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Sponsor-specific tools and resources for working with the National Institutes of Health (NIH)
Supporting the new FORMS-E Application Package at the University of Michigan
As you know, changes are coming with regard to certain National Institutes of Health (NIH)-funded proposals and projects, beginning January 25, 2018.
We've been working hard on resources to help ease this process!
U-M FORMS-E Worksheet
- A fillable PDF worksheet with some extracted questions from FORMS-E of the SF424 forms set. This worksheet is intended to help Research Administrators (RAs) collect the detailed data and scientific questions they will need from principal investigators (PIs) to more readily complete FORMS-E and the new PHS Human Subjects and Clinical Trials Information Form in the eResearch Proposal Management System (eRPM).
U-M FORMS-E Video
- Senior Project Representative Colleen Vogler from ORSP narrates our own video slide show providing an overview of NIH changes and a walkthrough of key items in the eResearch Proposal Management (eRPM) system.
And now, here's a quick checklist to help you prepare!
✔ Know if you have a Clinical Trial. Review the Four Question decision tree to find out if you are working on one.
✔ Use the correct funding opportunity announcement (FOA).
✔ Complete Good Clinical Practice Training.
✔ Register and report in ClinicalTrials.gov once your proposal is funded.
✔ For any NIH-funded multi-site study involving human subjects (whether a clinical trial or not), you may need a Single Institutional Review Board (sIRB).
✔ Start early to correctly complete the new SF424 FORMS-E. It takes more time and requires the PI's input.
Additional NIH Resources
- Frequently Asked Questions (FAQs)
- Case Studies
- NIH Audio/Slides on Human Subjects Research and Changes
- NIH Video Walkthrough of PHS and Human Subjects FORMS-E
* Thanks to the Research Administration Advisory Council (RAAC)'s appointed workgroup (led by Chris DeVries with support from Constance Colthorp, Cindy Dames Kathy Devereux, Melissa Karby, Cathy Leibovitz, and Colleen Vogler)
** Thanks to Neil Carver, Constance Colthorp, Lori Deromedi, Carolyn Pappas, and Colleen Vogler
NIH Salary Cap for grants and cooperative agreements.
The salary cap remains unchanged for 2018. See NIH Guidance for 2017.
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
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
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
Refer to Federal Research Terms and Conditions, housed on the NSF website.
NIH Reminder: Biosketch Requirements