RESEARCH FUNDING: HOW TO PROSPER IN 2012 AND BEYOND

Leonard H. Rome, Ph.D.Senior Associate Dean for Research

http://research.mednet.ucla.edu

Thursday, April 19th, 12 noon, 13‐105 CHSThursday, April 19th, 12 noon, Live Stream 

THE HARD REALITY

• 10‐15 years ago, one could expect to apply for one's first NIH R01, directly after completing a postdoctoral fellowship. Today, the average age for someone to receive their first R01 grant award is over age 40. 

• In 2005, 15‐18% of grants were funded, depending on the NIH institute. For FY 2010 less than 10% will be funded. For the past 6‐7 years funding for NIH itself has been flat which means in real dollars the NIH budget has gone down for 6‐7 years.

How do you  get started?

• Understand what is expected.• Set realistic goals.• Explore your opportunities.• Get ready early.• Take advantage of internal review.

THE HIGH COSTS OF RESEARCH

• Personnel 60-85% of total costs• Lab assistant (college graduate) $30,000+• Staff research associate I (college grad +

experience) $35,000+• Research nurse >$100,000• Postdoctoral fellow $38-46,000• Portions of P.I.’S and co-P.I.S’ salary• All salaries must provide benefits (+20-30%)• Graduate student $27,000 + tuition

THE COSTS OF RESEARCH

• Supplies– Bench science ~ 20-40% total

• High costs: animal colonies

– Clinical/social science ~10-15%

• Equipment maintenance• But: physical plant and administration costs

usually charged to “overhead”• Shared instrumentation grants

Major Sources:Investigator Initiated Grants (RO1)

NIH – National Institutes of Health ($32B*)NSF – National Science Foundation ($7.4B*)ACS – American Cancer Society (~$0.1B)AHA – American Heart Association

Program Project Grants (PO1, UO1, NIRT etc..)Other Government

AHQR, DOD, DOE, DARPA…Large Foundations (HHMI ($0.8B), Keck, etc…)Small Foundations (Disease specific)

CF, MS, Breast cancer, etc.

SOURCES OF FUNDING FOR RESEARCH

2011 Budget Request

OTHER USEFUL TYPES OF FUNDING

• California– CIRM (stem cell)

– Tobacco

• Training Grants (Graduate Students, Post‐Docs)

• Industry (UC Discovery Program)

• Private Donors (Clinical Departments)

• UCLA ‐ Intramural Programs

The NIH Alphabet Soup of Award Types

R Awards (Research Project Grants; RPGs) • R01 Research Grants • R03 Small Research Grant • R15 Academic Research Enhancement Awards

(AREA) • R21 Exploratory/Development Grants • Bioengineering Research Partnership (BRP)

Awards • R13-U13 Support for Conferences and Scientific

Meetings • R41, R42, R43, R44 SBIR-STTR Small Business

Innovation Research and Small Business Technology Transfer Awards

F Awards (Fellowships) 

• F30 NRSA Predoctoral MD/PhD Fellowships • F31 NRSA Individual Predoctoral

Fellowships to Promote Diversity in Health-Related Research

• F31 NRSA Individual PredoctoralFellowships

• F32 NRSA Individual Postdoctoral Fellowships

• F33 NRSA Individual Senior Fellowships

K Awards (Career Development) K01 Mentored Research Scientist Development

Award K02 Independent Scientist Award K07 Academic Career Award K08 Mentored Clinical Scientist Research Career

Development Award K23 Mentored Patient-Oriented Research Career

Development Award K24 Midcareer Investigator Award in Patient-Oriented

Research K25 Mentored Quantitative Research Career

Development Award K99/R00 Pathway to Independence Award

Other AwardsP01 Program Project

P20 Exploratory Grants

P30 Biomedical Research Core Centers

P50 Specialized Center

S10 Shared Instrumentation Awards

S10 Awards - High End Instrumentation (HEI)

T32 NRSA Institutional Training Grant

U01 Research Project Cooperative Agreement

NIH Clinical Trial Planning Grant (R34) Program

NIH Pathway to Independence (PI) Award (K99/R00)

http://grants.nih.gov/grants/funding/funding_program.htm

• Agency Sources (NIH, NSF, ACS web sites)

http://grants.nih.gov/grants/oer.htm

http://www.nsf.gov/funding/

http://www.cancer.org/Research/ResearchProgramsFunding/institutional-research-grants

• University of California - OTThttp://www.ucop.edu/ott/welcome.html

• UCLA Sponsored Research - Funding Opportunity Databaseshttp://www.research.ucla.edu/era/who/whoven.htm

• UCLA School of Medicine, Dean’s Officehttp://research.mednet.ucla.edu - Search Engine

• UCLA School of Medicine, Departments• Other Sites - links to agencies etc..

