Contract table of contents

ARTICLE H.21. HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH

All HPSCRUG (Human Pluripotent Stem Cell Review Group) approved research involving human embryonic germ cells shall be conducted in accordance with the NIH Guidelines for Research Using Human Pluripotent Stem Cells ( http://stemcells.nih.gov/policy/guidelines.asp )

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****(USE BELOW IN SOLICITATIONS AND CONTRACTS THAT INCLUDE RESEARCH INVOLVING HUMAN EMBRYONIC GERM CELLS WHEN THE CONTRACT IS TO BE AWARDED PRIOR TO RECEIVING APPROVAL FROM THE HUMAN PLURIPOTENT STEM CELL REVIEW GROUP (HPSCRG). ADDITIONAL INFORMATION TO COMPLETE THIS ARTICLE: Second Paragraph: Include the paragraph, or language substantially the same to reflect the specifics of the contract, when contract award has been made prior to review and approval of the HPSCRG. Choose the applicable language contained within the brackets and delete the language that is not appropriate or tailor specific language that would be more appropriate to your contractual situation. Note: If HPSCRG approval has been received prior to contract award, the entire second paragraph should not be included in the contract .)****

ARTICLE H.22. HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH

Federally funded research involving the use of human embryonic germ cells derived from fetal tissue shall not be conducted under this contract until Human Pluripotent Stem Cell Review Group (HPSCRG) review and approval has been obtained. Once approved by the HPSCRG, all research shall be conducted in accordance with the NIH Guidelines for Research Using Human Pluripotent Stem Cells ( http://stemcells.nih.gov/policy/guidelines.asp).

Any work under this contract which requires research involving the use of human embryonic germ cells shall not be conducted under this contract until the HPSCRG review and approval have been obtained, and documented by written notice of such approval by the Contracting Officer. If the HPSCRG disapproves the documentation presented by the Contractor, [the contract may be terminated in accordance with the Termination of Convenience Clause referenced in Article I.1. of this contract/ OR the Contracting Officer may elect not to exercise Option(s)                            of this contract in accordance with the Option Clause referenced in Article I.3. of this contract.] In addition, it may be necessary for the Contracting Officer to invoke FAR Clause 52.242-15, Stop Work Order, referenced in the CLAUSES INCORPORATED BY REFERENCE Article in Section F of this contract if the review and approval process cannot be accomplished in a time frame that allows for continuity of this research effort.

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****(USE BELOW IN SOLICITATIONS THAT INVOLVE HUMAN STEM CELL RESEARCH.)****

ARTICLE H.23. HUMAN STEM CELL RESEARCH

All research conducted under this contract shall be in accordance with NIH Guidelines on Human Stem Cell Research ( http://stemcells.nih.gov/policy/pages/2009guidelines.aspx ), and shall involve the use of approved human embryonic stem cells (hESCs) or derivatives that are listed on the NIH Human Embryonic Stem Cell Registry ( http://grants.nih.gov/stem_cells/registry/current.htm ).

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  Sections II and III of the National Institutes of Health Guidelines for Research Using Human Stem Cells ( http://stemcells.nih.gov/policy/pages/2009guidelines.aspx ) apply specifically to human embryonic stem cells (hESCs).
  
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    Section II details the eligibility criteria used by NIH to determine if specific hESC lines are eligible for use in NIH-funded research.
    
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    Section III explains the responsibility of NIH-funding recipients to assure that hESCs used in NIH-funded research are approved by NIH.
    
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  Section IV sets limits on certain animal studies using all types of human pluripotent stem cells, including, but not limited to, those developed by methods such as the expression of genes involved in establishing pluripotency (e.g. the "Yamanaka factors") and the culturing of embryonic germ cells from primordial germ cells. Prohibited experiments include those in which the cells are introduced into non-human primate blastocysts and the breeding of animals in which the cells may contribute to the germ line.
  
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  Section V details other types of research not eligible for NIH funding: the derivation of stem cells from human embryos and research using hESCs derived from sources other than human embryos created using in vitro fertilization for reproductive purposes.

  Research involving the use of human embryonic stem cells, or derivatives, that are not listed on the NIH Registry may not be conducted with Federal funding. Derivatives include, but are not limited to, subclones of hESC lines, modified hESC lines (such as a line expressing green fluorescent protein), differentiated cells developed from hESC lines (such as muscle progenitor cells), and cellular materials (such as DNA, RNA, and proteins). Thus, no federal funds may be used for the generation of new data from unapproved hESC lines or derivatives. However publicly accessible data from unapproved lines or derivatives are not considered "derivative" and therefore not subject to this prohibition. Such publicly accessible data can be used and analyzed with federal funds.

  
   
  

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****(USE BELOW IN ALL SOLICITATIONS AND CONTRACTS FOR R&D REQUIREMENTS INCLUDING SBIRs.)****