2014-04-21

[DIV28SUPER] more detail on NIH resubmission policy is out

Regarding the new NIH resubmission policy

 

 

See the new policy announcement at http://1.usa.gov/P8caVG  and some discussion on http://1.usa.gov/1gDtcCO

 

 

Submission Policy FAQs

 

A.      Resubmission Policy Basics

 

1.    What is the current policy on resubmissions?

 

NIH permits one resubmission of an unfunded application (see NOT-OD-09-016).

 

For all application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date (see NOT-OD-14-074).

 

Resubmissions (A1) must be submitted within 37 months of the new (A0) application (see NOT-OD-10-140)

 

For more details on the Resubmission Policy, visit the Resubmissions webpage.

 

2.    Which types of grant programs does the resubmission policy apply to?

NIH’s resubmission policy applies to applications submitted to all grant and cooperative agreement funding opportunities that allow resubmissions.

 

3.    If I submit an idea again as a new application, will it be given a new grant number? 

Yes.

 

4.    Are resubmissions of revisions allowed?

Generally. The funding opportunity announcement will indicate whether resubmissions of revisions are allowed.

 

5.    Must I wait for my summary statement before submitting my idea again?

Yes.

 

6.    Which application due date should I use when submitting a new application?

All applications submitted as new must target due dates designated for new applications, regardless of whether the previous submission was a competing renewal, a resubmission, or a new application.

 

7. If I am eligible for continuous submission, when does the April 17 policy change affect me?

The policy [NOT-OD-14-074] applies to applicants eligible for continuous submission for all applications submitted April 17, 2014 and beyond.

 

B.       Understanding a New Application vs a Resubmission Application  

 

1.    What distinguishes a new application from a resubmission application?

A resubmission application must contain an Introduction, which addresses the comments from the previous review and often changes marked in the text; a new application makes no reference to a previous submission.

 

2.    Can I submit a resubmission application if the funding opportunity announcement says resubmissions are allowed, or can I submit a new application instead?

An A1 application is the only way that you may specifically address the critiques of the previous review.  A new application may not have an introduction responding to the previous critiques, and can only be submitted after the summary statement is received, unless the funding opportunity announcement says otherwise.  All applicants should submit applications that reflect the current status of the field, new preliminary data, or new plans in response to new findings or strategies.   

3.    Is there a benefit to submitting a resubmission rather than a new application?

A resubmission allows you to provide a one page introduction and to mark changes in the text, to tell reviewers directly how you have addressed their critiques.  Alternatively, the introduction allows you to explain why you did not address them.

4.    My application was not discussed. Should I develop a new application or try to address the reviewers’ comments in a resubmission application?

This issue should be considered on a case-by-case basis. Read the summary statement carefully and note weaknesses that you could address in a reasonable length of time. Discuss the critiques with your collaborators, colleagues, and/or senior researchers/mentors to get their suggestions. Talking to the PO may be helpful, since s/he may be able to interpret the critiques and analyze them with you objectively. The PO also can discuss your options going forward. It is possible for an application that carefully addresses the reviewers’ comments to go from being “not-discussed” to receiving outstanding scores upon resubmission.

 

5.    Am I allowed to submit the same application as a new and a resubmission application in the same Council round?

Generally, no. NIH will not allow duplicate or highly overlapping applications to be under review at the same time. This includes: 1) a new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application; and 2) a resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. (NOT-OD-14-074)

6.    My resubmission application was not funded. May I now submit it as a new application?

Yes. Investigators should take into account the scores of the previous application, the reviewer comments, and advice from NIH program staff when deciding whether to submit the application as new. Should you decide to submit the application as new, take advantage of the comments from reviewers to reshape your application, but remember, you should not directly reference the previous review in the new application. Work from the prior funding period should be presented as preliminary data and/or rationale for the proposed research.  Publications from the prior work may be cited in the reference list, as applicable, and/or listed in the biosketches of the investigators.

 

7.    My resubmission of a competing renewal application (Type 2 A1) was not funded.  Will it still be considered a renewal application if I submit it as new?

After a resubmission of a competing renewal (Type 2) application that is not funded the next submission should be submitted as a new application (Type 1 A0) on the new application due date, and it will lose any association with the previously funded grant.   As a new Type 1, the application would be due on the new application due date, not the renewal application due date, and would not contain a Progress Report or introduction in response to previous critiques.

 

8.     If my resubmission (A1) has not yet been reviewed, may I withdraw this application and replace it with another resubmission?

You may withdraw an A1 application before the date of review and submit another A1 for a later, appropriate due date. Note that NIH will not accept a resubmission application that is submitted later than 37 months after the due date of the initial (A0) application (see NOT-OD-10-140).