How do you get information?

MIXED GRANT PORTFOLIOS DESIRABLE

• NIH funds subject to cutbacks

• Restrictions on NIH funds (salary cap, foreign travel)

• Restrictions on training grants (us residents or citizens)

• The effects of recession on funding by private foundations

HOWARD HUGHES MEDICAL INSTITUTEFY 2009

• $14 billion endowment

• $730 million/yr in support for 375 investigators and labs (Superstars!)

• $101 million/yr for grants outside HHMI

From HHMI Website 2010

PRIVATE FOUNDATIONSTop 20 U.S. Foundations Awarding Grants for Medical Research

• Foundation Name State Dollar Amount No. of Grants• 1. Bill & Melinda Gates Foundation WA $270,976,718 26• 2. The Starr Foundation NY 33,075,000 14• 3. Burroughs Wellcome Fund NC 25,804,239 83• 4. Flight Attendant Medical Research Inst, Inc. FL 20,461,776 143• 5. Avon Foundation NY 16,216,577 16• 6. The Dana Foundation NY 15,506,843 50• 7. W. M. Keck Foundation CA 14,970,000 16• 8. The Picower Foundation NY 13,198,221 8• 9. Eli & Edythe L. Broad Foundation CA 12,689,219 45• 10. The Robert A. Welch Foundation TX 10,960,000 37• 11. Doris Duke Charitable Foundation NY 10,748,600 26• 12. The Rockefeller Foundation NY 10,701,679 9• 13. The Abramson Family Foundation FL 10,300,000 4• 14. The G. Harold & Leila Y. Mathers Foundation NY 9,114,200 44• 15. The Robert Wood Johnson Foundation NJ 8,999,782 29• 16. The Sidney Kimmel Foundation PA 8,050,000 3• 17. James S. McDonnell Foundation MO 7,558,779 43• 18. F. M. Kirby Foundation, Inc. NJ 7,210,500 32• 19. Irene Diamond Fund NY 6,490,495 13• 20. Charitable Leadership Foundation NY 6,434,695 1

Circa 2005, Modified from Foundation Center Statistical Services

NIH SPENDING

NHGRI

NIAMSNIEHS

NEI

NIA

NIDA

NCRR

NICHDNIMH

NINDSNIDDK

NIGMS

NIAID

NHLBI

NCI

INSTITUTE BUDGETS

NIH GRANT PROCESS

INSTITUTE(S) ASSIGNED(27 INSTITUTES AND CENTERS)

COVER THE WHOLE RANGEOF BIOMEDICAL RESEARCH

INITIAL REVIEW GROUP(STUDY SECTION)

SPECIFIC EXPERTISEIN THE AREA OF THE PROPOSAL

ADVISORY COUNCIL(SECONDARY REVIEW)MINOR ADJUSTMENTS

CAN AFFECT MARGINAL PROPOSALS

AWARD

ADMINISTRATION AND FINANCIAL REVIEW

CENTER FOR SCIENTIFIC REVIEW

UPLOAD GRANT PROPOSAL

GRANT PROPOSAL

• Directed to a panel of experts with diverse backgrounds and interests

• Three reviewers do in‐depth review• Proposal must inform and persuade

– Important for science– Important for human health– Feasible – The investigator and team can do it– The proposed budget is justified

SCORINGImpact Score Descriptor Additional Guidance on Strengths/Weaknesses

High

1 Exceptional Exceptionally strong with essentially no weaknesses 

2 Outstanding Extremely strong with negligible weaknesses 

3 Excellent Very strong with only some minor weaknesses 

Medium

4 Very Good Strong but with numerous minor weaknesses 

5 Good Strong but with at least one moderate weakness 

6 Satisfactory Some strengths but also some moderate weaknesses 

Low

7 Fair Some strengths but with at least one major weakness 

8 Marginal A few strengths and a few major weaknesses 

9 Poor Very few strengths and numerous major weaknesses 

Non‐numeric score options: NR = Not Recommended for Further Consideration, DF = Deferred, AB = Abstention, CF = Conflict, NP = Not Present, ND = Not DiscussedMinor Weakness: An easily addressable weakness that does not substantially lessen impactModerate Weakness: A weakness that lessens impactMajor Weakness: A weakness that severely limits impact 

REVIEW CRITERIA

• SIGNIFICANCE

• INVESTIGATOR

• INNOVATION

• APPROACH

• ENVIRONMENT

• OVERALL IMPACT

REVIEW CRITERIA

• SIGNIFICANCE

• INVESTIGATOR

• INNOVATION

• APPROACH

• ENVIRONMENT

• OVERALL IMPACT

SIGNIFICANCE

• Does the project address an important problem or a critical barrier to progress in the field? 

