New NIH application guidelines: Changes to appendix and post-submission materials policies

NIH has released an updated application guide that includes two significant policy changes effective Jan. 25, 2017.

1) As we reported earlier this year, most appendix materials for applications have been eliminated. The only materials you may submit in the appendix section 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 forms
  • Blank surveys, questionnaires, data collection instruments
  • FOA-specified items. 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.

Note: Papers and manuscripts are no longer acceptable as appendix materials.  Applications submitted with other appendix materials than those listed above will be withdrawn.

2) Current NIH and AHRQ policy concerning post-submission materials has been consolidated and simplified. This applies to materials that are submitted after the grant application has been submitted but prior to peer review.  The new policy reflects the guiding principle that post-submission materials will only be accepted if they’re the result an unforeseen event. The policy does not allow for submission of materials to correct oversights or errors discovered after the application submission.

The full announcement outlines allowable post-submission materials for all applications as well as those specific to T, F, and K series applications. Detailed requirements for submitting these materials are also provided.