 

9.     If my application has been reviewed, and the score released, may I submit an overlapping application, or withdraw the application and replace it with another one?

No.  Once your application has been reviewed, you must wait for release of the summary statement before submitting an application. 

 

10.  My investigator-initiated application was not funded. May I submit this application in response to an appropriate Request for Applications (RFA)?

Yes. In most cases a previously unfunded investigator-initiated application that is submitted in response to an RFA is to be prepared as a new application. See NOT-OD-09-100.

 

11.  If an application submitted in response to an RFA is not successful, is it considered new if I submit it to a different funding opportunity?

If the application is not successful through the RFA and is subsequently submitted to a different RFA or to a program announcement (such as the standard “parent” announcement), then it is considered a new application. If your application was submitted previously to a PA and you want to now submit it to an RFA, it is considered a new application. If you submit a new application to a PA and then submit to an RFA, you can subsequently resubmit to the PA as an A1. For more information on submission following an RFA review, see policy notice NOT-OD-09-100.

 

12.  Are all submissions to RFAs new applications?

For most RFAs that have a single receipt date, all applications will be considered new. Some RFAs have multiple receipt dates and allow resubmission applications to the same RFA (designated with the grant number suffix “A1”). The text of each RFA should clearly state which types of applications are allowed (new, resubmission, renewal, revision). This can be a complicated issue, and it is best to contact the program official listed in the RFA.

13.  Can I submit the same application in response to two different FOAs simultaneously?

In most cases, two or more applications that have scientific overlap in the experiments proposed are not allowed in peer review at the same time, even if one is to an RFA and the other(s) to a PA/PAR/PAS. There are exceptions to this rule. NIH allows subprojects of Program Project Grant applications to be submitted as research applications (R01, R03, R15, R21, etc.) in the same cycle. In most cases, a second application for the same project should not be submitted until after the summary statement for the original submission has been released. See more information on overlapping applications.

14.  Must I change an application that was already reviewed in order to submit it as new?

Although NIH will not assess the similarity of the science in the new (A0) application to any previous submission when accepting it for review, we encourage investigators to take into account critiques from the previous review and advice from program staff. Remember, duplicate or highly overlapping applications are not allowed in review at the same time. Remember also that the NIH will not accept an A0 or A1 application if an appeal of initial peer review is pending on a substantially overlapping application.

 

C.       Preparing Your Application

 

1.    When should I resubmit?

You should resubmit the application when you can address the weaknesses described in the summary statement. Often, additional preliminary data are needed to address the criticisms. Therefore, you may need to skip a due date or two and plan on including the results from additional experiments. Note that the standard due dates for resubmission applications are often later than those for new applications.  An application can be resubmitted up to 37 months after the original application’s due date; after that, it will be considered a new application and should not refer to the previous review. However, as the time increases between the original application and the resubmission, reviewers may expect more preliminary data, as evidence that the investigator is productive and committed to the project. Alternatively, you may discuss with your Program Officer the possibility of submitting a new application rather than a resubmission application.

 

2.    Do I need to respond to all of the reviewers’ comments, or can I disregard comments that seem to me to be unjustified?

The introduction of your resubmission application should address all of the weaknesses described in the summary statement.  If you disagree with a reviewer’s statement, explain why, and provide additional information.  Avoid responses that could be seen as argumentative.  Ask a colleague to read the reviewers’ critiques and your responses prior to resubmission, to confirm that you have addressed the critique in a way that is informative and non-confrontational.

 

3.    If my application is not funded, may I use the same application form for the subsequent resubmission or new application?

Possibly. If you are applying to a new funding opportunity announcement (FOA), you must use the form associated with that FOA. When submitting to the same FOA as the previous application, you must check the funding opportunity to make sure that no form updates have happened since your previous submission.  If a more recent form version is available, you will need to transfer your information to that form. See Do I Have The Right Electronic Forms For My Application?

 

4.    How do I distinguish the application as being a new application or a resubmission application on the application form?

Box 8 of the SF 424 (R&R) cover allows you to select the application type as either new or resubmission.

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

You should not refer to the previous submissions in the cover letter to the new application, as it will be given a new number and will not be compared to the previous submissions when accepting it for review.

6.     What is the page limit for the introduction to a resubmission application and how do I indicate changes?

Generally, the introduction is limited to one page unless otherwise specified in the FOA. For example, an exception is made for R25, Ts, Ds and some K applications, to allow a 3 page introduction to the resubmission application. See the Table of Page Limits for more information.

