On March 9, 2009, President Barack Obama issued an Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The National Institutes of Health Guidelines for Human Stem Cell Research (Guidelines) implement this Executive Order as it pertains to extramural NIH-funded stem cell research. The Guidelines establish policy and procedures under which the NIH will fund research involving human embryonic stem cells (hESCs) and certain uses of human induced pluripotent stem cells (iPSCs) and work to ensure such research is ethically responsible, scientifically worthy and conducted in accordance with applicable law.
The University of Iowa is responsible for ensuring that all stem cell research conducted at or sponsored by the University complies with the Guidelines. Compliance authority on campus is placed with the Human Pluripotent Stem Cell Committee (hPSCC). The hPSCC reviews stem cell research and approves those projects in conformity with the Guidelines and in accordance with the general principles expressed in the Guidelines for Human Embryonic Stem Cell Research (National Academies’ of Science, 2005) and its subsequent amendments. The hPSCC is appointed by and advises the Assistant Vice President for Research Compliance.
Researchers at the University of Iowa must be in compliance with the Guidelines, irrespective of the source of funding.
Eligibility of Human Embryonic Stem Cells for Research
The eligibility of hESCs for research purposes is governed by the NIH. Researchers may use hESCs that are posted on the NIH Registry or they may establish eligibility for NIH Funding by submitting a compliance of assurance with Section II (A) of the Guidelines. The Institutional Review Board (IRB) will review the compliance of assurance and any part of a research project that meets the federal definitions of human subject research and/or clinical investigation.
Stem Cell Research Registration
Principal investigators (PIs) involved in stem cell research are responsible for:
- Reviewing the Guidelines.
- Completing a Human Pluripotent Stem Cell Registration Document (hPSCRD) and submitting this document to EHS’s Biosafety Office.
The University of Iowa follows the procedures and policies as outlined in the Guidelines and expressed in the Guidelines for Human Embryonic Stem Cell Research and its subsequent amendments. These
policies and procedures, and the review procedures of the hPSCC, are summarized in hPSCC’s Policy and Standard Operating Procedures.
Registration may be required with the Institutional Animal Care and Use Committee (IACUC) if the project involves animal use and/or with the Institutional Biosafety Committee (IBC) if the project involves recombinant DNA.
The hPSCC will review for compliance all submitted hPSC Registration Documents and an approval/disapproval letter will be sent to the PI. The hPSCC will prohibit the initiation of experiments that are ineligible for NIH Funding. Prohibited experiments include:
- The introduction of hESCs or human iPSCs into non-human primate blastocysts.
- The breeding of animals where the introduction of hESCs or human iPSCs may contribute to the germ line.
- The derivation of stem cells from human embryos.
- Research using hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or in vitro fertilization (IVF) embryos created for research purposes.
The hPSCC will review all correspondence between the PI, IRB, IBC, IACUC and NIH, where applicable, in addition to the hPSC Registration Document.
International Society for Stem Cell Research
International Society for Stem Cell Research – Stem Cell Treatments
National Institutes of Health Resource for Stem Cell Information
Office of Animal Resources – University of Iowa
eIBC – for Recombinant DNA Registration