• If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? 

• How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

REVIEW CRITERIA

• SIGNIFICANCE

• INVESTIGATOR

• INNOVATION

• APPROACH

• ENVIRONMENT

• OVERALL IMPACT

INVESTIGATOR• Are the PD/PIs, collaborators, and other

researchers well suited to the project? • If Early Stage Investigators or New Investigators,

or in the early stages of independent careers, do they have appropriate experience and training?

• If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

• If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

REVIEW CRITERIA

• SIGNIFICANCE

• INVESTIGATOR

• INNOVATION

• APPROACH

• ENVIRONMENT

• OVERALL IMPACT

INNOVATION

• Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

• Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?

• Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

REVIEW CRITERIA

• SIGNIFICANCE

• INVESTIGATOR

• INNOVATION

• APPROACH

• ENVIRONMENT

• OVERALL IMPACT

APPROACH

• Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

• Are potential problems, alternative strategies, and benchmarks for success presented?

• If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

APPROACH

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

REVIEW CRITERIA

• SIGNIFICANCE

• INVESTIGATOR

• INNOVATION

• APPROACH

• ENVIRONMENT

• OVERALL IMPACT

ENVIRONMENT

• Will the scientific environment in which the work will be done contribute to the probability of success?

• Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?

• Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

REVIEW CRITERIA

• SIGNIFICANCE

• INVESTIGATOR

• INNOVATION

• APPROACH

• ENVIRONMENT

• OVERALL IMPACT

OVERALL IMPACT

• Will the project exert a sustained, powerful influence on the research field?

• Overall impact score is NOT the average of all criterion scores but is the score that determines funding!

COMMON CRITICISMS

• SIGNIFICANCE– The project, even if successful, is not likely to

change the field or human health– Important questions were missed

• INNOVATION– It has it already been done– Someone more qualified is already doing it– The methods and approaches are standard and

do not push the field forward

COMMON CRITICISMS• FEASIBILITY

– Population characteristics• The subjects cannot be recruited• The experiment is not adequately powered

– The amount of work is excessive for the resources or time available

– Reagents and methods are not up to the task

• FOCUS– The work will not result in a coherent body of knowledge

• CONTINGENCY PLANNING– Alternative outcomes were not considered in the plan– The whole project hinges on the outcome of one part

Basic Guidelines for Successful Grant Writing

• Identify sources of funding• Know what your funding source expects• Know the requirements/limitations of the grant (e.g., for 

citizenship, etc.)• Start ahead of time• Get someone else to review it before you submit it• Know your own limits/abilities• Know when/where to ask for help• Learn who will be reviewing your grant (influence this if you can!)• Know the process by which grant submission/review/notification 

occurs• Understand the scoring system and what you need to do if you 

choose to resubmit

http://dgsom.healthsciences.ucla.edu/dgsom/newsmedia/1172011‐milman

Applying For Your First RO1

Standard Form 424, Application for Federal Assistance (Research and Related), abbreviated SF424 (R&R)

NIH has detailed instructions: http://grants.nih.gov/grants/ElectronicReceipt/prepare_app.htm

NIH PROPOSAL FORMAT• RO1 example ‐ Parent Funding Opportunity Announcement, 

FOA: PA‐11‐260• NOTE: NUMBER OF PAGES, FONT, SPACING AND MARGINS• ELECTRONIC SUBMISSION ONLY, WITH FEW EXCEPTIONS• ADMINISTRATIVE INFORMATION• PERSONNEL AND BUDGET• BIOGRAPHICAL SKETCHES OF INVESTIGATORS (INCLUDING 

PERSONAL STATEMENTS)• RESOURCES AND FACILITIES• RESEARCH PLAN• INCLUSION OF DIVERSE POPULATIONS• HUMAN AND ANIMAL USE• REFERENCES

RESEARCH PLAN

• SPECIFIC AIMS

• SIGNIFICANCE

• INNOVATION

• PRELIMINARY STUDIES/PROGRESS

• APPROACH

SPECIFIC AIMS• Market your application to reviewers

– Briefly state the impact of the research on your field.

