National Institutes of Health Guidelines on
Human Stem Cell Research
SUMMARY: The National Institutes of Health (NIH) is hereby publishing final 
"National Institutes of Health Guidelines for Human Stem Cell Research" 
(Guidelines).
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 (hESC) research, to the extent permitted by law.
These Guidelines implement Executive Order 13505, as it pertains to 
extramural NIH-funded stem cell research, establish policy and procedures 
under which the NIH will fund such research, and helps ensure that 
NIH-funded research in this area is ethically responsible, scientifically 
worthy, and conducted in accordance with applicable law. Internal NIH 
policies and procedures, consistent with Executive Order 13505 and these 
Guidelines, will govern the conduct of intramural NIH stem cell research.
EFFECTIVE DATE: These Guidelines are effective on July 7, 2009.
SUMMARY OF PUBLIC COMMENTS ON DRAFT GUIDELINES: On April 23, 2009 the NIH 
published draft Guidelines for research involving hESCs in the Federal 
Register for public comment, 74 Fed. Reg. 18578 (April 23, 2009). The 
comment period ended on May 26, 2009.
The NIH received approximately 49,000 comments from patient advocacy groups, 
scientists and scientific societies, academic institutions, medical 
organizations, religious organizations, and private citizens. The NIH also 
received comments from members of Congress. This Notice presents the final 
Guidelines together with the NIH response to public comments that addressed 
provisions of the Guidelines.
Title of the Guidelines, Terminology, and Background:
Respondents felt the title of the NIH draft guidelines was misleading, in 
that it is entitled "National Institutes of Health Guidelines for Human Stem 
Cell Research," yet addresses only one type of human stem cell. The NIH 
notes that although the Guidelines pertain primarily to the donation of 
embryos for the derivation of hESCs, one Section also applies to certain 
uses of both hESCs and human induced pluripotent stem cells. Also, the 
Guidelines discuss applicable regulatory standards when research involving 
human adult stem cells or induced pluripotent stem cells constitutes human 
subject research. Therefore, the title of the Guidelines was not changed.
Respondents also disagreed with the definition of human embryonic stem cells 
in the draft Guidelines, and asked that the NIH define them as originating 
from the inner cell mass of the blastocyst. The NIH modified the definition 
to say that human embryonic stem cells "are cells that are derived from the 
inner cell mass of blastocyst stage 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."
Financial Gain
Respondents expressed concern that derivers of stem cells might profit from 
the development of hESCs. Others noted that because the stem cells eligible 
for use in research using NIH funding under the draft Guidelines are those 
cells that are subject to existing patents, there will be insufficient 
competition in the licensing of such rights. These respondents suggested 
that this could inhibit research, as well as increase the cost of any future 
clinical benefits. The Guidelines do not address the distribution of stem 
cell research material. It is, however, the NIH's expectation that stem cell 
research materials developed with NIH funds, as well as associated 
intellectual property and data, will be distributed in accordance with the 
NIH's existing policies and guidance, including "Sharing Biomedical Research 
Resources, Principles and Guidelines for Recipients of NIH Grants and 
Contracts" and "Best Practices for the Licensing of Genomic Inventions." 
http://ott.od.nih.gov/policy/Reports.html Even where such policies are not 
directly applicable, the NIH encourages others to refrain from imposing on 
the transfer of research tools, such as stem cells, any conditions that 
hinder further biomedical research. In addition, the Guidelines were revised 
to state that there should be documentation that "no payments, cash or in 
kind, were offered for the donated embryos."
Respondents were concerned that donor(s) be clearly "apprised up front by 
any researchers that financial gain may come from the donation and that the 
donor(s) should know up front if he/she will share in the financial gain." 
The Guidelines address this concern by asking that donor(s) was/were 
informed during the consent process 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, such as who may be the recipients of 
cell transplants. The Guidelines also require that the donor(s) receive(s) 
information that the research was not intended to provide direct medical 
benefit to the donor(s); that the results of research using the hESCs may 
have commercial potential, and that the donor(s) would not receive financial 
or any other benefits from any such commercial development.
