Appendices 2017: Do Not Pass Go. Do Not Collect $200.

With the major November NIH deadlines about to pass us by, many will turn their attention to their 2017 submissions.  As you pursue your application strategies, chances are you’re considering the use of an appendix to bolster your argument for funding.  Proceed with caution: the appendix rules for 2017 are not what they once were.

 

The only allowable appendix materials in 2017 are:

  • Blank informed consent/assent forms
  • Blank surveys, questionnaires, data collection instruments
  • Funding opportunity announcement-specified items

Clinical trial applications may also include clinical trial protocols and/or investigator’s brochures from Investigational New Drug (IND), as appropriate.

 

Note that the revision of allowable appendix material has significantly reduced inclusion potential.  If you weren’t sure before whether you could submit that manuscript, good news: under the new rules, you definitely cannot!  No manuscripts allowed!

 

This announcement was made via NOT in August (check out the full text of NOT-OD-129). The penalties for submitting out-of-bounds material is withdrawal and non-review.  Ouch.   If you have questions about what this change means, or how it may affect your application, give us a shout and we’ll help you talk through it.

Well, That Was Unexpected: PD/PI Credential Error

Federal government systems are constantly evolving, and sometimes what was fine yesterday is an error today.  During the submission process for an SF424 on Monday, we received the following error, even though the PD/PI eRA Commons ID was very clearly and correctly present in the proper field:

 

NIH has received the electronic grant application Grants.gov Tracking # GRANT00000000 / PI XXXXXXX. NIH was unable to process your application because it was missing critical information required by NIH. NIH requires that the PD/PI’s correct eRA Commons User ID be entered in the ‘Credential’ field for the PD/PI on the R&R Senior/Key Person Profile (Expanded) component of the application.

Because the Credential field was not completed accurately, your application was considered incomplete; therefore the eRA Commons could not fully check the application against the instructions in the application guide and the funding opportunity announcement. You may receive new error and/or warning messages once you submit a changed/corrected application to Grants.gov.

 

After some trial and error, and intrepid GCO found that re-entering the eRA Commons ID in all capital letters (‘GSMITH’ instead of ‘gsmith’) allowed the application to go through.  As a precautionary measure, you may wish to use all caps on your PD/PI credentials going forward!

Watch Your Asterisk

As the June 5 deadline approaches for NIH new R01s, take a moment to double-check your PDF file names (and make sure all of your attachments are PDFs, come to that). NIH systems can be touchy with unexpected character recognition, and no one wants an error at 4:58p next Friday. Remember: file names should be less than 50 characters, including punctuation and spaces. Names CAN contain any of the following characters:

  • A-Z
  • a-z
  • 0-9
  • underscore: _
  • hyphen: –
  • space
  • period
  • parenthesis
  • curly braces: { }
  • square brackets: [ ]
  • tilde: ~
  • exclamation point
  • comma
  • semicolon
  • at sign: @
  • number/pound sign: #
  • dollar sign
  • percent sign
  • plus sign
  • equal sign

 

Names CANNOT contain any of the following:

  • Two or more spaces in a row between words or characters
  • Ampersand: &
  • Apostrophe (note: the official NIH list of acceptable characters includes apostrophes, but we have encountered more than one error when using apostrophes so we recommend avoiding them)

 

Be safe: keep it simple!  For more tips on compliant file attachments, look over NIH’s PDF Guidelines.  Questions about what you’re reading? Drop us a note!

You May Need an Appendectomy

Strictly-speaking, we’re speaking of the removal of information in a document appendix, of course. The “Appendices” section of the SF424 cannot be used to get around the page limits of other sections (the most popular? Research Strategy, which is limited to 12 pages for an R01 in case you’re counting along).  Information that *is* allowed as appendices includes:

  •   Up to 3 of the following types of publications (any exceptions will be noted in your announcement):
    • Manuscripts and/or abstracts accepted for publication but not yet published
    • Published manuscripts and/or abstracts only when a free, online, publicly available journal link is not available
    • Patents materials directly relevant to the project
  • Surveys, questionnaires, data collection instruments, etc.
  • Clinical protocols
  • Informed consent documents (as necessary)

Information that is NOT allowed in the appendix is:

  • Published manuscripts and/or abstracts that are publicly available in a free, online format
    •  Note: you can reference these in the application, and URLs and PMCID numbers can be included in the References Cited section.  There is no limit on the number of references you can site, but applicants are encouraged to be “both judicious and concise.”
  • Graphic images of gels, micrographs, photographs, etc.  These may be included in your research plan and are therefore subject to the page limit.  The  SF 424 (R&R) Application Guide sets forth guidance as to size and resolution of images that you may include in your plan
    • Note: there are some liberties that may be taken with PAPER SUBMISSIONS ONLY.  If you are planning on submitting via paper application, please contact RAS and we will clarify your latitude.

For more details on what is and is not allowable, check out NOT-OD-07-018.  If you’re unclear on whether your planned appendix is permissible, drop RAS a note; we’ll help you figure it out!

You Don’t Bring Me Warnings Anymore

Sometimes, relationships that we have been in for a very long time start to change and before we know it, we find ourselves asking, “do I even know you anymore?”  This can happen with friends, family, neighbors… and NIH submission forms.  Yes, our beloved Forms B package has evolved to Forms C, and the new Forms C set has stopped taking out the trash, calling when it’s going to be out late, and allowing our little quirks to slide.

Here are some of the issues the RAS office has seen this week:

  1. Problem: The “PD/PI” classification generates an error kickback. Possible source: In the past, we have been allowed to choose “PD/PI” from the drop-down menu to classify personnel on the application, and then use a similar drop-down menu further into the application to classify the PD/PI again in a different section.  In the new Forms C set, subsequent PD/PI classification is now done with a text box in which you type the classification instead of selecting it from a drop-down menu.  The sticky wicket here is that the NIH error bot searches by string; therefore, you must type exactly “PD/PI” in the text line to precisely match the selection in the drop-down from the previous section’s classification.  Selecting “PD/PI” and then later typing “Principal Investigator,” for instance, will result in your application being returned with an error.
  2. Problem: Your budget justification generates an error. Possible source: You used boxes or tables.  In the past, boxes and tables were a great way to organize the information in your budget justification.  The new bot in the NIH system, however, does not recognize this formatting and will return it as an error.
  3. Problem: You receive and error indicating that your attachments must be PDFs, but they are all PDFs.  Possible source: You may have accidentally included editable fields in your PDF document; the NIH systems do not allow these.  Be sure to “flatten” your PDF documents before upload

 

What Is The Difference Between an Error and a Warning?  An “error” is any anomaly that will prevent the application from going forward to further consideration. Errors usually indicate significant inaccuracies, inconsistencies, omissions, or incorrect formatting that have been identified in the body of the application. “Warnings”, on the other hand, indicate discrepancies that are acceptable, but are considered worthy by the NIH of bringing to the applicant’s attention due to the high possibility that it is a mistake. It is the applicant’s choice whether to make a change based on the warning.

For more detailed information about errors and warnings generated by the NIH validation system, we have adapted this Errors and Warnings document for your use.

 

How Do I Correct Errors in my Application?  NIH provides a detailed list of instructions for how to correct any errors your application may generate.  Be sure to submit your application well before the deadline to allow time for error correction; an application with errors is considered not submitted and you will not be given extra time to make changes.

 

With a little time, patience and understanding, you, too, can fall in love with your NIH submission forms all over again!