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Evaluation of Overlapping Applications

While NIH no longer limits the number of times you can resubmit an application with essentially the same content and scope as an earlier application, it is not allowable to have overlapping applications under review at the same time. Rules and policies published in the NIH Guide NOT-OD-14-074 include detailed guidance about the new process for NIH and AHRQ. This new guidance is effective for application due dates after April 16, 2014.

What has changed
  • Following an unsuccessful resubmission (A1) application, applicants may submit a new (A0) application for the next appropriate due date, with any amount of overlap in scientific content.
  • Following an unsuccessful new (A0) application, applicants may submit a new (A0) application for the next appropriate due date, with any amount of overlap in scientific content.
What has not changed
  • Two applications with overlapping aims may not be under review at the same time. An application may not be submitted before the summary statement of an earlier, overlapping application has been issued.
    • A resubmission (A1) application may not submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • A new (A0) application may not be submitted before issuance of the summary statement from the review of the previous overlapping new (A0) or resubmission (A1) application.
    • Two applications with overlapping aims cannot be under review at the same time, even if they are for different activity codes (e.g., R01 and R21) or if they are submitted to different funding opportunity announcements (including one RFA and one PA, etc).
    • An application may not be submitted if it has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

While there is a next-round resubmission option available for certain New Investigator R01 applications, for other applicants using R01 and other activity codes, this may mean that an overlapping application may not be submitted the very next round. This would be the case in the situation where a summary statement for one application has not been issued before the very next new application submission date.

The NIH time limit for accepting resubmission (A1) applications remains in effect (see NOT-OD-12-128 and NOT-OD-10-140). The NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.

NIH uses the following policies to identify duplicate or overlapping applications, ensure our decisions are fair, and address concerns. The same principles apply whether your application is reviewed by CSR or another NIH Center or Institute. Understanding how we determine whether an application is overlapping or not will help you submit applications that can advance into the NIH peer review and funding process.

Who Is Responsible for Ensuring Compliance with NIH Policy?

We expect investigators and their institutions to follow these rules and policies so institutions can submit applications that are eligible to advance in the review process. Once an application is received at NIH, we may stop the review process at any time for the reasons stated below. Many individuals work together to identify potential problem applications: scientists in CSR’s Division of Receipt and Referral, Scientific Review Officers at CSR and the Institutes/Centers, peer reviewers, NIH Program Directors, and Grants Management staff.

We strive to identify problems and take action as early as possible after submission. If we identify a potential problem at the time of the review meeting, we ask reviewers to complete the review without prejudice. We then will thoroughly analyze the situation and withdraw the application as necessary, usually before the score is released and summary statement is written.

What Do We Look for?

“Significant and substantial change in content and scope” is what we consider when we determine if one application is indeed new or overlaps with another application currently under review or submitted for the same or overlapping review round.

When we compare applications, we examine all parts , particularly the Specific Aims and Research Strategy sections using text comparison software and the expertise of those mentioned above. Subsequent versions of an application may be quite different and are still considered to be overlapping if many of the hypotheses, aims, and/or outcome measures are the same or highly similar.

We do not use a set formula. We make a scientific judgment on a case-by-case basis after carefully considering many factors.

Examples of Changes that Could be Substantial
  • Using significantly different model systems
  • Changing the disease model
  • Using a similar methodological approach for a substantially different question
  • Asking a significantly different question
  • Using a very different methodological approach to address a similar issue
Examples of Changes that Are Not Substantial
  • Rewording large sections of the application while retaining the scientific goals and objectives
  • Adding one or more new collaborator(s)
  • Changing the Principal Investigator
  • Making changes to sections such as the Significance or Innovation but not changing the intent of the application
  • Including additional preliminary data
  • Making substantial additions to the pre-existing Approach when the majority of the old design persists in the “new” application
  • Deleting parts of the Approach such that the subsequent application is merely a subset of the a concurrent submission
  • Requesting assignment to a different NIH Institute/Center or review by a different Scientific Review Group
  • Submitting the application to a different program announcement (PA, PAS or PAR)
Whenever possible, we give the applicant the choice of which of the two applications will proceed to review. The final decision, however, is made by the CSR Division of Receipt and Referral.

Examples of Situations Where Concurrent Applications are Not Allowable
  • Alternating (next round) submissions of two applications with highly overlapping aims, when the summary statement of the first application has not been released at the time the second application is submitted.
  • Concurrent submissions of an application to both an RFA and a Program Announcement (PA/PAR/PAS)
  • Concurrent submission of two applications with different activity codes (e.g., R21 and R01) where the aims of one application are the same or significantly overlap with those in the other application.
Examples of Situations Where Concurrent Applications that Are Allowable
  • R01 or other research applications identical to a subproject in a program project or complex center grant application.
  • Research applications identical to an Independent Scientist Award (K02) application

 

You may submit a previously unfunded RFA application as a new investigator-initiated application and vice versa so long as the previous review is complete and the summary statement has been released. This is because an RFA often will have special considerations of eligibility, scientific scope, budgetary limits, and/or review criteria. See related NIH Guide notices: NOT-OD-03-019 and NOT-OD-09-100.


Resubmission Time Clock

NIH 37-month limit for resubmissions. The window for submission of an A1 resubmission application closes 37 months after your initial submission. After that time, any future application you submit on the same general topic must be submitted as a new application. Given the pace of scientific discovery, NIH would expect this application to manifest substantial changes in its scope and approach.

How Does NIH Address Unallowable Applications?
To ensure our decisions are fair and address applicant concerns and rebuttals, we have set up a multilevel assessment process for handling unallowable applications.
  • The Division of Receipt and Referral withdraws applications that are clearly unallowable. If staff have questions about a specific application or if an applicant disputes a withdrawn application, the case is referred to the Scientific Overlap Committee.
  • The Scientific Overlap Committee performs further analysis and makes recommendations. This committee includes senior staff from CSR’s five review divisions, NIH Institutes/Centers and an ex officio (non-voting) member from CSR’s Division of Receipt and Referral. We recruit temporary members when needed to provide input on applications requiring specialized expertise. The goal of this committee, which currently examines about a half a dozen applications a week, is to give all applicants the opportunity to have an independent committee consider their explanation for why the applications are different.
  • The Arbitration Board is consulted if an applicant rebuts the previous decision to the CSR Director. This board includes 12 scientific staff from across NIH, meets once a week and adds additional consistency to decisions. No members of the Scientific Overlap Committee or Division of Receipt and Referral staff serve on this board. CSR’s Director finalizes the decision of this board and communicates the result to the applicant. The Division of Receipt and Referral takes action when requested by the CSR Director.


Get More Information

Questions and Answers on Resubmission of NIH Research Grant Applications

Relevant NIH Guide Notices

NIH and AHRQ Announce Updated Policy for Application Submission (NOT-OD-14-074)

Reminder and Clarification of NIH Policies on Similar, Identical, or Essentially Identical Applications, Submission of Applications Following RFA Review, and Submission of Applications with a Changed Activity Code

Resubmission of Unpaid RFA Applications and Resubmission of Applications with a Changed Grant Activity Mechanism

Time Limit for NIH Resubmission Applications

Get Answers to Specific Questions Contact CSR’s Division of Receipt and Referral

301 435-0715 or csrdrr@mail.nih.gov