Clone Rights–Involuntary Soldiers, Sex Slaves, Lab Rats, Etc

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This section contains the 7 postings comprising the Original Proposal --

(1) 8/5/2016 -- “Clone Rights -- Involuntary Soldiers, Sex Slaves, Lab Rats, Etc. (including the text of the NIH proposed changes to the 2009 Human Stem-Cell Research Guidelines as published in the 8/6/2016 Federal Register)

(2) 8/5/2016 -- “What If Yale U’s 50% Human DNA Were All Dominant Traits???” (including the Discussion Outline for our 4/9/2008 meeting 8 years ago)

(3) 8/9/2016 -- “Marked Changes To The 2009 Human Stem-Cell Research Guidelines”

(4) 1/29/2017 -- “Human-Pig Chimeras -- Decent Behavior Despite Open Barn Door” (including 1/26/2017 Washington Post article)

(5) 1/31/2017 -- “Is the Fed Gov (NIH) Funding Nazi-Style Death Camps?” (to which it is respectfully suggested that the correct answer is “not yet, but soon”)

(6) 1/31/2017 -- “The Human-Pig Chimera Report From The Salk Institute” (ver batim text)

(7) 2/7/2017 -- “The Article in Britain’s ‘Nature’ About Rat-Mouse Chimeras” (ver batim text)

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These 7 postings were viewed 609 times before being transplanted here from the "Possible Topics for Future Meetings" section of this bulletin board.

Clone Rights–Involuntary Soldiers, Sex Slaves, Lab Rats, Etc

Postby johnkarls » Thu Feb 09, 2017 7:43 pm

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Originally posted by johnkarls » Fri Aug 05, 2016 8:19 pm
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Is the Fed Gov (NIH) Funding Nazi-Style Death Camps?


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There follows immediately below this paragraph the original 8/5/2016 topic proposal which was originally entitled “Clone Rights -- Involuntary Soldiers, Sex Slaves, Lab Rats, etc.” As of 1/31/2017, I have changed the title to more accurately describe what is happening so far as we know. Although the reader should examine everything that follows for essential background, the latest developments compelling the change in the proposal title are contained in the third section below (posted 1/29/2017 and entitled “Human-Pig Chimeras -- Decent Behavior Despite Open Barn Door”) and the fourth section below (posted 1/31/2017 and entitled “Is the Fed Gov (NIH) Funding Nazi-Style Death Camps?”).

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I propose that we study today’s NIH Proposal for Human Stem Cell Research.

This would dovetail nicely with the focus of our 4/9/2008 meeting 8 years ago entitled “Clone Rights: Involuntary Soldiers, Sex Slaves, Human ‘Lab Rats’ Etc.” for which we viewed together --

The 2005 Hollywood movie “The Island” which starred Ewan McGregor and Scarlett Johansson, and which dealt with the creation of human clones whose organs, whenever needed by their human “sponsors” who had financed their creation, could be harvested for transplant to the “sponsor” while the clones, of course, died;

and for which our short meeting description was --

How would you like to be an involuntary soldier, sex slave, human "lab rat" etc. WITH NO CONSTITUTIONAL RIGHTS JUST BECAUSE (1) the stem cells from which you were created came from skin cells rather than an embryo, or (2) your DNA is only 99% of the way from chimp DNA to human DNA (or any of the chimp-human DNA combinations the Yale U Biology Dept has created and is creating)??? Re (2), how do legal classifications based on % of human DNA differ from legal classifications in the Old South based on % of African-American blood, or legal classifications in Hitler's Third Reich based on % of Jewish blood???

There follows immediately below a description of the NIH proposal in Nature (the International Weekly Journal of Science), following which is the text of the NIH proposal itself as it appeared today in the Federal Register.

The NIH public-comment period expires 9/6/2016.

However, if we decide to focus on this topic for our 9/14/2016 meeting, it is suggested that --

(1) We file a protest with the NIH by their 9/6/2016 deadline complaining about the shortness of their comment period EVEN IF THE NIH IS ENTITLED BY LAW TO RUSH THIS THROUGH SO QUICKLY. After all, this is an important issue.

(2) If we decide to launch a Six-Degrees-Of-Separation E-mail Campaign, we direct it at both the N.I.H. and at President Obama. And include both our comments on the merits and A STIFF COMPLAINT ABOUT THE SHORTNESS OF THE COMMENT PERIOD. After all, even if such short comment periods are permitted by law, Yours Truly will bet any amount and any odds that the law does not REQUIRE (vs. permit) such a short comment period.


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nature.com/news/us-agency-lifts-ban-on-funding-human-animal-hybrids-1.20379

Nature – International Weekly Journal of Science – 8/5/2016


US Agency Lifts Ban on Funding Human–Animal Hybrids -- Researchers in the United States Will Soon Be Able to Resume Creating Chimaera-Based Projects.
By Sara Reardon


Since September 2015, researchers have been banned from receiving funding from the US National Institutes of Health (NIH) for adding human stem cells to animal embryos, creating blends called chimaeras. But a proposal by the NIH released on 4 August would lift the funding moratorium, except for certain situations. It would also set up a panel to review the ethics and oversight of grant applications.

