Research
Categories of hES Cell Research
Category I -- in vitro work with pre-existing coded or anonymous hES cell lines.
Category IIa -- work involving the derivation of new hES cell lines;
Category IIb -- work that introduces hES cells into nonhuman animals;
Category IIc -- hES cell work in which personally identifiable information about the embryo, oocyte, or somatic cell donor is readily ascertainable by the investigator.
Research involving hESC -- Investigator's Responsibilities
All Wesleyan faculty, staff, and students proposing research involving hES cells must submit an Application for ESCRO Committee Approval (link). The application requires that investigators:
1. Clearly identify which category of hES cell research is being proposed.
2. Provide documentation of the provenance of the hES cell lines. If lines other than NIH approved and coded lines are used, documentation must include evidence that the procurement process was approved by an IRB with specific evidence that principles of informed consent and protection of confidentially were followed.
3. Provide evidence of compliance with any required IRB, Institutional Animal Care and Use Committee, and other mandated institutional reviews.
4. Investigators proposing Category II research must also provide additional information and documentation depending on the type of Category II work proposed.
For Category II a -- Provide scientific rationale for the need to generate new lines; Justify the basis for the numbers of embryos or oocytes needed; Identify and address ethically sensitive issues raised
For Category IIb -- Describe the non-human animal used and the stage of development (embryonic, fetal, or postnatal) when hES cells will be introduced; Describe the probable pattern and effects of differentiation, integration, and/or migration of the human cells with the non-human animal tissue; Identify and address ethically sensitive issues raised
For Category IIc -- if private personally identifiable information about the donor is readily ascertainable by the investigator, IRB approval for the use of material from identifiable donors must specifically address the process by which informed consent was obtained and confidentiality waived.
Impermissible hES cell research
The ESCRO will not approve the following types of research at this time:
a. Research involving in vitro culture of any intact human embryo, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first;
b. Research involving the introduction of embryonic stem cells obtained from any species (including humans) into human embryos;
c. Breeding of animals in which human embryonic stem cells have been introduced at any stage of development.