Nih R01 Resubmission Cover Letter
Resubmitting an Application
If your current application will not be funded, it is usually possible to send a resubmission (formerly called a revised application). Consult with your Program Officer about the resubmission process. Generally speaking, the NIH allows you to make one resubmission after the original submission. You are typically allowed one additional page at the beginning of the resubmission (the "Introduction to the Resubmission"), in which you respond to the comments from the previous review. The only exceptions to the 1 page Introduction are for Training (T), R25, D43, D71, and K12 applications, all of which are allowed a 3-page Introduction for resubmissions.
Note that per NIH Guide Notice NOT-OD-14-074, for 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 due date. NIH will not assess the similarity of the science in the new (A0) application to any previously reviewed submission when accepting an application for review.
These guidelines can help in your resubmission:
- Effective December 4, 2014, NIH has removed the requirement to identify “substantial scientific changes” in the text of a resubmission by “bracketing, indenting, or change of typography.” Rather, it is sufficient to outline the changes made to the Resubmission application in the Introduction.
- 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. The page limit for the Introduction may not exceed one page unless indicated otherwise in the Table of Page Limits. See also: NOT-OD-15-030.
- Talk with your Program Officer about the summary statement:
- If the reviewer's comments are useful, incorporate responses to them into the resubmitted application.
- If you disagree with a reviewer's comments, address them in your introduction. Be clear and polite.
- If your application is not funded after the second resubmission, you may submit the same idea as a new application for the next appropriate due date.
The following guidance may assist you in developing a strong application that allows reviewers to better evaluate the science and merit of your proposal. This page provides tips for demonstrating to reviewers and NIH staff the high quality of the personnel involved in you project and documenting resources and institutional support of the project. We provide information for new investigators and foreign applicants, as well.
Though the advice provided is relevant for all research grants, it is general in nature and geared toward the NIH Research Project (R01). The tips should not replace your organization's internal guidance, specific advice provided by NIH program or grants management staff, or instructions found in the funding opportunity announcement or application guide.
What to Know Before You Start Writing
Where to Find Instructions for Writing Your Application
Application forms are posted with each funding opportunity announcement. Form-by-form, field-by-field instructions for completing your application may be found on the How to Apply - Application Guide page under the blue header for Form Instructions. Use these instructions in conjunction with the guidance in the funding opportunity announcement (including the Related Notices section of the announcement) to develop your application.
What Peer Reviewers Look For
Careful preparation and an understanding of how your application will be reviewed can help you build a solid application. During NIH’s peer review process, we convene a panel of non-Federal scientists to review your application. Although a number of factors contribute to whether your application will be funded, we place great emphasis on the review of scientific merit. The following sections describe the criteria reviewers employ to evaluate applications. Read them carefully for helpful hints on the information and content you should include in the application to garner a favorable evaluation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Learn more about how applications are scored.
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit and in providing an overall impact score, but will not give separate scores for these items.
- Protections for Human Subjects
- Inclusion of Women, Minorities, and Children
- Vertebrate Animals
Be sure to address any of these additional review criteria that apply to your application, as reviewers will consider them when assigning overall impact/priority scores.
Note: These are general review criteria for evaluating unsolicited research project grant applications. NRSA fellowship award, career development award, and specific funding opportunity announcements (FOAs) may have different or additional special review criteria. Applicants should look in the funding opportunity announcement to which they are applying and familiarize themselves with the review criteria by which their application will be evaluated.
Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
- Applications from Foreign Organizations
- Select Agent
- Resource Sharing Plans
- Authentication of Key Biological and/or Chemical Resources
- Budget and Period Support
Note: Certain funding opportunity announcements (FOAs) that are published in the NIH Guide for Grants and Contracts may list additional elements under each of the above criteria related to the specific requirement of the FOA.
Learn more about how applications are reviewed and scored on our peer review process page.