IRB Review under the Common Rule
Respondents suggested that the current regulatory structure of IRB review 
under the Common Rule (45 C.F.R. Part 46, Subpart A) addresses the core 
ethical principles needed for appropriate oversight of hESC derivation. They 
noted that IRB review includes a full review of the informed consent 
process, as well as a determination of whether individuals were coerced to 
participate in the research and whether any undue inducements were offered 
to secure their participation. These respondents urged the NIH to replace 
the specific standards to assure voluntary and informed consent in the draft 
Guidelines with a requirement that hESC research be reviewed and approved by 
an IRB, in conformance with 45 C.F.R. Part 46, Subpart A, as a prerequisite 
to NIH funding. Respondents also requested that the NIH create a registry of 
eligible hESC lines to avoid burdensome and repetitive assurances from 
multiple funding applicants. The NIH agrees that the IRB system of review 
under the Common Rule provides a comprehensive framework for the review of 
the donation of identifiable human biological materials for research. 
However, in the last several years, guidelines on hESC research have been 
issued by a number of different organizations and governments, and different 
practices have arisen around the country and worldwide, resulting in a 
patchwork of standards. The NIH concluded that employing the IRB review 
system for the donation of embryos would not ameliorate stated concerns 
about variations in standards for hESC research and would preclude the 
establishment of an NIH registry of hESCs eligible for NIH funding, because 
there would be no NIH approval of particular hESCs. To this end and response 
to comments, these Guidelines articulate policies and procedures that will 
allow the NIH to create a Registry. These Guidelines also provide scientists 
who apply for NIH funding with a specific set of standards reflecting 
currently recognized ethical principles and practices specific to embryo 
donation that took place on or after the issuance of the Guidelines, while 
also establishing procedures for the review of donations that took place 
before the effective date of the Guidelines.
Federal Funding Eligibility of Human Pluripotent Cells from Other Sources
Respondents suggested that the allowable sources of hESCs potentially 
available for federal funding be expanded to include hESC lines from embryos 
created expressly for research purposes, and lines created, or pluripotent 
cells derived, following parthenogenesis or somatic cell nuclear transfer 
(SCNT). The Guidelines allow for funding of research using hESCs derived 
from embryos created using in vitro fertilization (IVF) for reproductive 
purposes and no longer needed for these purposes, assuming the research has 
scientific merit and the embryos were donated after proper informed consent 
was obtained from the donor(s). The Guidelines reflect the broad public 
support for federal funding of research using hESCs created from such 
embryos based on wide and diverse debate on the topic in Congress and 
elsewhere. The use of additional sources of human pluripotent stem cells 
proposed by the respondents involve complex ethical and scientific issues on 
which a similar consensus has not emerged. For example, the embryo-like 
entities created by parthenogenesis and SCNT require women to donate 
oocytes, a procedure that has health and ethical implications, including the 
health risk to the donor from the course of hormonal treatments needed to 
induce oocyte production.
Respondents noted that many embryos undergo Pre-implantation Genetic 
Diagnosis (PGD). This may result in the identification of chromosomal 
abnormalities that would make the embryos medically unsuitable for clinical 
use. In addition, the IVF process may also produce embryos that are not 
transferred into the uterus of a woman because they are determined to be not 
appropriate for clinical use. Respondents suggested that hESCs derived from 
such embryos may be extremely valuable for scientific study, and should be 
considered embryos that were created for reproductive purposes and were no 
longer needed for this purpose. The NIH agrees with these comments. As in 
the draft, the final Guidelines allow for the donation of embryos that have 
undergone PGD.
Donation and Informed Consent
Respondents commented in numerous ways that the draft Guidelines are too 
procedurally proscriptive in articulating the elements of appropriate 
informed consent documentation. This over-reliance on the specific details 
and format of the informed consent document, respondents argued, coupled 
with the retroactive application of the Guidelines to embryos already 
donated for research, would result in a framework that fails to appreciate 
the full range of factors contributing to the complexity of the informed 
consent process. For example, respondents pointed to several factors that 
were precluded from consideration by the proposed Guidelines, such as 
contextual evidence of the consent process, other established governmental 
frameworks (representing local and community influences), and the changing 
standards for informed consent in this area of research over time. 
