Writing a Grant

Also see: An Application's Journey Through NIH

Introduction

The typical successful R01 (regular research) grant application has as its basis a testable hypothesis in a biological area of high current interest. It includes a short, concise series of specific aims that address the central hypothesis. A well written background section is used to indicate the significance of the proposed work and review important information gleaned from the literature and the investigator's previous work that would allow reviewers to easily understand the hypothesis. Proposed experiments are clearly described in detail, with suggestions for proceeding with the work should they fail to produce the expected outcome. There is a body of solid preliminary data that demonstrates the likelihood for success of these experiments. Finally, sufficient information must be included to convince reviewers and NIH staff of the high quality of the applicant, the coinvestigators (including letters stating their willingness to participate in the research), available research resources, the applicant institution and demonstration of its support of the applicant.

The application is written on application form PHS 398. Follow instructions to the letter, including margin and typeface size, page length, and the table of contents. Applications can be rejected without review if they violate these guidelines. The application must be reviewed and signed by the appropriate university or other institutional administrative staff, and must contain documentation of approval of animal or human subjects protocols by the appropriate institutional committees.

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For the First-Time Applicant

• Ask for advice. Start on the application well in advance of the submission deadline and ask more experienced colleagues to read it over and offer suggestions. Check the NIH web site and identify those Program Directors who might be interested, then give them a call to discuss the proposed research.



• Submission deadlines are true deadlines. Unsolicited applications must be postmarked on the deadline, applications submitted in response to an RFA or RFP must be received at NIH on the deadline.



• Do your homework to help steer your application through NIH. You are allowed to suggest a study section and/or an Institute in the cover letter submitted with your application. Talk to Institute staff to ensure it will have a home if it gets a good score in review. Consider asking for a "secondary" assignment to a second Institute if at all appropriate. This will allow both Institutes to consider funding the application if it gets a good score in review. Search through the research interests of the different IRGs and their componant study sections, and look at the rosters of reviewers. Once a likely study section has been identified, talk to the SRA (the NIH official that runs the study section) to make sure that he/she will accept the application for review.



• Don't give up if an application isn't funded the first time. The summary statement critiques can be used to improve the grant so that it does better the second time it is reviewed. NIH allows a grant to be revised and resubmitted twice.



• First-time applicants may have less preliminary data and fewer publications than more seasoned investigators would. Reviewers and NIH staff understand this. More emphasis is placed on the applicant's demonstration that he or she is truly independent of any former mentors, has some of his or her own resources and institutional support, and is able to independently lead a laboratory. Other important points are a demonstrated clear understanding of the literature, understanding of the strengths and weaknesses of proposed techniques, clear and precise language, ability to present and discuss significance of data, a clear experimental plan, etc.



• New applicants make two common mistakes. One is including too little detail about proposed studies and insufficient justification for the significance of the problem. Another is proposing far more work than can be reasonably done during the grant period.



• Be realistic about the time things take. In general it takes about a year to collect preliminary data, 1 to 2 months for IRB or IACUC approval for human or animal protocols at the parent institution, 1 to 2 months to write the grant, 5 to 6 months from submission to review, 1 to 2 months to receive the summary statement following review, and 9 months from submission to funding. There are 3 submission deadlines each year, and revised applications are due 1 month later than new applications. Therefore, the earliest a revised grant can be submitted is 9 months after the original submission. Plan accordingly.

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Think Like a Reviewer

The typical peer reviewer:

• has a breadth and depth of knowledge, experience, and wisdom and is capable of understanding and judging a large range of work. He or she has a vested interest in ranking the applications in an unbiased, fair, scientifically rigorous way, knowing that the interests of the scientific community are served by giving the best scores to those grants that are most likely to contribute to our body of knowledge.



• may not be extremely familiar with all techniques used in a grant, or may have used the techniques, but does not have experience with the specific biomedical pursuit found in the grants under review. All parts of the grant must therefore be clear and written in such a way that a non-expert can understand them.



• may not know the applicant personally, or feel comfortable with his or her level of independence, knowledge of the field, ability to design experiments with appropriate controls, ability to decide what to do if proposed experiments don't work out, etc. It is the job of the applicant to convince the reviewer.



• may not fully understand the significance of the research area without a clear, compelling argument presented in the application.



• is capable of understanding and interpreting preliminary data if well-presented.  These data must therefore be appropriate for support of the proposed science.



• must read 10 to 15 applications in great detail and form an opinion about all of them. The successful application is clear and precise, is easy to read, has a detailed experimental design section, and is free of typographical and other errors.

