1. The NIH Grant Machine Steve Zullo Program Officer NIBIB
Office or Program Evaluation and Strategic Partnerships
Not just Technology,  Technology Development.  Make it count.
Increase Your Opportunity to Get That Award:
NIH Weekly Guide-Funding Opportunities:

3. Grantswritership at NIH-
NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.
Grantswritership at NIH-
Drinking From
The Firehose
The goals of the agency are as follows:
- foster fundamental creative discoveries, innovative research strategies, and their applications as a basis to advance significantly the Nation's capacity to protect and improve health;
- develop, maintain, and renew scientific human and physical resources that will ensure the Nation's capability to prevent disease;
- expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and
- exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.
In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:
- in the causes, diagnosis, prevention, and cure of human diseases;
- in the processes of human growth and development;
- in the biological effects of environmental contaminants;
- in the understanding of mental, addictive and physical disorders; and
- in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists. 3

4. Applicant: “..don’t need help if I have…”
A great idea to solve a significant biomedical problem
An innovative solution
The tools to get the job done
right team
right resources
enough data to support feasibility-mechanism dependent
Send
Outlined the path to get there
A compelling application written to the instructions
following the format
including all administrative requirements
Successfully posted the application through grants.gov

5. For everybody else… …Buckle Up: here we go!
… improving health by leading the development and accelerating the application of biomedical technologies

6. Federal Agencies in Science and Technology have different
Research $$ by Discipline
(in billions of constant FY08 dollars)
Federal Agencies in Science and Technology have different
missions
cultures
rules
levels of support
expectations
Research Support by Agency
(in billions of constant FY08 dollars)
But the same overall goal
protect the security, health, and well being of Americans
maintain knowledge and application superiority
fuel the engine of US economic growth
Federal R&D as % of GDP
Total US R&D Investment
(in $B)
Source:

7. (Intramural Research)
The Broad Reach of the NIH
NIH is an institution
(Intramural Research)
~ 6,000 scientists
~ 10% of NIH budget
NIH supports institutions & people
(Extramural Research)
> 4,000 institutions
> 300,000 scientists & research personnel
~ 85% of the NIH budget

8. One way to succeed at NIH Grant Writing
Finding your NIH niche
Get help from the inside
Writing competitive grants
Getting the right review

9. 27 Institutes and Centers (ICs)
Finding your NIH niche
NIH is not homogenous. Each IC has different
missions & priorities
budgets
funding strategies

10. What does NIH support? Essential Building Blocks of Research
Finding your NIH niche
Essential Building Blocks of Research
Mechanisms of biology and behavior, data science, new technologies
Cryo-Electron Microscopy
Single cell analysis
Developing Effective Treatments and Cures
Cancer Immunotherapy
Tissue Chips; Regenerative Medicine
Health Promotion and Disease Prevention
Vaccines (e.g. influenza)
Implementing 21st Century Cures Act
All of Us (Precision medicine)
Integrating clinical, environmental, lifestyle, genetic data over time
Individual variability effects on disease onset, progression, prevention, treatment
Health records of a million volunteers
Battling Opioid Addiction
New treatments for pain
Understanding and managing drug misuse
Cancer Moonshot
Prevention and early detection
Immunotherapy
Pediatric cancer
Data sharing
BRAIN Initiative
Fundamental science
Neuroimaging and mapping

11. NIBIB – the “Technology Institute” Our Mission
To improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care.
Finding your NIH niche

12. Targeting IC priorities – an example
Finding your NIH niche
Developing and accelerating the application of biomedical technologies… [via] integrating the physical and engineering sciences with the life sciences to advance basic research and medical care…
NIBIB mission
NIGMS mission
…supports basic research that increases understanding of biological processes, lays foundation for advances in disease diagnostics...
BASIC RESEARCH*
TECHNOLOGY DEVELOPMENT
Novel sensing approach using a chemical signaling process
Fundamental understanding of a chemical signaling process
Application of the chemical sensor:
NIGMS <- To further research
To diagnostics -> NIBIB

13. Everything you need is online - really
How do I apply for funding?
Does the NIH support my type of research?
Which funding opportunities are available?
&
your Institute or Center (IC) of interest

