Funding Announcements for Three Technology Development Stages

The three stages of technology development have distinct purposes: to demonstrate novelty, innovation, and utility. Each of these stages are supported with a specific FOA.

  1. Novelty - Evaluating new, unrevealed concepts for feasibility or proof of concept (R21)
  2. Innovation - Inventive research and development for proving value of a Prototype (R01)
  3. Utility - First biological applications of validated tools to solve unknown biomedical hypotheses (NIH parent R01)

Stage I: Exploratory Feasibility Studies Not Yet Supported by Proof of Concept

The R21 step supports novel concepts that have not yet been tested for feasibility. Thus unpublished data are not allowed. Because proof of concept must not already be developed, NIGMS expects the projects to be high-risk. Unpublished experiments are not allowed whether they support the premise of the project, the expertise of the investigators, or establish feasibility by mitigating high risk bottlenecks. Applications that include unpublished data will be administratively withdrawn. R21 applications to may include figures from the published literature that are clearly referenced in the figure legend. Preprints and full descriptions that can be referenced would be allowed, as described in NOT-OD-17-050. Applications may include descriptive illustrations or theoretical charts that do not contain data.

Projects that have minimal testing of feasibility are not eligible for the R21 mechanism. Instead, a project that is at an intermediate stage, with some preliminary data or proof of concept, but with substantial remaining risk, might be appropriate for a 3-year R01 application with a reduced budget mechanism. The R21 mechanism is intended for exploratory evaluation of novel concepts rather than early support of newly established laboratories. For a historical comparison of mechanisms, see the recommendations and analyses describing overall success rates and caveats for using R21 funding leading to a follow-up R01 project.

Technology R21 applications cannot be renewed.

Stage II: Focused Technology Research Development and Validation

The R01 is for technologies that already have been shown to be feasible but need further technical work to produce a useful prototype. Four-year grants support development projects, to validate and optimize a new technology. If a project is at an intermediate stage with partial demonstration of feasibility, but with substantial remaining risk, a 3-year R01 proposal with a reduced budget might be an appropriate mechanism to minimize risk by rapidly evaluating project feasibility. Projects that are well supported by feasibility studies and propose to develop fully functional prototypes might require higher budgets and a 4-year duration (5 years for Early Stage Investigators). Specific aims should include validation of technology against known standards such as synthetic models and characterized, gold-standard biological samples. Applications for later stage technology refinement, extension, or hardening with a high likelihood of success would be less competitive biological samples.

Technology R01 applications can only be renewed once.

Stage III: Technology Optimized and Applied to Untested Biological Hypotheses

The parent R01 funding announcement is appropriate for projects that include both technical advances and biological hypotheses or discovery. Unlike the technology focused funding announcements, the parent R01 applications are evaluated for overall impact on the field of interest, rather than the potential utility of a technical project for future biological research.

For both the R21 and R01 FOAs, we are seeking inventive technology. R21 and R01 technology development applications should be innovative and include measurable intermediate and final objectives. Innovation is evaluated by the increment of technical advance over the state-of-the-art, so a clear description of current technology is important. A favorable comparison against the state of the art should be postulated in the Significance section and tested in the Research Plan. The Significance section should also describe how the technical advance would have utility for future biological investigations within the mission of NIGMS. The R21and R01 project objectives should gain new technological knowledge and measure quantitative advances over state of the art technology. The research plan should be rigorous with defined objectives and describe risk management.

KEY DIFFERENCES
Years of support
2
3 to 5
Criteria
Novel and innovative
Innovative with future utility
Feasibility
Not yet tested
Already established
Unpublished data
Not allowed
Encouraged
Final objectives
Proof of concept
Working prototype
R21 Application Requirements
or the application will be
No unpublished data
withdrawn
No forecasting proof of concept
withdrawn
Support future NIGMS biomedical research
withdrawn
No biological hypotheses
not funded