Anatomy of an NIH research proposal

Themes

Description

Specific Aims

Background

Significance & Innovation

Approach overview

Approach by aim

Approach: Data analysis

Approach: Summary

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Every proposal is different, but the figure above illustrates an archetypal NIH R01 type description and research plan. A research proposal is composed of certain themes that recur throughout the proposal that emphasize the significance, approach, and qualifications of the investigator and team. These themes are present with varying level of detail and emphasis in different sections.

In this view, the composition of a proposal is like the composition of of music. In composing music there are discrete musical ideas (e.g., A, B, C. D) that organize into phrases. These phrases repeat throughout a composition in varied form (e.g., A', B', C', D'). Some short phrases repeat with little variation as motifs. Although I am showing a particular arrangement of ideas (for example, my specific aims is organized: A,B,C,A), an investigator may choose a different arrangement to highlight different strengths of a particular plan.

Themes

So what are the main ideas communicated in a proposal? Well, at least as far as the research plan is concerned: not surprisingly these are easily identifiable as the major dimensions upon which volunteer peer reviewers will evaluate a proposal for the NIH: Significance, Approach, and Investigator.

Although there are discrete sections of a proposal labeled "significance" and "approach" and sometimes "investigator" (e.g., training awards) the effective communication of the strengths of these aspects of a proposal must be carried through many sections of a research proposal.

Note what is not here: Innovation and Environment. Innovation is -- in my view -- an emergent quality. Meaning, all of the other aspects of the proposal come together to form innovation. More on this below.

Environment is not emphasized in this post, but in some circumstances the environment may be very important. For example, taking advantage of a unique sample or natural experiment, or a unique and valuable resource that is available.

The Significance theme (not the same as the Significance section, see below) has three aspects. These include the research context, the knowledge gap, and the proposed research.

The research context is shown in blue, because this is not something that reviewers (should) use in scoring your application. By research context I mean what is the health outcome, how important is it to the public's health, and what is known about it. Alzheimers disease may have a more important public health impact than ingrown toenails, but a lousy proposal studying Alzheimers disease might not score as well as an excellent proposal studying ingrown toenails. The research context is part of the storytelling of the proposal, but will not weigh heavily in the judgement of the quality of the proposal.

The knowledge gap is shown in a dark green. This also largely storytelling. What are the range of unknowns in the health outcome being studied? Most critical for the evaluation of a research proposal is a clear description of the knowledge to be gained by the proposed research, shown in light green.

Repetition <-> Consistency

There is a good deal of repetition in an NIH proposal. Repetition is necessary because: (1) Repetition is a literary device that repeats the same words or phrases a few times to make an idea clearer and more memorable (link), and (2) because reviewers may not read a proposal in the order it is presented, each section should stand on its own and repetition (and cross-referencing) ensures reviewers get the key messages regarding significance, approach, and investigator in all sections.

Resist the urge to make repeated phrases different from each other. Small differences in the technical interpretation of words may result in what appear to a reviewer as inconsistencies.

Description

The description is a summary of the specific aims page. Probably one of the last things prepared for a research proposal.

Throughout your proposal, minimize jargon and acronyms. Acronyms that would not be recognized by a researcher outside your field should be avoided. If you must use acronyms, write them out long hand (LH) the first time they are used in each section (because reviewers may not read the proposal in the order it is presented).

Specific Aims

The specific aims page is the most important part of the proposal.

Reviewers - who are human beings - will likely have made up their mind if they like your proposal or not after reading the aims page. How a reviewer feels after reading the aims will color how the rest of the proposal is read and interpreted . Reading for weaknesses or strengths to confirm their initial impression.

For this reason, the aims page is the part of the proposal that deserves your greatest effort and attention. The aims page may be the first part of a proposal generated, but you should return to it often and make the message crisp, compelling, and accessible.

In my view, good specific aims pages are very light on background. The focus needs to be on the proposed research, both the approach you plan and the significance of the research. The language must be easy to understand to someone who is not an expert in your field of study. Convince the reviewer that the topic and approach are important, within the capability of you and your team, and will advance the field.

Background

An important part of this section is what was very recently referred to as Premise, but now it's Rigor of the Prior Research. Investigators must (and reviewers will be looking for) "describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project." Reviewers are specifically instructed to consider (link):

Is the prior research that serves as the key support for the proposed project rigorous?
Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?

Make sure you convince them.

See:

Read about what is meant by rigor of the prior research. For a while this was known as premise (NIH, PDF).

I have boilerplate text on this section available here.

Significance & Innovation

I show Significance and Innovation as gray boxes because I believe these sections integrate most of the other themes of the research plan.

Significance. See the NIH definition (below). Find questions in that description, and write sentences that explain how your research addresses such questions. Bring together what is known, what will be learned, and the implications of what will be learned. Explain that that is what makes the research significant.

Innovation is not only or necessarily an advanced method of data collection or analysis (e.g., ecological momentary assessment, hierarchical linear modeling, modern psychometric methods, machine learning). Innovation is the culmination of what new knowledge will be generated and the relevance of that new knowledge for research or clinical practice. Attempts to be innovative using shiny new data collection or analysis techniques, when those are not well suited to the question or approach, can be damaging to a research proposal.

See:

NIH on Significance: Does the project address an important problem or 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? (link)

NIH on 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? (link)

Also see: Morgan Giddings blog post on Significance and Innovation (link)

Approach overview

I like a high level overview of the research approach. The entire approach must be very detailed, but it can be useful to orient the reviewer to all what is coming and remind them how it relates to the overall goal. It can't hurt to remind how it addresses weaknesses in the prior research, and how you and your team are exquisitely suited to address the research goals.

There may be elements of the approach that are common to all aims, and they can be described in the overview section as well.