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Sponsor-specific tools and resources for working with the National Institutes of Health (NIH)
News and Updates
NIH Updates FY18 Stipend Levels for Trainees
May 10, 2018
FORMS-E Application Package Resources
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.
- Updated wording on question 4.5.
- 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.
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 Appendix Reminder
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.)