Transcript of the 
What Happens to Your NIH Grant Application Video

Narrator: 
What happens to your NIH research grant application: an overview of the peer review process.

NIH is the largest supporter of biomedical and behavioral research in the world. In a typical year researchers submit about 80,000 grant applications of various kinds seeking support for fellowships, program projects, research resources centers, training programs, small businesses, and individual investigator research. In regards to this latter category of grant support, NIH is always looking for exciting investigator-initiated research ideas, particularly those from new or early-stage investigators seeking funding for their first R01 award. We've created this video to help those of you new to the NIH funding world to understand what will happen to your research grant application after it has been submitted and what generally you can do to enhance the quality of your application.

The NIH is actually a plural organization composed of 27 distinct institutes and centers, or ICs. Twenty-four of these fund research in their respective health-related fields. The Center for Scientific Review or CSR, however, is a separate non-funding, but very key, part of NIH. It is the point of intake for NIH grant applications and is where about 70% of them are reviewed initially. The 24 funding ICs of the NIH are essentially clients of CSR and use the results of its merit evaluations of applications as part of their deliberations on funding.

Our objective with the rest of this presentation is to give you an overview of the process by which your NIH grant first comes into the NIH, through to the point of final decisions of the funding ICs on allocation of support. We describe how the sponsoring ICs are designated; how the study section or expert scientific review group is chosen to review your application; how the first level peer-review evaluation is done by this study section; and how to distinguish the roles of Review Officers and Program Officers in serving you and the needs of your application. When we speak of the two-level review system at NIH, we refer to the first level as being review by a study section or scientific review group, usually at CSR, that results in a report or summary statement  that is sent to Program Officers at the sponsoring IC for their use. The second-level review is evaluation by that institute’s internal staff and Advisory Council. 

The chain of events from receipt of application, to first-level review, to second-level review, to earliest possible funding forms a process.
At NIH there are three major calendar cycles of this process that are staggered in overlap at any given time of the year. The NIH Guide to Grants and Contracts details for you the specified application deadlines that initiate each cycle. 

So we see now that on a cyclic basis applications are handled by CSR which receives all the NIH grant applications, refers them to NIH institutes and centers for sponsorship consideration and to the relevant scientific review groups for expert evaluation, and CSR in fact reviews the majority of these grant applications for scientific merit. Let’s examine more closely how CSR actually executes its roles.

Nearly all of the study sections and scientific review groups that you are familiar with come under the aegis of CSR, not one of the 24 funding ICs. Altogether CSR has about 240 study sections and scientific review groups, and these are organized into integrated review groups (or IRG's), which are essentially departments where closely allied scientific disciplines and expertise is brought to bear to evaluate science with related broad themes. These IRG's in turn are organized in groups under five major scientific divisions according to broad biomedical or health-related domains.

However, upon arriving at CSR, your application's first stop is actually a critical sixth scientific administrative division called the Division of Receipt and Referral or DRR. At DRR the referenced funding opportunity announcement, individual grant history, and your entire application are examined by teams of scientists to assure compliance with application rules, but also to make initial recommendations on which scientific review group is best suited to examine your application, based on broad subject coverage guidelines for each scientific review group or study section. It also chooses one or more institutes or centers to consider for sponsorship of your application based on the overall mission and specific programmatic mandates and interests of the institutes and centers. DRR scientists have on hand detailed descriptions of the integrated review groups and study sections and of the institutes and centers and their missions upon which to make their judgments. 

However, your input into this assessment process is welcomed as well.  You are free to help CSR get your application to the appropriate study section or review group by examining CSR's integrated review group and scientific review group descriptions online at the CSR Web site. By virtue of both design of the spectrum of study sections and the inherent nature of science, there frequently will be two or more study sections that plausibly could examine your application. The panels are not orthogonal to each other. If, after studying the descriptions of the groups that you think most likely to be interested in your objectives, you find one that you would most like your application to be assigned to, then you can make the written request to CSR. 

