The forthcoming revision of the NIH Grants Policy Statement (NIHGPS), scheduled for release in November, introduces several significant updates applicable to all NIH grants and cooperative agreements awarded from the revision date onward. This updated policy statement supersedes the previous 03/31/2015 version and integrates new statutory, regulatory, and policy changes, aiming to clarify existing policies and reflect recent legal and procedural developments.
Key changes include enhanced requirements for genomic data sharing, such as the expectation for applicants generating large-scale genomic data to provide sharing plans and to adhere to NIH data use codes. The revised policy reiterates NIH’s authority to withdraw non-compliant applications, clarifies persistent obligations for ClinicalTrials.gov results reporting beyond the period of performance, and updates provisions regarding informed consent for research using newborn screening blood spots. It strengthens the regulatory nature of requirements related to human fetal tissue research and reduces administrative burden by allowing effort reductions during no-cost extensions without prior approval. The update also expands definitions regarding changes in human subjects research, enables data transfer to cloud environments under the Genomic Data Sharing Policy, and mandates electronic reporting of inventions via the iEdison system. Collectively, these changes reinforce NIH’s commitment to data sharing, regulatory compliance, and administrative efficiency.
