Application Submission & Review Process
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 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 two 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 two-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.
Application Preparation Instructions
To complete the ESCRO new application download the ESCRO Application Form. (Links to FAQs relevant to each section of the application are embedded in the form.)
Gather required 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)
Submit ESCRO Forms
Submit completed ESCRO forms electronically to firstname.lastname@example.org in either of the following formats:
- MS Word Format If you would like ESCRO to make minor corrections to completed forms after consulting with you, please send an MS Word version of the application along with a scanned (PDF) copy of the signature page. Alternatively, you can also submit the signature page by fax at 206-685-9210 or hard copy to UW Box 351202.
- Adobe PDF Format If you would prefer not have ESCRO make minor corrections or edits after submittal, please email the entire completed application in PDF format to email@example.com.
Amendments to Existing Applications
The two types of amendments to an ESCRO application, significant and not significant, involve different levels of oversight by the ESCRO committee.
Significant amendments involve substantive changes. For example, if you are proposing changes to methodology, objectives, or source of cell lines, these are considered substantive changes and would require a formal amendment form to be filed. Amendments can be filed to an existing project independently or with renewals.
Not significant amendments
Not significant amendments do not require a formal amendment form but do need to be reported at the time of renewal in applicable sections of the renewal. Examples of these types of amendments include personnel changes, facilities changes, contact phone number changes. Including not significant amendments in a formal amendment form will be accepted by the ESCRO office but is not required.
Full vs. Minimal Review
Depending on the nature of the proposed amendment, it may receive full or minimal ESCRO review. If an amendment requires full ESCRO review, it will be placed on the next respective ESCRO Committee meeting agenda. The ESCRO Compliance Analyst will inform you of the type of review by email. Once the amendment is finally approved, the approval information will be posted in the “approval status” section of the ESCRO website. Approval documents will be sent to you through email.
The rule of thumb regarding whether an amendment should be submitted as a new ESCRO submission should be based on whether your existing proposal in which two of the proposal’s core features* might change.
*Core features: Purpose, source of cells, or methods
Complete an Amendment form for any hESC research involving significant changes to existing ESCRO approved hESC research. (Links to FAQs relevant to each section of the application are embedded in the form.)
A Financial Supplement is required if the research involves non-federally approved hESC lines.
Renewals & Annual Surveys
Both Renewals and Annual Surveys are used to capture data regarding hESC lines here at the UW. Relevant forms will be emailed to PIs by the ESCRO Compliance Analyst, with some information already completed. Renewals require ESCRO review and are requested at least every three years; however, annual surveys do not require ESCRO review and are requested annually.
The default approval period for ESCRO review is three years; however, if the ESCRO committee identifies further risks or other concerns, the approval period may expire sooner and thus require renewal sooner.
The ESCRO Office will send a reminder email to the PI and contact person informing them when their current ESCRO record will expire. This notice will be sent four (4) months prior to the expiration date of each respective ESCRO record. Attached to the email will be a renewal form with a financial supplement if the ESCRO record involves federally-disapproved hESC lines. These forms will contain some prefilled information using current data on file with the ESCRO office. Examples of prefilled information include contact information, financial information if applicable, and information related to hESC lines. Renewal forms will not be available on the ESCRO website, since these are routed by the ESCRO Compliance Analyst.
Minimal Review (renewals)
If your existing research project requires minimal ESCRO review, the ESCRO office requests that you submit the completed renewal form no later than 30 days prior to the expiration date. After the ESCRO office receives the completed renewal, the ESCRO Compliance Analyst will contact you through email and/or phone to communicate any findings that may need resolution. After the ESCRO Chair has approved the research project, the approved electronic copies will be sent to the Principal Investigator’s and contact person’s email address.
Full Review (renewals)
If your existing project requires full ESCRO review, the ESCRO office requests that you submit the completed renewal form by the submission deadline date listed in the notice so that the project is reviewed at the next convened ESCRO Committee meeting. 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. Approved electronic copies will be sent to the Principal Investigator’s and contact person’s email address.
The ESCRO office is charged with maintaining data on existing hESC lines created here at the UW and maintaining that data in an ESCRO registry. Additionally, the registry will capture which hESC proposals use federally-allowable hESC lines and federally-unallowable hESC lines.
The annual survey is a vehicle that the ESCRO office will use to collect real-time information from PIs regarding hESC lines for administrative purposes only. The ESCRO Compliance Analyst will email annual surveys to PIs annually.
No ESCRO approval is needed for annual surveys
However, PIs will be reminded at the time of the annual survey that any significant amendments that may occur to their ESCRO record must receive ESCRO review and approval prior to implementing the amended procedures.