Activities that Require hSCRO Review
- Policy Statement
- Activities that may be permitted after review by the UCI hSCRO
- Activities that are not permitted and will not be approved by the UCI hSCRO
- CIRM Guidance
All research or clinical investigations that involve the use of pluripotent human stem cells shall be reviewed and approved by the UCI hSCRO before such activities are initiated by or for UCI. This review requirement applies to the use of human gametes and embryos (e.g., blastocysts), the derivation and/or use of human embryonic (hESCs) or fetal stem cells, induced pluripotent stem cells (iPS) derived from adult cells, any cells which can differentiate into a gamete, and any other human pluripotent stem cells.
It is not necessary to obtain hSCRO approval for adult tissue specific stem cells such as hematopoietic cells or mesenchymal cells unless such cells have been shown to, or are being induced to differentiate into the three major germ lines.
Activities that may be permitted after review by the UCI hSCRO:
- Generation of new lines of human pluripotent stem cells from whatever source and by whatever means.
- Use of human gametes, embryos or human adult, fetal or embryonic stem cells.
- Activities involving the introduction of human adult, fetal or embryonic cell lines into nonhuman animals at any stage of embryonic, fetal, or postnatal development; provided that investigators evaluate the probable pattern and effects of differentiation and integration of the human cells into the nonhuman animal tissues.
- Activities in which the identity of the donors of blastocysts, gametes, or somatic cells from which human stem cells were derived is readily ascertainable or might become known to the investigator.
NOTE: Activities that are reviewed and approved by the UCI hSCRO may require additional review by the UCI IRB, IACUC, IBC and/or COIOC committees.
Activities that are not permitted and will not be approved by the UCI hSCRO include, but are not limited to, the following:
- The culture in vitro of any intact human embryo, regardless of derivation method, after the appearance of the primitive streak or after 12 days whichever is earlier. The 12-day prohibition does not count any time during which the blastocysts and/or cells have been stored frozen.
- The introduction of human embryonic stem cells (hESCs) into nonhuman primate blastocysts and/or the introduction of any hESCs into human blastocysts.
- The breeding of an animal into which hESCs have been introduced at any stage of development.
- Introduction of hESCs into a human uterus or equivalent, or any experiments attempting human reproductive cloning.