NIH limits the number of times you can resubmit an application with essentially the same content and scope as an earlier application. Rules and policies published in the NIH Guide include detailed guidance about the standards and limitations used by NIH to evaluate potential duplicate and overlapping applications: NOT-OD-10-080 and NOT-OD-09-100,
Understanding how we determine whether an application is new or not will help you submit applications that can advance into the NIH peer review and funding process.
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.
Which Applications Are Problems?
· Applications submitted as new (A0) but appear to be resubmissions (A1)
· Applications submitted as new but are substantially similar to an unsuccessful A1 application
· Applications submitted as second resubmissions (A2)
· Duplicate applications
· Overlapping applications
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 your “new” application is indeed new or a resubmission of an earlier application.
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—particularly when the “new” application is responsive to the critiques of another application.
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
- Changing the application in response to the previous reviewers’ critiques
- 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 old one or 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)
In addition to comparing a submission to previous applications we also assess overlap between two concurrently submitted applications. Excessive overlap may be the grounds for withdrawal of one overlapping application. 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 Overlap that Are Substantial
- Alternating submissions of two applications with highly overlapping aims
- 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 a subset of those in the other.
Examples of Situations Where Concurrent Applications that Are Allowable
- R01 or other research applications identical to a subproject in a program project or center grant application
- Research applications identical to an Independent Scientist Award (K02) application
Allowable Changes in Activity Codes
· You may submit an A0 (new) application under a different activity code (R01 to R21, for example) with any degree of overlap with the original application if the summary statement for the first application has been released before the overlapping application is submitted.
But once you make such a switch, you cannot resubmit the application for the original activity code. Any future submissions on the same topic must meet the requirement for manifesting a significant change in content and scope from the original research design.
· 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 now has a 37-month limit for resubmissions. If you do not submit an A1 version of your application within the 37 months of your initial submission or if your A1 is not successful by the end of this period, a future application you submit on the same general topic will be considered a new application. Given the pace of scientific discovery, NIH would expect this application to manifest substantial changes in its scope and approach. See related NIH Guide notice.
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 or may ask the applicant to submit an introduction. If a questioned application is found to be an allowable resubmission rather than new, CSR will ask for an introduction that includes response to the previous reviewers’ critiques. 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 and an ex officio 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 be fair to all applicants by using the same criteria.
· 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 as needed.
Get More Information
Relevant NIH Guide Notices
Get Answers to Specific Questions
Contact CSR’s Division of Receipt and Referral: 301 435-0715