The purpose of this document is to describe the University of Washington’s policy, procedures, and expectations for assuring the compliant and ethical conduct of research involving human gametes, human embryos, human embryo models, and the development and study of human embryonic stem cells (hESCs) or human induced pluripotent stem cells (hiPSCs) and their pluripotent derivatives (“covered research”).
The University of Washington believes that such covered research is essential to expanding fundamental scientific knowledge of cellular and developmental human biology. The University has further concluded that such research presents significant potential for developing treatments for a large number of serious and debilitating human diseases and health conditions, including genetic diseases, tissue injuries, spinal cord injuries, developmental disorders, infertility, degenerative diseases such as heart disease, and various diseases of the nervous system and other organs.
It is the University’s policy to permit and encourage qualified investigators to engage in responsible and ethical covered research. This research must be conducted with appropriate oversight and in accordance with all applicable laws, rules, and regulations.
To ensure that covered research is conducted with the highest scientific and ethical integrity, the University of Washington believes that oversight of this sensitive area of research should be informed by international consensus. Therefore the University of Washington policy and guidelines for covered research are modeled after those of the International Society for Stem Cell Research (ISSCR), known as the ISSCR Guidelines for Stem Cell Research and Clinical Translation.
All covered research by University of Washington research personnel shall be subject to review, approval, and ongoing monitoring by the University’s specialized Human Embryo and Embryonic Stem Cell Research Oversight Committee (ESCRO Committee) responsible for evaluating the unique aspects of the science and the ethical considerations of the research.
- In vitro research utilizing hESC lines, including but not limited to those on the NIH Stem Cell Registry
- Generation of a new hESC line from a human embryo
- Creation of a human embryo for research purposes
- Generation of embryo models (e.g. gastruloids, blastoids, assembloids) that contain hESCs or hiPSCs
- Introduction of hESCs or hiPSCs into an animal
- Generation of gametes from hESCs or hiPSCs
- Generation of organoids from hESCs or hiPSCs that could contain human brain cells potentially capable of developing neural networks
This list of examples of research requiring ESCRO Committee review is not all-inclusive. Furthermore, these examples do not imply that the ESCRO Committee will necessarily approve a research project addressing these or other avenues of research. Approved research projects must conform to the ethical guidelines established by the University and must be scientifically justified.
In addition to ESCRO Committee review, some hESC research projects require review by the Institutional Review Board (IRB), the Institutional Biosafety Committee (IBC), the Radiation Safety Committee, the Institutional Animal Care and Use Committee (IACUC), and/or by other University committees, as applicable.
Examples of Research and other Activities Exempt from ESCRO Committee Review
- Research involving the use of naturally occurring adult stem cells (e.g., hematopoietic stem cells)
- Research using hiPSCs in vitro that does not involve the applications described under Examples of Research Activities Requiring ESCRO Committee Review
- Research involving the use of human cord blood that does not otherwise involve covered research
- Procedures conducted for clinical care that do not otherwise involve covered research, such as:
- Transplantation of stem cells as part of a recognized and accepted medical treatment for a disease or condition
- In vitro fertilization for reproductive purposes.
This list of examples of activities exempt from ESCRO Committee review is not all-inclusive. The investigator should consult the ESCRO Committee for clarification of the need for review.
Funding and facility considerations
According to current U.S. law, research that involves the fertilization of human oocytes or the destruction of human embryos for research purposes, including the derivation of human embryonic stem cell lines, may not be funded with Federal government funds. At the University of Washington, investigators conducting this type of research may do so with non-Federal funds, in facilities and with equipment paid for with non-Federal funds.
Research personnel conducting covered research must comply with applicable UW, NIH, and other policies, rules and regulations governing such activity, including GIM 36. It is the responsibility of the investigator to seek guidance from the ESCRO Committee and other applicable institutional committees when there is a question about the level and type of review necessary.
University Policy GIM 36 on Human Embryo Stem Cell Research is the governing policy for UW investigators and is based on the following guidance and policy:
- NIH Guidelines on Human Stem Cell Research
- Executive Order, March 9, 2009
- National Academies of Science (NAS) Stem Cell Information Guidelines and Amendments
- International Society for Stem Cell Research (ISSCR) Guidelines for Stem Cell Research and Clinical Translation
Investigators intending to conduct covered research should consult with the ESCRO Committee at the UW Office of Research regarding the research review process. The application form may be found at the UW ESCRO website.
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Office of Research
Details on changes to this GIM are available from the Office of Research (firstname.lastname@example.org), (206) 616-0804