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Rigor and Transparency in NIH & AHRQ Research Grant APPLICATIONS​​
NIH has clarified and revised application instructions and review criteria to enhance the reproducibility of research findings through increased scientific rigor and transparency. ​

Please use the updated FORMS-D forms and application guide.

Applications that were submitted for due dates before May 24, 2016 should have used FORMS-C forms and application guide.

Summary The following changes went into effect ​January 25, 2016.

1.) Additional requirements in the Research Strategy section (page limits have not changed)
  • Scientific Premise
    Applicants must describe the general strengths and weaknesses of the prior research being cited by the investigator as crucial to support the application.

  • Scientific Rigor
    Applicants must apply scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. Robust results are obtained using methods designed to avoid bias and can be reproduced under well-controlled and reported experimental conditions.

  • Biological Variables
    NIH expects that sex as a biological variable (in addition to age, weight and underlying health conditions) will be factored into research designs, analyses and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex.

2.) New "Authentication of Key Biological and/or Chemical Resources" attachment required
  • NIH expects that key biological and/or chemical resources will be regularly authenticated to ensure their identity and validity for use in the proposed studies. Key biological and/or chemical resources may or may not be generated with NIH funds and:​

    • ​​may differ from laboratory to laboratory or over time
    • may have qualities and/or qualifications that could influence the research data
    • are integral to the proposed research

  • These include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics.

3.) Reviewers will consider the following additional rigor and transparency questions when reviewing applications:
  • ​Is there a strong scientific premise for the project?

  • Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?

  • Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Rigor and Transparency in Application and Review

​Key Area ​Section ​Additional Application Instructions ​Additional Language for Reviewers
Scientific Premise​ ​Research Strategy: Significance ​​"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."​
​"Is there a strong scientific premise for the project?"
​​Scientific Rigor ​Research Strategy: Approach ​"Describe the experimental design and methods proposed and how they will achieve robust and unbiased results." ​"Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work​ proposed?"
​Biological Variables ​Research Strategy: Approach ​"Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans." ​"Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?"​
​Resource Authentication ​Other Research Plan Attachment ​"Briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used the in the proposed studies." ​"For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources."

NIH Rigor and Transparency.PNG


Original Announcement via Research News​

Grants Affected Most research grants are affected (including small business and complex research grant applications).

Excluded grant codes: C06, G08, G11, G12, G13, G20, R13, S06, S10, S21, SB1, U13, U55, UB1, UC6, UC7, UG4, UH4, X02, and 333.

Research Resource and Related grants or components (P30, P40, P41, P2C, R24, R28, U24, U41, U42, and U2C) may have slightly revised review language; please refer to the Funding Opportunity Announcement.

Rigor and transparency changes for training and individual fellowship application is delayed until 2017 per NOT-OD-16-034 issued on 12/17/2015. 

QuestionsIf ​you have questions about these updated guidelines, please contact NIH directly at reproducibil​ity@nih.gov.

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