The NIH released a Significant Changes document this week summarizing the main grants policy changes and clarifications that will be implemented in the FY2016 NIHGPS. The revised NIHGPS, expected to be available in November, will represent an update to the March, 31, 2015 version and will be applicable across all NIH grants and cooperative agreements effective the revision date. To inform the research community of these changes immediately, the document released this week outlines the following significant changes:
- Genomic Data Sharing: Applications proposing to generate large-scale human and/or non-human genomic data are expected to include a genomic data sharing plan.
- Application Non-Compliance: Applications deemed non-compliant with NIH guidelines during the review process may be withdrawn from consideration.
- Clinical Trial Reporting: New ClinicalTrials.gov Requirement Text will be added to clarify that results reporting is still required after the period of performance has ended.
- Change in Scope: Expands the description of change in scope from the approved involvement of human subjects and what additional approvals / changes in designation are required.
- Terms and Conditions language: What was formerly termed “guidance” as it relates to human fetal tissue research is now considered “regulatory requirement.”
- Administrative Requirement: To reduce administrative burden, NIH will allow recipients to reduce effort during a NCE without prior approval.
Read the full list of changes here.