14. I’m lost, gotta call NIH-where’s the signal?
Get help from the inside
I’m lost, gotta call NIH-where’s the signal?

15. Who do I contact to discuss my proposal?
Who to contact…
Who do I contact to discuss my proposal?
Get help from the inside
about the scientific and technical aspects of your application (pre-application, post-review, during the award…)…
Program Director (PD)
Find them on the solicitation
See also the IC’s programmatic descriptions
for questions during the review…
Scientific Review Officer
(SRO)
Listed on the eRA Commons link to your submitted proposal
See also the review group rosters at the CSR web site
Pre-Application
Assess the “fit” to the IC, Program(s)
Start the conversation early: develop your ideas together
Choose the right activity/mechanism
Brief on Review Issues: Dos/Don’ts
Post Review
Analyze the Summary Statement: deeper insights from the Review
Understand the rating and assess the likelihood of funding
BEWARE! Nothing is certain until you have it in writing
During the Award
Discuss problems in execution (rebudgeting, re-scoping, extensions…)
Find an administrator to address unusual issues
Brag about important discoveries – share your publications
Anytime
Arrange introductions so you can serve on advisory boards, workshop panels, etc.
Discover what’s New and Coming Soon in Funding Opportunities
for help with the business aspects of a proposal…
Grants Specialist
(GS)
Listed on the eRA Commons link to your submitted proposal
See also the FOA and points of contact

16. Getting to the Top: Writing Great Grants
… improving health by leading the development and accelerating the application of biomedical technologies
Getting to the Top: Writing Great Grants
Components of successful applications
Strong Idea
Strong Science
Strong Team
Strong Presentation
Match idea/science to the right NIH Institute
Every IC has specific mission
Hone high-quality grant writing skills
Articulate the need to capture the opportunity
Communicate scientific content compellingly
Follow all the instructions, and ‘write for the reviewers’ 16

17. NIH RePORTER

18. How does NIH solicit applications?
Funding Opportunity Announcements (FOA) published through
the NIH Guide (
grants.gov
Parent Announcements cover basic activity codes
investigator-initiated applications
Special Opportunities to fill gaps
Requests for Applications (RFA), a one-time call with set aside funds
Program Announcement (PA) highlights areas of focus
Program Announcement with Special Review (PAR) for special consideration and “protected” review
Program Announcement with Set Aside (PAS) essentially, an RFA with multiple receipt dates

19. Funding Mechanisms R01 (4-5 yrs, $250 - 400K+, renewable)
R21: NIBIB 2 types: NO PRELIMINARY DATA, Exploratory/Developmental Research Grant, 2 yrs, innovative, high-risk/high-reward, early stage
R21: NIBIB TRAILBLAZER-New Investigator PI only
R03: Small Grant Program, 1-2 yrs, feasibility/pilot studies, collection of preliminary data, secondary data analysis
R01: Research Project Grant, 3-5 yrs, strong preliminary data
R15 / AREA awards: for institutions with little NIH funding
SBIR / STTR
Cooperative Agreements – U series: substantial programmatic involvement by the awarding Institute
Training grants – F series, K series, K99/R00
Program Project / Center Grants: P series: large, multi-project efforts with a diverse array of research activities
Resource Grants – R24, R25, X01
Conference Grants – R13, U13
R01 (4-5 yrs, $ K+, renewable)
Convincing preliminary data for each aim
Longer term questions
Multiple complexities
R21 ($275K spread over 2 yrs, non-renewable)
High(er) risk and reward
Little/no supporting data
R03 (2 yrs, $50K per year, non-renewable)
succinct task(s)

20. NIBIB Notices of Special Interest (NOSI)
“NOSI” replaces “Parent Announcements” at NIH; First NIBIB NOSIs
Follow up from Innovations in Technologies to Extend the Golden Hour Workshop 3/2019.
Physiological Monitoring and Point of Care Technologies for Trauma Care, NOT-EB
Ultrasound and Optics-based Devices for Trauma Care, NOT-EB
Radiation Monitoring for Trauma Care, NOT-EB
X-ray-based Devices for Trauma Care, NOT-EB
From NIH Scientific Data Council Strategic Plan and Guide Notice recommendation on Fast Healthcare Interoperability Resources (FHIR®) Standard, NOT-OD
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Applications Directed at the Adoption of the Fast Healthcare Interoperability Resources (FHIR®) Standard, NOT-OD
Šeila Selimović
Tiffani Lash
Randy King
The Innovations in Technologies to Extend the Golden Hour Workshop was held in March and organized by NIBIB and USUHS (Seila Selimovic worked with Col. Todd Rasmussen from USUHS to chair this meeting) with support from HHS, NIH, ASPR, BARDA, DARPA, CCCRP, and FDA.
Program Contact: Seila Selimovic
Todd Merchak
George Zubal

