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Review and Approval for Human Embryonic Stem and Induced Pluripotent Stem Cell Based Research:

 

In 2005, the CAB/ESCRO assumed the responsibility for review of human embryonic stem (hES) cell based research in the laboratory and in animals.  Recently, the scope of the Committee on Assessment of Biohazards and Embryonic Stem Research Oversight (CAB/ESCRO) has changed to address the recent changes in the regulations dealing with federal funding for hES cell based research and as the National Academy of Sciences Guidelines for Human Embryonic Stem Cell Research have been expanded and amended. The CAB/ESCRO now includes generation and use of induced human pluripotent stem (iPS) cells including the use of iPS cells in animals.  This latter responsibility, oversight of use of hES and iPS cells in animals, is shared with the Institutional Animal Care and Use Committee.  When the CAB/ESCRO reviews hES cell research involving the derivation of new hES cell lines, the committee membership is expanded to include all necessary expertise for the appropriate review and approval of the proposed research as outlined by the National Academy of Sciences (2008). 

All research involving generation and use of hES and iPS cells requires registration with the CAB/ESCRO.  Particular sections of the Biological Research Registration (BRR) form must be completed and submitted along with all required documentation prior to the initiation of any research project involving either hES or iPS cells.  If an investigator wishes to use hES cells that are not on the NIH Registry, the investigator must either amend their existing registration (BRR) or submit a Biological Research Registration for CAB/ESCRO review to cover this research. In either instance, a new registration (BRR) or an amendment, the investigator must also submit documentation showing that the derivation of the particular hES cells conformed to the NIH requirements for listing in the NIH Registry prior to CAB/ESCRO review of the registration document. Where derivation of new hES cells is proposed please contact the Biosafety Program at 2-3477 or email bsp@mit.edu for assistance. 


Investigators should be aware of the following CAB/ESCRO requirements for supporting documents for registration of research involving hES and iPS cells.  In addition information concerning generation and use of iPS cells is outlined below.

  • Federally Approved hES Cell Lines
    • Source of hES cells : commercial entity or investigator at another institution
    • Documentation of Source: Documentation or assurance from commercial source that the hES cells being sent are on the NIH Registry. If hES cells are from an investigator at another institution, the investigator must send a letter verifying that hES cells are on the NIH Registry or include the information outlined below for non-NIH registered hES cell lines.

  • Pre-Existing Non-Federally Approved hES Cell Lines
    • Source of hES Cell Line: commercial or investigator at another institution
    • Documentation of Source
      • Letter of assurance that hES cells were derived under an Institutional Review Board (IRB) approved process. Please include a copy of the informed consent document and approval letter from the IRB. It should be clear that there were no financial inducements in the embryo donation process; that the embryos were not created for research purposes; the identity of the embryo donors is not known to the MIT investigator.
      • Documentation needs to be on letterhead from the approving IRB and include the IRB OHRP assurance number.
    • MIT investigators must document that a source of non-federal funding for research involving these particular hES cells exists.
    • A plan must be developed to ensure separation of all supporting materials and equipment for work with all non-NIH registered hES cells. Please contact Biosafety Program (2-3477) for help with development of this plan.
    • Contact the Office of Sponsored Programs for information on funding issues surrounding research involving non-NIH registered hES cell based research.

  • Derivation of New hES Cells
    • Please contact the Biosafety Program at 2-3477
    • As noted above the CAB/ESCRO with additional expertise convenes for the review of this research. 
    • The investigator must submit a completed Biological Research Registration form plus all required approvals from all other Institute committees, for example the IACUC and IRB, as needed.  
    • Final approval for this research lies with the CAB/ESCRO and work may not commence without this final approval.
    • Investigators should be aware that NIH will not fund the derivation of new hES cells.  Non-federal sources of funding must be in place prior to CAB/ESCRO approval.

  • Derivation of iPS cells
    • The source of the human tissue or cells must be outlined in the Biological Research Registration.  It must be clear that the identity of the donor is protected. This material falls under the OSHA Bloodborne Pathogen Standard and additional safety information and training will also be needed.
    • The proposed methods for generation of the iPS cells must be outlined in the BRR.

  • Use of hES and iPS cells in Animals
    • No animal into which hES or iPS cells have been introduced at any stage of development should be allowed to breed.
    • Experiments in which hES cells, their derivatives, or other pluripotent cells are introduced into nonhuman fetuses and allowed to develop into adult chimeras will be reviewed by the CAB/ESCRO.  Careful consideration will be given to the extent of human contribution to the resulting animal. Consideration of any major functional contributions to the brain would be a main focus of any review.  

  • hES and iPS Cell Research that is not permitted
    • Research involving the  culture of any intact human embryo, regardless of derivation method.
    • Research in which hES or iPS cells are introduced into nonhuman primate blastocysts or in which any embryonic stem cells or other pluripotent cells are introduced into human blastocysts.

     

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