parthenogenesis, and/or IVF embryos created for research 
purposes, is not allowed under these Guidelines.
    NIH funding of the derivation of stem cells from human embryos is 
prohibited by the annual appropriations ban on funding of human embryo 
research (Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/
09), otherwise known as the Dickey-Wicker Amendment.
    According to these Guidelines, there are some uses of human 
embryonic stem cells and human induced pluripotent stem cells that, 
although those cells may come from allowable sources, are nevertheless 
ineligible for NIH funding.
    For questions regarding ongoing NIH-funded research involving human 
embryonic stem cells, as well as pending applications and those 
submitted prior to the issuance of Final Guidelines, see the NIH Guide 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-085.html.

DATES: Written comments must be received by NIH on or before May 26, 
2009.

ADDRESSES: The NIH welcomes public comment on the draft Guidelines set 
forth below. Comments may be entered at: http://nihoerextra.nih.gov/stem_cells/add.htm. Comments may also be mailed to: NIH Stem Cell 
Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland 20892-
7997. Comments will be made publicly available, including any 
personally identifiable or confidential business information they 
contain.

SUPPLEMENTARY INFORMATION: On March 9, 2009, President Barack H. Obama 
issued Executive Order 13505: Removing Barriers to Responsible 
Scientific Research Involving Human Stem Cells. The Executive Order 
states that the Secretary of Health and Human Services, through the 
Director of NIH, may support and conduct responsible, scientifically 
worthy human stem cell research, including human embryonic stem cell 
research, to the extent permitted by law.
    The purpose of these draft Guidelines is to implement Executive 
Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-
funded research, to establish policy and procedures under which NIH 
will fund research in this area, and to help ensure that NIH-funded 
research in this area is ethically responsible, scientifically worthy, 
and conducted in accordance with applicable law. Internal NIH 
procedures, consistent with Executive Order 13505 and these Guidelines, 
will govern the conduct of intramural NIH research involving human stem 
cells.
    Long-standing Department of Health and Human Services regulations 
for Protection of Human Subjects, 45 CFR part 46, establish safeguards 
for individuals who are the sources of many human tissues used in 
research, including non-embryonic human adult stem cells and human 
induced pluripotent stem cells. When research involving human adult 
stem cells or induced pluripotent stem cells constitutes human subject 
research, Institutional Review Board review may be required and 
informed consent may need to be obtained per the requirements detailed 
in 45 CFR part 46. Applicants should consult http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
    As described in these draft Guidelines, human embryonic stem cells 
are cells that are derived from human embryos, are capable of dividing 
without differentiating for a prolonged period in culture, and are 
known to develop into cells and tissues of the three primary germ 
layers. Although human embryonic stem cells are derived from embryos, 
such stem cells are not themselves human embryos.
    Studies of human embryonic stem cells may yield information about 
the complex events that occur during human development. Some of the 
most serious medical conditions, such as cancer and birth defects, are 
due to abnormal cell division and differentiation. A better 
understanding of the genetic and molecular controls of these processes 
could provide information about how such diseases arise and suggest new 
strategies for therapy. Human embryonic stem cells may also be used to 
test new drugs. For example, new medications could be tested for safety 
on differentiated somatic cells generated from human embryonic stem 
cells.
    Perhaps the most important potential use of human embryonic stem 
cells is the generation of cells and tissues that could be used for 
cell-based therapies. Today, donated tissues and organs are often used 
to replace ailing or destroyed tissue, but the need for transplantable 
tissues and organs far outweighs the available supply. Stem cells, 
directed to differentiate into specific cell types, offer the 
possibility of a renewable source of replacement cells and tissues to 
treat diseases and conditions, including Parkinson's disease, 
amyotrophic lateral sclerosis, spinal cord injury, burns, heart 
disease, diabetes, and arthritis.

