Review And Approval
Prior to the use in research for the covered cell types, investigators should submit an application to the Northwestern University Committee on Human Stem Cell Research (NUCHSR). Submit completed forms to email@example.com. The Office for Regulatory Affairs (ORA) will notify you when the form is received. ORA will also inform you if and when the application is approved. Examples of activities requiring NUCHSR review include but are not limited to:
- Creation of a new hESC line by any means, including through use of stem cell nuclear transfer (SCNT), human zygotes, spindle transfer, or a human embryo furnished by an in vitro fertilization clinic or other lawful source;
- Payment to a donor solely for the purpose of creating a human embryo to be used in hESC research;
- Research in which personally identifiable information about the donor of the blastocysts, morulae, gametes, or somatic cells from which the hESCs or iPSCs were derived is readily ascertainable or might become known to the investigator;
- Research using NIH ineligible hESC lines that have not been pre-approved for such use by the NUCHSR;
- iPSC research that includes experiments designed or expected to yield gametic cells and tissues;
- Mixing human totipotent stem cells or iPSCs with pre-implantation human embryos. In no case shall such experiments be allowed to progress for more than 14 days of development in vitro, or past the point of primitive streak formation, whichever is first;
- Clinical research in which cells of human totipotent or pluripotent stem cells or iPSCs are transplanted into living human subjects. In no case shall such research involve implantation of human totipotent or pluripotent stem cells into a human uterus;
- In vitro culture of an intact human embryo;
- Research that generates animal chimeras using human cells, including, but not limited to, introducing hESCs, human totipotent stem cells or iPSCs into animals other than humans or primates at any stage of embryonic, fetal, or postnatal development; and
- Research that involves the introduction of hESCs into non-human primates at any stage of fetal or postnatal development.
- Gene editing in human embryos or hESCs up to 14 days.