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Working with NIH

Sponsor-specific tools and resources for working with the National Institutes of Health (NIH)

Did You Know?


National Institutes of HealthNIH has a great collection of email newsletters and blogs you can subscribe to, including the periodic NIH eSubmission Items of Interest

Sign up for one or more of NIH's mailing lists:

News and Updates

NIH Updates FY18 Stipend Levels for Trainees
New stipend levels for Kirschstein National Research Service Award (NRSA) awards for undergraduate, predoctoral, and postdoctoral trainees and fellows. - May 10, 2018

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. - March 27, 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

NIH Forms E Workshop Snapshot

  • 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). 

Changes 

  1. Added guidance to Study Record header information (p. 4).
  2. Added additional outcome measures (p. 12) and guidance on question 4.3 (p. 7).
  3. Added “Reset Question” buttons.
  4. Corrected guidance on attachment 3.5 (p. 5), indicating it is required for clinical trials and optional for human subjects.
  5. Added version history table and link to document on ORSP website. U-M FORMS-E Video.
  6. Added row "unknown/not reported" in FORMS-E human subjects worksheet (immediately before "total" row) in the cumulative enrollment table.
  7. 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

* 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.)

NIH, Uniform Guidance, and Prior Approvals

Refer to Federal Research Terms and Conditions, housed on the NSF website.

NIH Reminder: Biosketch Requirements  

NIH Biosketch Information

ORSP Website NIH-Related Pages

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
  • U-M FORMS-E Worksheet

    A fillable PDF worksheet with an extraction of some of the questions in FORMS-E for the SF424 forms set. This worksheet is intended to help Research Administrators (RAs) collect the detailed data and scientific questions they will need from their principal investigators (PIs) to more readily complete FORMS-E in the eResearch Proposal Management System. 

Video Presentations

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