[[Page 18579]]

    NIH currently funds ongoing research involving human embryonic stem 
cells as detailed under prior Presidential policy. Under that policy, 
Federal funds have been used for research on human embryonic stem cells 
where the derivation process was initiated prior to 9 p.m. EDT August 
9, 2001, the embryo was created for reproductive purposes, the embryo 
was no longer needed for these purposes, informed consent was obtained 
for the donation of the embryo, and no financial inducements were 
provided for donation of the embryo.
    These draft Guidelines would allow funding for research using only 
those human embryonic stem cells that were derived from embryos created 
by in vitro fertilization (IVF) for reproductive purposes and were no 
longer needed for that purpose. Funding will continue to be allowed for 
human stem cell research using adult stem cells and induced pluripotent 
stem cells. Specifically, these Guidelines describe the conditions and 
informed consent procedures that would have been required during the 
derivation of human embryonic stem cells for research using these cells 
to be funded by the NIH. NIH funding for research using human embryonic 
stem cells derived from other sources, including somatic cell nuclear 
transfer, parthenogenesis, and/or IVF embryos created for research 
purposes, is not allowed under these Guidelines.
    Please note that, for NIH funded research using the permitted human 
embryonic stem cells, the requirements of the Department's protection 
of human subjects regulations, 45 CFR part 46, may or may not apply, 
depending on the nature of the research. For further information, see 
Human Embryonic Stem Cells, Germ Cells and Cell Derived Test Articles: 
OHRP Guidance for Investigators and Institutional Review Boards.
    NIH funding of the derivation of stem cells from human embryos is 
prohibited by the annual appropriations ban on funding of human embryo 
research (Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/
09), otherwise known as the Dickey-Wicker Amendment.
    According to these Guidelines, there are some uses of human 
embryonic stem cells that, although those cells may come from allowable 
sources, are nevertheless ineligible for NIH funding.
    In developing these draft Guidelines, the NIH consulted its 
Guidelines issued in 2000, as well as the thoughtful guidelines 
developed by other national and international committees of scientists, 
bioethicists, patient advocates, physicians and other stakeholders, 
including the U.S. National Academies, the International Society for 
Stem Cell Research, and others.
    As directed by Executive Order 13505, the NIH shall review and 
update these Guidelines periodically, as appropriate.
    The Draft Guidelines Follow:

National Institutes of Health Guidelines for Human Stem Cell Research

I. Scope of Guidelines

    These Guidelines describe the circumstances under which human 
embryonic stem cells are eligible for use in extramural NIH-funded 
research, and they also include a section on uses of human embryonic 
stem cells or human induced pluripotent stem cells that are ineligible 
for NIH funding.
    For the purpose of these Guidelines, ``human embryonic stem cells'' 
are cells that are derived from human embryos, are capable of dividing 
without differentiating for a prolonged period in culture, and are 
known to develop into cells and tissues of the three primary germ 
layers. Although human embryonic stem cells are derived from embryos, 
such stem cells are not themselves human embryos.

II. Guidelines for Eligibility of Human Embryonic Stem Cells for Use in 
Research

    A. The Executive Order: Executive Order 13505, Removing Barriers to 
Responsible Scientific Research Involving Human Stem Cells, states that 
the Secretary of the Department of Health and Human Services (DHHS), 
through the Director of the NIH, may support and conduct responsible, 
scientifically worthy human stem cell research, including human 
embryonic stem cell research, to the extent permitted by law.
    B. Eligibility of Human Embryonic Stem Cells Derived from Human 
Embryos: Human embryonic stem cells may be used in research using NIH 
funds, if the cells were derived from human embryos that were created 
for reproductive purposes, were no longer needed for this purpose, were 
donated for research purposes, and for which documentation for all of 
the following can be assured:
    1. All options pertaining to use of embryos no longer needed for 
reproductive purposes were explained to the potential donor(s).
    2. No inducements were offered for the donation.
    3. A policy was in place at the health care facility where the 
embryos were donated that neither consenting nor refusing to donate 
embryos for research would affect the quality of care provided to 
potential donor(s).
    4. There was a clear separation between the prospective donor(s)'s 
decision to create human embryos for reproductive purposes and the 
prospective donor(s)'s decision to donate human embryos for research 
purposes.
    5. At the time of donation, consent for that donation was obtained 
from the individual(s) who had sought reproductive services. That is, 
even if potential donor(s) had given prior indication of their intent 
to donate to research any embryos that remained after reproductive 
treatment, consent for the donation should have been given at the time 
of the donation. Donor(s) were informed that they retained the right to 
withdraw consent until the embryos were actually used for research.
    6. Decisions related to the creation of human embryos for 
reproductive purposes were made free from the influence of researchers 
proposing to derive or utilize human embryonic stem cells in research. 
Whenever it was practicable, the attending physician responsible for 
reproductive clinical care and the researcher deriving and/or proposing 
to utilize human embryonic stem cells should not have been the same 
person.
    7. Written informed consent was obtained from individual(s) who 
sought reproductive services and who elected to donate human embryos 
for research purposes. The following information, which is pertinent to 
making the decision of whether or not to donate human embryos for 
research purposes, was in the written consent form for donation and 
discussed with potential donor(s) in the informed consent process:
    a. A statement that donation of the embryos for research was 
voluntary;
    b. A statement that donor(s) understood alternative options 
pertaining to use of the embryos;
    c. A statement that the embryos would be used to derive human 
embryonic stem cells for research;
    d. Information about what would happen to the embryos in the 
derivation of human embryonic stem cells for research;
    e. A statement that human embryonic stem cells derived from the 
embryos might be maintained for many years;
    f. A statement that the donation was made without any restriction 
or direction regarding the individual(s) who may receive medical 
benefit from the use of the stem cells;
    g. A statement that the research was not intended to provide direct 
medical benefit to the donor(s);