You are encouraged to submit along with your application a cover letter.  This cover letter might include such information as suggested institute or center to sponsor your science, suggested review group assignment, and, if you wish, the identification of individuals in your field who you think potentially could be in serious conflict of interest. You could identify areas of expertise, broadly speaking, that are needed to evaluate the science of your application, and you can discuss any other special considerations that you think should be brought to the attention of review officers at the CSR. Note however that it is not appropriate to use the cover letter to suggest specific scientists among your peers who would be good reviewers of your application. This decision is something that is reserved to the scientific staff within CSR. 
Here for instance is a sample cover letter presenting the kinds of basic information that can be useful to CSR scientists in handling your application.

The overall peer review process of your application is managed by a designated federal official who has doctoral level expertise relevant to your field, a scientific review officer. This SRO will perform administrative and technical review of your application to ensure its completeness and accuracy, and he or she will also select the members of the panel of reviewers to evaluate all applications on the panel’s docket. 

From among those on the panel, the SRO designates at least three scientists, with experience relevant to your scientific aims, to lead the review of your application. Extra reviewers may be recruited as needed to insure your application is appropriately judged. Reviewers and other panelists receive applications and their specific assignments generally six to eight weeks in advance of the scheduled date of the meeting, allowing them plenty of time to examine proposals and prepare extensive observations and initial evaluations. It is typical for each member of a review panel to be assigned several applications from the study section’s docket.

Importantly, for R01 applications data indicating whether you are a New Investigator is present for reviewers to regard. A New Investigator in NIH context is an applicant who has not yet successfully competed for a substantial NIH research grant. Early Stage Investigators are New Investigators who are within 10 years of completing their terminal research degree or their medical residency at the time they apply for R01 grants.  This status is clearly identified for panelists to consider. This is consistent with the NIH-wide commitment to identifying and funding an appropriate percentage of R01 New Investigators.

What is a study section meeting like? Each CSR scientific review group meeting gathers typically 12 to 25 or so experts in closed session, who primarily are from academia but also from biotech industry and sometimes government research laboratories. Typically about 60 to 100 applications are presented in the review group meeting over one to two days of working time. An SRO presides as the official government representative, and from among the scientific peers on the panel, the SRO has designated one to serve as chair of the group, directly managing the discussion process. 
While most panels have reviewers meeting face-to-face, some are convened wholly or partially via electronic platforms. These added modes are utilized to provide maximum flexibility in bringing together the appropriate expertise for review of research proposals.

As the presiding government official convening the meeting, the scientific review officer: Will manage the study section proceedings to ensure that policy is followed and reviews are fair. 
After the meeting, the SRO prepares for each application a summary statement that includes a written synopsis, or resume, of the actual panel discussion - for those applications that are discussed – and responds to NIH institute and center requests for information about study section recommendations.
While NIH and CSR value all applications highly, the limits of time resources dictate that actual discussion focus on the strongest subset of the whole, roughly the top half or so by preliminary scoring. The remaining applications will not be discussed unless explicitly called forward by at least one member of the panel. Even if your application is not discussed, you will receive the detailed critiques from your assigned reviewers.

We've talked broadly about evaluation and alluded to scoring. Let's look at more detail of how this is done. The ultimate score in evaluation for discussed applications is the overall impact score, which is an assessment of the likelihood that the project will exert a sustained and powerful influence on the research field involved. 

To arrive at an overall impact judgment, NIH guides reviewers to evaluate each application first according to a set of five specific core criteria. These are: Significance, Investigators, Innovation, Approach, and Environment. After assessing these five criteria, reviewers develop then, by synthesis, an overall impact judgment that embodies the summary perspective of that reviewer. Each assigned reviewer is expected to discuss openly how he has arrived at the synthesis even though there is no prescription as to how one should do that. 

Reviewers are asked to provide a numerical score for each of the five criterion areas and for overall impact. The NIH system uses a one to nine integer scale to do this. 
Other issues that reviewers should consider when scoring an application, but which are not explicitly scored criteria by themselves, include such features as the handling of human subjects; the involvement of women, minorities and children in clinical studies; the involvement of vertebrate animals in studies; and the handling of hazardous materials. Be aware that while not explicit categories for scoring, these too factor into the overall impact evaluation that reviewers give to each application.  

