Reminder of New Policies Now – Or Soon To Be – In Effect

A number of NIH policies became effective in January. Here’s a brief recap:

Effective January 1, 2017:

Final Research Performance Progress Reports: As of January 1, NIH no longer accepts the Final Progress Report (FPR) form for most grants. Instead, grantees must provide final progress reports using the Final Research Performance Progress Report (Final RPPR) format, which is submitted electronically through a new eRA Commons module. Read more in the NIH Guide (NOT-OD-17-022) and Nexus, and read about the “Interim RPPR” further below.

Good Clinical Practice Training:  NIH expects NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials to have Good Clinical Practice (GCP) training. As long as steps are being taken to meet the policy expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be completed after the Jan 1, 2017 effective date. See last month’s Nexus for help identifying training opportunities.

Effective January 18, 2017:

Clinical Trial Reporting Requirements: NIH expects investigators conducting clinical trials (funded in whole or in part by the NIH) to ensure that these trials are registered at ClinicalTrials.gov within 21 days of first-patient enrollment and that the results information from these trials is submitted to ClinicalTrials.gov within one year of trial completion. NIH’s policy complements a new federal regulation to improve the accessibility of information on clinical trial availability and on the outcomes and results of completed trials. Read more on the Open Mike blog and in updated FAQs.

Effective January 25, 2017:

Application Appendix Materials: NIH eliminated most types of appendix materials for grant applications intended for due dates on or after January 25.  Applications will be withdrawn if they are submitted with appendix materials that are not specifically listed in NOT-OD-17-035, or specified in the specific funding opportunity announcement to which you are applying.

Post-submission Materials: NIH clarified the types of materials that can be submitted due to unforeseen events after submission of the grant application but prior to the initial peer review. The consolidated post-submission materials policy also makes changes related to how publications that have been accepted for publication should be communicated as a post-submission material (form and content), post-submission materials for training and fellowship applications, and the timing of post-submission materials submitted to the final due date of a Request for Application (RFA). For details, read more in the NIH Guide (NOT-OD-16-130).

Updated Application Font Guidelines: NIH updated its recommended font list and no longer requires that black text be used within grant application attachments. Read more in the NIH Guide (NOT-OD-17-030NIH Guide.

Effective February 9, 2017:

Interim RPPRs: If you submitted a renewal (Type 2) application that is under consideration, NIH Guide notice NOT-OD-17-037 explains that you must still submit a progress report via eRA Commons no later than 120 calendar days from the period of performance end date of your existing award. If the competing renewal is funded, NIH will treat this “Interim RPPR” as the annual performance report for the final year of the previous competitive segment.  If the competing renewal is not funded, NIH will treat the Interim RPPR as the institution’s Final RPPR.

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