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Frequently Asked Questions
Appendix Policy
Initial Posting: February 3, 2017
Last Revised: February 3, 2017

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  A. Appendix Policy

  1. Since my new application was submitted under the old Appendix policy can my A1 resubmission be grandfathered under that policy or must it conform to the new policy?
    All applications submitted after January 25, 2017 must follow the policy in NOT-OD-16-129.  Applications will not be “grandfathered.”
  2. What is allowed in the Appendix?

    Only the items listed in NOT-OD-16-129, plus any additional items if specifically listed in the individual funding opportunity announcement as required or optional.

  3. What are some examples of things not allowed in the appendix?
    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
    This is not intended to be a definitive list of unallowed materials; these examples are provided for purposes of clarity.
  4. May I put publications, manuscripts, or abstracts in the appendix?
    No.  However, news of a publication can be shared as post-submission materials.  See NOT-OD-16-130 for instructions.
  5. My application covers an ancillary study to a clinical trial. May I include the protocol for the parent clinical trial in the appendix?

    No, unless the parent clinical trial protocol is specified in the funding opportunity announcement as optional or required for applications proposing ancillary studies.

  6. My application does not meet the NIH standard for a “clinical trial” but I am still planning to conduct clinical research that will use samples from human subjects participating in a clinical trial. May I include a clinical trial protocol?

    No, unless the parent clinical trial protocol is specified in the funding opportunity announcement as optional or required for applications proposing ancillary studies

  7. May I put a clinical trial protocol in the appendix of my R34 Clinical Trial Planning Grant?

    No.  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.  

  8. What is a Data Collection Instrument?

    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.  

  9. Are lists or tables of the data to be collected or the measures under study considered to be blank data collection instruments?
    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.
  10. Can you give me some examples what you mean by “blank surveys, questionnaires, and/or data collection instruments”?

    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”.


     

  11. I have an intervention manual, published paper, or other document that contains copies of the data collection instruments we plan to use in the study. May I include the parent document in the appendix since the data collections instruments are in it?

    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. 

  12. May I include the instructions for how to administer a survey or questionnaire with the survey or questionnaire?

    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.

  13. May I put the script for a behavioral intervention in the appendix?

    Yes, if the script is a series of questions that will be asked of participants in your trial.  

  14. May I include the instructions that tell participants how to fill out a survey, questionnaire or other data collection instrument with that blank instrument?

    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.

  15. May I include screenshots of an on-line survey or questionnaire?

    Yes, IF the screenshots only show the blank fields participants will use to enter the data.  Samples of pre-filled forms are not allowed.

  16. May I include screenshots from an on-line test my subjects will take?

    No.   This is not a blank data collection instrument.

  17. May I put videos in the Appendix?

    No.  Current information for submitting videos can be found in NOT-OD-12-141.

  18. Can letters of support be placed in the Appendix?

     

    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. [CC([1]Insert link to the “examples” document.

  19. Would providing a hyperlink to more information be allowed?

    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.

  20. Reviewers requested additional information that will not fit within the pages of the Research Strategy. May I put this in the Appendix since it was requested by the reviewers?

    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-16-129, plus any additional items specifically listed in the individual funding opportunity announcement as required or optional are allowed in the Appendix.

  21. Can NIH remove unallowed Appendix materials and send applications to review?
    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.
  22. Can NIH tell reviewers to ignore the unallowed Appendix materials so that the application can be reviewed?
    No.  Applications with noncompliant Appendices are withdrawn from the review process as announced in NOT-OD-16-129.  The application must be submitted again, with a compliant appendix, for any subsequent due date, in order to be sent forward to review.
  23. Why am I getting a warning about appendix material when I submit my application?

    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:
    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)
     

  24. Can items not allowed in the Appendix be placed elsewhere in the application?
    In general, no.  Items simply moved elsewhere in the application may result in your application being withdrawn (see NOT-OD-17-035).  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.
  25. The instructions for appendix materials in the funding opportunity announcement do not match the instructions for appendix materials in NOT-OD-16-129 or the NIH Application Guide. Which one do I follow?

    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.  




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