Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

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Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research
Notice Number: NOT-OD-19-128
Release Date: July 26, 2019
The purpose of this notice is to inform the extramural research community of upcoming HHS requirements and review considerations regarding research that is supported by the NIH and involves the proposed use of human fetal tissue obtained from elective abortions (HFT) in extramural applications for grants, cooperative agreements and R&D contracts. These requirements are in addition to the existing requirements as detailed in the NIH Grants Policy Statement (4.1.14). In addition, NIH reminds the community of expectations to obtain informed consent from the donor for any NIH-funded research using HFT (NOT-OD-16-033).
Currently, when an application/proposal for research involving HFT is submitted to NIH, the Authorized Organizational Representative’s (AOR) signature certifies that researchers using these tissues are in compliance with sections 498A and 498B of the Public Health Service (PHS) Act and the NIH Grants Policy Statement.

NIH is implementing requirements regarding the documentation of the use of HFT in research, as NIH does with other research materials and models, to ensure that it is utilized for research only when scientifically justifiable, and in the least amount possible to achieve the scientific outcomes. NIH will require applicants and contract offerors to provide detailed information addressing the use of HFT in applications/proposals and reports. These requirements are designed to enable NIH to assess whether extramural research applicants/contract offerors and recipients/awardees/contractors are adequately assuring compliance with all applicable laws and HHS/NIH policies concerning the acquisition and use of HFT obtained from elective abortion.

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