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Budget

The requested funds are "direct costs," funds that go directly for the research project and investigator salaries. The applicant institution is also awarded "indirect costs," or overhead. This is a percentage of the direct costs, and the rate is negotiated between the institution and the NIH. If requested direct costs are below $250,000 per year, the modular budget format must be used, where the budget is some number of $25,000 modules. Detailed budgets are required for requests of greater than $250,000/year. Permission from NIDDK must be obtained prior to submission if the requested budget is higher than $500,000 direct costs per year. (see notice). Justify your budget request in an accompanying narrative. Whether modular or detailed, the requested dollar amount should be based on a realistic, thorough understanding of the real costs of the proposed work.

When part of the project is done at a second institution, this is usually funded via a "subcontract" from the parent grant. The second institution will also get indirect costs with this money, which also comes from the direct costs of the parent grant. These subcontract indirect costs must be included in the requested budget of direct costs.

NIH sets the allowed ceilings for stipend levels paid by NRSA grants and salary caps for personnel on regular research grants.

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Institutional Approval for Protocols Using Animal Subjects (IACUC) and Human Subjects (IRB)

A grant application cannot be funded without documentation of approval by the appropriate university (or other research institution) committees of all research protocols involving animals or people as subjects. Institutional Review Boards (IRB, human subjects) and Institution Animal Care and Use Committees (IACUC) need ample time, often 2 months or more, to approve new protocols. In addition, an Assurance of Compliance identification number for studies involving human subjects, or an Animal Welfare Assurance identification number for studies on animals (available from the institution Grants and Contracts Office) must be included on the application face page.

NIH policy was recently changed to allow applications that use human subjects to be submitted without prior IRB approval (see notice). If a grant receives a good score upon review, the principal investigator should begin the process to obtain approval of his IRB. No application can be funded without this approval. In addition, the principal investigator and all key personnel must submit a description of education they have completed in the protection of human subjects (see notice). Applications with animal research subjects must still arrive at NIH with documentation of IACUC approval included.

For human subjects, a grant application must provide information pertaining to six items described in Section C of the instructions for the application. These are the characteristics of the subjects; the sources of research materials; recruitment plans and consent procedures; potential risks; procedures for protecting against or minimizing potential risks; and potential benefits to the subjects and to mankind. In addition, new policies at NIH require that clinical research subjects include minorities and women (Inclusion of Women and Minorities in Clinical Research), and that wherever possible, children are also to be included (Inclusion of Children in Research Involving Human Subjects). (The Office for Human Research Protections (OHRP)) sets these policies.

For animal subjects, a grant application must provide information on the following five items: a detailed description of the proposed use of the animals; a justification for the choice of species and number of animals to be used; information on the veterinary care of the animals; an explanation of procedures to ensure the animals will not experience unnecessary discomfort, distress, pain, or injury; and a description of and justification for any euthanasia method to be used.

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Prohibition of URLs in Grant Applications

NIH has recently instituted a policy that prohibits the use of World Wide Web addresses (URLs) in grant and contract 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 25-page limit, and thereby giving an unfair advantage to some applicants and a large additional burden for reviewers.

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Co-investigator/Consultant Letters

Most scientific work requires collaberation between researchers, and NIH is dedicated to fostering such relationships. The grant application should contain a signed letter from each collaberator to the applicant that lists the contribution he or she intends to make and his or her enthusiasm for the work. These letters are often the primary assurance the reviewers have that this work will in fact be done.

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Special Instructions for New Investigators

NIH has recently discontinued its FIRST award (R29), a 5-year, $350,000 grant given only to new investigators.

All applicants for NIH support should be certain to now use the June 2002 version of the Public Health Service PHS 398 application kit. It is particularly important that new investigators (as defined below) check the "new investigator" box on line 3 of the face page in order to be certain they are identified correctly. NIDDK will use this information as part of the criteria for funding applications.

A "New Investigator" is a principal investigator on an application or grant assigned to NIDDK who has not previously served as such on any PHS-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or a mentored research career development award (e.g., K01, K08, K22, K23). Current or past recipients of Independent Scientist and other non-mentored career awards are not considered new investigators. Scientists who have served as principal investigators of independent laboratories and received support comparable to that provided by a regular research grant (R01) from other sources (such as intramural NIH, other governmental agencies, private foundations or industry) will not be considered as new investigators.

For the first-time applicant, it is understood by reviewers and NIH staff that there may be less preliminary data and fewer publications than a more seasoned investigator would have.  Instead, more emphasis is placed on the applicant's demonstration that he or she is truly independent of any former mentors, has some of his or her own resources and institutional support, and is able to independently lead a laboratory.

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