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Sponsor-specific tools and resources for working with the National Institutes of Health (NIH)
Changes to certain National Institutes of Health (NIH)-funded proposals and projects were implemented on January 25, 2018. We've prepared some resources to help ease this process.
U-M FORMS-E Worksheet
- Download this 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).
- Added guidance to Study Record header information (p. 4).
- Added additional outcome measures (p. 12) and guidance on question 4.3 (p. 7).
- Added “Reset Question” buttons.
- Corrected guidance on attachment 3.5 (p. 5), indicating it is required for clinical trials and optional for human subjects.
- Added version history table and link to document on ORSP website. U-M FORMS-E Video.
- Added row "unknown/not reported" in FORMS-E human subjects worksheet (immediately before "total" row) in the cumulative enrollment table.
- Senior Project Representative Colleen Vogler from ORSP narrates a video slideshow 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 Liebowitz, and Colleen Vogler)
** Thanks to Neil Carver, Constance Colthorp, Lori Deromedi, Carolyn Pappas, and Colleen Vogler
NIH Salary Cap : $189,600
NIH Salary Cap for 2018 - $189,600
On March 7, 2018, NIH issued Guidance on Salary Limitations for Grants, Cooperative Agreements FY 2018 (NOT-OD-18-137). The Executive Level II salary has increased to $189,600.
All proposals to NIH may now use the new salary cap for budgeting purposes, effective January 7, 2018. For active awards, if funds are available, grantees may re-budget funds to accommodate the new cap with the effective date (not required). However, when and if re-budgeting know that no additional funds will be provided, and the amount must fit within your authorized budget. View NIH's history of Salary Caps.
Additionally, please remember that at this time, while the FY 2018 budget for the federal government passed last week, NIH has not received an FY 2018 appropriation and is operating under the "Continuing Appropriations Act, 2018" (Public Law No: 115-56, or "the Continuing Resolution"). NIH will publish the annual Notice of legislative mandates to provide information on any statutory provisions that limit the use of NIH grant funds in FY 2018.
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