Research Resources, Institutional Support and Available Expertise
Sufficient information must be included to demonstrate to reviewers and NIH staff the high quality of the PD/PI, the co-investigators, available research resources, and the applicant institution and its support of the project.
Applicants should clearly state that they have the appropriate resources to conduct the research, such as adequate equipment and laboratory space. When possible, include letters of commitment for these resources.
- Understand the level of resources needed to compete.
- Conduct an organizational assessment.
- Determine what resources and support your organization has and what additional support you'll need.
- Consider whether the available equipment and facilities are adequate and whether the environment is conducive to the research.
Independence and Institutional Support:
This is important for all investigators, but particularly for new and early stage investigators or those who are early in their independent careers:
- Provide reviewers evidence that you have the appropriate experience and training to lead and manage the research project.
- Letters of reference and institutional commitment are important.
- Mention any start-up funds, support for a technician, etc. This is a positive indicator of institutional commitment to the peer reviewers.
Collaborators and Consultants:
Determine the expertise needed for your research study team (individuals, collaborating organizations, resources, etc.). Most scientific work requires collaboration among researchers, and NIH is dedicated to fostering such relationships.
- Include letters of commitment in your application that clearly spell out the roles of the collaborators. The grant application should contain a signed letter from each collaborator to the applicant that lists the contribution he or she intends to make and his or her commitment to the work. These letters are often the primary assurance the reviewers have that this work will in fact be done.
- For consultants, letters should include rate/charge for consulting services.
- If you are planning to apply with multiple-principal investigators, then take the following into consideration:
- The format, peer review and administration of applications submitted with multiple PIs do have some significant differences from the traditional single-PI application. Therefore, it is essential to consider all aspects of the funding mechanism before applying, regardless of the type of research proposal to be submitted.
- All applicants proposing team science efforts are strongly encouraged to contact their NIH program officials at the earliest possible date to discuss the appropriateness submitting with multiple-PIs for the support of their research.
Although not a requirement for assignment purposes, you are allowed to request that the Division of Receipt and Referral in the Center for Scientific Review assign your application to a particular review group for initial peer review and to an NIH institute or center for possible funding.
- Reviewers with expertise in your area will best recognize the potential for your research to advance science. Review the rosters of the scientific review groups to get your application assigned to a study section where some members have the appropriate expertise to review your project.
- Specify your assignment request in a cover letter or in the assignment request form included in your application. Follow the application guide instructions as to what you may and may not request, and what information should go in the cover letter vs the assignment request form.
- Only NIH staff with a need to know are provided access to your assignment request and cover letter. Reviewers to not access to them.
This is an opportunity to also provide names of any reviewers that may have a conflict of interest and should not be considered as reviewers of your application. It is important to match your area of research with the areas reviewed by the study section.
Are You a New or Early Stage Investigator?
- Determine whether you qualify as a new investigator based on the NIH definition of new investigator. NIH offers funding opportunities tailored to new investigators, such as the NIH Director's New Innovator Award. More information on NIH programs designed for new investigators can be found on the New Investigators Program Web page.
- NIH staff is on the lookout for new and early stage investigators. Check your eRA Commons account and ensure your funding history and the date of your residency or terminal degree are accurate to ensure that you are identified appropriately as a new or early stage investigator. The eRA system calculates eligibility based on the information associated with the applicant’s PD/PI profile and account.
- It is to your advantage to identify yourself as a new investigator because reviewers are instructed to give special consideration to new investigators. Reviewers will give greater consideration to the proposed approach, rather than the track record.
- First-time applicants may have less preliminary data and fewer publications than more seasoned investigators, and NIH reviewers understand this. Reviewers instead place more emphasis on how the investigator has demonstrated that he or she is truly independent of any former mentors, whether he or she has some of his or her own resources and institutional support, and whether he or she is able to independently lead the research.
Foreign Involvement: Institution and/or Investigator
- Foreign PD/PIs and those from foreign institutions should ensure their eligibility by checking the eligibility guidelines provided in every FOA.
