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Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (2010) / Chapter Skim
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Appendix A: National Institutes of Health Guidelines for Research Using Human Stem Cells
Pages 9-16

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From page 9...
... 46, Subpart A establish safeguards for individuals who are the sources of many human tissues used in research, including non-embryonic human adult stem cells and human induced pluripotent stem cells. When research involving human adult stem cells or induced pluripotent stem cells constitutes human subject research, Institutional Review Board review may be required and informed consent may need to be obtained per the requirements detailed in 45 C.F.R.
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From page 10...
... Applicant institutions are urged to consult OHRP guidances at http:// www.hhs.gov/ohrp/policy/index.html#topics. To ensure that the greatest number of responsibly derived hESCs are eligible for research using NIH funding, these Guidelines are divided into several sections, which apply specifically to embryos donated in the U.S.
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From page 11...
... Applicant institutions proposing research using hESCs derived from embryos donated in the U.S. on or after the effective date of these Guidelines may use hESCs that are posted on the new NIH Registry or they may establish eligibility for NIH funding by submitting an assurance of compliance with Section II (A)
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From page 12...
... Specifically: i. Decisions related to the creation of human embryos for reproductive purposes should have been made free from the influence of researchers proposing to derive or utilize hESCs in research.
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From page 13...
... B Applicant institutions proposing research using hESCs derived from embryos donated in the U.S.
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From page 14...
... 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 pluripo tent stem cells, i.e., human cells that are capable of dividing without differentiating for a prolonged period in culture, and are known to de velop into cells and tissues of the three primary germ layers.
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From page 15...
... 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.
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Key Terms

  • nih funding
  • human embryos
  • using hescs
  • research purposes
  • induced pluripotent

  • embryos donated
  • human induced
  • pluripotent stem
  • embryonic stem
  • hescs derived

  • primary germ
  • reproductive purposes
  • germ layers
  • reproductive treatment
  • applicant institutions

  • effective date
  • using human
  • human embryonic
  • stage human
  • proposing research

  • adult stem
  • institutions proposing
  • sought reproductive
  • donated outside
  • pluripotent cells

  • individually identifiable
  • voluntary written
  • nevertheless ineligible
  • written consent
  • establish eligibility


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