As published in NOT-OD-07-015 - November 13, 2006

NOTE: The following Questions and Answers on NIH’s Resubmission Policy are outdated. Please refer to NIH Guide notices NOT-OD-09-003 and NOT-OD-09-016 as well as http://grants.nih.gov/grants/policy/amendedapps.htm for information on the new NIH Policy on Resubmission Applications.

1. Why does the National Institutes of Health (NIH) limit the number of resubmissions?
   
2. What distinguishes a “new” application from a “revised” application?
   
3. Is it acceptable to change the title and abstract of my unfunded A2 application and submit it as a new application?
   
4. My competing renewal (A2) did not receive a fundable score after three reviews . Although my broad goals remain the same, I plan to take this work in a new direction.  Is it acceptable to submit a new application?  How different does my application have to be?
   
5. What is the current practice at the NIH to determine if an application is “New” and not simply another version of a project that has already received three reviews?
   
6. Is there a consequence to submitting an application that has been reviewed three times (Original, A1, A2) as a new application?
   
7. Does this policy apply only to R01s?
   
8. My R01 application was reviewed and did not receive a fundable score.  May I submit the application using a different grant mechanism, for example, as an R21 (Exploratory/Developmental Research) grant?
   
9. The second resubmission (A2) of my application did not receive a fundable score.  May I submit it as a new application if I remove the aim that the reviewers didn't like?
   
10. My application has been reviewed three times (the initial plus two resubmissions) and even though the score steadily improved with each resubmission, the A2 application still did not receive a fundable score. May I split the aims into two new applications as the reviewers suggested?
11. My A2 application will be reviewed in two weeks. I am not satisfied with my submitted application. May I withdraw this application now and retain the option of another A2 submission?
12. My A2 application was reviewed, but did not receive a fundable score.  My collaborator has new ideas to expand upon within the general theme of the proposed research.  Can this person develop these ideas and submit a new application?
13. A different PI is being proposed for an application that has had an initial review.  Is this application considered a new application or does the review under the previous principal investigator count as one of the three potential submissions?
14. I am submitting a new application in the same topic area of science as my A2. Should I address my changes or the fact that this is a new application in a cover letter?
15. Only part of my A2 application was funded: a) the scope of my work was reduced; and/or b) the length of time for my award was cut. May I submit a new grant application for the unfunded aims?
16. May I use preliminary data reported in my A2 application in my new application?
17. May I use the same literature review that I wrote for my A2 application in my new application?
18. I responded to a Request for Applications (RFA) funding opportunity that permitted resubmissions of unfunded applications from a previous RFA; however, my application was not funded. If I submit the unfunded grant application as an investigator-initiated application, is it considered “new” or an A2?
19. My A2 investigator-initiated application was just reviewed, but did not receive a fundable score.  May I submit this grant in response to an appropriate RFA?
20. After three reviews of an application for an Institutional Training grant, what constitutes a “new” application?

1. Why does the National Institutes of Health (NIH) limit the number of resubmissions?

Present NIH policy (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-041.html) allows consideration of three versions (Original, A1 and A2) for most grant mechanisms. The policy was established following analysis of data indicating that investigators who receive initial funding for an amended application have a lower success rate in obtaining support for a follow-on competing application. In general, it was noted that the likelihood of subsequent success decreased with an increasing number of amendments. This policy applies to all NIH extramural funding mechanisms that allow resubmissions whether reviewed in CSR or another NIH Institute/Center.

2. What distinguishes a “new” application from a “revised” application?

A new application is one that presents a new line of research, by the proposed investigators, that has not been previously peer reviewed by the NIH.  As stated in the NIH Guide notice, a new application following three reviews of a previous application (original plus 2 resubmissions) should exhibit “a significant change in direction and approach” and “include substantial changes in all sections of the Research Plan.”

3. Is it acceptable to change the title and abstract of my unfunded A2 application and submit it as a new application?

No, it is not enough to change the title and abstract. You must take a “fresh approach.” You must substantially change your aims, the questions that you are asking, the approach and/or methods that you are using to address your research questions, and consequently the potential outcomes that might be expected.

4. My competing renewal (A2) did not receive a fundable score after three reviews . Although my broad goals remain the same, I plan to take this work in a new direction.  Is it acceptable to submit a new application?  How different does my application have to be?

An application in the same general area of research but with different components (e.g., aims, methods, outcomes) may be sufficiently different.  Simply changing the title and asking for a new review group is not sufficient.  As stated in the Guide Notice, the application must exhibit “a significant change in direction and approach”, and “include substantial changes in all sections of the Research Plan.”  What constitutes “fresh,” “significant” and “substantial” is inevitably a scientific judgment for which no set of universally applicable examples can be provided. In general, it must be a creditable attempt to present a fresh approach. The evolution of scientific ideas proceeds rapidly and should also be factored into the changes proposed for the submission of a new application.

For example, an investigator may inquire if moving from one model system to another is different enough.  That will depend on how different the research is in the two proposals.  For instance, if the investigator is looking at the same transcription factors in different strains of transgenic mice, the differences may be considered insufficient; but changing both from transgenic mice to yeast and from one kind of transcription factor to another may well be sufficient.  Also, in clinical studies, changes that appear small may sometimes nonetheless be very significant (for example, same intervention, different disease; same intervention, different population; same intervention, different outcome measure; etc.).

5. What is the current practice at the NIH to determine if an application is “New” and not simply another version of a project that has already received three reviews?

New applications received by the NIH are screened multiple times and checked to determine if the application is a new application. The first check is done within the Division of Receipt and Referral in the Center for Scientific Review (CSR).  Subsequent checks are performed by the Scientific Review Administrator in charge of the review meeting, by the reviewers themselves or by NIH program staff.  Previous applications are analyzed for similarities to the current application and Summary Statements are also considered.