23. Begin here… Project Title: really a quick summary of the project
Writing competitive grants
Project Title: really a quick summary of the project
Principal Investigator(s) and Key Personnel: defines role, commitment
Overall goal: resolve an important issue in a timely manner
Specific goal: best stated as a hypothesis (a strong claim, substantiated by data)
Impact: 2-3 sentences, define success, distill innovation and significance

24. Significance – Innovation – Investigator(s) – Approach – Environment
Specific Aims page - formula for success
Writing competitive grants
Tell your story in five compelling, concise, plain-language paragraphs!
1. Outline an important medical problem and your timely, innovative solution. Describe the big picture quantitatively. How can science/engineering help?
2. Define the challenge for this application. What is your specific target and hypothesis? How will you get there? How do you know?
3. State each of your Specific Aims in a single sentence in bold face. Identify strategies, methods, assays to be used, and data expected.
4. Overview of the competencies of the team and the resources. Why is this the right group at the right place and time? Outline your specific skill sets.
5. What happens when you succeed? What are the next steps? How will paradigms shift or treatment change, and what will this project contribute?
(6. Contingency-Flexibility-Ideas Changes might be needed for success? )
Significance – Innovation – Investigator(s) – Approach – Environment

25. Research strategy Demonstrate that the investigator has:
Significance (10% of available space):
Reviewers will not hunt for the value in your application
Stand out in your ideas and execution plans
Significance is about context: find and target the best Study Section
Innovation (5% of available space)
Innovative aspects must be obvious
Does not have to be a new idea, but could be a new approach
Succinct analysis of the literature is key – do you know your field?
Balance feasibility with bold research
Are you offering something new or is your approach incremental?
Approach
Explicitly state Scientific Premise – does your idea make sense?
Previous studies – (not only yours) do you know your field?
Support feasibility- be careful of any restrictions on preliminary data
How is your approach not just different, but better?
Experimental design and methods – do you know how to do research?
Demonstrate that the investigator has:
mastery of (and/or access to) the required techniques
ability to manage and work with partners
sufficient attention to key details (i.e. accurate, carefully assembled figures, tables, graphs)
Provide sufficient, relevant details in your application! Consider your reviewers’ time!
Writing competitive grants

26. Research strategy / Approach
Methods: how will the research be done?
Do tasks relate to the Specific Aims?
Provide an overview and conceptual framework. Connect all the dots.
Are the experiments logical, grounded, and well-integrated?
Why are the proposed methods the best way to go? Be sure this study is not “a technology looking for a problem”
Less detail needed for established techniques
Alternatives for high risk elements add to the feasibility
Explain inclusion/exclusion of biological variables (e.g. sex, age)
Biohazards identified here, then fully discussed in a subsequent section
Are end-points/milestones clearly defined, with appropriate benchmarks? Is there a sensible timeline?
Is the appropriate statistical analysis included? Demonstrate rigor.
Cite relevant data, especially yours!
Integrate observations from other fields: be disruptive BUT…
Connect the dots
Propose alternatives for the riskier aspects
Writing competitive grants

27. Placement in Application
Enhancing Reproducibility:
Rigor and Transparency
New!!
Element
Definition
Placement in Application
Notes
Scientific Premise
Key data justifying project
Significance
Exploratory science may need more explanation
Scientific Rigor
Robust, unbiased experimental design, methodology, analysis, interpretation, results reporting
Approach
Transparency establishes firm research foundation, supports innovation
Relevant Biological Variables
Critical factors affecting health or disease (e.g. sex, age, source, weight, genetic strain)
Consideration of sex required for human/animal studies
Key Resource Authentication
Integral components with inherent variability or unique characteristics (e.g. cell lines, biologics, specialty chemicals)
Attach plan (single page) as appendix
Not factored into scoring, but required prior to funding
Writing competitive grants

