The Review Process

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

1. Research that is permissible after administrative review by the ESCRO Chair or his/her designee
   
   
   • 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.


2. Research that is permissible after approval through an expedited review which is conducted by two members of the ESCRO committee designated by the ESCRO Chair and who report their decision to the ESCRO committee. The category includes but is not limited to the following activities:
   
   
   • Research using pre-existing anonymous or coded hESC lines or their derivatives in vitro that does not involve the creation of embryos from gametes derived from hES cells.


3. 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.)


4. 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:
   
   
   1. Creation of human embryos for research purposes, including those created from gametes derived from hESC lines
      • Requires IRB approval for any gamete donation
   
   
   2. Human somatic cell nuclear transfer (SCNT) into Enucleated Non-Human Oocytes
      
      
   3. Human SCNT into Enucleated Human Oocytes
      • Requires written procedures and practices to protect human oocyte donors
      • Requires refined SCNT techniques that reduce the quantity of required oocytes
      • Requires stringent written policies and practices to ensure that derived embryos are used only for the intended research purpose


5. 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.