The forthcoming revision of the NIH Grants Policy Statement (NIHGPS), effective for all NIH grants and cooperative agreements from its November release, introduces several significant changes aimed at aligning policy with recent legal, statutory, and regulatory updates. The revised statement will replace the previous version (dated March 31, 2015) and will clarify and modify requirements across multiple domains, including genomic data sharing, application compliance, informed consent for research, and reporting of clinical trial results. Notably, the updated policy emphasizes the mandatory inclusion of genomic data sharing plans in relevant grant applications, reiterates the NIH’s authority to withdraw non-compliant applications, and clarifies that results must be reported to ClinicalTrials.gov even after a study's period of performance has ended.
Further modifications address legal compliance and administrative processes, including the reclassification of guidance on human fetal tissue research as a regulatory requirement and the reduction of administrative burden by permitting reductions in effort during a no-cost extension without prior NIH approval. Important procedural updates include expanded requirements for prior NIH approval in cases involving changes to human subject involvement, provisions permitting the transfer of controlled-access genomic data to cloud storage under the Genomic Data Sharing Policy, and a new mandate that recipients report inventions electronically via iEdison. Collectively, these changes are designed to increase clarity, promote compliance, and streamline grant management processes in line with evolving NIH priorities and regulations.
