Contract table of contents

ARTICLE H.21. RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES (Including Human Gene Transfer Research)

All research projects (both NIH-funded and non-NIH-funded) involving recombinant or synthetic nucleic acid molecules that are conducted at or sponsored by an entity in the U.S. that receives any support for recombinant or synthetic nucleic acid research from NIH shall be conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules ( NIH Guidelines ) available at: http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines ). All NIH-funded projects abroad that include recombinant or synthetic nucleic acid molecules must also comply with the NIH Guidelines .

The NIH Guidelines stipulate biosafety and containment measures for recombinant or synthetic nucleic acid research, which is defined in the NIH Guidelines as research with (1) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell, i.e. recombinant nucleic acids, or (2) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e. synthetic nucleic acids, or (3) molecules that result from the replication of those described in (1) or (2). The NIH Guidelines apply to both basic and clinical research. Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidelines .

Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of the contract for any work related to recombinant or synthetic nucleic acid research or a requirement for the Contracting Officer to approve any or all recombinant or synthetic nucleic acid molecule projects under this contract. This includes the requirement for the institution to have an Institutional Biosafety Committee (IBC) registered with the NIH Office of Science Policy that complies with the requirements of the NIH Guidelines . Further information about compliance with the NIH Guidelines can be found on the NIH Office of Science Policy website available at: http://osp.od.nih.gov /.
 

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

ARTICLE H.22. 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 THAT INCLUDE THE SALE OF RESEARCH SUBSTANCES AND/OR LIVING ORGANISMS. NOTES: Carefully read the OALM/OAMP/DAPE Guidance on the REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING ORGANISMS before including this Article in solicitations/contracts. Include the following attachments in solicitations/contracts when using this Article: Monthly Summary of Sales; Sample Recipient Invoice; NIH Pay.gov User Guide; and price list (optional for solicitation). The contract shall describe any relevant standards for the safety and use of the research substances and/or living organisms. This information must also be furnished to eventual recipients of such research materials before they are physically transferred. Where appropriate, recipients shall be required to execute an assurance certificate whereby they agree not to use the research substances and/or living organisms in any unauthorized or unsafe manner. Such assurances shall be obtained by the Contractor before the research substances and/or living organisms are shipped/transferred to the recipient and shall be forwarded to the Government and retained as part of the contract file. The Program Office shall perform an assessment of the nature of the research substances and/or living organisms to be made available to potential recipients to determine whether the contract should include a requirement to obtain a release and indemnification agreement from recipients (whether payment is requested or the substances/organisms are provided free of charge). If the Program Office determines that there is potential risk (e.g., risk of property damage or personal injury resulting from use of the research substances and/or living organisms), consultation with the General Law Division, Office of General Counsel, HHS, is recommended and language similar to that provided in Section F.4. of the Guidance should be incorporated into any resultant contract.