Applicants and Reviewers Francis Collins MD NIH Director December 2 2016 Welcome Recorded Earlier NIHs mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health lengthen lif ID: 1009889
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1. Briefing for Basic Research Applicants and Reviewers
2. Francis Collins, M.D.NIH Director December 2, 2016Welcome! Recorded Earlier
3. NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.NIH . . . Turning Discovery Into Health
4. Noni Byrnes, Ph.D.Director, Division of Basic and Integrative Biological SciencesNIH Center for Scientific Review December 2, 2016NIH Peer Review Briefing for Basic Research Applicants and Reviewers
5. What Analysis of One NIH Institute’s Funding for Basic Science RevealedDr. Bob Finkelstein, NINDSWhat NIH Is Doing to Encourage and Foster Basic Science ResearchDr. Noni Byrnes, CSRAdvice for Applicants Dr. Bob Finkelstein, NINDSYour Questions Expert PanelWhat We’re Going to Cover
6. Recorded EarlierRobert FinkelsteinDirector, Division of Extramural ResearchNINDS, NIHTrends in NINDS Support of BasicNeuroscience
7. NINDS = The National Institute of Neurological Disorders and Stroke at NIHOur mission:“To seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease” Mission of NINDS
8. Trends in funding of basic and applied research Changes in funding through different grant mechanisms (R01, P01, R21, etc.)Trends in funding of investigator-initiated vs. NINDS-initiated researchAnalysis of NINDS Expenditures
9. Basic ResearchAimed at understanding the structure and function of the nervous system. Can involve studies performed in vitro, in animals, or in humans.Applied ResearchAimed at developing or testing diagnostics, therapeutics, or preventive interventions, whether in vitro, in animals, or in humans. Working Definitions
10. Basic ResearchBasic / Basic: understanding the normal nervous system; in vitro, in animals, or in humansBasic / Disease Related: understanding the mechanisms of neurological disease; in vitro, in animals, or in humansApplied ResearchApplied / Translational: up to, but not including, first in human studiesApplied / Clinical: first in human through phase III trials Subcategories
11. 12 neuroscientists analyzed ~ 3000 NINDS grants from selected years (initially: 1997, 99, 2002, 05, 08, 10, 11)Established categorization criteriaAnalyzed the Specific Aims and Research Strategy of each grant applicationHigh inter-rater reliabilityAnalysis Strategy
12. Basic and Applied Expenditures
13. Subcategories
14. Basic // Basic Funding Decline
15. What is causing this decline?
16. Basic/Basic Applications Are Declining…
17. …Even Though They Have a Higher Probability of Being Funded!
18. Scientific progress (e.g., the identification of disease genes) has led to more opportunities for disease-related researchMany other funders (e.g., disease foundations) focus on disease-related research)Belief that NIH favors disease-related research:Assumption that review is biased against Basic/Basic researchNIH initiatives often focus on disease-related researchPublic Health Relevance statement suggests that all research must have a direct connection to disease (has now been changed)Why Are Basic/Basic Applications Declining?
19. Subcategories (Updated)
20. What NIH Is Doing to Encourage and Foster Basic Science Research
21. Five Examples of NIH-wide Efforts
22. 03 Aug 2012:Vol. 337 Issue 6094, pp. 5031. NIH Reaffirmed its Commitment to Basic Research
23. 25 Mar 2016: Vol. 351Issue 6280, pp. 1405All NIH Institute Directors Reaffirmed Their Commitment
24. 25 Mar 2016: Vol. 351Issue 6280, pp. 1405“We recognize that many of the most important medical advances trace back to basic research that had no explicit disease link.”All NIH Institute Directors Reaffirmed Their Commitment
25. NIH applicants should describe how, in the short or long-term, the proposed research would contribute to the NIH mission. Basic and applied research are equally important to this mission.2. NIH Clarified Instructions on the Required Statement on Public Health Relevance
26. NIH applicants should describe how, in the short or long-term, the proposed research would contribute to the NIH mission. Basic and applied research are equally important to this mission.2. NIH Clarified Instructions on the Required Statement on Public Health Relevance
27. NIH-wide initiatives such as the Common Fund includes support basic research. For example:4D NucleomeGlycoscienceTransformative R013. NIH Has Established Multiple Funding Initiatives to Advance Basic Research
28. NIH-wide initiatives such as the Common Fund includes support basic research. For example:4D NucleomeGlycoscienceTransformative R01Most NIH Institutes and Centers include basic research funding portfolios 3. NIH Has Established Multiple Funding Initiatives to Advance Basic Research
29. NIH-wide initiatives such as the Common Fund includes support basic research. For example:4D NucleomeGlycoscienceTransformative R01Most NIH Institutes and Centers include basic research funding portfolios Many NIH Institutes and centers issue specific initiatives to advance basic research. For example:NIDA’s Extracellular Vesicle Tools, Technologies, and Products for Neuroscience Research; NIAID’s High-Priority Immunology Program to support the growth of the NIAID portfolio of investigator-initiated R01 grants in fundamental immunology. NICHD’s Biophysical and Biomechanical Aspects of Embryonic Development3. NIH Has Established Multiple Funding Initiatives to Advance Basic Research
30. 4. The CSR Director Holds In-person and Video Orientation for All Incoming Study Section Chairs
