For applications submitted to due dates between January 25, 2017 and January 24, 2018: Only the items listed in NOT-OD-16-129/NOT-OD-17-035, plus any additional items if specifically listed in the individual funding opportunity announcement as required or optional.
For applications submitted to due dates on or after January 25, 2018: Only the items listed in NOT-OD-17-098, plus any additional items if specifically listed in the individual funding opportunity announcement as required or optional.
If it is not specifically listed as allowed in the Notices or in FOA used to submit the application, it is not allowed.
However, for purposes of clarity, a few examples of unallowable appendix items include but are not limited to:
Methods or instructions for conducting the research
Methods or instructions for analyzing the data
Manuals
Clinical trial protocols, or protocol synopses, in applications that do not propose to conduct a clinical trial
Investigator’s Brochure section from an FDA IND application in applications that do not propose to conduct a clinical trial.
Lists of abbreviations, definitions, or codes
Data or other information, either preliminary or published, including tables, charts, graphs, figures, diagrams, graphics, images, screen shots, etc.
Powerpoint presentations
Papers, posters, or abstracts, including those in preparation, submitted, accepted for publication, or posted as pre-prints
Reports, including market survey reports, and summaries of reports or sample reports
Patents, patent applications, or materials intended for a patent application
Hyperlinks
Videos
Flyers, curricula, course descriptions
Case studies
Files containing a mixture of allowed and unallowable Appendix materials
Items that appear to be “similar to” one of the allowed Appendix items
Items specified in the FOA as not allowed in the Appendix
Additional items not allowed in applications submitted for due dates between January 25, 2017 and January 24, 2018 (unless otherwise specified in FOA as required):
Clinical trial protocols, or protocol synopses, in applications not proposing a clinical trial
Investigator’s Brochure from an FDA IND Application, in applications not proposing a clinical trial.
Additional items not allowed in applications submitted for due dates on or after January 25, 2018 (unless otherwise specified in FOA as required):
Clinical trial protocols, or protocol synopses
Investigator’s Brochure section from an FDA IND application
This is not intended to be a definitive list of unallowed materials; these examples are provided for purposes of clarity.
No, unless the parent clinical trial protocol is specified in the funding opportunity announcement as optional or required for applications proposing ancillary studies.
No, unless the parent clinical trial protocol is specified in the funding opportunity announcement as optional or required for applications proposing ancillary studies
For application due dates between January 25, 2017 and January 24, 2018: Clinical trial protocols may only be included in appendices of applications proposing to conduct clinical trials and not applications planning to conduct a clinical trial in the future, unless specified in the funding opportunity announcement as optional or required.
For application due dates on or after January 25, 2018: No, unless the clinical trial protocol is specified in the funding opportunity announcement as optional or required.
It is a blank questionnaire, survey or other kind of form on which data will be collected and recorded during the conduct of research. It does not include instructions for use, methods for collection of the data, or procedures for analysis of the collected data.
No. Information integral to the experimental design and analysis, including the types of data and information to be collected as part of the study, must be included within the page limits of the Research Strategy. However, if a form has been created on which to record that information, a blank copy of that form may be included in the appendix as a data collection instrument.
These are blank forms, which are defined by Webster’s as a “printed or typed document with blank spaces for insertion of required or requested information.” It is important that appendix material excludes instructions to the investigative team including methods for collecting and recording the data, methods for analyzing the data, and the data itself. Short instructions to the study participants – e.g., the human subjects in your study – explaining how to complete the survey/questionnaire are allowed. Here are some examples of what we mean by “blank surveys, questionnaires, and/or data collection instruments”.
No, you may not include the intervention manual, paper or other parent document unless it is specified in the funding opportunity announcement as optional or required. You can include copies of any blank data collection instruments extracted from that manual or document.
No. Instructions and procedures that describe how any member of the investigative team (including collaborators) will conduct the research is part of the experimental methods and, as such, should be addressed within the page limits of the research strategy.
Yes, if the instructions are explicitly included to enable the human subjects (e.g., study/trial participants) to fill out the survey, questionnaire, or other blank data collection instrument.
No. Letters of Support should be attached to the PHS 398 Research Plan Form in the Other Research Plan Section, attachment #13. Please see the SF424(R&R) Application Guide Section G.400 – PHS 398 Research Plan Form for more instructions.
No. Hyperlinks and URLs are only allowed when specifically noted in the individual funding opportunity announcement (FOA) and form field instructions (e.g. , biosketches, publication lists). It is highly unusual for a FOA to allow links in Specific Aims, Research Strategy, or the Appendix. If the FOA you are using does not state that you can put this information in your application or Appendix, then it is not allowed, whether the linked information is critical to the review or not. See information under Format Attachments in the SF424(R&R) Application Guide.
No. All information required for the review must be found within the pages of the Specific Aims and Research Strategy. Only the items listed in NOT-OD-17-066, plus any additional items specifically listed in the individual funding opportunity announcement as required or optional are allowed in the Appendix.
NIH cannot change or modify applications after submission. The application must be submitted again, with a compliant appendix, for any subsequent due date in order to be sent forward to review.
No. Applications with noncompliant Appendices are withdrawn from the review process. The application must be submitted again, with a compliant appendix, for any subsequent due date, in order to be sent forward to review.
All applications that include appendix materials receive a warning to remind applicants of our latest appendix policy. The warning is not an indicator as to whether or not the included appendix material is acceptable. It is simply informational.
Warning text for applications submitted for due dates between January 25, 2017 and January 24, 2018 Unless specified in the funding opportunity announcement (FOA), appendix material is no longer accepted for most grant applications submitted to NIH, AHRQ and NIOSH (NOT-OD-16-129). Applicants should consult the FOA and the aforementioned notice to ascertain if the inclusion of appendix material is permitted. Applications may be withdrawn and not reviewed if they contain appendix materials that are not specifically referenced in the notice or FOA. (000.37)
Warning text for applications submitted for due dates on or after January 25, 2018:
In general, no. Items simply moved elsewhere in the application may result in your application being withdrawn. However, many items not allowed in the Appendix are specified as required in other parts of the application or allowed within the page limits of the Research Strategy section.
Instructions in the funding opportunity announcement for additions to or further restrictions on the types or amounts of materials allowed in an Appendix supersede other general NIH instructions for Appendix materials.
NIH Staff