– Briefly state why you chose the project.

– Convey its significance and innovation.

– Use terms a broad audience can understand.

• Choose Specific Aims peer reviewers can easily assess. Each one should be an achievable end point rather than a best effort.

• You should probably limit your application to one Specific Aim a year. For new applicants, being too ambitious is a common mistake.

• Have no more than one or two sets of experiments for each aim. If you need more, reorganize.

SPECIFIC AIMS (continued)• Think of your Specific Aims as the framework of your 

application, as an expanded table of contents for your Approach section.– Make each aim a header in your approach section.

– Design experiments to address each aim.

• Describe your Specific Aims as well‐focused objectives to achieve.– Describe options with milestones depending on results.

– Have aims that test your hypothesis.

SPECIFIC AIMS

• 1 page‐ a longer version of the abstract.• Typically 3‐4 numbered goals.• Use them also as subheadings for the research plan.

• Introduce them with 1‐2 paragraphs that provide the rationale and background.

• Conclude with 1‐2 paragraphs that describe significance.

SPECIFIC AIMS

RATIONALE AND SIGNIFICANCEHYPOTHESES

SIGNIFICANCE AND INNOVATION

1‐2 PARAGRAPHS

3‐4 AIMS(NUMBERED)

1‐2 PARAGRAPHS

12 3

4

1 PAGE TOTAL

USE AIMS AS SUBHEADINGS FOR APPROACH SECTION

SIGNIFICANCE

• Frame the problem and its general significance.• Briefly review relevant literature and preliminary data.• Interpret and identify gaps in knowledge.• Indicate in general terms how you will fill them.• Show how the work is new and unique.• Assess the potential impact on science and

health.• Refer to NIH priorities as articulated in RFAs and

consensus conferences.

INNOVATION• Briefly describe how the work is new and unique and

how it will add significantly to what's known.

• If your application is highly innovative, you'll need to build a strong case for your ability to challenge the existing paradigm and your reason for doing so.

• To show how the work is innovative, present a broad view of your field and the significance of the research.

APPROACH

• Sections correspond to specific aims• You can briefly reiterate significance and innovation• Integrate preliminary data into the rationale• Present the logical structure of the proposal• Use multiple approaches but prioritize• Discuss pitfalls and alternatives• Discuss data analysis and interpretation• Common or routine methodology can be lumped at

the end• Flow charts may be helpful

APPROACH

• Provide your own key data supporting the rationale for the proposal

• Demonstrate relevant technical expertise• Introduce the research team and its

special skills• Point out special resources that distinguish

the proposal

THE LAYOUT OF EACH SPECIFIC AIMBRIEF BACKGROUND AND SIGNIFICANCE

HYPOTHESES/RATIONALESTRATEGY AND INNOVATION

ANTICIPATED RESULTSPITFALLS AND ALTERNATIVESSIGNIFICANCE

EXP 1

EXP 2 EXP 3EXP 4

HELPFUL HINTS

• Use headings and subheadings.

• Break up the text with figures and charts.

• Be reader friendly!!

• Communicate excitement - but be realistic.

• Close with “future directions” and a timeline.

More Advice• Be Careful How Much You Propose and How Innovative You Are.

• Sharpen your application's focus. Novice PIs often overshoot their mark by proposing too much.– Propose few Specific Aims -- one for each year of funding requested is

a good rule of thumb -- and a plan with a limited scope.

– Make sure the scale of your hypothesis and Specific Aims fit your request of time and resources.

– Be sure your hypothesis is provable and your aims doable with the resources and time you are requesting.

• Beware of Being Too Innovative– Research does not necessarily have to create a new paradigm. To be

innovative it can: Shift a current paradigm, or refine, improve, or propose a new application of an existing concept, method, instrumentation, or clinical intervention.

– It's generally less risky to use an innovative approach to solve an existing problem than to take on a problem that's highly innovative.

