Working with NIH

Overview of U-M Sponsored Projects with NIH

• National Institutes of Health (NIH) - Sponsoring U-M Research FY2018 

News and Updates

NIH Salary Cap for 2019 - $192,300
On April 17, 2019, NIH issued Guidance on Salary Limitations for Grants, Cooperative Agreements FY 2019 (NOT-OD-19-199). The Executive Level II salary has increased to $192,300.  

NIH 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 NIH FORMS-E Worksheet

• Download this fillable NIH FORMS-E 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 

Document Version	Date	Document Revisions
v.1	12/21/2017	(Original document)
v.2	1/16/2018	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.
v.3	1/24/2018	Corrected guidance on attachment 3.5 (p. 5), indicating it is required for clinical trials and optional for human subjects.
v.4	2/23/2018	Added version history table and link to document on ORSP website.
v.5	4/6/2018	Updated page references. Added “Unknown or Not Reported” Racial Category to Cumulative enrollment table (p. 10).
v.6	5/7/2018	Updated wording on question 4.5.
v.7	6/15/2018	Added clarifying language in the instructions for the following questions: 2.5, 2.6, 2.7, 2.8, 3.4, and 4.2.d.

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   Here's a quick checklist to help you prepare!

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   ✔  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.

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   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

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   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.)

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   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