Human Stem Cell Research

Submit New Stem Cell Project Application

February 10, 2017

  1. Complete the ESCRO New Application.
  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).
    • 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).
    • 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 WashU 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 WashU 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.