Section 18: Stem Cell Research
18.1 Human Embryonic Stem Cells (See Section 2: Definitions)
18.1.1 Applicable Guidance, Regulations, and Laws
In March 2009, previous restrictions for use of federal funding for human embryonic stem cells (hESC) derivation and research were removed and/or reduced by the President. In order to facilitate research using hESC, the National Institute of Health (NIH) created a Human Embryonic Stem Cell Registry listing those lines that are eligible for use in NIH funded research.
The NIH has updated and published “Guidelines for Human Embryonic Stem Cell Research” that offers a set of ethical standards for performance for research with hESC.
All clinical research involving stem cell-derived test articles is subject to US Food and Drug Administration (FDA) regulations at 21 CFR Parts 312 and 812, regardless of the source of funding. This research is also subject to FDA’s IRB and informed consent regulations at 21 CFR Parts 50 and 56. Clinical investigations involving the transplantation of cells or test articles derived from hESC or fetal tissue into human recipients is subject to Public Law 103-43, “Research on Transplantation of Fetal Tissue”. Other federal, state, or local laws may also apply to transplantation or other research involving these cells or test articles.
18.1.2 Human Embryonic Germ Cells Derived from Fetal Tissue
Research involving the derivation or utilization of human embryonic germ cells from fetal tissue must also comply with the fetal tissue transplantation research statutes and may be conducted with federal funding support.
Research deriving or utilizing human embryonic germ cells from fetal tissue should comply with the informed consent law applicable to fetal tissue transplantation research. The informed consent process should inform potential donors, pursuant to making the decision whether to donate fetal tissue for research purposes, with the following information:
- A statement that fetal tissue will be used to derive human pluripotent stem (hPS) cells for research that may include human transplantation research.
- A statement that the donation is made without any restriction or direction regarding the individual(s) who may be the recipient(s) of transplantation of the cells derived from the fetal tissue.
- A statement as to whether or not information that could identify the donors of the fetal tissue, directly or through identifiers linked to the donors, will be removed prior to the derivation or the use of hPS cells.
- A statement that derived cells and/or cell lines may be kept for many years.
- A disclosure of the possibility that the results of research on hPS cells may have commercial potential, and a statement that the donor will not receive financial or any other benefits from any such future commercial development; and
- A statement that the research is not intended to provide direct medical benefit to the donor.
18.1.3 Ineligible Research Involving hESC or Human Induced Pluripotent Stem Cells
- Research in which hESC (even if derived from embryos donated in accordance with federal guidelines) or human induced pluripotent stem cells (hiPSC) are introduced into non-human primate blastocysts.
- Research involving the breeding of animals where the introduction of hESCs (even if derived from embryos donated in accordance with federal guidelines) or hiPSC may contribute to the germ line.
Other Research Not Eligible for NIH Funding
- NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding human embryo research (Section 509, Omnibus Appropriations Act, 2009, Prb. L. 111-8, 3/11/09) otherwise known as the Dickey amendment.
- Research using hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes.
18.2 Research with Adult Stem Cells
Generally, the collection or derivation of human multi-potent and pluripotent stem cells from sources other than embryos does not involve the same issues as encountered with hESC and is subject to the guidance and regulations for sampling any tissue from human research subjects. The use of the cells, however, may raise ethical issues similar to those encountered with hESC. The National Academies Press guide for hESC research contains a section on non-embryo derived hPS cells and lists several considerations when working with adult stem cells.
18.3 IRB Review Requirements
The following criteria apply concerning the requirement for IRB review of proposed research:
- In vitro research involving stem cells from which the identity of the donor cannot readily be ascertained by the investigator is not considered to be human subjects research and is not subject to IRB review. This assumes that the investigator and research institution do not have access to private information related to the cell line and that the holder of the identifiable private information related to the cell line has agreed that such information will not be released.
- Research involving cells that have already been derived and established, where the donor may be identified, including cells that retain links (such as a code) to identifying information, is considered to be human subjects research and is required to undergo IRB review and approval.