- Significant Amendments
- Not-Significant Amendments
- Full vs. Minimal Review
- Amendment Form
- Financial Supplement
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
Please 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.
If your research involves non-federally approved hESC lines, please complete the financial supplement.