Respondents argued that the Guidelines should be revised to allow for a 
fuller array of factors to be considered in determining whether the 
underlying ethical principle of voluntary informed consent had been met. In 
addition to these general issues, many respondents made the specific 
recommendation that all hESCs derived before the final Guidelines were 
issued be automatically eligible for Federal funding without further review, 
especially those eligible under prior Presidential policy, i.e., 
"grandfathered." The final Guidelines seek to implement the Executive Order 
by issuing clear guidance to assist this field of science to advance and 
reach its full potential while ensuring adherence to strict ethical 
standards. To this end, the NIH is establishing a set of conditions that 
will maximize ethical oversight, while ensuring that the greatest number of 
ethically derived hESCs are eligible for federal funding. Specifically, for 
embryos donated in the U.S. on or after the effective date of the 
Guidelines, the only way to establish eligibility will be to either use 
hESCs listed on the NIH Registry, or demonstrate compliance with the 
specific procedural requirements of the Guidelines by submitting an 
assurance with supporting information for administrative review by the NIH. 
Thus, for future embryo donations in the United States, the Guidelines 
articulate one set of procedural requirements. This responds to concerns 
regarding the patchwork of requirements and guidelines that currently exist.
However, the NIH is also cognizant that in the more than a decade between 
the discovery of hESCs and today, many lines were derived consistent with 
ethical standards and/or guidelines developed by various states, countries, 
and other entities such as the International Society for Stem Cell Research 
(ISSCR) and the National Academy of Sciences (NAS). These various policies 
have many common features, rely on a consistent ethical base, and require an 
informed consent process, but they differ in details of implementation. For 
example, some require specific wording in a written informed consent 
document, while others do not. It is important to recognize that the 
principles of ethical research, e.g., voluntary informed consent to 
participation, have not varied in this time period, but the requirements for 
implementation and procedural safeguards employed to demonstrate compliance 
have evolved. In response to these concerns, the Guidelines state that 
applicant institutions wishing to use hESCs derived from embryos donated 
prior to the effective date of the Guidelines may either comply with Section 
II (A) of the Guidelines or undergo review by a Working Group of the 
Advisory Committee to the Director (ACD). The ACD, which is a chartered 
Federal Advisory Committee Act (FACA) committee, will advise NIH on whether 
the core ethical principles and procedures used in the process for obtaining 
informed consent for the donation of the embryo were such that the cell line 
should be eligible for NIH funding. This Working Group will not undertake a 
de novo evaluation of ethical standards, but will consider the materials 
submitted in light of the principles and points to consider in the 
Guidelines, as well as 45 C.F.R. Part 46 Subpart A. Rather than 
"grandfathering," ACD Working Group review will enable pre-existing hESCs 
derived in a responsible manner to be eligible for use in NIH funded 
research.
In addition, for embryos donated outside the United States prior to the 
effective date of these Guidelines, applicants may comply with either 
Section II (A) or (B). For embryos donated outside of the United States on 
or after the effective date of the Guidelines, applicants seeking to 
determine eligibility for NIH research funding may submit an assurance that 
the hESCs fully comply with Section II (A) or submit an assurance along with 
supporting information, that the alternative procedural standards of the 
foreign country where the embryo was donated provide protections at least 
equivalent to those provided by Section II (A) of these Guidelines. These 
materials will be reviewed by the NIH ACD Working Group, which will 
recommend to the ACD whether such equivalence exists. Final decisions will 
be made by the NIH Director. This special consideration for embryos donated 
outside the United States is needed because donation of embryos in foreign 
countries is governed by the laws and policies of the respective governments 
of those nations. Although such donations may be responsibly conducted, such 
governments may not or cannot change their national donation requirements to 
precisely comply with the NIH Guidelines. The NIH believes it is reasonable 
to provide a means for reviewing such hESCs because ethically derived 
foreign hESCs constitute an important scientific asset for the U.S.