The new rules shorten the developmental window during which human cells can be introduced into non-human primate embryos, disallowing it before the stage of development in which the central nervous system begins to form. This is intended to limit the number of human cells that would make up the chimaera’s brain. They also prohibit breeding animals that contain human cells, so as to prevent a human-like embryo from growing in a non-human womb or the birth of an animal that is more humanized than its parents.

Any grant applications that fall into a grey area would undergo a panel review. “It would be an extra set of eyes to make sure we’re not triggering any animal-welfare issues,” says Carrie Wolinetz, associate director for science policy at the NIH in Washington DC. The panel will pay particular attention to applications involving primates, mammals at very early stages of development or those in which human cells could affect an animal's brain. Past a certain point of development, rodent embryos with human cells that could affect brain development are exempt from panel review, says Wolinetz. This is because NIH’s scientific advisers think that the rodent brain is substantially different from ours and would not become human-like.

Chimaeras are a growing area of research. Currently, researchers use them to study early embryonic development and to create animal models of human diseases. But one major goal is to engineer animals to grow human organs. The organs could later be harvested from the adult animal and used for transplantation into a patient.

Unlike in the United States, it is illegal to perform such research without approval in the United Kingdom, even with private funding. Laws introduced in the United Kingdom in January mandate extra reviews of proposals involving certain types of chimaeras, including ones that would have a human appearance or features such as faces or hands.

Mixed reviews

Reactions from researchers have been mixed. Steven Goldman, a neuroscientist at the University of Rochester in New York, says that the 2015 moratorium was overkill and is relieved that it will now be lifted. The new guidelines, he says, are “more intelligent from the standpoint of where the science is”.

But Ali Brivanlou, a developmental biologist at the Rockefeller University in New York City says that the NIH proposal focuses on the wrong aspects of the issue. Rather than restricting the timing of modification, he says, there should be more focus on limiting the percentage of the animal that ends up being human.

“On a positive note, it’s amazing that this is going on,” he says, because there are many related questions and ethical issues that should be debated publicly.

Françoise Baylis, a bioethicist at Dalhousie University in Halifax, Canada, thinks that the new rules leave many questions unanswered. Currently, there are only two types of research subject, human and non-human, and there are clear distinctions on how to treat them. With chimaeras, researchers risk creating a third category for which there are no research guidelines, she says. “We just tend to say we’ll treat them like non-human animals, as if nothing happened,” Baylis says.

The NIH rules and other countries’ laws focus on cognition as the important factor for limiting chimaera research. But that is not necessarily the best way to determine how humanized animals should be categorized because it can be subjective, Baylis says. For instance, people who are cognitively impaired are still treated as human subjects in research, whereas very intelligent primates are not.

These are the kinds of questions that the oversight panel will discuss when reviewing specific grant applications, says Wolinetz. The panel will give recommendations to the scientific grant reviewers, which could include suggestions such as not allowing certain types of chimaeras to be brought to term, or monitoring an adult chimaera’s behaviour before continuing the experiment. “There are no hard and fast lines,” she says. “There’s going to be some on-the-job learning.”

The NIH’s rule is now open for public comment for 30 days, after which the agency will issue a final rule and lift the moratorium. Wolinetz hopes that this will be ready in time for the grant cycle that begins in January 2017.


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federalregister.gov/articles/2016/08/05/2016-18601/request-for-public-comment-on-the-proposed-changes-to-the-nih-guidelines-for-human-stem-cell


Request for Public Comment on the Proposed Changes to the NIH Guidelines for Human Stem Cell Research and the Proposed Scope of an NIH Steering Committee's Consideration of Certain Human-Animal Chimera Research

A Notice by the National Institutes of Health on 08/05/2016

This document has a comment period that ends in 32 days (09/06/2016)

Summary

The National Institutes of Health (NIH) is requesting public comment on a proposal to amend Section IV and Section V of the NIH Guidelines for Human Stem Cell Research and on the proposed scope of certain human-animal chimera research that will be considered internally by an NIH steering committee to provide programmatic input to the director of the relevant NIH Institute(s) or Center(s) or equivalent NIH officials responsible for funding decisions.

Table of Contents Back to Top

• DATES:
• ADDRESSES:
• SUPPLEMENTARY INFORMATION:

DATES: Back to Top

Written comments must be received by the NIH on or before September 6, 2016 in order to be considered.

ADDRESSES: Back to Top

Public comments may be entered at: http://grants.nih.gov/grants/rfi/rfi.cfm?ID=57. Comments may also be mailed to: Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-9838. Comments will be made publicly available. Comments received, including any personal information, will be posted without change to http://grants.nih.gov/grants/rfi/responses_57.cfm.

