Ten Ingredients for Writing Research Grant Proposals
Background
Investigators seeking funding to conduct implementation research face the challenges of preparing a high-quality proposal and demonstrating their capacity to conduct the proposed study. Researchers need to demonstrate the progressive nature of their research agenda and their ability to build cumulatively upon the literature and their preliminary studies. Because implementation science is an emerging field involving complex and multilevel processes, most investigators may feel "new to the field." Furthermore, young investigators may have less preliminary data, and the path to successful proposal writing may seem less clear.
This article identifies ten important ingredients in well-crafted implementation proposals; in particular, it addresses how investigators can set the stage for proposed work through pilot data and a well-crafted and rationalized proposed study approach. It addresses questions such as: What preliminary work is important in the grant applications, and how can implementation researchers meet this challenge? How can investigators balance scientific impact with feasibility? Where in an implementation research proposal can investigators demonstrate their capacity to conduct a study as proposed?
The Importance of the Question
A significant and innovative research question is the first and primary ingredient in a successful proposal. A competitive implementation research application needs to pursue scientific questions that remain unanswered, questions whose answers advance knowledge of implementation with generalizability beyond a given setting. By definition, implementation research in health focuses on a health condition or disease, healthcare settings, and particular evidence-based interventions and programs with promise of reducing a gap in quality of care. It is conducted in usual care settings with practical quality gaps that stakeholders want to reduce.
However, to make a compelling argument for scientific innovation and public health significance, a research grant application must have potential beyond reducing a quality gap and implementing a particular evidence-based healthcare practice. The application must have the potential to advance the science of implementation by yielding generalizable knowledge. With only one journal devoted solely to implementation science, researchers must be aware of implementation literature scattered across several discipline-specific journals. Implementation researchers – akin to students with multiple majors – must demonstrate their grounding in implementation science, health diseases, disorders, treatments, and real-world healthcare delivery.
Although implementation science is often characterized as an emerging field, its bar for scientifically important questions is rising rapidly. Descriptive studies of barriers have dominated implementation science for too long, and the field is urged to "move on" to questions of how and why implementation processes are effective. Accordingly, the Institute of Medicine has identified studies comparing the effectiveness of alternative dissemination and implementation strategies as a top-quartile priority for comparative effectiveness research. However, experimental studies testing implementation strategies need to be informed by systematic background research on the contexts and processes of implementation. While investigators must demonstrate their understanding of these complexities, their grant proposals must balance feasibility with scientific impact. This paper addresses the challenges of preparing grant applications that succeed. Though this article focuses on U.S. funding sources and grant mechanisms, the discussed principles should be relevant to implementation researchers internationally.
Guidance from Grant Program Announcements
Grant review focuses on the significance of proposed aims, impact and innovation, the investigator's capacity to conduct the study as proposed, and support for the study hypotheses and research design. The entire application should address these issues. Investigators early in their research careers or new to implementation science often struggle to demonstrate their capacity to conduct the proposed study and the feasibility of the proposed methods. Not all National Institutes of Health (NIH) program announcements require preliminary data. However, those that do are clear that applications must convey investigator training and experience, capacity to conduct the study as proposed, and support for the study hypotheses and research design. The more complex the project, the more important it is to provide evidence of capacity and feasibility.
The R01grant mechanism is typically large in scope compared to the R03, R21, and R34a. Program announcements for grant mechanisms that are preliminary to R01 studies give important clues on how to set the stage for an R01 and demonstrate feasibility. Investigator capacity can be demonstrated by describing prior work, experience, and training relevant to the application's setting, substantive issues, and methodology – drawing on prior employment and research experience. For example, the NIH R03 small grant mechanism is often used to establish the feasibility of procedures, pilot test instruments, and refine data management procedures for subsequent R01.
The NIH R21 and the R34 mechanisms support the development of new tools or technologies; proof of concept studies; early phases of research that evaluate the feasibility, tolerability, acceptability, and safety of novel treatments; demonstrate the feasibility of recruitment protocols; and support the development of assessment protocols and manuals for programs and treatments to be tested in subsequent R01 studies. These exploratory grants do not require extensive background material or preliminary information but serve as sources for gathering data for subsequent R01 studies. These grant program announcements provide a long list of how pre-R01 mechanisms can be used, and no single application can or should provide all the stage-setting work exemplified in these descriptions.
Review criteria, typically available on funding agency websites or within program announcements, may vary slightly by funding mechanism. However, grants are typically reviewed and scored according to such criteria as significance, approach (feasibility, appropriateness, robustness), impact, innovation, investigator team, and research environment.
Table 1 summarizes the ten ingredients, provides a checklist for
reviewing applications before submission, and ties each ingredient to
one or more of the typical grant review criteria.
| Proposal ingredient | Key question | Review criteria | Check (yes/no) |
|---|---|---|---|
| 1. The care gap or quality gap | Does the proposal have clear evidence that a gap in quality exists? | Significance Impact | |
| 2. The evidence-based treatment to be implemented | Is the evidence for the program, treatment, or set of services to be implemented demonstrated? | Significance Innovation | |
| 3. Conceptual model and theoretical justification | Does the proposal delineate a clear conceptual framework/theory/model that informs the design and variables being tested? | Approach Innovation | |
| 4. Stakeholder priorities, engagement in change | Is there a clear engagement process for the stakeholders in place? | Significance Impact Approach Environment | |
| 5. Setting's readiness to adopt new services, treatments, programs | Is there clear information reflecting the setting's readiness, capacity, or appetite for change, specifically around adopting the proposed evidence-based treatment? | Impact Approach Environment | |
| 6. Implementation strategy/process | Are the strategies to implement the intervention clearly defined and justified conceptually? | Significance Impact Innovation | |
| 7. Team experience with the setting, treatment, and implementation process | Does the proposal detail the team's experience with the study setting, the treatment whose implementation is being studied, and the implementation processes? | Approach Investigator team | |
| 8. Feasibility of proposed research design and methods | Does the methods section contain as much detail as possible, as well as lay out possible choice junctures and contingencies, should methods not work as planned? | Approach Investigator team | |
| 9. Measurement and analysis section | Does the proposal clarify the key constructs to be measured, corresponding to the overarching conceptual model or theory? | Approach Investigator team | |
| Is a measurement plan clear for each construct? | |||
| Does the analysis section demonstrate how relationships between constructs will be tested? | |||
| 10. Policy/funding environment; leverage or support for sustaining change | Does the proposal address how the implementation initiative aligns with policy trends? | Impact Significance |
Table 1 Ten Key Ingredients for Implementation Research Proposals