Quorum Policy:  The SCRO shall meet to approve motions only if a quorum is present.  A quorum consists of three members with expertise in ethics and legal issues, two members with biomedical research expertise, one non-affiliated community member, one compliance administrator, and one additional member.

The SCRO will review all research activities included in a project, including projects spanning several years. A protocol application will not be approved if any one of its component activities is prohibited at the time of review.

Each component project of a State of Connecticut Group or Hybrid grant will be reviewed and approved separately. Therefore each project leader should submit a separate SCRO protocol application.

The SCRO Chair or his/her designee will review the research application and assign the proposal to one of the five categories described below. The SCRO Chair will notify the researcher of the final result of the review process.

Research that is permissible after administrative review by the SCRO Chair or his/her designee applying both to hESC cells and iPS cells:

• Research funded by the State of Connecticut Stem Cell Fund not involving any human cells or tissues
• Research funded by the State of Connecticut Stem Cell Fund involving in vitro use of human adult stem cells derived from human fetal tissue, placental tissue, or cord blood.
• In vitro research limited to the development of a teratoma or teratomata to evaluate pluripotency.

Research that is permissible after approval through an expedited review which is conducted by two members of the SCRO committee designated by the SCRO Chair and who report their decision to the SCRO committee.

The category includes but is not limited to the following activities:

• In vitro research using pre-existing anonymous or coded hESC lines or their derivatives that does not involve the creation of embryos from gametes derived from hES cells or any of the categories of research noted below.

Research that is permissible after approval through a full committee review.

This category includes but is not limited to the following activities:

• Research funded by the State of Connecticut Stem Cell Fund introducing human adult stem cells or human stem cells derived from human fetal tissue, placental tissue, or cord blood into nonhuman animals at any stage of the animal’s development.
• Research introducing hES cells or their derivatives into nonhuman animals at any stage of the animal’s development.
• Research in which the identity of the human donor of embryos, gametes, or somatic cells for hESC research might become known to the investigator.
• Research to derive human embryonic stem cell lines from embryos originally created for reproductive purposes and which are no longer required for such purposes. Appropriate IRB approval must be obtained for the informed consent of the embryos and the value of the proposed research fully supported.
• Research to derive human embryonic stem cell lines using parthenogenesis or androgenesis requires IRB approval for donation of human gametes.

Research Requiring More Stringent Scientifc and Ethical Full Committee Review.

The ethically sensitive nature of research activities in this category requires a particularly compelling case to demonstrate that there is no less invasive or ethically problematic alternative and that this research has distinctive promise.  The scientific validity and ethical appropriateness of a research strategy may alter as the field advances, either increasing or decreasing.  Therefore research activites in this category may require evaluation periodically to determine their scientifc promise and ethical appropriateness relative to the current state of stem cell science. In no case shall any embryo or embryo-like entity be permitted to develop for more than 14 days or past the point of primitive streak development, whichever occurs first.

This category includes but is not limited to the following activities:

• Creation of human gametes or totipotent cells from pluripotent stem cells.
• Creation of human embryos for research purposes, including those created from gametes derived from human ESC or iPS cell lines.
• Introduction of hES cells or iPS cells or their derivatives into non-human prenatal animals.
• Introduction of hES cells or iPS cells or their derivatives into the brain or central nervous system of non-human animals.
• Human somatic cell nuclear transfer (SCNT) into enucleated non-human oocytes.
• Requires written procedures and practices to protect human oocyte donors;
• Requires refined SCNT techniques so that the fewest possible oocytes are needed;
• Requires stringent written policies and practices to ensure that derived embryos are used only for the intended research purpose.

Research that is prohibited at this time.

• Introduction of hESC cells into nonhuman primate blastocysts or any types of embryonic stem cells into human blastocysts.
• Breeding of an animal into which hESC cells have been introduced at any stage of development
• Implantation into any nonhuman animal or human of any intact human embryo or embryo-like entity created by nuclear transfer.
• In no case shall any human embryo or embryo-like entity be permitted to develop in vitro for longer than 14 days or past the formation of the primitive streak, whichever occurs first.