Forthcoming S2S Changes for NIH Human Fetal Tissue Requirements

Important Kuali changes for S2S NIH Submissions effective 9/25/19

NIH recently released clarification for the changes as announced in NOT-OD-19-137 regarding Human Fetal Tissue (HFT)* research. 

Summary of Kuali impacts: Research involving HFT must be designated in the Kuali budget even when costs will not be incurred and two new HFT required attachments should be added by your user as the proposal attachment type “Other.”

The Kuali code will be updated by 9/18/19.  I am writing today to help you plan for these changes in advance. An additional correspondence with instructions will be sent when the development changes are in production or available for self-hosted patches. There will be a change to the application code and one change to your current process for NIH submissions.

1. Kuali Application Change: RR_Budget and RR_Budget10 will be updated to include a new line #9 under the Other Section titled “Human Fetal Tissue Costs” this line will only populate in the RR Budget forms when the corresponding, (to be added with this development) object code is added in a proposal budget which is included for submission. This line MUST appear in any budget where research includes HFT, even if there is no corresponding expense. (See NIH Guide, “Other” Section in budget for details https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general/g.300-r&r-budget-form.htm#F ) The budget justification must also provide these details even where no expense is planned. *Note:  Kuali will do our best to provide this to you as seamlessly as possible, but it may require additional rates mapping for the new object code.  If that is necessary, we will provide additional guidance.
2. Process Change: Additional HFT attachment types must be specifically named and added in the Other Section of the RR Other Project Information form. Users must select the Proposal attachment type of “Other” and then add the description of either HFTSampleIRBConsentForm.pdf or HFTComplianceAssurance.pdf to each of the attachments. Both attachments MUST appear with that naming convention if HFT Research. 

*Human Fetal Tissue (HFT):  For the purposes of the requirements of this Notice, research involving HFT is defined as research involving the study, analysis, or use of primary HFT, cells, and derivatives, and human fetal primary cell cultures obtained from elective abortions and includes the following:

• human fetal primary or secondary cell cultures, whether derived by the investigator or obtained from a vendor.
• animal models incorporating HFT from elective abortions, including obtaining such models from a vendor.
• derivative products from elective abortion tissues or cells such as protein or nucleic acid extracts.
• any human extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi, if obtained from the process of elective abortion.