If you think you are going to receive funding for new human embryonic stem cell (hESC) research, or intend to begin an internally funded hESC research project, complete and submit a new application to Embryonic Stem Cell Research Oversight (ESCRO).
Research Requiring Full vs. Minimal Review
Depending on the proposed research activities, your ESCRO application may receive either minimal or full review. The following table gives guidelines for the types of research that require minimal versus full review. The ESCRO Chair and/or Committee will make this determination.
- In vitro hESC research utilizing hESC lines that have been pre-approved for such use by the ESCRO Committee;
- In vitro hESC research utilizing hESC derived cell lines obtained from hESC lines that have been pre-approved for such use by the ESCRO Committee; and
- Other types of hESC research that the Vice Provost for Research has made a written determination, after due consideration of the likely risks and benefits of such research, that such categories are appropriate for minimal review.
The above excerpt was taken from GIM 36, Section V-D-3
- hESC research in which further human consent beyond that already obtained is required;
- Creation of a new hESC line or hESC derived cell line by any means, including through use of somatic cell nuclear transfer (SCNT), human zygotes, or a human embryo furnished by an in vitro fertilization clinic or other lawful source;
- Introduction of hESC into a nonhuman animal;
- Research in which personally identifiable information about the donor of hESC is readily ascertainable or may become known;
- Mixing human totipotent stem cells and pluripotent stem cells with pre-implantation human embryos;
- In vitro culture of an intact human embryo; and
- Breeding of an animal having hESC.
If your research qualifies for minimal ESCRO review, the review process will take approximately 2 weeks from the time ESCRO receives your application. The ESCRO Compliance Analyst will contact you through email and/or phone to communicate any findings that may need to be resolved within that 2 week period. After the ESCRO Chair has approved the research proposal, the ESCRO Compliance Analyst will email approved electronic copies of the ESCRO materials to the Principal Investigator and contact person’s email addresses.
The ESCRO Chair may determine that some ESCRO applications submitted for minimal ESCRO review require full ESCRO Committee review. The ESCRO Compliance Analyst will notify you through email and/or phone to inform you of this decision and its rationale.
If your new research potentially qualifies for full ESCRO review, please submit your proposal to ESCRO, ad hoc Committees are assembled as needed. If the ESCRO Committee identifies further issues that need clarification, formal correspondence will be sent to you through email identifying detailed Committee findings within 5 calendar days of the meeting date. The ESCRO Compliance Analyst will email approved electronic copies of the ESCRO materials to the Principal Investigator and contact person.
Please complete a new application form for any hESC research requiring ESCRO review. Links to FAQs relevant to each section of the application are embedded in the form.
To complete the ESCRO new application, you will need the following information:
- Contact information
- Name(s) of the hESC line(s) you plan to use
- Name, address, and contact information of the collaborator who provided the hESC line(s)
- Location of where the research will take place
- Short abstract describing the research
- Signatures of Department Head and School Dean
- Scientific portion of grant, if available
- In some cases, more detailed scientific description of activities
- Provenance documentation (if available)
If your research involves non-federally approved hESC lines, please complete the financial supplement.