Following are brief summaries of recent Health and Human Services (HHS) and NIH updates. For real-time updates and true expertise, do visit the links and read the entire NIH Notices. Subscribe to NIH publications like Nexus or the NIH Guide Listserv.
Here is what we think you will want to explore and note!
NIH Salary Cap increased for grants and cooperative agreements.
The new salary cap is interim until made permanent by NIH.
Though NIH will not increase awards to accommodate this change, you can begin to charge at that salary level as of that date if you choose to do so. Note that a project should be consistently applying the same cap for all investigators who are subject to a cap. View a history of Salary Caps.
NIH operates under a Continuing Resolution for
NIH has published some additional information regarding FY17 funding. The “Further Continuing and Security Assistance Appropriations Act, 2017” signed by President Obama on December 10, 2016, continues government operations through April 28, 2017, at 99.8% percent of the FY2016 enacted level.
Consistent with past NIH practices, the NIH will issue non-competing research grant awards at a level below that indicated on the most recent NOA (generally up to 90% of the previously committed level).
Upward adjustments to awarded levels may occur after FY 2017 appropriations are enacted but NIH has noted that they expect institutions to monitor their expenditures carefully during this period.
NIH Appendix Reminder: Most previously allowed items now eliminated
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 Applications will be withdrawn if they are submitted with appendix materials that are not specifically listed in NOT-OD-17-035, or specified in the funding opportunity announcement to which you are applying.
The policy eliminates most items that investigators previously included in the application appendix. For current and future grant submissions please be sure that application appendices are consistent with the items identified in NOT-OD-16-129 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-129.html). Applications will be withdrawn and not reviewed if they are submitted with inappropriate appendix materials.
In short, the only allowable appendix materials are:
For applications proposing clinical trials (unless the FOA provides other instructions for these materials):
Clinical trial protocols
Investigator's brochure from Investigational New Drug (IND), as appropriate
For all applications:
Blank informed consent/assent form;
Blank surveys, questionnaires, data collection instruments;
FOA-specified items. (NOTE: If appendix materials are required in the FOA, review criteria for that FOA will address those materials, and applications submitted without those appendix materials will be considered incomplete and will not be reviewed.)
NIH, Uniform Guidance, and Prior Approvals
We recently learned that NIH changed the requirements for obtaining NIH prior approval to issue subawards at fixed amounts. Previously, NIH waived the prior approval requirement during their implementation of the Uniform Guidance.
However, with the release of their latest version of the NIH Grants Policy Statement – Nov. 2016, which applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2016, NIH now requires prior approval to issue fixed-pricesubawards of any dollar amount up to the simplified acquisition threshold ($150,000). See section 220.127.116.11 of the NIHGPS, and the Significant Changes Document.
Clinical Practice, Clinical Trials, Post-Submission Materials, Fonts, and Other Key Items
A summary of other good recaps from Nexus regarding recent policies.
Effective January 1, 2017:
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.
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 from these trials are 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:
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), and the timing of post-submission materials prior to the initial peer review. 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-17-030) NIH Guide.