Information for potential applicants of RFA-MH-20-140 about generating models of the developing human nervous system

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A recently issued BRAIN notice of funding opportunity (RFA-MH-20-140) targets development and validation of advanced human cell-based assays to model brain structure and function. Potential applicants may appreciate clarity on how the HHS policy on research involving human fetal tissue obtained from elective abortions may affect proposed research.

As was previously announced, NIH recently issued a new request for applications (RFA-MH-20-140) [Research to Develop and Validate Advanced Human Cell-Based Assays To Model Brain Structure and Function (R01 Clinical Trial Not Allowed)]). The purpose of this BRAIN RFA is to stimulate basic research to develop next-generation, human cell-derived assays with improved fidelity to complex human brain, spinal cord, and/or organ circuit physiology, which will ultimately facilitate analysis of higher order functional deficits relevant to complex nervous system diseases. The intent is to fund the development of human tissue models that closely mimic and can be used to faithfully model aspects of human biology, but that do not rely on the use of human fetal tissue obtained from elective abortions (HFT). Because the application deadline (November 1, 2019) falls after the publication of a recent NIH Guide Notice regarding the proposed use of HFT, potential applicants may appreciate clarity on how the HHS policy may affect proposed research using HFT.

This RFA encourages innovative approaches that are first-in-class, those that propose to substantially exceed what we know in tissue organization and function, and/or those that aim to improve robustness and reproducibility of circuit or systems-level measures. High risk, high impact approaches are encouraged. The applications should define the current state of technology as a benchmark against which the new assay system(s) will be developed and measured.

In developing human tissue models that mimic but do not use HFT, these examples would be exempt from the HHS policy:

  • Human cell cultures, derivative human products (e.g., DNA, RNA, protein), and extra-embryonic human cells and tissues that were not derived from an elective abortion
  • Already-established human fetal cell lines established prior to June 5, 2019
  • Human fetal cells present in maternal blood or other sources
  • Human embryonic stem cells or human embryonic cell lines
  • Research on transplantation of HFT into humans for therapeutic purposes

Please refer to the NIH Guide Notice for research proposing the use of HFT.

Applications for this RFA are due November 1, 2019. Anyone interested in applying with further questions may contact the program officer for this NOFO, Dr. David Panchision (panchisiond@mail.nih.gov).

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