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nih forms e

NIH Changes for Applications with Due Dates On or After January 25, 2018

February 5, 2018 - NIH Forms E Human Subjects / Clinical Trials Form Issues

Please be aware of issues we've experienced with the new Human Subjects/Clinical trials (HS/CT) form.

Non-Compliant Special Characters
  • The new HS/CT form has fillable text boxes/fields that must accommodate lengthy sections of text, BUT only accepts plain text/unicode. 

  • No symbols or “special” characters are allowed

    • “Special characters” include a few things that you might not consider “special” and that Word automatically substitutes for you.  A summary of the characters causing issues:
    • “smart” or “curly” (open/close) quotes
    • Em/en dashes (the long dash)
    • Symbols, and Greek letters – i.e., spell out alpha, beta, micro; use >= instead of the symbol
    • Bullets – use dash or asterisk instead
    • Superscripts and subscripts
    • (You will also lose any formatting: bold, italics, underlining)
  • InfoEd will not let you complete the HS/CT Form Page is you have special characters

How to Convert a Word Document to Unicode Text 
Character Limits
  • People are running into the character limits in some of the fields when trying to cut and paste information from a completed protocol. 
  • Allow extra time to edit to shorten your text.
  • View this Power Point from LCOM November 2017 Info Session, which has screen shots of the HS/CT form and converts the character limits to approximate page lengths for your convenience (slides 31 and 35).
Plan to Submit Proposal 1-2 Days Before Deadline
  • For these reasons, as well as general unfamiliarity with the new form, it is taking up to two days for experienced faculty and administrators to complete the HS/CT form successfully.
  • SPA strongly encourages you to route early, so we can help validate the form, and submit to NIH early.  
  • SPA recommends the proposal be submitted NIH at least 1-2 days ahead of the due date, to allow extra time to identify and correct any errors that arise during validation.  

UVM Resources

Info Sessions - How Do Changing NIH Policies Impact Me?

During the past year, the National Institutes of Health (NIH) has instituted new requirements for studies involving clinical trials and human subjects, as well as new forms that go into effect for NIH applications with deadlines on or after January 25, 2018.  Representatives from the Office of the VP for Research, the Research Protections Office, Sponsored Projects Administration, and the Office of Clinical Trials Research presented two training sessions in November, 2017 to help Principal Investigaors prepare for this transition.  The slides are presented here: 

Two Short Videos to Explain the Changes

NIH Application Forms E

UVM Resources
NIH Resources
  • NOT-OD-18-009 -Reminder: FORMS-E Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2018 
  • NOT-OD-17-119 - New NIH "FORMS-E" Grant Application Instructions Available for Due Dates On or After January 25, 2018 
  • NOT-OD-17-114 - Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018
  • NOT-OD-17-098 - Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018 
  • NOT-OD-17-062 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018 

Updated FOAs for Clinical Trials

For due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. The purpose of this policy is to improve NIH's ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.

last updated 11/14/17

Last modified February 05 2018 09:27 AM

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