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March 2017 Updates

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.

NIH issued Interim Guidance on Salary Limitation for Grants and Cooperative Agreements (NOT-OD-17-049) (March 17, 2017). The Executive Level II salary was previously set at $185,100, and it increased to $187,000, effective January 8, 2017. 

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
Non-Competing Awards

NIH operates under a Continuing Resolution (NOT-OD-17-048)

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 Applications will be withdrawn if they are submitted with appendix materials that are not specifically listed in NOT-OD-17-035, or specified in the funding opportunity announcement to which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-price subawards of any dollar amount up to the simplified acquisition threshold ($150,000).  See section 8.1.2.11 of the NIHGPS, and the Significant Changes Document.

ORSP has updated our Prior Approval Matrix to keep track of what is required for the Uniform Guidance.
 


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-17-030NIH Guide.


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. Remember to always read the funding announcement, subscribe to the guide, and contact your ORSP Government team project representative with any questions.
 

Grants Policy Statement 

https://grants.nih.gov/policy/nihgps/index.htm 

R01 Checklist

The Research Project Grant (R01) is the original and historically oldest grant mechanism used by NIH. The R01 provides support for health-related research and development based on the mission of the NIH. ORSP has created an R01 Checklist to support you in your submissions.

(December 2015)

NIH Individual Development Plans (IDPs)


U-M Genomic Data Sharing Policy for NIH 

(March/April 2015)According to NIH's new genomic data sharing policy, proposals submitted on or after January 25, 2015, in which the research generates large-scale human or non-human genomic data, you must ensure your data will be publicly available via a federal database or approved alternative. Read U-M's step-by-step instructions for Genomic Data Sharing on our website to help you.  


 


NIH Non-Compliance can have serious consequences

(April 15, 2015) Consistent with the trend that budgets are tight and more competitive than ever, NIH reminded research grantees that noncompliant applications can lead to denial, for reasons such as:



NIH Reminder: Biosketch Requirements  

(March 2015) Remember, the modified biosketch format is required for applications submitted to NIH for due dates on or after May 25, 2015. Read more.

References and Resources

  • NIH R01 Proposal Checklist

    Provided a finalized proposal is received within ORSP’s internal deadline, ORSP will check the following items on a standard unsolicited proposal under the National Institutes of Health’s parent R01 announcement when prepared as a Grants.gov application in the eRPM system.

  • NIH's eRA eSubmission Items of Interest

Questions?

ORSP Primary Contact for NIH Projects

Terri Maxwell, Senior Project Representative, e-mail: tmax@umich.edu

Also see:
Electronic systems at eRA Commons.
Subscribe to the eRA Items of Interest emails