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This document outlines the changes and requirements for the preparation of R01 grant applications to the NIH, detailing specific guidelines for research plans, attachments, and application procedures.
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How to fill out NIH Changes to R01 Application Preparation—Effective January 25, 2010

01
Review the NIH Changes to R01 Application Preparation guidance document thoroughly.
02
Identify the specific sections that have been updated or changed since previous guidance.
03
Gather all necessary documents and data required for the application.
04
Follow the new formatting guidelines, including page limits, font specifications, and margins.
05
Complete the required forms accurately, ensuring that all information matches the updated guidelines.
06
Ensure that all budget information is detailed and adheres to the new requirements.
07
Include any additional components required by the new guidance, such as biosketches or letters of support.
08
Proofread the application for clarity, consistency, and adherence to the new requirements before submission.

Who needs NIH Changes to R01 Application Preparation—Effective January 25, 2010?

01
Researchers applying for R01 funding from the NIH.
02
Institutions and organizations submitting grant applications to the NIH.
03
Administration staff who support grant application processes.
04
Any stakeholders involved in the preparation of NIH grant applications.
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Changes made to a Resubmission application should only be outlined in the Introduction attachment. The Introduction must include a summary of substantial additions, deletions, and changes to the application. It must also include a response to weaknesses raised in the Summary Statement.
You must submit the resubmission application within 37 months of the new, renewal, or revision application it follows. Thereafter, the application must be submitted as a new application. After an unsuccessful resubmission (A1), you may submit the idea as a new application.
Only approximately 15% of R01 and R01-equivalent grants are accepted for funding on the initial submission. However, this statistic increases to >30% if the appropriate steps are taken to revise and resubmit the grant.
You must submit the resubmission application within 37 months of the new, renewal, or revision application it follows. Thereafter, the application must be submitted as a new application. After an unsuccessful resubmission (A1), you may submit the idea as a new application.
The Simplified Framework for NIH Peer Review Criteria retains the five regulatory criteria (Significance, Investigators, Innovation, Approach, Environment) but reorganizes them into three factors — two will receive numerical criterion scores and one will be evaluated for sufficiency.
Pre-Submission Approval - Large Budget ($500k/year or more) Pre-submission approval may be required before the NIH application due date for applications requesting $500,000 or more in direct costs in any year. If pre-submission approval is required and not granted, your application will not be accepted.
NIH is adopting the Biographical Sketch Common Form and the Current and Pending (Other) Support Common Form in 2025 as per the White House Office of Science and Technology Policy (OSTP) memorandum on Policy Regarding Use of Common Disclosure Forms for applications and Research Performance Progress Reports (RPPRs).
For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency.

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NIH Changes to R01 Application Preparation—Effective January 25, 2010 refers to a set of modifications and guidelines set by the National Institutes of Health regarding the preparation and submission of R01 grant applications. These changes are intended to improve the application process and enhance the quality of proposals submitted for funding.
All applicants preparing R01 grant applications for submission to the NIH are required to adhere to the guidelines stipulated in the NIH Changes to R01 Application Preparation, effective January 25, 2010. This includes both new applicants and those submitting renewal or resubmission applications.
To fill out the NIH Changes to R01 Application Preparation, applicants should follow the updated forms and templates provided by the NIH, ensuring they meet all specified requirements and guidelines. Detailed instructions and requirements can be found in the application package or on the NIH website.
The purpose of NIH Changes to R01 Application Preparation is to streamline the application process, clarify the expectations for applicants, and promote the submission of high-quality and impactful research proposals. These changes aim to enhance the overall efficiency and efficacy of the funding process.
Applicants must report specific information including the research strategy, significance of the project, innovation, approach, and any other relevant information as stipulated in the updated guidelines. This includes detailed descriptions of the research plan, timelines, and budget justification according to the new format.
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