UW Research

September 3, 2019

NIH: Human Fetal Tissue Research – Clarifications and FAQs published

The NIH announced clarifications and FAQs for the new Human Fetal Tissue (HFT) research requirements effective 9.25.19.

In addition to accounting for HFT research in the budget and budget justification, it must be addressed in the cover letter, research plan, and applicants must also:

  • Include two attachments in the “Other Attachments” section of the R&R Other Project Information form (HFT Sample IRB Consent Form, HFT Compliance Assurance)
    • HFT Sample IRB Consent Form:
      • The UW Human Subjects Division will post an IRB-approved consent form that can be used for this purpose, by September 19th.
      • Search for consent in Forms and Templates. The new consent form will be called TEMPLATE: Consent Form, Fetal Tissue Research.
    • HFT Compliance Assurance:
      • A a letter signed by the PI attesting to compliance with specific consent-related requirements outlined in the NIH policy.
  • Include specific info in the Research Strategy attachment regardless of whether Human Subjects research is proposed or not.

If you are planning to submit a proposal with HFT research on or after 9.25.19 please follow the NIH guidance. NIH will NOT review applications that do not address all of the required information, including the detailed budget.

NIH Guidance:

NOT-OD-19-128 – Requirements Regarding Proposed Human Fetal Tissue Research
NOT-OD-19-137 -HFT Clarification & FAQs published
NIH Grants Policy Statement Human Fetal Tissue Research 4.1.14
NIH: NOT-OD-16-033 – Informed Consent for Human Fetal Tissue Research
HHS June 5, 2019 Statement

7.31.19 UW Announcement on HFT Research Requirement