nih research grant proposal preparation slides & suggestions collected over the years

NIH Research Grant Proposal Preparation

slides & suggestions collected over the years

Examples dated (old screen shots) Basic messages still relevant Please read slide notes for guidance Originally targeted junior faculty seeking first R01

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

Types of Awards

Research Project (R01) Small Research Project (R03) Exploratory Study (R21) Pathway to Independence (K99/R00) Career Development (K Award) Diversity Supplements

Funding Mechanisms Explained:http://grants2.nih.gov/grants/funding/funding_program.htm

Types of Awards

Types of Awards

http://grants.nih.gov/training/careerdevelopmentawards.htm

Types of Awards

Types of Awards

Pathway to Independence (PI) 150-200 awards in FY2006-2007 Open to US citizens & non-citizens Years 1-2: mentored post-doc phase Years 3-5: independent research Must obtain assistant professor position to move on to second phase

grants.nih.gov/grants/new_investigators/pathway_independence.htm

Types of Awards

Types of Awards

Diversity Supplements Applicants from underrepresented

racial and ethnic groups Applicants with disabilities Applicants from a family below

established low-income thresholds Applicants from a disadvantaged

social, cultural, or educational environment (rural, inner city)

http://grants.nih.gov/grants/guide/pa-files/PA-05-015.html

Types of Awards

Request for Application (RFA) Program Announcement (PA) Cleared Concepts Research Priorities Program Areas

http://grants2.nih.gov/grants/guide/index.html

Types of Awards

Types of Awards

NIH Guide Table of Contents Weekly Notification Service

[email protected] NIHTOC-L your name

http://www.nia.nih.gov/GrantsAndTraining/

grants.gov/search/subscribeAdvanced.do

Types of Awards

http://nihroadmap.nih.gov/

Types of Awards

New Non-competing Renewal Competing Renewal Revised (original submission plus up to 2 revisions allowed)

NIH Review Process

NIH publicizes its research priorities to help investigators plan projects NIH staff members welcome contact from investigators NIH wants to fund solid research that advances public health

NIH Review Process

43,069 applications in FY2005 (vs 27,798 in FY2000) Referral officer assigns applications to review group Referral officer assigns to Institute for funding

Make this task as easy as possible!

Your application is here.

NIH Review Process

Review assignments based on: Cover letter Grant title Abstract Specific Aims

Cover letter includes grant mechanism, prior contact with NIH program officers, and referral suggestions for institute/center, IRG (integrated review group), & study section

Referral takes up to 6 weeks

NIH Review Process

Electronic submission involves PI & OSP Grants.gov can take up to 2 business days to acknowledge receipt of files eRA Commons can take up to 2 business days to acknowledge receipt PI & OSP have up to 2 days to verify uploaded application (both must verify) Cover letter optional-but still important!

NIH Review Process

Scientific Review Administrator Reviews all applications Assigns 2+ reviewers Assigns 2+ discussants Determines policy for

submission of supplementalmaterial by PI

Determines if special reviewexpertise is needed

http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-002.html

http://grants1.nih.gov/grants/peer/comparison_evaluation.doc

NIH Review Process

Streamlined (unscored) applications All members designate half of all

applications received as streamlined

Applications streamlined by 2 or more members are not discussed or scored

Streamlined applications returned to PI with comments only from assigned reviewers

NIH Review Process

Reviewers & discussants evaluate non-streamlined applicationsInstitute program officers can attendSummary statement preparedMembers mark priority scores(1.0-1.5 = outstanding)Percentile based on ranking compared with applications reviewed at last 3 meetings

NIH Review Process

120 hours to prepare R01 application7-8 hours to critique (reviewers)<1 hour to read (discussants)15 minutes to discuss & score (entire group)

Do EVERYTHING PossibleTo Facilitate Review Process!

