Notice Number: NOT-GM-19-010
Key Dates
Release Date: December 20, 2018
Related Announcements
PAR-17-046
This notice supersedes:
NOT-GM-18-014
Issued by
National Institute of General Medical Sciences (NIGMS)
Purpose
This Notice consolidates the changes and clarifications published in NOT-GM-17-008 and NOT-GM-18-014 and specifies additional modifications to several sections of PAR-17-046 "Exploratory Research for Technology Development (R21)” to clarify that:
- Feasibility must not have already been established for the proposed research since the project outcome should be a proof of concept.
- Unpublished data for any purpose must not be included.
- Data presented in figures or any section of the application must include a citation. Acceptable sources for data include published literature, preprint or publicly available product of research as described in NOT-OD-17-050.
As highlighted in previous Notices, preliminary or unpublished data are not permitted in applications submitted to this FOA. NIGMS will not fund applications that include biomedical research aims.
Part 1. Overview Information
Funding Opportunity Purpose
Original language in FOA:
This initiative will support exploratory research leading to the development of innovative technologies for biomedical research. The program will recognize and reward high risk approaches with potential for significant impact. Projects will entail a high degree of risk or novelty, which will be offset by a correspondingly high potential impact. However, the possible impact is likely to be far off. Application of the proposed technology to specific biomedical questions is considered beyond the scope of the program and should not be included. Preliminary data demonstrating feasibility of the proposed approach indicates that the project is beyond the scope of this program and therefore unsuitable for this funding opportunity.
Modifications consolidated to read:
This initiative will support exploratory research leading to the development of innovative technologies for biomedical research. The program will recognize and reward high risk approaches with potential for significant impact. Projects will entail a high degree of risk or novelty, which will be offset by a correspondingly high potential impact. However, the possible impact is likely to be far off. Application of the proposed technology to specific biomedical questions is considered beyond the scope of the program and should not be included. The goal of this FOA is to support proof of concept studies for feasibility and exploratory technology development. Feasibility must not have already been established in the literature or with preliminary data. Published data can be used to establish the current state of the art but can not forcast or predict project outcomes. Preliminary data for any purpose might appear to forcast the likelihood of success. Therefore, no unpublished data is allowed. While unpublished data are not permitted, references and data from widely available preprints that have a Digital Object Identifier (DOI) are acceptable.
Part 2. Section I. Funding Opportunity Description
Appropriateness for this Program
Original language in FOA:
No Preliminary Data: Availability of preliminary data is an indication that the proposed project has advanced beyond the exploratory stage defined by this program and will make the application unsuitable for this funding opportunity. Consideration should be given to submitting such projects to the companion R01 program (PAR-17-045).
High-Risk Exploratory Research: Applications through this FOA for exploratory research projects may propose a single specific solution to a broadly stated biomedical research need, with the goal of determining the feasibility of that approach. Alternatively, a proposed project may take a broader approach that will explore several possible solutions, leading to an improved understanding of the best technical avenues to pursue in order to create a new capability. This less directed approach may lead to a better understanding of the relative merits or likelihood of success of multiple potential approaches to be pursued in developing a technology.
This program will support proof-of-principle research leading to advances in technology. Because new ideas are essential to this process, the projects will entail a high degree of risk or novelty, which will be offset by a correspondingly high potential impact. However, the possible impact is unlikely to be immediate. Substantial additional development of the technology after completion of the project is likely to be necessary. The program will recognize and reward high risk approaches with the potential for significant impact.
No Biological Aims: Biomedical relevance is an essential element of NIH research. However, the exploratory stage of technology development should not include immediate short-term application of nascent technologies to challenging biomedical research questions because an insistence on explicit linkage to a specific research problem and the immediate demonstration of an immature technology’s effectiveness in that context can distort the technology development process. It can also diminish focus on development of genuinely innovative technology in favor of incremental improvements to existing technologies. In the early stages of technology development, insistence on biomedical applications is counterproductive. Therefore, in this program, application to specific biomedical questions in the timeframe of the proposed project is considered beyond the scope of the program and should not be included.
Milestones: A milestone is a defined event, achievement, or important stage that is used to indicate the progress of a project. Milestones should be descriptive of what will be done and when it will be completed.
