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NIAID Guidelines for Determining Whether a Resubmitted Program Project Application Qualifies as New

Purpose

Below are NIAID’s guidelines for identifying a new program project application. NIAID staff should use these guidelines to evaluate whether a program project application is sufficiently new when a PI previously submitted unsuccessfully and cannot resubmit.

Staff use this information in conjunction with theLock icon: This link will not work for public visitors.Decision Tree For Whether a Resubmission P01 Is a New Application.

NIH announced its policy on this topic in the October 8, 2008, and May 15, 2009, Guide notices.

Guidelines

A new P01 application must be substantially different from a previous application in content and scope. While this determination is ultimately a scientific judgment, here are the general attributes of a significantly changed application:

  • Changes to the Research Strategy significantly alter the direction and approach of the overall program.
  • There are fundamental changes in the questions asked or outcomes examined.
  • For new projects, all sections of the Research Plan, particularly the Specific Aims and the Research Strategy, have substantial changes.

The following are more specific changes that are required:

  • Overall Program
    • At least 50 percent of the research projects are new.
    • Overall results, data sets, or outcomes are substantially different, as reflected in the Program Overview.
  •  Individual Projects. The returning projects have significant changes, for example:
    • The scope and direction of the proposed research are substantially changed in the Specific Aims and consequent changes in the Research Strategy.
    • The hypothesis may remain the same if the Specific Aims and Research Strategy are substantially modified.
    • Additional items for projects:
      • Investigating the same question in a new animal model would probably not be considered new research, but may in some cases, depending on the research question and animal model.
      • Preliminary data from the original application may be used if still appropriate.
      • Expected results, data sets, or outcomes must be significantly different.
  • Core or Cores
    • As resources, cores do not necessarily need to change.
    • However, cores must appropriately reflect changes to the Research Strategy.

The following changes would not be significant enough to qualify an application as new:

  • Rewording title and Specific Aims, while the scientific goals remain the same.
  • Incorporating minor changes in response to reviewer comments.
  • Changing the PI or project or core leaders.
  • Changing only the significance and innovation sections of the projects.
  • Dropping weaker projects while keeping the rest of the application.
  • Changing the program overview section only.
  • Adding more parameters—for example, changing the animal model, pathogen, or population, or expanding the scope while keeping the theme or question. (Conversely, changing any of those factors is not required for a project to be new.)

Procedures for NIAID Staff

Use the following procedures to determine whether a previously submitted application qualifies as new.

Communications With  Applicants

  • The PI’s letter requesting approval to submit an unsolicited P01 application should contain a detailed description of why the application is new.
  • If the letter does not address this issue, do not grant approval to submit.  

Determination Process

  • Within two weeks of receiving an application, the program officer and scientific review officer review it to determine whether it qualifies as new.
  • The program officer, consulting with the scientific review officer, decides whether an application qualifies as new.
  • If they disagree, the matter is resolved by the NIAID P01 Resubmission Adjudication Committee (NPRAC).
    • NPRAC is an internal committee with a representative from each extramural program division and the Scientific Review Program, typically a program officer and scientific review officer and their alternates.
    • The committee is chaired by the associate director for operational infrastructure, Division of Extramural Activities (DEA).

Procedure for Withdrawal

 Appeals

  • The DEA director handles applicant appeals. 
  • NPRAC does not consider appeals.

 

Last Updated July 08, 2011

Last Reviewed September 20, 2012