If your application is among the ones discussed, then - post-discussion - each member of your study section will provide a private overall impact score for it assuming that they have no conflict of interest. These scores are expected to be within the numerical range established by the final overall impact scores announced by the assigned reviewers at the table, unless a dissenting member of the panel openly declares himself to be ‘out of range.’ The full set of overall impact scores will be averaged to 1 decimal place and multiplied by 10. Therefore, the 81 possible final priority scores will range from 10, most meritorious, to 90 least meritorious.  Your budget is considered AFTER scoring.  The review group will either recommend the budget to be funded as requested or suggest specific changes. 

Scores of all applications are released within 3 days of the meeting and available through your NIH Commons account. Your electronic application file (or grant folder) is available throughout the review process and includes all pertinent background information on you, the applicant, as well as the application and supporting materials themselves. 
The results of the review group’s meeting are transmitted to your sponsoring institute or center in the form of a summary statement. This is a written document that presents scores for each of the review criteria presented by the assigned reviewers, the written critiques of those reviewers, and any administrative notes if observations on administrative matters were made by the panel. 

If, further, your application was actually discussed at the meeting, you receive an overall impact priority score, a summary or resume of the discussion itself - written by the SRO - and a summary budget recommendation offered by the entire panel. Summary statements are released within 30 days of the meeting except for R01 applications submitted by New Investigators or Early Stage Investigators, which are released within 10 days of the meeting. 
Upon release, you may discuss the contents of the summary statement with the Program Officer; however, the SRO who prepared it is not at liberty to do so. 

NIH recognizes that preparing an application takes a lot of intensely creative thought and activity. To make sure you generate optimum impact with your application, here are some broad practical tips to consider: Read the instructions that are offered for the kind of mechanism that you are applying for. Never assume that reviewers will know exactly what you mean in writing your research plan. Do offer pertinent literature references in the area that you're proposing to do research.  State the rationales of proposed investigations that you would undertake. Include well-designed and clear tables and figures. Present an organized and lucid write up. Obtain pre-submission informal review from faculty, or other colleagues that you may know, who can give you feedback and who perhaps have experience themselves with the NIH review process. These and other grant writing tips of general nature can be found online at the NIH Web site at the following URL.

And thinking upon what one of your peers might look for as a reviewer of an application, keep the following practical ideas in mind. Generally speaking, reviewers are most favorably impressed by: The concept of the significance and impact of the application. The conveyance of exciting ideas. The clarity of writing. The presentation of realistic aims and timelines. Brevity with things that everybody really does know commonly. And also acknowledgment of limitations of the study’s approach. And a generally clean and well written application - proof read for typographical errors - also makes a very favorable impression.

Where can you get help or have questions answered during the various stages of the application preparation, submission and review process?  Before you submit your application, a Program Officer at one of the institutes or centers that you would like to consider supporting your work can talk with you about the relevance of your aims and objectives to the central mission of that institute or center. You also may talk to a scientific review officer who heads a study section or scientific review group that you think could be a very appropriate venue for your initial review. Both Program Officers and Review Officers are very happy to confer with applicants and give them general guidance - although keep in mind that such is generally not binding but advisory only. After submission of your application and before the date of the review meeting, your scientific review officer serves as the primary point of inquiry regarding matters relating to the handling of your grant application. After the date of review has come, your assigned program officer takes over as the principal point of contact for discussing your application, the outcome of the review process, and the potential implications for funding.

General information on all the granting process - review, programmatic issues, instructions for submitting an application - may be found online at grants.gov.  Or if you wish to talk to somebody directly, you may call the following telephone number.  There are indeed several very useful Web sites that can provide you varied information about the stages of the review process. These are some of the ones where you'll find several helpful summary documents that can guide you along the way.
Note the link to a video presentation of a mock study section. This offers a useful reenactment of a typical review meeting.  

We hope that you have found this brief presentation of the role of the Center for Scientific Review - and the nature of the NIH scientific review process in general - to be very useful. We at CSR and the whole of NIH gladly anticipate serving you in your quest to advance the forefronts of human knowledge in your area of investigation. Please feel free to contact review or program staff for any further questions that you may have.

This video was produced by the Center for Scientific Review at the National Institutes of Health within the U.S. Department of Health and Human Services.