- Foreign PD/PI's and those from foreign institutions are highly encouraged to contact a NIH program officer as soon as possible in the planning and writing stages.
- Foreign applicants can learn more at our Information for Foreign Applicants and Grantees page.
Develop Your Budget
This step will be one of your most time-consuming in the writing process.
- Know what type of budget will be required to submit with your application (found in your FOA).
- Understand the various components of the budget, working with your institution’s central grants office and department administrator.
- Contact NIH program officials regarding allowability and other budgetary questions.
- For more information, see Develop Your Budget.
Your Research Plan
The research plan describes the proposed research, stating its significance and how it will be conducted. Remember, your application has two audiences: the majority of reviewers who will probably not be familiar with your techniques or field and a smaller number who will be familiar.
- All reviewers are important to you because each reviewer gets one vote.
- To succeed in peer review, you must win over the assigned reviewers . They act as your advocates in guiding the review panel's discussion of your application.
- Write and organize your application so the primary reviewer can readily grasp and explain what you are proposing and advocate for your application.
- Appeal to the reviewers and the funding ICs by using language that stresses the significance of your proposed work.
Additional Elements Required in a Grant Application
The following elements need to be included in the grant application as appropriate. Unless stated, these elements do not influence the rating (priority score) of the application. However, the reviewers are asked to comment on the adequacy of the information provided for each element. Any concerns the reviewers identify may negatively affect and postpone the granting of an award.
- Bibliography & References Cited
Provide a bibliography of any references cited in the Research Plan. Each reference must include the names of all authors (in the same sequence in which they appear in the publication; you can use “et al.” convention in place of listing all authors in a citation), the article and journal title, book title, volume number, page numbers, and year of publication. Make sure that only bibliographic citations are included. Be especially careful to follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application.
- Care and Use of Vertebrate Animals in Research
If you are planning to use live vertebrate animals in the project, you must adhere to the requirements in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy): HTML Version and PDF Version. For an overview of what is required in your application and detailed instructions, see the Vertebrate Animals Section webpage. Additional information can be found at:
- Consortium/Contractual Arrangements
Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s).
- Consultants and Collaborators
Attach appropriate letters from all consultants and collaborators confirming their roles in the project. For consultants, letters should include rate/charge for consulting services.
- Facilities & Other Resources
This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work.
- Inclusion of Women, Minorities and Children in Research
Peer reviewers will also assess the adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children, as appropriate, for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. Check out the NIH inclusion of women and minorities policy website which has resources such as a decision tree to help you determine which of your studies are subject to NIH’s inclusion policy.
- Multiple PD/PI
For applications designating multiple PDs/PIs, you must include a leadership plan.
- Protection of Human Subjects from Research Risk
Applicants must assure NIH that all human subjects are protected. Reviewers will assess the potential risk to human subjects in proposed research and evaluate what protections are in place to guard against any research-related risk. Awards cannot be made until assurances are on file with the Office for Human Research Protections (OHRP). Decision charts are presented that are helpful in thinking through relevant human subject protections issues (see http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html).
- Resource Sharing Plan(s)
This section includes Data Sharing Plan, when applicable, and Sharing Model Organisms. For more information on data sharing, please see the NIH website at /grants/ policy/data_sharing/.
- Select Agents
Identify any select agents to be used in the proposed research. Select agents are hazardous biological agents and toxins that HHS or USDA have identified as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. CDC maintains a list of HHS and USDA Select Agents and Toxins.
- Use of Internet Sites
NIH instituted a policy that prohibits the use of World Wide Web addresses (URLs) in grant applications in the place of text describing the same material. This is because of the potential for providing a large amount of extra material from a Web site beyond what would fit in the page limit, and thereby giving an unfair advantage to some applicants and a large additional burden for reviewers.
Important Writing Tips
You’ve planned, you’ve researched, you understand the application…now it’s time to write. A well-written, well formatted application is an important key to success. Remember the details when formatting attachments!