NIH Review Process

Institute Advisory Council: Reviews summary statements Evaluates application for program

relevance Approves funding Awards funding based on priority

scores

NIH Review Process

43,069 grants submitted (new, cont, suppl) – 9,599 funded (22.3%) in FY2005

740 Roadmap submissions – 127 funded (17.2%)

221 NCRR submissions – 31 funded (14.0%)

666 NIAAA submissions – 203 funded (30.5%)

3,166 NINDS submissions – 700 funded (22.1%)

6,325 NCI submissions – 1,292 funded (20.4%)

Trends: http://grants2.nih.gov/grants/award/awardtr.htmSuccess rates: http://grants2.nih.gov/grants/award/success.htm

Improving Your Odds

Read PAs & RFAs Monitor institute research priorities Contact program officers in target institute Discuss your ideas, their needs

Improving Your Odds

http://nccam.nih.gov/research/

Improving Your Odds

Improving Your Odds

Search CRISP for current & past research in same or similar areas NIH likes to see their tools put to use Helps you avoid areas already well funded

http://crisp.cit.nih.gov/

Improving Your Odds

Identify best study section Study section rosters online Identify one or more institutes for funding

http://cms.csr.nih.gov/

Improving Your Odds

http://era.nih.gov/roster/index.cfm

Improving Your Odds

ALWAYS submit cover letter (paper & electronic)

Suggest specific study group for review Suggest one or more target institutes Refer to RFA or PA number and title Refer to program officer with whom you have been working Identify yourself as a new investigator

Improving Your Odds

New investigators are NOT penalized New investigators allowed higher payline priority score More emphasis on research potential than on track record More emphasis on research plan than on preliminary results

http://grants.nih.gov/grants/new_investigators/index.htm

Improving Your Odds

Improving Your Odds

Seek “feed forward” before writing Identify 2-4 specific aims Discuss hypothesis & approach with grant-funded colleagues & biostatistician Contact NIH program officer Contact fiscal/grants administrator

Improving Your Odds

Use short, concise sentences Make points clearly Use diagrams to illustrate models Use tables to summarize data NEVER assume reviewers “know what you mean” Never create additional work for the reviewer

Improving Your Odds

Organize application for logical flow of ideas & actions Everything fits together Nothing is superfluous Nothing is omitted Time table is detailed & realistic

Improving Your Odds

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

Improving Your Odds

Why you would not want funding: Must think of innovative ideas Must do the work Must publish papers Must submit grant progress reports Must write yet more grants for

continued funding

Improving Your Odds

How to Avoid Funding Recycle old ideas Skip literature review Avoid all contact with NIH Do not let anyone else read grant Wait until due date to contact research

administration Save time – don’t read instructions Include jargon & sweeping generalities

Research Plan Strategies

Specific Aims Background & Significance Preliminary Studies Research Design & Methods 25-page limit – read instructions!


Specific Aims is the MOST important section of Research Plan Concise, valid, innovative hypothesis Achievable objectives that will provide useful data whether outcome is positive or negative Creates focus for entire application 1 page (bullet each aim separately)


Specific aims define methodsSpecific aims must be: Tangible Specific Concrete Measurable Realistic


Specific Aims Pitfalls: Lack of new, original, or innovative idea Fishing expedition Focus on method No relation to future research or public

health Not measurable Incremental advance in knowledge Not achievable in time available


Background & Significance reviews published & unpublished data in field (supportive or not) Identify gaps in current knowledge Justify hypotheses & approaches taken Emphasize significance of findings Clearly state public health implications 2-4 pages


Background Pitfalls: Inappropriate, incomplete, or

haphazard use of literature Questionable rationale for proposal Uncertainty regarding future direction

or significance of results (esp if negative)

Lack of knowledge of relevant published literature (including alternative theories or approaches)


Preliminary Studies struts your stuff Establishes feasibility of proposal Demonstrates your qualifications & dedication to do the proposed work Shows the hypothesis can be readily & clearly tested 5-6 pages


Preliminary Studies Pitfalls: Lack of general research experience Lack of experience in essential

methodology Lack of critical interpretation of

preliminary data (whether performed by you or others)

Lack of dedication to career in research Preliminary data not published (lots of

abstracts with no articles shows lack of productivity & commitment)


Research Design & Methods should be the easiest section to write Detailed cookbook instructions for what exactly you will do Anticipate problems & include Plan B Logical sequence & timetable Design MUST achieve Specific Aims Show how results will lead to future experiments & translation to practice


www.ninds.nih.gov/funding/grantsmanship_checklist.htm


Explain in detail for all anticipated results: Analysis Interpretation Dissemination Application to future work