Respondents expressed concern that it might be difficult in some cases to 
provide assurance that there was a "clear separation" between the 
prospective donor(s)' decision to create embryos for reproductive purposes 
and the donor(s)' decision to donate the embryos for research purposes. 
These respondents noted that policies vary at IVF clinics, especially with 
respect to the degree to which connections with researchers exist. 
Respondents noted that a particular clinic's role may be limited to the 
provision of contact information for researchers. A clinic that does not 
have any particular connection with research would not necessarily have in 
place a written policy articulating the separation contemplated by the 
Guidelines. Other respondents noted that embryos that are determined not to 
be suitable for medical purposes, either because of genetic defects or other 
concerns, may be donated prior to being frozen. In these cases, it is 
possible that the informed consent process for the donation might be 
concurrent with the consent process for IVF treatment. Respondents also 
noted that the initial consent for IVF may contain a general authorization 
for donating embryos in excess of clinical need, even though a more detailed 
consent is provided at the actual time of donation. The NIH notes that the 
Guidelines specifically state that consent should have been obtained at the 
time of donation, even if the potential donor(s) had given prior indication 
of a general intent to donate embryos in excess of clinical need for the 
purposes of research. Accordingly, a general authorization for research 
donation when consenting for reproductive treatment would comply with the 
Guidelines, so long as specific consent for the donation is obtained at the 
time of donation. In response to comments regarding documentation necessary 
to establish a separation between clinical and research decisions, the NIH 
has changed the language of the Guidelines to permit applicant institutions 
to submit consent forms, written policies or other documentation to 
demonstrate compliance with the provisions of the Guidelines. This change 
should provide the flexibility to accommodate a range of practices, while 
adhering to the ethical principles intended.
Some respondents want to require that the IVF physician and the hESC 
researcher should be different individuals, to prevent conflict of interest. 
Others say they should be the same person, because people in both roles need 
to have detailed knowledge of both areas (IVF treatment and hESC research). 
There is also a concern that the IVF doctor will create extra embryos if 
he/she is also the researcher. As a general matter, the NIH believes that 
the doctor and the researcher seeking donation should be different 
individuals. However, this is not always possible, nor is it required, in 
the NIH's view, for ethical donation.
Some respondents want explicit language (in the Guidelines and/or in the 
consent) stating that the embryo will be destroyed when the inner cell mass 
is removed. In the process of developing guidelines, the NIH reviewed a 
variety of consent forms that have been used in responsible derivations. 
Several had extensive descriptions of the process and the research to be 
done, going well beyond the minimum expected, yet they did not use these 
exact words. Given the wide variety and diversity of forms, as well as the 
various policy, statutory and regulatory obligations individual institutions 
face, the NIH declines to provide exact wording for consent forms, and 
instead endorses a robust informed consent process where all necessary 
details are explained and understood in an ongoing, trusting relationship 
between the clinic and the donor(s).
Respondents asked for clarification regarding the people who must give 
informed consent for the donation of embryos for research. Some commenters 
suggested that NIH should require consent from the gamete donors, in cases 
where those individuals may be different than the individuals seeking 
reproductive treatment. The NIH requests consent from "the individual(s) who 
sought reproductive treatment" because this/these individual(s) is/are 
responsible for the creation of the embryo(s) and, therefore, its/their 
disposition. With regard to gamete donation, the risks are associated with 
privacy and, as such, are governed by requirements of the Common Rule, where 
applicable.
Respondents also requested clarification on the statement in the draft 
Guidelines noting that "although human embryonic stem cells are derived from 
embryos, such stem cells are not themselves human embryos." For the purpose 
of NIH funding, an embryo is defined by Section 509, Omnibus Appropriations 
Act, 2009, Pub. L. 111-8, 3/11/09, otherwise known as the Dickey Amendment, 
as any organism not protected as a human subject under 45 C.F.R. Part 46 
that is derived by fertilization, parthenogenesis, cloning or any other 
means from one or more human gametes or human diploid cells. Since 1999, the 
Department of Health and Human Services (HHS) has consistently interpreted 
this provision as not applicable to research using hESCs, because hESCs are 
not embryos as defined by Section 509. This long-standing interpretation has 
been left unchanged by Congress, which has annually reenacted the Dickey 
Amendment with full knowledge that HHS has been funding hESC research since 
2001. These guidelines therefore recognize the distinction, accepted by 
Congress, between the derivation of stem cells from an embryo that results 
in the embryo's destruction, for which federal funding is prohibited, and 
research involving hESCs that does not involve an embryo nor result in an 
embryo's destruction, for which federal funding is permitted.
