#  Submission Process 

 



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### **New Protocols**

Submit the following materials with a new protocol:

- *ESCRO Application*, available on the Forms Page
- Research Plan
- If human subjects or identifiable human material:
    - IRB approval
    - consent form(s) that include all the ESCRO-required items (or an explanation for any that are missing)
    - any other materials used in the course of the study, e.g., recruiting materials, letters to subjects, protocol forms
- If animal subjects:
    - IACUC approval (e.g., signed protocol face page)
    
    Note: IACUC materials are *not* required if all you are doing is generating teratomas to test for pluripotency.
- ESCRO, IRB, and IACUC applications and approvals (including approved consent form) from all collaborating schools/institutions
- [COMS](http://www.hms.harvard.edu/orsp/coms/index.htm) Approval Letter

### **Annual Renewals**

Submit the following materials with an annual renewal:

- *Progress Report Form*, available on the Forms Page
- Any new materials not previously reviewed
- Any materials that have changed, including the Research Description, recruiting materials, consent forms, etc.
- Documentation of any approvals that have expired or will expire in the near future, including IRB, IACUC, or collaborator approvals (Note: Documentation of COMS approval is only required if changes were made.)
- Any other materials, as directed by the Progress Report Form