COMMON REASONS FOR FAILURE

• Goals are not significant• Lack of new or original ideas• Lack of demonstrated accomplishment

(relative to stage)• Weak scientific rationale • A superficial or unfocused approach• A lack of understanding of the literature• Inadequate methodology for goals• Lack of experience in essential methods

COMMON REASONS FOR FAILURE

• An illogical, disorganized or presumptive approach

• An uncritical approach• Scope is excessive for the budget,

resources or experience• Lack of key experimental detail (must be

provided very strategically in the new short format)

RESUBMISSION

• Only one resubmission• Subsequent proposals may be screened for

similarity• Introductory page is used for direct rebuttal

and summary of changes• Significance and innovation concerns are

difficult to rebutt• The best rebuttal to criticism of approach are

new data and interim progress

A Little OptimismYes, these are tough times. The competition for research dollars has never been greater and the amount of research funding has remained flat.

However, there are still billions of dollars available for research funding from a variety of sources including the federal government, foundations, the state of California and the University.

This research money will be spent and those who are competitive will be funded. You are faculty at one of the top research universities in the world. You got here because you have what it takes to be successful.

AcknowledgementsSpecial thanks to:• Tomas Ganz, PhD, MD, Professor of Medicine and Pathology• John S. Adams, MD, Director, Orthopaedic Hospital Research

Center

Leonard H. Rome, Ph.D.Senior Associate Dean for Research

http://research.mednet.ucla.edu

For additional copies of this presentation and larger views of these slides, please visit the Junior Faculty Lecture Series page found on the Diversity website:www.DGSOMDiversity.UCLA.edu

NEW NIH RO1 GRANT CHECKLIST1. All PIs must registered in eRA Commons with PI role & up‐to‐date

profile

2. Electronic Submission (see SF424 (R&R))

3. Note proper formats, margins, attachments, figures etc.

4. Cover Letter

5. Project summary/Abstract No more than 30 lines of text• succinct description of work, long term objectives, specific aims making

reference to public health significance

6. Narrative (Relevance) No more than 3 sentences• relevance of research to public health in lay terms

7. Bibliography & References Cited• Incl. all authors, article/journal/book title, vol#, pg.#, year of publication (no

page limit). Articles resulting from NIH support use reference number (PubMed Central or NIH Manuscript Submission)

Additional material (not discussed in the lecture)

NEW NIH RO1 GRANT CHECKLIST (continued)8. Facilities & Other Resources

• Describe facilities, lab space, computers, office space and sq. ft available, equipment available, (as applicable) animals, animal care and use info, vet facilities, IBC description, human subject protection, statistical consulting, computing, archiving, software. How environment contributes to success; institutional investment in the success of investigator.

9. Equipment: list major items of equipment available for project and pertinent capabilities

10. Biographical Sketch(s)• 4 pages‐ add personal statement, no more than 15 publications. Use form at:

http://grants1.nih.gov/grants/funding/424/index.htm

11. Budget and Justification Modular format if less than $250,000 direct costs/year‐budgets >$500,000/yr requires Program Officer approval.

12. Research Plan‐ Section 1 Introduction‐ 1 page – Resubmission or revisions only

13. Research Plan‐Section 2 Specific Aims (Add innovation and impact) 1 page

14. Research Plan Section 3 Research Strategy 12 pages includes background & significance, research design and methods & preliminary studies/progress)• (3a) Significance (3b) Innovation (3c) Approach

NEW NIH RO1 GRANT CHECKLIST (continued)

15. Research Plan Section 4‐17 have no page limits(4) Inclusion Enrollment Report (Renewal Revisions using human subjects only)

(5) Progress Report Publications (Renewals Only: see Part II, Section 4.3 of Application Guide)

(6) Protection of Human Subjects: if ‘yes’ attachments 6‐9 required

(7) Inclusion of women and minorities

(8) Targeted Planned Enrollment

(9) Inclusion of Children

(10) Vertebrate Animals (if yes, attachment required: see page I‐111 in SF 424 Application Guide)

(11) Select Agent Research (see pg. I‐112 in SF 424 Application Guide)

(12) Multiple PD/PI Leadership Plan (must be included if more than one PI‐ see pg. I‐113)

(13) Consortium/Contractual (if yes, explain programmatic, fiscal and admin. arrangements)

(14) Letters of Support (consortium and consultant letters)

(15) Resource Sharing Plan(s): Data Sharing Plan (for projects over $500,00/yr direct costs 1 paragraph), Sharing Model Organisms http://grants.nih.gov/grants/policy/model organism/index.htm, Genome Wide Assoc. Studies http://grants.nih.gov/grants/guide/notice‐files/NOT‐OD‐07‐088.html

(16) Appendix

16. Modular Budget