Notice Number: NOT-GM-17-008

Key Dates
Release Date: May 2, 2017

Issued by
National Institute of General Medical Sciences (NIGMS)

Purpose

The purpose of this Notice is to clarify the text regarding preliminary data and biomedical research aims in several sections of PAR-17-046 "Exploratory Research for Technology Development (R21)", as outlined below. Preliminary data is not permitted in applications in response to this FOA. Inclusion of biomedical research aims is strongly discouraged, for the reasons explained below.

Part 1. Overview Information

Funding Opportunity Purpose

Currently reads:
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.

Modified 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. 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. Preliminary data must not be included in the application. Applications including preliminary data will be considered noncompliant with the FOA instructions.

Part 2. Section I. Funding Opportunity Description

Appropriateness for this Program

Currently reads, in part:
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.

Modified to read:
No Preliminary Data: Applications in response to this FOA must not include preliminary data. For the purposes of this FOA, preliminary data is defined as unpublished results supporting the feasibility of the proposed Specific Aims. Availability of preliminary data is an indication that the proposed project has advanced beyond the exploratory stage defined by this program, and makes the application unsuitable for this funding opportunity. Projects for which preliminary data is available may be submitted in response to the companion R01 FOA (PAR-17-045).

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 under this FOA that include aims addressing an open biomedical question will not be considered for funding.
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. 

Application to well-characterized model systems to assess performance 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.

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

Currently reads, in part:

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.

Modified 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. Applications must not include preliminary data. Applications including preliminary data will be considered noncompliant with the FOA instructions.

For purposes of this FOA, preliminary data is defined as unpublished results supporting the feasibility of the proposed Specific Aims. Data or results, as well as figures presenting data or results in the Research Strategy must clearly reference the publication from which they are taken.

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. See instructions above regarding preliminary data.

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Douglas M. Sheeley, Sc.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: sheeleyd@mail.nih.gov