28. Human and Animal Subjects
Writing competitive grants
Important considerations in overall application scoring (feasibility of the work) and as pre-award administrative issues.
Safeguarding the rights and welfare of individuals as subjects in research based on DHHS regulations and established, internationally recognized ethical principles.
INCLUSION requirements have changed!
CLINICAL TRIALS definitions!!
OHRP
Office of Human Research Protections
Research involving a living individual about whom an investigator obtains either data through interaction or identifiable, private information…
Blood/sample collection
Test compound/medicine administration
Environment manipulation
Survey or Interview
Psychological testing
Know name, SSN, or other identification
Collect data
Test a new educational technique
Involve children, prisoners, pregnant women
Unless the study is exempt, b/c
#1. is conducted in an educational setting involving normal practice
#2. uses low risk tests, interverviews, observations and unidentifiable subjects
#4. collects of uses existing data or specimens if publicly available or de-identified
Additional documentation needed for funding:
FWA (Federal-Wide Assurance with OHRP
IRB approval, granted annually
EDU (Human Subjects Education, certified by the institution)
Grantees are responsible for the humane care and treatment of animals under NIH- supported activities.
grants.nih.gov/grants/olaw 28

29. Clinical Trial Optional Clinical Trial Required
Clinical Trials
Writing competitive grants
Does your study
Involve one or more human subjects?
Prospectively assign participants (s) to intervention(s)?
Evaluate the effects on the subject(s)?
Have a health-related biomedical or behavioral outcome?
If “yes” to all…
Clinical Trial Optional
Clinical Trial Required
Clinical Trial not allowed
FOAs now
come in
three flavors:
enhancing transparency in clinical research

30. New Investigators (NI): never had a large NIH award
Biosketches
Writing competitive grants
Required for all investigators
Each participant in a Multiple-PI application must show complementary and integrated expertise
List degrees chronologically
A. Personal statement: your experience, qualifications needed for this project, with up to four publications as evidence
B. List positions, honors, concluding with current position
C. Contributions to Science
Brief description of five areas: historical background, findings and impact
May include up to four publications (or other data, e.g. patents) as evidence
Include a link to complete publication list in PubMed
D. Research Support: overview, distinguish from proposed
Ongoing and completed projects over past three years
Listed by relevance to the proposed work
New Investigators (NI): never had a large NIH award
Early Stage Investigator (ESI): within 10 years of terminal degree (NI subset)

31. Resources and Facilities
Identify and justify
Facilities
Laboratory and offices, clinical sites, animal housing/handling, machine/electronics shops - if applicable
Multiple performance sites, as applicable
Equipment (especially if unusual)
How the environment will contribute to success
institutional support, intellectual rapport, access to subject populations
For Early Stage Investigators: institutional investment in your success
classes, training, collegial support, mentorship programs, logistical support, protected time for research with salary support, etc.
Handling of biohazards
Consider safety of research personnel and/or environment
Writing competitive grants

32. Budgetary issues http://grants.nih.gov/grants/developing_budget.htm
Writing competitive grants 32

33. Getting funded in an emerging field
Writing competitive grants
NIH funds high risk/high reward research if there is…
Potential for high impact
Novel approach, not necessarily a new idea (a fundamental publication builds credibility)
Deep expertise in the general area on the team (confidence in capability is key)
A compelling research plan—anticipate obstacles and propose alternatives

34. How to win over the peer reviewers
Own your impact: tackle an important and difficult problem
engineers beware: lead with an urgent issue, NOT your cool tools/technologies
discovery (basic) science or technology development (non-hypothesis driven) ok
Hit all review criteria on the Specific Aims page
Balance premise (the possible) with novelty (the new and exciting)
feasibility = most relevant previous (foundational) data + sound, logical pathway
defend assertions with publications (especially yours, but citing reviewers a plus)
Keep it clear
short term objectives inform long term goals
milestones > bold, general ideas, contingencies
experience, expertise count
Define success and point to the next grant/activity
Employ good grantswritership
limit jargon/acronyms
reinforce (don’t repeat) important ideas
use legible/sensible figures
strategically place an overview as “eye candy”
proofread! Get other eyes to see it also!
Writing competitive grants

35. Submitting your application
Writing competitive grants
Contact your PO prior to submission:
Mandatory: Application with budget >$500,000 direct costs for any single year; R13 Conference Grants; Training grants
Optional: When RFA’s request a Letter of Intent
Recommended: When you think about applying for any grant
Submitting your application on Grants.gov:
Only the Authorized Organizational Representative (AOR) has the authority to submit applications.
You are responsible for verifying that the application is viewable in the eRA Commons. If you can’t view the application in the Commons, we can’t review it.
You must correct all errors before the eRA system will assemble an application image.
If you experience a system issue that you believe threatens your ability to submit on time, carefully follow guidelines to document your problems and continue working to resolve your issues.
Grants.gov is the portal for NIH applications
eRA Commons is the doorway to the NIH system 35