Some respondents wanted to ensure that potential donor(s) are either 
required to put their "extra" embryos up for adoption before donating them 
for research, or are at least offered this option. The Guidelines require 
that all the options available in the health care facility where treatment 
was sought pertaining to the use of embryos no longer needed for 
reproductive purposes were explained to the potential donor(s). Since not 
all IVF clinics offer the same services, the healthcare facility is only 
required to explain the options available to the donor(s) at that particular 
facility.
Commenters asked that donor(s) be made aware of the point at which their 
donation decision becomes irrevocable. This is necessary because if the 
embryo is de-identified, it may be impossible to stop its use beyond a 
certain point. The NIH agrees with these comments and revised the Guidelines 
to require that donor(s) should have been informed that they retained the 
right to withdraw consent for the donation of the embryo until the embryos 
were actually used to derive embryonic stem cells or until information which 
could link the identity of the donor(s) with the embryo was no longer 
retained, if applicable.
Medical Benefits of Donation
Regarding medical benefit, respondents were concerned that the language of 
the Guidelines should not somehow eliminate a donor's chances of benefitting 
from results of stem cell research. Respondents noted that although hESCs 
are not currently being used clinically, it is possible that in the future 
such cells might be used for the medical benefit of the person donating 
them. The Guidelines are meant to preclude individuals from donating embryos 
strictly for use in treating themselves only or from donating but 
identifying individuals or groups they do or do not want to potentially 
benefit from medical intervention using their donated cells. While treatment 
with hESCs is one of the goals of this research, in practice, years of 
experimental work must still be done before such treatment might become 
routinely available. The Guidelines are designed to make it clear that 
immediate medical benefit from a donation is highly unlikely at this time. 
Importantly, it is critical to note that the Guidelines in no way disqualify 
a donor from benefitting from the medical outcomes of stem cell research and 
treatments that may be developed in the future.
Monitoring and Enforcement Actions
Respondents have expressed concern about the monitoring of funded research 
and the invocation of possible penalties for researchers who do not follow 
the Guidelines. A grantee's failure to comply with the terms and conditions 
of award, including confirmed instances of research misconduct, may cause 
the NIH to take one or more enforcement actions, depending on the severity 
and duration of the non-compliance. For example, the following actions may 
be taken by the NIH when there is a failure to comply with the terms and 
conditions of any award: (1) Under 45 CFR 74.14, the NIH can impose special 
conditions on an award, including but not limited to increased 
oversight/monitoring/reporting requirements for an institution, project, or 
investigator; and (2) under 45 CFR 74.62 the NIH may impose enforcement 
actions, including but not limited to withholding funds pending correction 
of the problem, disallowing all or part of the costs of the activity that 
was not in compliance, withholding further awards for the project, or 
suspending or terminating all or part of the funding for the project. 
Individuals and institutions may be debarred from eligibility for all 
Federal financial assistance and contracts under 2 CFR Part 376 and 48 CFR 
Subpart 9.4, respectively. The NIH will undertake all enforcement actions in 
accordance with applicable statutes, regulations, and policies.
National Institutes of Health Guidelines for Research Using Human Stem Cells
Scope of Guidelines
These Guidelines apply to the expenditure of National Institutes of Health 
(NIH) funds for research using human embryonic stem cells (hESCs) and 
certain uses of induced pluripotent stem cells (See Section IV). The 
Guidelines implement Executive Order 13505.
Long-standing HHS regulations for Protection of Human Subjects, 45 C.F.R. 