SUPPLEMENTARY INFORMATION: Back to Top

On July 7, 2009, the NIH issued the NIH Guidelines for Human Stem Cell Research (“Guidelines”) 74 FR 32170 (July 7, 2009) to implement Executive Order 13505 (March 9, 2009), as it pertains to NIH-funded stem cell research, to establish policy and procedures under which the NIH will fund such research, and help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.

Since the Guidelines were issued in 2009, growing knowledge and advancement of stem cell biology has created new research opportunities. Some scientists are exploring strategies for growing human tissue and organs in animals through the introduction of human pluripotent cells into early stage embryos of non-human vertebrate animals. These experimental designs raise questions regarding where the human cells might go in the developing animal and how they might function, such as whether the human cells might contribute to the central nervous system and affect the cognition of the animal.

While considering these issues, on September 23, 2015, the NIH issued a funding moratorium (http://grants.nih.gov/grants/guide/noti ... 5-158.html) on “NIH Research Involving Introduction of Human Pluripotent Cells into Non-Human Vertebrate Animal Pre-Gastrulation Embryos.” The NIH subsequently held a workshop with experts on November 6, 2015, to review the state of the science and discuss animal welfare issues.

The workshop illustrated that while there are significant challenges to creating chimeric models, there is clear interest and potential in producing animal models with human tissues or organs for studying human development, disease pathology, and eventually organ transplantation. In the interest of moving the field forward while preserving the NIH's opportunity to provide continuing assessment and oversight of this emerging area of research, the NIH has decided to establish a steering committee to provide programmatic input to the director of the relevant NIH Institute(s) or Center(s) (or equivalent NIH official responsible for funding decisions) on certain human-animal chimera research proposals. The committee will be composed of federal employees. The committee is expected to consider and offer the director of the relevant NIH Institute(s) or Center(s) (or equivalent NIH official responsible for funding decisions) programmatic input on factors, such as, (1) the characteristics of the human cells to be introduced (including potency and any modifications of those cells); (2) characteristics of the recipient animal (e.g., species, stage of development, and any modifications that affect location or function of human cells); (3) other data relevant to the likely effects on the animal (e.g., changes in cognition, behavior, or physical appearance); (4) planned monitoring (including animal welfare assessments); and (5) any staging of proposed research (e.g., assessing the outcome of a particular experiment before conducting a further experiment). This internal programmatic work will be conducted independent of, and in addition to, the usual peer review procedures for research at the NIH. The relevant IC director(s) will consider the input from the steering committee, in addition to other NIH programmatic input, as well as the funding recommendations and evaluations of the initial Scientific Review Group and the relevant Institute or Center's Advisory Council or Board. The committee will also monitor trends in this general field of research and the use of new technologies, and may provide such analysis and advice to the NIH leadership.

The NIH also proposes to revise the Guidelines to expand the existing prohibition on introducing human pluripotent stem cells into blastocyst stage nonhuman primate embryos to include pre-blastocyst stage nonhuman primate embryos; and to expand the prohibition on research involving the breeding of animals where the introduction of hESCs or human induced pluripotent stem cells may contribute to the germ line to include any human cells that may result in the formation of human gametes.

Therefore, NIH is requesting public comment on:

(1) The following proposed changes to the Guidelines.

Sections IV and V of the Guidelines currently state:

IV. 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:

A. 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.

B. 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.

V. Other Research Not Eligible for NIH Funding

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 (Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, 3/11/09), otherwise known as the Dickey Amendment.

B. 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.

The NIH is proposing to amend the Guidelines as follows:

IV. Research Not Eligible for NIH Funding:

A. Research in which human pluripotent stem cells are introduced into non-human primate embryos up through the end of the blastocyst stage, is not eligible for funding.

B. Research involving the breeding of animals where the introduction of human cells may contribute to the germ line, is not eligible for funding.

C. NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations limitations on the funding of human embryo research (see e.g. Section 508, Omnibus Appropriations Act, 2016, Pub. L.114-113, 12/18/15), otherwise known as the Dickey Amendment.

D. 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.

(2) The NIH is also requesting public comment on the proposed scope of research (e.g., grant applications, contract proposals, intramural research protocols, etc.) to be considered by an NIH steering committee to provide programmatic input to the director of the relevant Institute or Center (or equivalent NIH official responsible for funding decisions). The NIH proposes the scope of research include research in which:

a. Human pluripotent cells are introduced into non-human vertebrate embryos, up through the end of the gastrulation stage, or

b. human cells are introduced into post-gastrulation non-human mammals (excluding rodents), such that there could be either a substantial contribution or a substantial functional modification to the animal brain by the human cells.

While the NIH seeks public comment on the proposed changes to the Guidelines, and on the proposed scope for an NIH steering committee's consideration of certain research, NOT-OD-15-158 will remain in effect.

Dated: July 28, 2016.

Lawrence A. Tabak,
Deputy Director, National Institutes of Health.

[FR Doc. 2016-18601 Filed 8-4-16; 8:45 am]

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