NEW NIH HMS Research FETAL TISSUE Administrators Open Forum - - PowerPoint PPT Presentation

NEW NIH FETAL TISSUE REQUIREMENTS

HMS Research Administrators Open Forum October 9, 2019

Broader Definition of Human Fetal Tissue (HFT)

The new NIH Requirements APPL PPLY to HFT

• btained from elective a

abortion

• ns. HFT is

defined to include:

• human fetal pri

primary or

• r se

secondary c cell culture res, whether derived by the investigator

• r obtained from a vendor.
• animal m

models s incorporating HFT.

• derivative products such as pr

protein or

• r

nucl cleic a c acid extract acts.

• any human extra-embryon
• nic c

cells s and t tissu ssue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi The new NIH Requirements DO N NOT OT apply to:

• Materials NOT

OT derived from an elective abortion

• embryonic stem cells or embryonic cell lines,
• r
• already-established (as of June 5, 2019)

human fetal cell lines

What is Required?

■ Scientists submitting grants that involve HFT will be subject to review by a federal ethics panel and required to: – Provide a justification for the use of HFT and explain why other tissue types cannot be used, – Demonstrate that HFT donations were made through a more robust informed consent process than previously required, – Explain where the researchers plan to get the HFT, and – Provide written assurances that the

• riginal donation of HFT complied

with new NIH requirements

Who will be impacted?

■ PIs submitting competing grant applications involving the use of HFT for due dates on or after September 25, 2019 ■ PIs that add the use of HFT to on-going grants ■ NIH currently funds roughly 200 projects that use fetal tissue. ■ The expanded definition may impact PIs who were not previously considered to be conducting HFT research—e.g. – PIs using humanized mice that they receive from a vendor – PIs using umbilical cord tissue, cord blood, placenta,

• r amniotic fluid in their research

– PIs using derivative products such as protein or nucleic acid extracts

Potential Impacts

Delays in funding or potential non-funding of projects within a fundable score range Challenges in meeting page limitations Challenges in providing required assurances (PI and and Institution) Challenges in demonstrating when the requirements do not apply Addition of research involving HFT is considered a change in scope, requiring a competing revision application and compliance with new requirements, even for currently funded projects.

QUESTIONS?