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    Ethical Guidelines and Review Policies

    The University of Connecticut SCRO’s Policies and Guidelines for Human Stem Cell Research are consistent with the Guidelines for Human Embryonic Stem Cell Research (2005) and the Amendments to that document published by the National Research Council and the Institute of Medicine of the National Academies of Science and with Connecticut Gen.Stat.19a-32d to 19a – 32g. They are also informed by the guiding ethical principles below.

     Guiding Ethical Principles for Human Stem Cell and Other

    • Respect for human dignity and the inherent value of human life provide the basis for the following principles:• Promotion and protection of human health and well-being.
    • Respect for personal autonomy and self-determination.
      • Commitment to voluntary and informed consent by all donors of human tissues.
      • To prevent undue inducement there should be no financial incentives or direct or indirect payment for tissues or gametes for the expressed use in stem cells.
    •  Respect for donor privacy and confidentiality.
    • Respect for freedom of inquiry and the value of knowledge.
    • Respect for the diversity of moral positions regarding human embryonic stem cell (hESC) research.
    • No human embryo or embryo-like entities may be allowed to develop past 14 days or past the development of the primitive streak, whichever occurs first.
    • Human embryonic and pluripotent stem cell research may be undertaken only with a strong rationale in terms of its potential contribution to biomedical knowledge and human health and only in conformity with best research practices.

     ESCRO Review and Approval of Stem Cell Research

    Investigators must obtain SCRO approval prior to conducting any research that uses human embryonic stem cell lines or is directed at deriving human pluripotent cell lines using human embryos, gametes, or somatic cells. In addition, researchers seeking funding from the State of Connecticut Stem Cell Research fund must submit their proposals for ESCRO review, even if the proposals do not use human embryonic stem cells or are not directed at deriving human pluripotent cells.

     SCRO Protocol Criteria

    In order for a research project to be approved, investigators must submit a protocol application form and supporting documentation to the Chair of the SCRO showing that the following conditions are satisfied

    1.  All human tissues and hESC cell lines have been obtained with informed, voluntary consent. (See the SCRO website for all hESC lines previously approved by the SCRO and the list of the lines banked by the UC Stem Cell Core.)
    2.  All mandated reviews and approvals have been obtained from the Biosafety Committee, Animal Use and Care Committee, and the Institutional Review Board. The IRB must review research where there is any interaction or intervention with a living individual and information about that individual or tissue from the individual is obtained. Research involving access to Protected Health Information is also subject to HIPAA guidelines.
    3.  The project has clear objectives for advancing scientific knowledge to benefit human health.
    4.  There is a clear rationale for the experiments in relation to the research objectives.
    5.  The appropriate supporting background work has been completed either by the investigator or by other researchers. E.g. preliminary animal studies have been completed.
    6. Alternative methods for achieving the research objective that may be less ethically problematic have been evaluated and the chosen method shown to be preferable.
    7. The introduction of any human cells into nonhuman animals is necessary to achieve the research objectives, and, if applicable, there is an appropriate plan for monitoring the impact of the hESC on the animal’s behavior.
    8. The numbers of human embryos and gametes required for the research are the fewest necessary to achieve the research objectives.
    9. The Principal Investigator has implemented a system for ensuring that only authorized personnel have access to the human tissues and cells, enforcing a transparent tracking system in the lab for all human tissues and cells, and ensuring that all personnel have scientific and compliance training appropriate to their tasks.