Marked Changes--The 2009 Human Stem-Cell Research Guidelines

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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.
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johnkarls
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Joined: Fri Jun 29, 2007 8:43 pm

Marked Changes--The 2009 Human Stem-Cell Research Guidelines

Post by johnkarls »

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Originally posted by johnkarls » Tue Aug 09, 2016 6:13 pm
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My Proposal for a Possible Topic (the first posting above) included a brief introduction, an article from Nature Magazine explaining the NIH proposal, and the Official Request for Public Comment filed by the NIH in the Federal Register.

The NIH’s Official Request for Public Comment itself provides 5 long paragraphs labelled SUPPLEMENTARY INFORMATION.

Following which the NIH’s Official Request states: “Therefore, NIH is requesting public comment on: (1) The following proposed changes to the [2009 Human Stem-Cell Research] Guidelines ….. (2) The NIH is also requesting public comment on the proposed scope of research …..”

The purpose of this posting is to provide the Item (1) Proposed Changes to the 2009 Human Stem-Cell Research Guidelines in proper Legal Form which show marked additions and marked deletions.

It is EXTREMELY IRRITATING to any attorney to have to deal with the way the NIH has presented the changes.

[For non-attorneys, proper Legal From showing marked additions and marked deletions saves incredible amounts of time for all parties involved in negotiating agreements and other documents -- Yours Truly is NOT aware of any case in which an attorney has ever tried to fool opposing counsel by improperly marking proposed changes, though Yours Truly is virtually certain that doing so would result in DISBARMENT for the attorney AND A LAWSUIT by the aggrieved party for fraud against the opposing party for the unethical actions of the opposing party’s agent (i.e., its offending attorney)!!!]

The Proper Legal Form for marking changes is to mark any additions in bold underscored text, and mark any deletions in bold struck-through text. [Substitutions would be shown as a bold-underscored addition followed by the bold-struck-through text for which the addition is being substituted.]

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Unfortunately, this bulletin board does not permit underscoring and striking through.

Accordingly, additions will be shown in ALL CAPS and deletions will be shown as bracketed [ ].

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The Legal-Form Marked Proposed Changes to the 2009 Human Stem-Cell Research Guidelines =


IV. Research NOT ELIGIBLE FOR NIH FUNDING: [Using hESCs and/or Human Induced Pluripotent Stem Cells That, Although the Cells May Come From Eligible Sources, Is Nevertheless Ineligible for NIH Funding]

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[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:]
***********[End of Deleted Paragraph]**********

A. Research in which HUMAN PLURIPOTENT STEM CELLS ARE INTRODUCED INTO NON-HUMAN PRIMATE EMBRYOS UP THROUGH THE END OF THE BLASTOCYST STAGE, [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.] IS NOT ELIGIBLE FOR FUNDING.

[Marked Changes From Old IV-A]

B. Research involving the breeding of animals where the introduction of HUMAN CELLS [hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells] may contribute to the germ line, IS NOT ELIGIBLE FOR FUNDING.

[Marked Changes From Old IV-B]

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, PUBL.L. 114-113, 12/18/15) [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.

[Marked Changes From Old V-A]

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.

[No Changes From Old V-B]

EDITORIAL NOTE: There currently is a Section V which has the heading “Other Research Not Eligible for NIH Funding.” It contained only two paragraphs marked A and B which, with the changes marked above, have now become Items C and D of Section IV.


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PROPOSED SCOPE OF RESEARCH

This is just a reminder that the NIH is requesting public comment on TWO PROPOSALS: (1) Changes to the 2009 Human Stem-Cell Research Guidelines, AND (2) THE PROPOSED SCOPE OF RESEARCH.

Only the proposed changes to the former have just been rendered in Proper Legal Form.

The reader is cautioned NOT to overlook the Proposed Scope of Research (which is a de novo proposal, therefore NOT involving changes to be rendered in Proper Legal Form).

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