I haven't had time to digest all this, but a quick scan appears to me to be 
a continuation of the Bush policy.  The bottom line is this:
no NIH funds for embryos created for research, like SCNT or parthenogenesis, 
hybrids or chimeras (use of animals)
See last paragraphs of this article.

It is OK to create embryos for reproduction, over half of which fail to 
implant, but not to use your own egg and DNA.  Why did they ask for comments 
I wonder.

Maybe someone else can explain the donor "grandfathering". I will get you 
the whole thing soon.

Ray

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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