31. Highly significant projects with high overall impact may be:Basic/fundamental, mechanistic, or translational, clinical, or public health projectsProjects that use in silico, in vitro, or in vivo modelsA variety of model systems (cell lines, invertebrate or vertebrate animal models, or human subjects)Discovery based approaches that are not necessarily hypothesis-based but hypotheses generating.Technological, methods development, models creation, data analytic and analytic methods development effortsData collecting, cataloguing, cohort building or other resource development projectsChair Orientation Slide
32. 5. CSR Scientific Review Officers Hold Pre-meeting Training Teleconferences for their Reviewers
33. NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.NIH . . . Turning Discovery Into Health
34. Highly significant projects with high overall impact may be:Basic/fundamental, mechanistic, or translational, clinical, or public health projectsProjects that use in silico, in vitro, or in vivo models (cell lines, invertebrate or vertebrate animal models, or human subjects)Technological, methods development, models creation, data analytic and analytic methods development effortsData collecting, cataloguing, cohort building or other resource development projectsAn Application Does Not Need a Direct Link to Health or a Specific Health Outcome
35. Two Examples of Critiques Exhibiting Potential Translation Bias vs. Critiques Evaluating Basic Science Appropriately
36. The goal is to understand basic behavioral mechanisms, not to develop therapeutics or demonstrate how these linkages could advance knowledge of human health. This reviewer imposed expectations about potential translation of the proposed studies to health of vertebrates. Project Title: Studying Directed Behavior in an Invertebrate Model SystemDESCRIPTION (provided by applicant): Our ultimate goal is to understand how a simple, innate behavior emerges from the activity of the nervous system.SignificanceStrengths:The focus on central processing mechanisms is likely to provide key insights into innate behavior in invertebrates and could lead to more effective use of the XX modeling system.Weaknesses: It is not clear how the successfully achieved aims will impact the treatment of disease or the understanding of human health. Is there any evidence that invertebrate central processing mechanisms for detecting environmental alterations are remotely similar to those of vertebrates? It is unclear that the studies will lead in some way to prevention of insect-borne diseases.Example 1: Potential Reviewer Bias
37. Project Title: Studying Directed Behavior in an Invertebrate Model SystemDESCRIPTION (provided by applicant): Our ultimate goal is to understand how a simple, innate behavior emerges from the activity of the nervous system.SignificanceStrengths: The focus on central processing mechanisms is likely to provide key insights into innate behavior in invertebrates and could lead to more effective use of the XX modeling system.Weaknesses: None noted.Example 1: Without Bias
38. Assesses the significance and overall impact with the assumption that a direct link to human health is necessary.Project Title: Storing motion memories in the cerebellum Description: Using a defined mouse model, the investigators propose to develop an optogenetic toolbox, thus permitting precise characterization of associated neural circuitry which underlie both motor learning and the storage of motion memories.Overall Impact: …The concept of writing motor memories into the cerebellum to produce or shape specific motor behavior is very interesting and exciting. The only weakness that detracts from the significance of this proposal is that any impact on human disease and treatment is rather indirect. SignificanceStrengthsFundamental understanding associated with how sensorimotor information is integrated in the cerebellum is currently unknown. The project will develop new XYZ tools for the analysis (or control) of neural circuitry.Weaknesses: The project lacks studies to validate the new tools in a physiological context. As with the development of many tools for the analysis (or control) of neural circuitry, there is not a clear path to impact on human health. Example 2: Potential Reviewer Bias
39. Project Title: Storing motion memories in the cerebellum Description: Using a defined mouse model, the investigators propose to develop an optogenetic toolbox, thus permitting precise characterization of associated neural circuitry which underlie both motor learning and the storage of motion memories.Overall Impact: The concept of writing motor memories into the cerebellum to produce or shape specific motor behavior is very interesting and exciting. The project advances science by developing new tools that can identify the pathways between neural circuitry and fine motor behaviors, propelling both substantive and methodological advances in neural networks.SignificanceStrengthsFundamental understanding associated with how sensorimotor information is integrated in the cerebellum is currently unknown. The project will develop new XYZ tools for the analysis (or control) of neural circuitry.Weaknesses The project lacks studies to validate the new tools in a physiological context, but this weakness is inconsequential given the developmental stage of the project.Example 2: Without Bias
40. Remember :NIH interest in basic research has not diminished!NINDS “basic/basic” applications continue to do extremely well in CSR reviewA basic/basic proposal (with no disease link) can be considered of the highest significance level Advice to Applicants
41. Follow your passion: propose the research that you believe is most interesting and important! (enthusiasm is infectious)Don’t exaggerate when describing any clinical relevance of your proposal Be careful about adding disease aims to a purely basic proposal solely to impress reviewers. This can backfire if these aims are poorly conceived or executedAdvice to Applicants
42. Insider’s Guide to Peer Review for Applicantshttp://www.csr.nih.gov/applicantResources/Insider