Notice Number: NOT-OD-09-100

Key Dates
Release Date: May 15, 2009

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Purpose

The NIH and Public Health Service have had long-standing policies not to review the same or very similar application more than once.  These policies are of particularly timely importance due to the recent large number of applications submitted for FOAs under the Recovery Act, particularly those for RFA-OD-09-003, NIH Challenge Grants in Health and Science Research (RC1), and the potential large number of unfunded applications expected under this and other RFAs. There are many reasons for this policy, particularly the need to avoid added burdens on the review system, as well as on principal investigators and their institutions. 

The purposes of this Guide Notice are: 1) to remind Project Directors, Principal Investigators (PD/PIs) and applicant institutions that submissions of identical applications to one or more components of NIH or the Public Health Service are not allowed (http://grants.nih.gov/grants/guide/notice-files/not99-146.html); 2) to clarify that NIH will not review any new or resubmission applications containing one or more of the specific aims contained in a similar, identical, or essentially identical application until after the peer review process for the original application has been completed and a summary statement has been provided to the PD/PI(s); 3) to remind the community of existing NIH policy on resubmitting unfunded RFA applications and applications with a changed grant activity code (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html); and 4) to clarify that the application must be modified appropriately to fit the application requirements of the new FOA or activity code.  Applicant institutions are expected to take responsibility to ensure that applications submitted adhere to all of these policies and requirements. 

Non-compliant applications identified by NIH at any stage of the process (referral, peer review, program management, and/or grants management) will be withdrawn from funding consideration.

Policies

Submissions of Similar, Essentially Identical, or Identical Applications

Submission of identical applications to one or more components of the PHS is not allowed.  The NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes.  Likewise, identical or essentially identical grant applications submitted by different applicant organizations will not be accepted. 

Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the PD/PI are the original work of the PD/PI and have not been used elsewhere in the preparation and submission of a similar grant application.  Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state.  The reviewers can thus easily identify multiple grant applications for essentially the same project.  In these cases, application processing may be delayed or the application(s) may be returned to the applicant without review.

Essentially identical applications will not be reviewed except for: 1) individuals submitting an application for an Independent Scientist Award (K02) proposing essentially identical research in an application for an individual research project; and 2) individuals submitting an individual research project identical to a subproject that is part of a program project or center grant application.

Resubmission of Unfunded RFA Applications and Applications with a Changed Grant Activity Code

The majority of grant applications submitted to NIH each year are investigator-initiated.  However, the NIH Institutes and Centers also solicit grant applications on specific topics through the use of Requests for Applications (RFAs), such as the RFA-OD-09-003: NIH Challenge Grants in Health and Science Research (RC1).  Since an RFA often has special considerations of eligibility, scientific scope, and review criteria, unfunded RFA applications may be resubmitted as new applications to another FOA or activity code as long as the application is modified appropriately to fit the application requirements of the new FOA or activity code.  The general policy on application resubmission, stated below, applies to all activity codes that might be solicited via an RFA and to instances where there is a change in activity code.  There may, however, be exceptions to this policy, which will be clearly identified in the original RFA or in a follow-up RFA.

• When an application that was submitted in response to an RFA is not funded and the investigator wishes to submit an application on this topic as an investigator-initiated application, it is to be submitted as a new application, unless provision for a resubmission is clearly delineated in the RFA.  In addition, if a subsequent RFA specifically solicits resubmissions of unfunded applications from a previous RFA, the instructions in the second RFA should be followed.  In all other cases, an application submitted in response to an RFA and then resubmitted as an investigator-initiated application must be prepared as a new application.
• When a previously unfunded application that was originally submitted as an investigator-initiated application is to be submitted in response to an RFA, it is to be prepared as a new application.
• When an unfunded application that was reviewed for a particular research grant activity code is to be submitted for a different grant activity code, it is to be prepared as a new application.  In such cases it is not possible to continue both application lineages and it is not possible to submit a resubmission application for the first activity code.

In addition, due to the NIH policy of not allowing submission of, similar, essentially identical, or identical applications, no resubmission under the resubmission policy stated above may occur until after the peer review process is completed and a summary statement has been provided to the applicant.

Special Information for Pending Challenge Grant (RC1) Applications

It is important to note that NIH anticipates a large number of unsuccessful applications after the review of RFA OD-09-003, NIH Challenge Grants in Health and Science Research (RC1).  In accordance with the policies described above, the earliest a new application from that unfunded pool could be submitted is during the Cycle III due dates for new applications (available at (http://grants.nih.gov/grants/funding/submissionschedule.htm).  In addition the following conditions must be met:

• The initial peer review process is complete and the review outcome and summary statement are available on eRA Commons.  This is expected to occur in August, 2009. 
• The application is submitted as a new application on the appropriate date for new applications and makes no reference to the previous review (does not include an Introduction or identify the changes made). Note that applications that are incorrectly submitted on the dates for resubmission applications will not be allowed to be corrected and will have to wait until January, 2010 to submit as a new application. 
• There is an appropriate match of science topic and Institutes/Centers sponsoring the FOA. 
• The new application follows all the requirements for the FOA and activity code; these may be different than those in the original Challenge Grant RFA.  There is not a Parent Announcement for the RC1 activity code and thus applications will have to use other appropriate research activity codes – R01, R03, R15, R21, etc. 

Any reconfigured RC1 applications submitted that are found to be not in compliance with these policies will be withdrawn without further consideration.  In particular, any application submitted for Cycle II due dates before the initial review process is complete will be returned.

Inquiries

Questions concerning this Notice should be referred to GrantsInfo@mail.nih.gov.

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