All research that involves the use of human embryonic stem cells, human embryos, or their derivatives, must be reviewed and approved by the appropriate oversight committees (e.g., IRB, IBC, IACUC, Embryonic Stem Cell Research Oversight Committee [ESCRO]).
Human embryonic stem cell (hESC), as defined by the NIH: "A type of pluripotent stem cell derived from early stage human embryos, up to and including the blastocyst stage. hESCs 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."
See NIH Glossary for further definitions.
Embryonic Stem Cell Research Oversight Committee (ESCRO)
The ESCRO is an ad hoc committee managed by the Office of Research Integrity and Assurance (ORIA).
The ESCRO is responsible for the following:
- To assist investigators in assessing which regulations apply to proposed hESC Research activities;
- To ensure that the provenance of hESCs is documented, and that there was IRB approval of the procurement process in order to ensure adherence to the basic ethical and legal principles of informed consent and protection of confidentiality;
- To establish and maintain a registry of hESC Research, descriptive information about the types of research being performed, and the hESCs in use;
- To review evolving regulations and guidance;
- To ensure that all applicable hESC regulatory requirements are met and that hESC Research is conducted in accordance with the highest ethical standards.
Prior to the use of NIH funds, funding recipients should provide assurances, when endorsing applications and progress reports submitted to NIH for projects using hESCs, that the hESCs are listed on the NIH registry.
For guidance regarding applications proposing to use hESC see:
- hESCs approved for use under the NIH Guidelines for Human Stem Cell Research:
- Guidelines for Human Embryonic and Induced Pluripotent Stem Cells
- Clarification of Terms and Conditions of Awards using Human Embryonic Stem Cell; NOT-OD-10-029
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 pluripotent stem cells, i.e., human cells that 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 the cells may come from eligible sources, the following uses of these cells are nevertheless ineligible for NIH funding, as follows:
- Research in which hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells 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 these Guidelines) or human induced pluripotent stem cells 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 of human embryo research (Section 509, Omnibus Appropriations Act, 2009, Pub. 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, is not eligible for NIH funding.
On March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Executive Order stated that the Secretary of Health and Human Services, through the Director of 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. On July 7, 2009 the NIH issued its guidelines for the implementation of Executive Order 13505, as it pertains to extramural NIH-funded stem cell research. These guidelines were developed to “ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.”
Though the Obama administration has made possible broader funding for work with existing stem cell lines, the Dickey-Wicker Amendment still prohibits the federal government from funding any research that involves the destruction of human embryos, including the derivation of new stem cell lines. Therefore the NIH Guidelines specifically state that “prior to the use of NIH funds, funding recipients should provide assurances, when endorsing applications and progress reports submitted to NIH for projects using hESCs, that the hESCs are listed on the NIH registry .”
The National Academy of Sciences developed its first set of ethical standards for stem cell research in 2005. The guidelines were updated in 2007, 2008, and 2010.
The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit membership organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.