6. Is there a consequence to submitting an application that has been reviewed three times (Original, A1, A2) as a new application?

If there is a questionable application assigned to CSR for review, CSR staff may refer it to a CSR-convened committee that provides further analysis and recommendations to the Division of Receipt and Referral.  Institute and Center staff also performs a similar analysis.  When an application is determined to be another version of an application that has already received three reviews and in violation of this policy, the “virtual A3” application is administratively withdrawn and is not processed further.  The Division of Receipt and Referral, CSR, informs the project director/principal investigator and institution of this determination.

7. Does this policy apply only to R01s?

No. this policy applies to all funding mechanisms including research, institutional training and fellowship mechanisms. Please be aware that some Institutes and Centers have more restrictive limits on the number of resubmissions (e.g., grant applications over $500,000 direct costs in any given year).

8. My R01 application was reviewed and did not receive a fundable score.  May I submit the application using a different grant mechanism, for example, as an R21 (Exploratory/Developmental Research) grant?

Yes, but an R21 is intended to encourage exploratory/developmental research projects by providing support for the early conceptual stages of the work. For example, they usually do not require preliminary data.  Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area are generally not appropriate for R21 awards.  Specifics for this mechanism are available at: http://grants.nih.gov/grants/funding/r21.htm. Note that not all ICs participate in this mechanism. If the R01 application is changed to focus on a subset of aims and submitted as an R21, those aims may not be included in a R01 submission.

9. The second resubmission (A2) of my application did not receive a fundable score.  May I submit it as a new application if I remove the aim that the reviewers didn't like?

No. Removal of an aim in response to a previous review does not constitute a new application or a new line of research. The main objective of the science is essentially the same and it is NIH policy that the same project may not be reviewed more than three times.

An application in the same general area of research but with different components (e.g., aims, methods, outcomes) may be sufficiently different. A new application is one that presents a new line of research and one that has not been previously peer reviewed by the NIH.

10. My application has been reviewed three times (the initial plus two resubmissions) and even though the score steadily improved with each resubmission, the A2 application still did not receive a fundable score. May I split the aims into two new applications as the reviewers suggested?

This is not acceptable.  Even though there are now two applications, if the specific focus, question or approach has not changed, then the applications are both considered revisions of a project that has already been reviewed three times.

11. My A2 application will be reviewed in two weeks. I am not satisfied with my submitted application. May I withdraw this application now and retain the option of another A2 submission?

Yes, you may withdraw the application before the date of review and retain the option of submitting an A2.  Note that there is no longer a time limit for the submission of the first and second revisions (A1 and A2). If the application has gone to review, it may not be withdrawn.

12. My A2 application was reviewed, but did not receive a fundable score.  My collaborator has new ideas to expand upon within the general theme of the proposed research.  Can this person develop these ideas and submit a new application?

This is acceptable as long as the aims and research design are new ideas and that the research proposed is sufficiently different from that previously reviewed.

13. A different PI is being proposed for an application that has had an initial review.  Is this application considered a new application or does the review under the previous principal investigator count as one of the three potential submissions?

The review under the previous principal investigator does count toward the number of allowable resubmissions.  A new principal investigator does not make the application new if the overall scientific direction and approach of the project remain the same.

14. I am submitting a new application in the same topic area of science as my A2. Should I address my changes or the fact that this is a new application in a cover letter?

Address the changes in the cover letter if you feel that the topics are similar enough that there may be questions. This does not guarantee that NIH or the reviewers will agree with you. It may be helpful to discuss your situation with your program director.

15. Only part of my A2 application was funded: a) the scope of my work was reduced; and/or b) the length of time for my award was cut. May I submit a new grant application for the unfunded aims?

Possibly. You can submit a new application that incorporates the deleted aims if there has been a renegotiation of the scope (specific aims) of the research grant application and you have documentation from the funding IC to support the change. Consult the program director assigned to the application. This individual is the program contact shown in the upper left hand corner of your summary statement.

16. May I use preliminary data reported in my A2 application in my new application?

Yes, you may use the preliminary data if they are relevant to the aims of the new application. It is important that you take the time to read and consider the reviewers comments, contact the program person assigned to your application to discuss the strengths and weaknesses and take the time to write a new application.

17. May I use the same literature review that I wrote for my A2 application in my new application?

Unlikely.  The literature review may be substantially similar to the one in your A2, but given that many of your research aims will have changed, it would follow that you will need to up-date the literature review to make it relevant to the current aims.

18. I responded to a Request for Applications (RFA) funding opportunity that permitted resubmissions of unfunded applications from a previous RFA; however, my application was not funded. If I submit the unfunded grant application as an investigator-initiated application, is it considered “new” or an A2?

When an application that was submitted in response to an RFA is not funded and the investigator wishes to resubmit an application on this topic as an investigator-initiated application, it is to be submitted as a new application. The investigator will be allowed to submit the new application and up to two revised versions of this application, should that be necessary (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html).

19. My A2 investigator-initiated application was just reviewed, but did not receive a fundable score.  May I submit this grant in response to an appropriate RFA?

Yes, normally a previously unfunded investigator-initiated application that is submitted in response to an RFA is to be prepared as a new application. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html)

20. After three reviews of an application for an Institutional Training grant, what constitutes a “new” application?

The NIH recognizes that faculty, resources and areas of scientific strength continually evolve at institutions leading to significant changes in research training programs. Examples of “significant changes” that would be considered a new application might include, but are not limited to, an expansion of the focus of the proposed training, a significant change in training faculty consistent with the proposed program, adding a clinical component to a basic research type program or the opposite, and adding a pre- or postdoctoral training component.

Glossary:

A1: first resubmission

A2: second resubmission

A3: third resubmission (not permitted)