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NIH Grant Policy Statement Changes 2016

NIH Application Guide Changes

Effective for applications submitted as of 1/25/2016


NIH has released an updated SF424 (R&R) Application Guide to be used for proposals with due dates on and between January 25, 2016 and May 24, 2016.  The new guide includes significant changes on what is to be included in proposals.

The most significant change included with the updated application guide is to incorporate NIH’s initiative to enhance rigor and reproducibility in funded research  NOT-OD-16-011 and NOT-OD-16-012 .  To implement this initiative they have revised what is included in the Research Strategy Attachment, as well as, added a new attachment for Authentication of Key Biological and/or Chemical Resources.  A great source of information explaining this change, as well as how to incorporate the changes into proposals, can be found at NIH’s FAQ page:  Below we have included a brief summary of some important changes from the updated application guide.


Research Strategy Attachment

In the significance section, must now also address the following:

  • “Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.”


In the approach section, must now also include:

  • “Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.”
  • “If your study(s) involves human subjects, you are expected to explain how relevant biological variables are important to the proposed experimental design and analyses. The sections on the Inclusion of Women and Minorities and Inclusion of Children can be used to expand your discussion on inclusion and justify the proposed proportions of individuals (such as males and females) in the sample.”


Authentication of Key Biological and/or Chemical Resources New Attachment!

This is a new attachment required on the SF 424 (R&R) Other Project Information Form, in the Other Attachments field.  The single file should be named “Authentication of Key Resources Plan.”  The attachment must, “Briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies.  Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics. Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals.”


NIH provides a caution that the information in this attachment must focus only on authentication and/or validation of key resources to be used in the study; all other methods and preliminary data must be included within the page limits of the research strategy. Applications identified as non-compliant with this limitation will be withdrawn from the review process.


Vertebrate Animals

The criteria has been changed as follows:

  • “Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the “Research Strategy” section. Identify the species, strains, ages, sex, and total numbers of animals by species, to be used in the proposed work. If dogs or cats are proposed provide the source of the animals.”
  • “Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g. computational, human, invertebrate, in vitro).”
  • “Minimization of Pain and Distress: Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain, and injury.”
  • “Euthanasia: State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.”


Definition of Child

  Redefined age of child as individual under 18 instead of 21


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