 

Substantial scientific changes should be marked in the text of the Resubmission application by bracketing, indenting, or change of typeface. You must use an approved font (see application guide), that is black and 11 pt or larger. Do not underline or shade changes. Deleted sections should be described but not marked as deletions. If the changes are so extensive that essentially all of the text would be marked, explain this in the introduction. The Preliminary Studies/Progress Report section should incorporate work completed since the prior version of the application was submitted.

 

7.     Can a resubmission application have a different title than the original submission?

Yes, your resubmission application can have a different title than your original application. However, if there is a significant change in the content and scope of the proposed research, it may be best to develop a new application (see NOT-OD-10-080) Consult with your program official for further guidance.

 

8.    Can an additional PD/PI be added or removed before submitting a resubmission application?

A PD/PI can be added to or removed from the resubmission application. It is best to explain these changes in the introduction of your application. A change of PD/PI also needs to be noted via a checkbox in the application.

 

D.      Time Limits for Resubmission Applications

 

1.    When can an application no longer be resubmitted?
Resubmission applications may be submitted for an appropriate due date up to 37 months after the application due date of the initial application. Any application on the same topic that you submit more than 37 months from the initial receipt date is considered a new application; it should not refer to the previous review(s) and must be submitted for the appropriate due date for new applications. (See related policy
notice.)

 

2.     What happens to the time limit for resubmission applications if I choose to submit as new instead of as a resubmission?

The 37 month time limit for resubmissions starts with each application that is submitted as new.

 

3.     Why does the NIH set a time limit for resubmission applications? 

    Because of the pace of scientific discovery, NIH limits the timeframe in which applicants    can respond directly to critiques from peer review.

 

E.       Implications of Various Changes to Your Application

 

1.    Can an additional PD/PI be added or removed before submitting a Resubmission application?
A PD/PI can be added to or removed from the resubmission application. It is best to explain these changes in the introduction of your application. A change of PD/PI also needs to be noted via a checkbox in the application.

2.     My R01 application was reviewed and was not funded. May I submit the application using a different activity code, for example, as an R21 (Exploratory/Developmental Research) grant?

Yes, but you must wait until the summary statement for the previous submission is released and you need to look carefully at the requirements of the new activity code. Specifics for this activity are available at: NIH Exploratory/Developmental Research Grant Award. Note that not all ICs participate in this activity. 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 separate R01 submission. See Types of Grant Programs to learn about requirements for other activity codes. For more on the submission of applications with a changed activity code, visit NOT-OD-09-100.

 

3.     Only part of my 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.

 

F.    Review Issues

 

1.    How are resubmission applications reviewed?

Reviewers are instructed to evaluate the resubmission application as presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. For resubmitted renewals, the committee will also consider the progress made in the last funding period.

 

2. May I request that my resubmission application be reviewed by a different study section or have primary assignment to a different NIH IC than my original application?

Resubmission applications usually are assigned to the same study section and IC as the original application but you can request a change by submitting a cover letter with the resubmission application following the instructions in the SF424 (R&R) Application Guide.  It is a good idea to consult with your PO and/or SRO to discuss whether a change would be appropriate.

The Division of Receipt and Referral (DRR) at CSR is responsible for assigning applications to ICs and in some cases to Scientific Review Groups (SRGs). DRR usually accommodates requests if appropriately justified and requested well before the review meeting date, but reserves the right to make the final decision. ICs websites describe mission interest which can help applicants match topics of research to the appropriate funding component. The CSR website provides information regarding the focus of expertise of each of the standing study sections.   You may direct referral questions to the CSR Referral Office (301-435-0715).

3. What should I do if I do not agree with my IC or review group assignment?

Contact the NIH scientific review officer assigned to your application to discuss the review assignment.  Contact the Division of Receipt and Referral in the Center of Scientific Review to discuss the IC assignment.

4. Are reviewers allowed to consider previous submissions when reviewing    

    applications submitted as new?

No. The scientific review officer will remind reviewers that they must only consider the information included in the new application.

 

5. Can I resubmit or submit my application as new while my application is under appeal of the initial peer review?

No.  The appeal must be resolved in order for you to submit that application again.

 

 

Best wishes!

 

Mark

 

 

Mark D. Lindner, Ph.D.

Scientific Review Officer

Biobehavioral Regulation, Learning and Ethology (BRLE) Study Section

Center for Scientific Review (CSR), National Institutes of Health (NIH)

6701 Rockledge Dr. Bethesda, MD 20892 (zip code of 20817 for FedEx packages)

Mobile Phone: 301-915-6298

 

 

New for Grantees:          Expectation for Service on Study Sections and Peer Review Advisory Groups

New for Applicants:       Advance Notice - New NIH Policy on Post-Submission Application Materials

New for Reviewers:       Guidance for Shortened Applications

 

 

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