The expected results from projects funded under this announcement will be the demonstration of feasibility, including (a) proof of principle, or (b) preliminary data that indicates a promising avenue for future development.
For purposes of this FOA, the following are not considered to be early
- pursuit of a biological hypothesis
- biomarker discovery or validation
- development of drugs or therapies
- new uses of existing technologies that may be ready for advanced development and validation without substantial further development efforts.
Applications proposing projects with these goals are not appropriate for this program and should be submitted elsewhere.
Modifications consolidated to read:
Proof of Concept:The goal of this FOA is to support proof of concept studies to evaluate feasibility and exploratory technology development. Feasibility for the proposed research must not have already been established in the literature or in the application. Since proof of concept is not allowed, the project objectives must not be obvious based on the current state of the art. The expected outcome of the project should be a clear test of concept, either positive or negative. The concept should represent a significant advance over the state of the art since this FOA is designed for concepts that are highly innovative.
No unpublished Information: Since preliminary data for any purpose might appear to forcast or increase the likelihood of success, applications must not include or refer to preliminary or unpublished data, results, or conclusions. Unpublished results are not allowed, whether they support the state of the art, the expertise of the investigators, the feasibility of specific aims, or mitigate high risk bottlenecks. Risk should not be resolved with data, but can be mitigated by theoretical evaluation, alternative approaches, and well described criteria that would discriminate successful from unsuccessful project outcomes. Descriptive diagrams, conceptual charts or theoretical evaluations that do not contain unpublished data can be included. Inclusion of unpublished data will make applications noncompliant with FOA instructions and will be withdrawal without review.
Published data: Published data that establishes the current state of the art can be included. Any data that forcasts the project objectives or provides proof of concept are not allowed. Alowable data includes published literature, and unreviewed preprints, protocols, and publicly available research products, However, citations in the application to unpublished sources must include DOI and Object type as described in NOT-OD-17-050. Data only available in abstracts or on personal or institutional webpages without a DOI must not be included. Figures containing published data must include citations within the figure legend. Published data that is included in the research plan, biographical sketch or elsewhere in the application must be cited at each occurrence.
No Biological Aims: Applications in response to this FOA should not include biological aims. Biomedical relevance is an essential element of NIH research. However, this stage of technology development should not include immediate short-term application of nascent technologies to challenging biomedical research questions because an insistence on explicit linkage to a specific research problem and the immediate demonstration of an immature technology’s effectiveness in that context can distort the technology development process. It can also diminish focus on development of genuinely innovative technology in favor of incremental improvements to existing technologies. In the early stages of technology development, insistence on biomedical applications is counterproductive. Therefore, in this program, application to specific biomedical questions in the timeframe of the proposed project is considered beyond the scope of the program. Applications submitted to this FOA that include aims addressing an open biomedical question will not be considered for funding.
Milestones: A milestone (or intermediate objective) is a defined event, achievement, or important stage that is used to indicate the progress of a project. Milestones should be descriptive of what will be done and when it will be completed. Milestones should lead logically to the final project objectives.
The expected outcome from projects funded under this announcement will be the demonstration of feasibility, including (a) proof of concept, or (b) preliminary data that indicates a promising avenue for future development.
Application to well-characterized model systems to assess performance and validate accuracy is appropriate at this stage. To be considered for funding, applications of the technology must be limited to test systems chosen to facilitate development of the technology. The aims of the project must be focused entirely on the development of the technology.
For purposes of this FOA, the following are not considered to be early stage technology development activities:
- pursuit of a biological hypothesis
- biomarker discovery or validation
- development of drugs or therapies
- new uses of existing technologies that may be ready for advanced development and validation without substantial further development efforts.
Applications proposing projects with these goals are not early stage technology development and are not appropriate for this program.
Relevance of research topics for this FOA: The National Institute of General Medical Sciences (NIGMS) supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS-funded scientists investigate how living systems work at a range of levels from molecules and cells to organs and tissues, in research organisms, humans, and populations. NIGMS also supports the development of fundamental methods and new technologies to achieve its mission.