46, Subpart A 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 
C.F.R. 46, Subpart A. Applicants should consult 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
It is also important to note that the HHS regulation, Protection of Human 
Subjects, 45 C.F.R. Part 46, Subpart A, may apply to certain research using 
hESCs. This regulation applies, among other things, to research involving 
individually identifiable private information about a living individual, 45 
C.F.R. § 46.102(f). The HHS Office for Human Research Protections (OHRP) 
considers biological material, such as cells derived from human embryos, to 
be individually identifiable when they can be linked to specific living 
individuals by the investigators either directly or indirectly through 
coding systems. Thus, in certain circumstances, IRB review may be required, 
in addition to compliance with these Guidelines. Applicant institutions are 
urged to consult OHRP guidances at 
http://www.hhs.gov/ohrp/policy/index.html#topics
To ensure that the greatest number of responsibly derived hESCs are eligible 
for research using NIH funding, these Guidelines are divided into several 
sections, which apply specifically to embryos donated in the U.S. and 
foreign countries, both before and on or after the effective date of these 
Guidelines. Section II (A) and (B) describe the conditions and review 
processes for determining hESC eligibility for NIH funds. Further 
information on these review processes may be found at www.NIH.gov. Sections 
IV and V describe research that is not eligible for NIH funding.
These guidelines are based on the following principles:
Responsible research with hESCs has the potential to improve our 
understanding of human health and illness and discover new ways to prevent 
and/or treat illness.
Individuals donating embryos for research purposes should do so freely, with 
voluntary and informed consent.
As directed by Executive Order 13505, the NIH shall review and update these 
Guidelines periodically, as appropriate.
Eligibility of Human Embryonic Stem Cells for Research with NIH Funding
For the purpose of these Guidelines, "human embryonic stem cells (hESCs)" 
are cells that are derived from the inner cell mass of blastocyst stage 
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 hESCs are derived from embryos, 
such stem cells are not themselves human embryos. All of the processes and 
procedures for review of the eligibility of hESCs will be centralized at the 
NIH as follows:
Applicant institutions proposing research using hESCs derived from embryos 
donated in the U.S. on or after the effective date of these Guidelines may 
use hESCs that are posted on the new NIH Registry or they may establish 
eligibility for NIH funding by submitting an assurance of compliance with 
ection II (A) of the Guidelines, along with supporting information 
demonstrating compliance for administrative review by the NIH. For the 
purposes of this Section II (A), hESCs should have been derived from human 
embryos:
that were created using in vitro fertilization for reproductive purposes and 
were no longer needed for this purpose;
that were donated by individuals who sought reproductive treatment 
(hereafter referred to as "donor(s)") and who gave voluntary written consent 
for the human embryos to be used for research purposes; and
for which all of the following can be assured and documentation provided, 
such as consent forms, written policies, or other documentation, provided:
All options available in the health care facility where treatment was sought 
pertaining to the embryos no longer needed for reproductive purposes were 
explained to the individual(s) who sought reproductive treatment.
No payments, cash or in kind, were offered for the donated embryos.
Policies and/or procedures were 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).
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. 
Specifically:
Decisions related to the creation of human embryos for reproductive purposes 
should have been made free from the influence of researchers proposing to 
derive or utilize hESCs in research. The attending physician responsible for 
reproductive clinical care and the researcher deriving and/or proposing to 
utilize hESCs should not have been the same person unless separation was not 
practicable.
At the time of donation, consent for that donation should have been obtained 
from the individual(s) who had sought reproductive treatment. 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 for research purposes should have been given at the time of 
the donation.
Donor(s) should have been informed that they retained the right to withdraw 
consent for the donation of the embryo until the embryos were actually used 
to derive embryonic stem cells or until information which could link the 
identity of the donor(s) with the embryo was no longer retained, if 
applicable.