TIP #1: Make Your Project’s Goals Realistic
Don’t propose more work than can be reasonably done during the proposed project period.
- Before you start writing the application, think about the budget and how it is related to your research plan. Remember that everything in the budget must be justified by the work you've proposed to do.
- Be realistic. Don't propose more work than can be reasonably done during the proposed project period. Make sure that the personnel have appropriate scientific expertise and training. Make sure that the budget is reasonable and well-justified.
TIP #2: Be Organized and Logical
Why? Reviewers are accustomed to finding information in specific sections of the application. This creates an efficient evaluation process and saves reviewers from hunting for required information.
Start with an outline, following the suggested organization of the application. The thought process of the application should be easy to follow.
Note: Upon submission, NIH Systems will automatically add: headers, footers (time stamping, tracking number, FOA number, and page numbers). Therefore, do not include headers or footers.
- Write clear headings.
- Use sub-headings, short paragraphs, and other techniques to make the application as easy to navigate as possible. Be specific and informative, and avoid redundancies.
- Bookmark major sections.
- Use diagrams, figures and tables, and include appropriate legends, to assist the reviewers to understand complex information. These should complement the text and be appropriately inserted. Make sure the figures and labels are readable in the size they will appear in the application.
- Use bullets and numbered lists for effective organization. Indents and bold print add readability. Bolding highlights key concepts and allows reviewers to scan the pages and retrieve information quickly.
- Utilize white space effectively.
TIP #3: Write in Clear Concise Language
Why? A reviewer must often read 10-15 applications in great detail so your application has a better chance of being successful if it is easy-to-read and well-written.
- Write a clear topic sentence for each paragraph with one main point or idea. This is key for readability.
- Make your points as direct as possible. Avoid jargon or excessive language.
- Write simple and clear sentences, keeping to about 20 words or less in each.
- Be consistent with terms, references and writing style.
- Use the active, rather than passive, voice. For example, write "We will develop an experiment, "not "An experiment will be developed."
- Spell out all acronyms on first reference.
- If writing is not your forte, seek help!
TIP #4: Sell Your Idea on Paper
Capture the reviewers’ attention by making the case for why NIH should fund your research!
- Include enough background information to enable an intelligent reader to understand your proposed work.
- Support your idea with collaborators who have expertise that benefits the project.
TIP #5: Edit Yourself, but also Enlist Help
You’ve most likely been looking at the same words, sentences and paragraphs repeatedly! Allow someone with fresh eyes read your content, check your punctuation, and give you feedback on whether the content flows.
- Have zero tolerance for typographical errors, misspellings, grammatical mistakes or sloppy formatting. A sloppy or disorganized application may lead the reviewers to conclude that your research may be conducted in the same manner.
- Remember the Details! There are format requirements, such as font size, margins, and spacing. Make sure you are familiar with them before submitting your application and label sections as directed. You don’t want your application delayed because any of these details are not incorporated.
- If more than one investigator is contributing to the writing, it would be helpful to have one editor not only review for punctuation errors, but ensure that the application has a consistent writing style.
TIP # 6: Share for Comments
You’ve most likely been looking at the same words over and over! Allow someone with fresh eyes read your content, check your punctuation, and give you feedback on whether the content flows.
- Request your colleagues or mentors review a first draft of your specific aims early in the process. This step can save lots of valuable time.
- Allow time for an internal review by collaborators, colleagues, mentors and make revisions/edits from that review. If possible, have both experts in your field and those who are less familiar with your science provide feedback.
- Ask those who are providing a review to use a critical eye and evaluate the application using the peer review criteria
- Allow sufficient time to put the completed application aside, and then read it from a fresh vantage point yourself. Also, try proofreading by reading the application aloud.
- Conduct your own review based on the NIH's five peer review criteria. How would you rate your own application?
- Prior to submission, look over the entire grant application one final time. Remember, you want a convincing proposal that is also formatted according to the application guidelines, punctuation error-free, clear to read, and is to the point!