human stem cell research, human embryonic stem cells, hESCs, hESC, NIH Human Embryonic Stem Cell Registry, office for human research protections, OHRP, human pluripotent stem cell research prohibited with NIH funding

4.1.13 Human Stem Cell Research

Under Executive Order 13505 NIH may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law. NIH Guidelines on Human Stem Cell Research, implement the Executive Order. The Guidelines apply to the expenditure of NIH funds for research using hESCs and certain uses of induced pluripotent stem cells.

For the purpose of the NIH Guidelines, "human embryonic stem cells (hESCs)" are cells that are derived from the inner cell mass of blastocyst stage human embryos, 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 hESCs are derived from embryos, such stem cells are not themselves human embryos.

NIH recipients may use hESCs that have been approved by NIH in accord with the NIH Guidelines and are posted on the NIH Human Embryonic Stem Cell Registry, or may establish eligibility of specific cell lines for NIH funding by submitting a Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research (NIH Form 2890). Prior to the use of NIH funds, applicants and recipients must provide assurances, when endorsing applications and progress reports submitted to NIH for projects using hESCs, that the hESCs to be used are listed on the NIH Registry and will be used in accordance with any restrictions associated with the line as cited on the Registry. If a specific line from the NIH Registry cannot be identified at the time of submission, the applicant/recipient must provide a strong justification why one cannot be identified at that time and a certification that one from the NIH Registry will be used.

DHHS regulations for Protection of Human Subjects, 45 CFR 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 CFR 46, Subpart A.

In addition, 45 CFR 46, Subpart A, may apply to certain research using hESCs. This regulation applies, among other things, to research involving individually identifiable private information about a living individual, 45 CFR 46.102(f). The HHS Office for Human Research Protections (OHRP) considers biological material, such as cells derived from human embryos, to be individually identifiable when they can be linked to specific living individuals by the investigators either directly or indirectly through coding systems. Thus, in certain circumstances, IRB review may be required, in addition to compliance with these Guidelines. Applicant institutions are urged to consult OHRP guidance at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html.

4.1.13.1 Human Pluripotent Stem Cell Research Prohibited with NIH Funding

The following uses of hESCs, even if derived from embryos donated in accordance with the NIH Guidelines and listed on the NIH Registry, or human induced pluripotent stem cells, are prohibited:

  • Research in which hESCs or human induced pluripotent stem cells are introduced into non-human primate blastocysts.
  • Research involving the breeding of animals where the introduction of hESCs or human induced pluripotent stem cells may contribute to the germ line.

In addition, the derivation of stem cells from human embryos is prohibited in NIH funded research by the annual appropriations ban on funding of human embryo research known as the Dickey Wicker Amendment. NIH funding for research using hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is also prohibited.

NIH will not fund any new or competing grant applications or contract proposals for research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos.

  • Current research funding: NIH will not consider requests for administrative supplements or revisions to any grants or modification to R&D contracts that include costs for or involve research introducing human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos. Ongoing NIH awards will be addressed with the awardees on a case-by-case basis.
  • Peer reviewed competing applications: Any grant applications previously submitted to the NIH and already reviewed (through both the initial and Council levels of review) which propose to introduce human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos will be held for funding decisions until NIH has issued a policy notification. At that time, highly ranked applications can be modified, as necessary, to comply with the policy notification to receive full consideration for funding.
  • Competing applications/contract proposals pending submission and/or peer review: NIH will not review applications or contract proposals for research proposing to introduce human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos until NIH has issued a policy notification.
  • Once the policy notification is released, applicants for grants that have not completed initial peer review will have the opportunity to submit additional post-submission material to comply with the policy notification. Provided that the additional material can be sent 30 days before the initial peer review meeting, those grant applications will be reviewed and considered for funding. See instructions and details.
  • Once the policy notification is released, offerors for R&D contract proposals shall not submit additional material or information addressing the issue related to this notice after the cutoff date for receipt of proposals, unless directed to do so by the Contracting Officer.
  • Applications that completed initial peer review before issuance of this Notice will not proceed to Council review at this time. R&D contracts that have completed peer review and have been determined to be in the competitive range before issuance of this Notice may proceed to negotiations.
  • Alternatively, applicants may withdraw the application and submit again at the next available due date.