Human Stem Cell Research

Submit New Stem Cell Project Application

February 10, 2017

  1. Complete the ESCRO Application [DOC].
  2. Attach research plan (required)
    • For department funded research, attach a description of research significance and background, experimental design, and potential outcomes (see ESCRO Research Plan Template [DOC]).
    • For sponsored research, attach awarded grant application(s) that supports this research.
  3. If proposing to generate new hESC lines or use hESCs not on the NIH Registry
    • Provide documentation regarding
      • Procurement process to obtain specimens
      • Consent and reimbursement for donated materials
      • Compliance with legal requirements in relevant jurisdiction
      • IRB approval
  4. Attach a budget for this research (required)
    • For department funded research, attach an itemized list of expenses (see ESCRO Sample Budget Template [DOC]).
    • For sponsored research, attach budget for approved grant proposal
  5. Attach animal protocol (if applicable)
    • Does not need to be approved at this point
    • IACUC approval occurs after ESCRO approval
  6. Have your Department Chair (or designee) sign the ESCRO application (required)
  7. Email completed application and attachments to ORIE@wustl.edu
  8. Institutional Review Board (IRB)

Missouri Law requires all research using hESCs to receive IRB review, even if the research involves only anonymous cell lines

If your research uses only hESC line(s) on the NIH Registry

After receiving provisional ESCRO approval:

  • Log into myIRB
  • Complete a Non-Human Decision Form
  • Attach the ESCRO provisional approval letter and your complete ESCRO application

If your research uses hESC line(s) not on the NIH Registry or proposes to generate hiPSCs from human samples

  • Log into myIRB
  • Complete a New Project form or Modification (to add hESC/hiPSC)

  • ESCRO notifies IRB of provisional approval

9. Institutional Biological & Chemical Safety Committee (IBC)

  • Complete new IBC application or amend existing IBC approval to add work with hESC
  • IBC review may occur concurrently with ESCRO review
  • IBC approval is needed before ESCRO will give final approval

10. Material Transfer Agreements

  • A transferring agreement is required to receive material from another institution
  • Approval/authorization from the providing institution also may be required for internal transfers of hESCs between Washington University investigators
  • Contact the Office of Technology Management (OTM) for guidance on how to begin the process
  • MTAs are finalized after ESCRO approval is obtained

How long does it take to get ESCRO Approval?

  • New Applications – The WU ESCRO meets monthly. Review materials are circulated to committee members one week in advance of the meeting.
  • Renewals generally are approved within 1-2 days.