NIGMS supports research and technology development that is aimed at understanding general principles, mechanisms, and processes, and does not focus on specific classes of cells, tissues, organs, or diseases. In addition to preclinical and clinical research, other NIH Institutes and Centers (ICs) support basic research and technology development that is relevant to their specific health missions. Research and technology development that focuses on specific cell types, tissues, organ systems, or diseases, or has primarily clinical applications generally will be more appropriate for an IC other than NIGMS. See the List of NIH of Institutes, Centers, and Offices to learn more about their specific missions.
In accordance with the NIGMS mission, the goal of this FOA is to support exploratory research leading to the development of innovative technologies that are applicable to a wide range of biological systems. Technology development for applications in a disease and/or organ system focused basic, preclinical, and clinical research may be more appropriate for an IC other than NIGMS. If a technology is being piloted in a specific system that is primarily within the mission of another NIH IC, the project may be more appropriate for that IC. Some areas of technology development are supported by other NIH ICs and are not supported by NIGMS.
Applicants are strongly advised to consult with the Scientific/Research Contact listed in this FOA for guidance on assessing the relevance of their projects for NIGMS support under this FOA.
Part 2. Section IV.2 Content and Form of Application Submission
PHS 398 Research Plan
The following text has been added.
Specific Aims: Aims in the following areas are not considered early stage technology development and should not be included: (1) pursuit of a biological hypothesis; (2) biomarker discovery or validation; (3) development of drugs or therapies; or (4) new uses of existing technologies that may be ready for advanced development and validation without substantial further development efforts. Applications submitted under this FOA that include aims addressing these topic areas will not be considered for funding.
Research Strategy
Approach
Original language in FOA:
The rationale for the proposed technology development must be explained and should incorporate discussion of the broad opportunity or need that the new technology will address, as well as a discussion of why the approach or approaches to be explored have been selected. However, for this program, preliminary data demonstrating feasibility of the proposed approach is not necessary and should not be included.
This program is intended to support exploratory research, the outcome of which will be preliminary data that may provide the rationale for continued development of the subject technology. The research plan should describe the manner in which these preliminary data will be obtained and analyzed. The rationale for the experimental approach should be explained. The proposed exploratory research plan should have a high risk of failure. If feasibility has been demonstrated, the project is outside the scope of this program.
Modifications consolidated to read:
The rationale for the proposed technology development must be explained and should incorporate discussion of the broad opportunity or need that the new technology will address, as well as a discussion of why the approach or approaches to be explored have been selected. However, for this program, preliminary data demonstrating feasibility of the proposed approach indicates that the project has advanced beyond the scope of the program.
Project objectives should be novel and not obvious compared to the current state of the art. Evidence that the concept is achievable would demonstrate positive proof of concept which is not allowed in this FOA. Published data can be included if it describes the current state of the art but not the project objectives.
To ensure that feasibility or proof of concept has not been evaluated, applications must not include or refer to unpublished and/or preliminary data, results, or conclusions since these forecast an increased likelihood of success. Proof of concept or feasibility must not already be established by published or unpublished studies. Applications that have been evaluated by proof of concept or feasibility studies will be considered noncompliant with the FOA instructions and will be withdrawn without review.
All instances of published data must cite the publication, preprint, or interim research product from which they are taken. Citations to preprints and interim research products must include a DOI and object type as described in NOT-OD-17-050. Figures containing published data must include a citation within the figure legend. Data that cannot be attributed to a publication or interim research product with a DOI will be considered noncompliant with the FOA instructions and and will be withdrawn without review. Applications can include descriptive diagrams, conceptual charts or theoretical evaluations that do not contain unpublished data. Determination of compliance will be made after submission, based on information within the application. Post submission information will not be used to determine compliance.
This program is intended to support exploratory research, the outcome of which will be preliminary data that may provide the rationale for continued development of the subject technology. The research strategy should describe the manner in which these preliminary data will be obtained and analyzed. The rationale for the experimental approach should be explained. The proposed exploratory research plan should have a high risk of failure. If feasibility has been demonstrated, the project is outside the scope of this program.
All other aspects of this FOA remain the same.
Inquiries
Please direct all inquiries to:
Paul Sammak, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-8494
Email: [email protected]
and Human Services (HHS)
