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
Non-Compliant Special Characters
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
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:
or “curly” (open/close) quotes
dashes (the long dash)
and Greek letters – i.e., spell out alpha, beta, micro; use >=
instead of the symbol
– use dash or asterisk instead
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
- 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.
strongly encourages you to route early, so we can help validate the form, and submit to NIH early.
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
- 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
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
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
- NOT-OD-18-009 -Reminder: FORMS-E Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2018
- New NIH "FORMS-E" Grant Application Instructions Available for Due
Dates On or After January 25, 2018
- 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
- New NIH "FORMS-E" Grant Application Forms and Instructions Coming for
Due Dates On or After January 25, 2018
Updated FOAs for
For due dates on or after January 25, 2018, NIH will require
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
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