36. Receipt and Referral, Center for Scientific Review (CSR)
Once your application is submitted…
Getting the right review
Receipt and Referral, Center for Scientific Review (CSR)
Electronic SF424 R&R submitted through grant.gov and the eRA Commons
Error free, warnings addressed
to an NIH Institute (IC)
To Integrated Review Group (IRG) and then study section (SRG)
CSR Referral Office assigns the application…
Application assessed for completeness & eligibility
unique identifier (application number)
1 R01 EB
Notice of assignment available in eRA Commons in 4 weeks.
Check your eRA Commons account for updates! 36

37. CSR Study sections – peer review
Vascular and Hematology (VH)
AICS, ELB, HM, HP, MCH, VCMB, F10B
Molecular, Cellular and Developmental Neuroscience (MDCN)
BPNS, CMBG, CMND, DDNS, MNPS, NCF, NDPR, NOMD, NTRC, SYN
Behavior and Behavioral Processes (BBBP)
APDA, BRLE, CP, CPDD,
LCOM, MESH, MFSR
Bioengineering Sciences and
Technology (BST)
BDMA, BMBI, GDD, ISD, MABS, NANO
Biology of Development and Aging (BDA)
International/Cooperative Projects
Cell Biology (CB)
BVS, NCSD, CMAD, CSRS, DEV1/2, ICI, MBPP, MIST
Healthcare Delivery and Methodologies (HDM)
BCHI, BMRD, CIHB, CLHP, DIRH, HDEP, HSOD, NRCS
Infectious Diseases and Microbiology (IDM)
BACP, CRFS, DDR, HIBP, PTHE, VB, VIRA/B, F13
AIDS and AIDS Related Research (AARR)
ACE, ADDT, AIP, AMCB, AOIC, BSCH, BSPH, NAED, VACC
>200 Standing
Scientific Review Groups (SRGs or Study Sections) housed in 25 Integrated Review Groups at CSR
Surgical Sciences and Biomedical Imaging and Bioengineering (SBIB)
BMIT-A/B, BTSS, CMIP, MEDI, SAT, F15
Brain Disorders and Clinical Neuroscience (BDCN)
ANIE, ASG, BINP, CDIN, CNBT, CNN, CNNT, DBD, DPVS, NPAS, PMDA
Endocrinology, Metabolism, Nutrition and Reproductive Systems (EMNR)
MCE, ICER, CMIR, PN, CADO, IPOD, CIDO, INMP, F06
Biological Chemistry and Molecular Biophysics (BCMB)
BBM, MSFA/B/D/C/D, SBCA/B
Immunology (IMM)
CMIA/B, HAI, IHD, III, IMM-M, TTT, VMD, F07
Risk Prevention and Health Behavior (RPHB)
BMIO, PDRP, PRDP, RPIA, SPIP, F16
Genes, Genomes and Genetics (GGG)
MGA/B, GCAT, GVE, GHD, PCMB, TAG
Musculoskeletal Oral and Skin
Diseases (MOSS)
ACTS, MRS, MTE, ODCS, SBDD, SBSR, SMEP
Interdisciplinary
Medical Sciences and Training (IMST)
EBIT, various training
Oncology 1 – Basic Translational (OBT)
CAMP, CE, CG, MONC, TCB, TME, TPM
Digestive, Kidney and Urological Systems (DKUS)
CIMG, GMPB, HBPP, KMBD, PBKD, UGPP, XNDA
Cardiovascular and Respiratory Sciences (CVRS)
CCHF, CDD, CICS, ESTA, LCMI, LIRR, MIM, RIBT, F10A
Emerging Technologies and Training in Neuroscience (ETTN)
MNG, BNVT, NOIT, F01/2/3
&
Oncology 2 – Translational and
Clinical (OTC)
BMCT, CBSS, CDP, CII, CONC, DMP, DT, RTB
Population Science and Epidemiology (PSE)
BGES, CASE, EPIC, IRAP, KNOD, NAME, SSPA/B
Integrative, Functional and Cognitive Neuroscience (IFCN)
AUD, LAM, NAL, NMB, NNRS, SCS, SMI, SPC 37

