Clarification of NIH policy: limits on resubmission of applications The National Institutes of Health (NIH) issued the following notice to clarify their policy on the number of resubmissions (known previously as revisions or amendments) allowed for a NIH grant application. NIH will not consider a third resubmission (A3) or higher to any application for extramural support. However, there is no time limit for the submission of the first and second resubmissions (A1 and A2). Policy: On June 27, 1997, the NIH issued a notice in the NIH Guide for Grants and Contracts (see http://grants.nih.gov/grants/guide/notice-files/ not97-011.html ) that limited the number of resubmissions permitted as well as the time window during which those resubmitted applications would be received. On May 7, 2003, the NIH modified this policy by eliminating the two-year restriction on the receipt of resubmitted applications (see http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-041.html ). The present notice clarifies the policy and its implementation. The policy limiting the number of resubmissions was established following analysis of data indicating that investigators who receive initial funding for a resubmitted application have a lower success rate in obtaining support for a subsequent renewal (competing continuation) application. The likelihood of subsequent success decreased with an increasing number of resubmissions. Clarification of what constitutes a new application: Investigators who have submitted three versions (01, 01A1, 01A2, or 06, 06A1, 06A2, etc.) of an application and have not been successful often ask NIH staff what constitutes a “new application.” A new application is expected to be substantially different in content and scope with more significant differences than are normally encountered in a resubmitted (amended) application. A new application should include substantial changes in all sections of the research plan, particularly in the specific aims and the research design and methods sections. There should be fundamental changes in the questions being asked and/or the outcomes examined. Changes to the research plan should produce a significant change in direction and approach for the research project. What constitutes “significant” and “substantial” is inevitably a scientific judgment for which no set of universally applicable examples can be provided. Rewording of the title and specific aims or incorporating minor changes in response to comments of reviewers in the most recent summary statement does not constitute substantial changes in scope, direction or content. Requests for review by a different review committee or funding consideration by a different NIH institute are not sufficient reasons to consider an application as new. Applications received by the NIH are screened multiple times and checked to determine if the application is a new application, not simply another version of a project that has already received three reviews. The first check is done within the Division of Receipt and Referral (DRR) 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, and by NIH program staff. If there is disagreement about whether an application assigned to CSR for review is new or resubmitted, CSR staff may refer it to a CSR-convened committee that provides further analysis and recommendations to the Division of Receipt and Referral. The evaluation process includes the analysis of previous applications and summary statements to determine the similarities and differences to the current application. Individual institutes and centers have their own evaluation processes. When applications are determined to be a version of an application that has already received three reviews and in violation of this policy, they are administratively withdrawn and are not reviewed. The Division of Receipt and Referral in CSR informs the Program Director/Principal Investigator and institution of this determination. The following questions and answers resources should be of assistance in the process: http://grants.nih.gov/grants/policy/resubmission_q&a.htm For inquiries, contact: Office of Extramural Programs, Office of the Director, at 301-435-2768. Division of Receipt and Referral, Center for Scientific Review, 301-435-0715. -- Barry I. Milavetz, Associate Vice President for Research, Research Development and Compliance, barrymilavetz@mail.und.nodak.edu, 7-4278