[[Page 18580]]

    h. A statement as to whether or not information that could identify 
the donor(s) would be retained prior to the derivation or the use of 
the human embryonic stem cells (relevant guidance from the DHHS Office 
for Human Research Protections (OHRP) should be followed, as 
applicable; see OHRP's Guidance for Investigators and Institutional 
Review Boards Regarding Research Involving Human Embryonic Stem Cells, 
Germ Cells, and Stem Cell-Derived Test Articles and Guidance on 
Research Involving Coded Private Information or Biological Specimens, 
or successor guidances); and
    i. A statement that the results of research using the human 
embryonic stem cells may have commercial potential, and a statement 
that the donor(s) would not receive financial or any other benefits 
from any such commercial development.
    C. Prior to the use of NIH funds: Funding recipients must ensure 
that: (1) The human embryonic stem cells were derived consistent with 
sections II.A and B of these Guidelines; and (2) the grantee 
institution maintains appropriate documentation demonstrating such 
consistency in accordance with 45 CFR 74.53, which also details rights 
of access by NIH. The responsible grantee institutional official must 
provide assurances with respect to (1) and (2) when endorsing 
applications and progress reports submitted to NIH for projects that 
utilize these cells.

III. Research Using Human Embryonic Stem Cells and/or Human Induced 
Pluripotent Stem Cells That, Although the Cells May Come From Allowable 
Sources, Is Nevertheless Ineligible for NIH Funding

    This section governs research using human embryonic stem cells and 
human induced pluripotent stem cells, i.e., human cells that are 
capable of dividing without differentiating for a prolonged period in 
culture, and are known to develop into cells and tissues of the three 
primary germ layers. There are some uses of these cells that, although 
they may come from allowable sources, are nevertheless ineligible for 
NIH funding, as follows:
    A. Research in which human embryonic stem cells (even if derived 
according to these Guidelines) or human induced pluripotent stem cells 
are introduced into non-human primate blastocysts.
    B. Research involving the breeding of animals where the 
introduction of human embryonic stem cells (even if derived according 
to these Guidelines) or human induced pluripotent stem cells may have 
contributed to the germ line.

IV. Other Non-Allowable Research

    A. NIH funding of the derivation of stem cells from human embryos 
is prohibited by the annual appropriations ban on funding of human 
embryo research (Consolidated Appropriations Act, 2009, Pub. L. 110-
161, 3/11/09), otherwise known as the Dickey-Wicker Amendment.
    B. NIH funding for research using human embryonic stem cells 
derived from other sources, including somatic cell nuclear transfer, 
parthenogenesis, and/or IVF embryos created for research purposes, is 
not allowed under these Guidelines.

    Dated: April 17, 2009.
Raynard S. Kington,
Acting Director, NIH.
[FR Doc. E9-9313 Filed 4-22-09; 8:45 am]
BILLING CODE 4140-01-P