38. Cover letters help target your review
Applicants can suggest
Review Group assignment
Expertise necessary for a full and fair review
Primary (and secondary) Institute or Center (IC) assignment
Reviewers with potential conflicts
Getting the right review
Do not suggest possible reviewers, they will be disqualified.
Other Important Information
Reasons for a late submission
Note eligibility for continuous submission
Highlight this application as one of a set, if applicable
Acknowledge NIH approval for acceptance of
A budget >$500K/yr
Conference grant
Suggested format and other information at

39. NIH scoring system Getting the right review
Impact Full description Score Descriptor
Exceptionally strong with essentially no weaknesses
Extremely strong with negligible weaknesses
Very strong with only some minor weaknesses
Strong but with numerous minor weaknesses
Strong but with at least one moderate weakness
Some strengths but also some moderate weaknesses
Some strength but with at least one major weaknesses
A few strengths and a few major weaknesses
Very few strengths and numerous major weaknesses
Exceptional
Outstanding
Excellent
Very Good
Good
Satisfactory
Fair
Marginal
Poor
High
Medium
Low
Minor weakness: Easily addressable weakness that does not substantially lessen impact.
Moderate Weakness: Impact lessened.
Major Weakness: Impact severely limited.
overall impact score = panel average x 10
Most scores are then percentiled for comparison across review groups.

40. NIH’s review system for grants
Getting the right review
Scientific Review Group (SRG)
Independent outside review
Evaluate scientific merit, significance
Recommend length and level of funding
1st level
Output: Priority Score and Summary Statement
Advisory Council
assess quality of SRG process
offers recommendation to Institute Staff
evaluates program priorities and relevance
advises on policy
3 - 7 months
2nd level
Output: Funding Recommendations
Institute Director
makes final decision based on Council input, programmatic priorities
Must also Pass Administrative Review
months
Output: Awards or Resubmission 40

41. Who makes actual funding decisions?
The Institute Director!
Paylines vary.
Funding strategies vary.
Factors Considered:
Scientific merit
Contribution to Institute mission
Program balance
Availability of Funds 41

42. Close, but no award? You get one more try. Or write a new application.
It’s not personal
Revise and resubmit
Absorb the critiques
make suggested changes
provide additional justification for your original approach
Explain the changes in a one page “Introduction”
You get one more try.
Or write a new application.

43. Common problems Low/No significance
Unimportant problem limits significance
Unconvincing case limits impact; feasibility questionable
Irrelevant, inconsistent, or insufficient reference to published work
Weak PI/Research team: Insufficient experience with essential methodologies
Lack of innovation: evolutionary not revolutionary
Questionable reasoning in experimental approach
Errors in design = FATAL FLAW
Failure to consider potential pitfalls and alternatives
Diffuse, superficial, or unfocused research plan
Lack of critical experimental detail
Unrealistically large amount of work proposed
No clear milestones, decision points
Poor environment: weakly documented institutional support
Serious/unresolvable human/animal/biohazard issues, concerns

44. Take home messages Lots of directions and opportunities at the NIH
Monitor Institute websites and the NIH Guide (
Get to know the Program Director(s) for your scientific area and discuss your ideas
Fit with institute mission and priorities
Best grant mechanism or program
Best study section for review
Participate in workshops and symposia
Get fresh ideas and directions for your research
Become known to your peers (i.e. reviewers)
Write the best proposal you can
Participate in review of grant applications (serve on study sections)

45. Keep up with new policies
Rigor, Reproducibility, Transparency
Scientific premise now a scorable criteria; must be justified by data
Data processing must include statistical analysis (where applicable)
Relevant biological variables (sex, age, etc.) must be considered in experimental design
New
Rules!
IC Participation in R21(and R03) FOAs
Read the Solicitation! Some ICs do not use these mechanisms
Some ICs have their own basic versions, or use these mechanisms only for specific topics
Amount, type of PRELIMINARY DATA a key consideration for R21
Human Subjects
Inclusion Tables now required for all non-exempt human subjects research
NIH defines a CLINICAL TRIAL very broadly (answer the four questions)
FOAs recently subdivided into three types, based on clinical trials (not allowed, optional, required). Be sure to use the correct template!
Clinical trials funded by NIH grants must be registered at ClinicalTrials.gov and report findings
Notices
Read the Solicitation several times throughout your application process, watch out for Notices!

46. Thank you!

47. NIH’s support for biomedical research is…
highly complex
confusing
difficult to navigate
often frustrating
unpredictable
robust
flexible
broad
timely
reliable