Research Design & Methods Pitfalls: Diffuse, superficial, unfocused design Methods do not test hypothesis or

achieve specific aims Unrealistic timetable for methods No difficulties anticipated, no solutions

proposed for potential problems Inadequate attention to data analysis,

interpretation, and/or application


From: http://www.ninds.nih.gov/funding/grantsmanship_mistakes.htm


From: www.niaid.nih.gov/ncn/tools/ap-bettr.htm


A. Specific AimsSpecifically, we aim to:A.1 Do x, y, & zA.2 Show this & thatA.3 Demonstrate what works

B. Background & SignificanceB.1 Background info for specific aim A.1B.2 Background info for specific aim A.2B.3 Background info for specific aim A.3


Introduction to Revised Applications (1-3 p)

Deferential & grateful for reviewer input

Quote points to address directly from critiques – avoid paraphrasing, do not avoid or omit addressing any criticism

Do NOT get in pissing match with reviewers

Clearly & concisely explain responseRecognize you are not home-free – not all weaknesses addressed in summary statement


Appendices do not stretch 25-page limit (sent only to primary reviewer)

Include 3 published papers or abstracts (nothing submitted or in prep)

Include full-size or color versions of items in main application Include complete surveys, data collection tools, or other forms


Do NOT neglect Human Subjects or Vertebrate Animals sections Reviewers serve as temporary IRB – application must provide as much detail for reviewers as for IRB Consider requirements for these sections when preparing Research Plan itself

PHS 398

NIH requires the use of 11 point font - Arial, Helvitica, Palatino, Linotype, or Georgia typeface NEW Section G: Select Agent Research

NEW Section I: Multiple PI/PD Leadership Plan

Pay attention to Data/Resource Sharing

PHS 398

NOT an IRS-style form package! Logical forms, simple instructions, useful information collected Used to determine: Review assignment Qualifications of investigators Institutional compliance with NIH code Cost of research

PHS 398

Face Page Limit title to 81 characters including

spaces & punctuation Select title carefully – used to direct

review assignment Use funding cycle dates to calculate

start date … for example: 02/05/07 submission = 12/01/07 start

PHS 398

Description Page Write abstract last to reflect entire

application – review & revise carefully Be concise, clear, & complete – may be

only text read by most reviewers Do NOT cut & paste from the grant Clearly state public health relevance &

importance to NIH mission (electronic submission forces you to do this)

PHS 398

Key Personnel Page Key personnel are paid to participate

in the grant-funded work & cannot be changed without NIH notification

Other significant contributors include unpaid consultants & mentors with no committed percent effort (include biosketch but no other support)

PHS 398

Budget Pages NIH has sample modular budget

pages Department fiscal/grant administrator

can help with estimating costs & calculating salaries

PHS 398

Personnel Pages Summarizes education, training, &

professional career highlights Lists publications (except those in prep or

submitted) & presentations Lists recent research support Establishes qualifications to do proposed work

& appropriateness for role on proposed study Only 2 pages for career info & publications –

this restriction goes away with electronic submission

PHS 398

Resources Page Summary of physical space,

equipment, personnel, & other resources essential to study completion

Letters of support required for shared resources critical to proposed work

Justify reliance on external resources

THE FUTURE (is now)

NO standard application forms – EACH funding opportunity will have its own application package Register for notification of subsequent changes to the application package NIH Forms Website has samples only – do not use these for actual submissions

THE FUTURE (is now)

Office of Research (sponsored programs) must submit applications – NOT PIWrite down grants.gov tracking numberAuthorized institutional official AND PI must verify applications accepted at eRA CommonsDo NOT verify garbled images – if looks garbled when you view it, will look garbled to reviewersNIH has demo to practice application verification

THE FUTURE (is now)

Color welcome throughout narrative Do NOT include headers (PI name) or footers (page numbers) in narrative file – will be automatically generated Less $ spent on paper & referral-review process means more $ for grants

Summary

Fully develop study aims Contact NIH to discuss aims Review literature related to aims Design study to test & achieve aims Read & follow all instructions Be concise – be complete Seek input early & often

nih research grant proposal preparation slides & suggestions collected over the years

Documents

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