While there is no administrative requirement that the science in a new A0 application be substantively different from any previously reviewed submission, it is not allowable to have duplicate or highly overlapping applications under review at the same time as per 22.214.171.124 Submission of Resubmission Application. (NOT-OD-18-197 includes detailed guidance about resubmissions and overlap.) This policy applies to all overlapping applications submitted to any component of the Public Health Service (e.g., NIH, AHRQ, FDA, CDC, etc.).
- Two applications with highly overlapping aims may not be under review at the same time. An application is considered to be “under review” until its summary statement is issued, which means an overlapping application may not be submitted until after the summary statement of the other application has been released. This requirement also applies to initial peer reviews with multiple phases, e.g., editorial board reviews in which all summary statements are released together after a second phase, irrespective of the outcome of the first phase.
- 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 highly overlapping new (A0) or resubmission (A1) application.
- Two applications with highly 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.), or if one application was submitted for an earlier council round but is still under review at the time the overlapping application is submitted for the next council round.
- 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).
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 these 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.
What Do We Look for?
“Significant and substantial change in content and scope” is what we consider in determining if one application is indeed new or highly overlapping with another application currently under review or submitted for the same or adjacent review round.
When we compare applications, we examine all parts, particularly the Specific Aims and Approach sections. 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 making substantive changes to the scientific goals or expected outcomes 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 overlapping application is merely a subset of another application
- Requesting assignment to a different NIH institute/center or review by a different scientific review group
- Submitting the application to a different Funding Opportunity Announcement (e.g., PA, PAS, PAR, RFA)
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.
- Concurrent submissions of applications to any component of the Public Health Service.
Examples of Situations Where Concurrent Applications 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
- Concurrent submissions of applications to a component of the Public Health Service and a different Federal Agency (e.g. NSF), unless otherwise prohibited
Be aware of the details. After the summary statement has been released:
- You may resubmit using a different PA, PAR, or PAS that accepts resubmissions, provided eligibility and other requirements are met.
- You must submit a new application (not a resubmission) if switching between a PA, PAR, or PAS and RFA or if changing activity codes (see 126.96.36.199 Resubmission of Unfunded RFA Applications and 188.8.131.52 Submission of Resubmission Application, and NOT-OD-18-197).
The applicant organization is responsible for verifying eligibility and the accuracy, validity, and conformity with the most current institutional guidelines of all the administrative, fiscal, and scientific information in the application.
What Are Your Options if Your Application is Withdrawn?
When clearly unallowable applications are identified, the Division of Receipt and Referral usually withdraws the application(s) submitted later in time. If the PD/PI wishes to have the first application withdrawn instead, they should reach out to the person that issued the correspondence to determine if this is possible, or to firstname.lastname@example.org. If the PD/PI believes that the applications are distinct and wishes to dispute the determination of overlap itself, they should follow the “Disputing a Withdrawn Application” process described here. In this instance, the case is referred to the Scientific Overlap Committee, a trans-NIH committee of subject matter experts. The goal of this committee is to give all applicants the opportunity to have an independent committee consider their explanation for why the applications are different. The Scientific Overlap Committee largely focuses on the science in the Research Strategy. The case will be considered by the Director of the Division of Receipt and Referral if the PD/PI is disputing the facts rather than the determination of overlap.
Get More Information
Get Answers to Specific Questions: Contact CSR’s Division of Receipt and Referral
301 435-0715 or email@example.com