During the consent process, the donor(s) were informed of the following:
that the embryos would be used to derive hESCs for research;
what would happen to the embryos in the derivation of hESCs for research;
that hESCs derived from the embryos might be kept for many years;
that the donation was made without any restriction or direction regarding 
the individual(s) who may receive medical benefit from the use of the hESCs, 
such as who may be the recipients of cell transplants.;
that the research was not intended to provide direct medical benefit to the 
donor(s);
that the results of research using the hESCs may have commercial potential, 
and that the donor(s) would not receive financial or any other benefits from 
any such commercial development;
whether information that could identify the donor(s) would be available to 
researchers.
Applicant institutions proposing research using hESCs derived from embryos 
donated in the U.S. before the effective date of these Guidelines may use 
hESCs that are posted on the new NIH Registry or they may establish 
eligibility for NIH funding in one of two ways:
By complying with Section II (A) of the Guidelines; or
By submitting materials to a Working Group of the Advisory Committee to the 
Director (ACD), which will make recommendations regarding eligibility for 
NIH funding to its parent group, the ACD. The ACD will make recommendations 
to the NIH Director, who will make final decisions about eligibility for NIH 
funding.
The materials submitted must demonstrate that the hESCs were derived from 
human embryos: 1) that were created using in vitro fertilization for 
reproductive purposes and were no longer needed for this purpose; and 2) 
that were donated by donor(s) who gave voluntary written consent for the 
human embryos to be used for research purposes.
The Working Group will review submitted materials, e.g., consent forms, 
written policies or other documentation, taking into account the principles 
articulated in Section II (A), 45 C.F.R. Part 46, Subpart A, and the 
following additional points to consider. That is, during the informed 
consent process, including written or oral communications, whether the 
donor(s) were: (1) informed of other available options pertaining to the use 
of the embryos; (2) offered any inducements for the donation of the embryos; 
and (3) informed about what would happen to the embryos after the donation 
for research.
For embryos donated outside the United States before the effective date of 
these Guidelines, applicants may comply with either Section II (A) or (B). 
For embryos donated outside of the United States on or after the effective 
date of the Guidelines, applicants seeking to determine eligibility for NIH 
research funding may submit an assurance that the hESCs fully comply with 
Section II (A) or submit an assurance along with supporting information, 
that the alternative procedural standards of the foreign country where the 
embryo was donated provide protections at least equivalent to those provided 
by Section II (A) of these Guidelines. These materials will be reviewed by 
the NIH ACD Working Group, which will recommend to the ACD whether such 
equivalence exists. Final decisions will be made by the NIH Director.
NIH will establish a new Registry listing hESCs eligible for use in NIH 
funded research. All hESCs that have been reviewed and deemed eligible by 
the NIH in accordance with these Guidelines will be posted on the new NIH 
Registry.
Use of NIH Funds
Prior to the use of NIH funds, funding recipients should provide assurances, 
when endorsing applications and progress reports submitted to NIH for 
projects using hESCs, that the hESCs are listed on the NIH registry.
Research Using hESCs and/or Human Induced Pluripotent Stem Cells That, 
Although the Cells May Come from Eligible Sources, is Nevertheless 
Ineligible for NIH Funding
This section governs research using hESCs 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. Although the cells 
may come from eligible sources, the following uses of these cells are 
nevertheless ineligible for NIH funding, as follows:
Research in which hESCs (even if derived from embryos donated in accordance 
with these Guidelines) or human induced pluripotent stem cells are 
introduced into non-human primate blastocysts.
Research involving the breeding of animals where the introduction of hESCs 
(even if derived from embryos donated in accordance with these Guidelines) 
or human induced pluripotent stem cells may contribute to the germ line.
Other Research Not Eligible for NIH Funding
NIH funding of the derivation of stem cells from human embryos is prohibited 
by the annual appropriations ban on funding of human embryo research 
(Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, 3/11/09), 
otherwise known as the Dickey Amendment.
Research using hESCs derived from other sources, including somatic cell 
nuclear transfer, parthenogenesis, and/or IVF embryos created for research 
purposes, is not eligible for NIH funding.
Raynard S Kington, M.D., Ph.D.
Acting Director, NIH
Rayilyn Brown, Director AZNPF
Arizona Chapter National Parkinson Foundation
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In the body of the message put: signoff parkinsn