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How the NIH Can Help You Get FundedPresented by Michelle Kienholz, Author & BloggerMichelle's Book: http://www.amazon.com/How-NIH-Can-Help-Funded/dp/0199989648/

Michelle's Blog: http://writedit.wordpress.com

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How the NIH Can Help You Get Funded takes a novel, non-formulaic approach in teaching readers how to “write a grant” — and much more. The authors draw on their decades of experience working with both investigators and NIH personnel to anticipate their questions and concerns and help establish a comfortable, productive partnership between them.

With this book’s focus on applying this knowledge to their personal grant strategy, readers will learn:

• How the NIH operates at the corporate level, as well as the culture and policies of individual institutes and centers

• HowtheNIHbudgetevolvesoverthecourseofafiscalyearand why the timing is important

• How to customize NIH Web site searches and use the data to increase chances of success

• Howtoidentifyappropriateprogramofficers,studysections,and funding opportunities

The authors advise readers on developing each component of the grantapplicationinorderofthecomponents’influenceonthefinalimpactscore.Individualfundingmechanismsarereviewedalongwithgrantsmanshiptipsspecifictoeach.Readerslearntheimportance of reviewer-friendly formatting and organization of the text.

Amid ever-increasing competition for government research grants, How the NIH Can Help You Get Funded is an invaluable manual for how to pursue—and sustain—NIH funding.

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Michelle Kienholz has partnered with scientists, clinicians, and public health researchers from all disciplines at dozens of universities to develop grant applications for almost every federal agency, including most grant mechanisms for each of the institutes and centers at the NIH. She volunteers her knowledge and experience on her popular blog, Medical Writing, Editing and Grantsmanship (as writedit), through which she has learned the most common and vexing concerns of researchers who interact with the NIH and how best to foster a partnership between investigators and NIH personnel.Jeremy M. Berg served for eight years as Director of the National Institute for General Medical Sciences at NIH, where he championed transparency and communication. Prior to his time at NIH, he was at Johns Hopkins University for 19 years as a postdoctoral fellow, faculty member, and department chair. He is currently on the faculty of the University of Pittsburgh School of Medicine, where he serves in several key administrative positions and conducts research in computational biology and personalized medicine. He has received numerous research, teaching, and public service awards.

4 EASY WAYS TO ORDERPROMO CODE: 32398•Phone: 800.451.7556 •Fax: 919.677.1303 •Web: oup.com/us•Mail: Oxford University Press. Order Dept., 2001 Evans Road, Cary, NC, 27513

Dec 2013 • 224 pp. • Paperback9780199989645 • $29.95/$23.95

How the NIH Can Help You Get Funded

An Insider’s Guide to Grant StrategyMichelle L. Kienholz and Jeremy M. Berg

How the NIH Can Help You Get Funded

Straight from the Author’s Mouth

Michelle Kienholz mlk39@pitt.edu

writedit.wordpress.com

How the System Works   National Institutes of Health

  Institutes & Centers

  Center for Scientific Review

  Office of Extramural Research

  Federal Budget Process (or lack thereof)

  NIH Funding Data & Trends

  Funding Mechanisms

How the Application Works   Telling Your Story Well

  Presenting Your Message Well

  Getting By with a Little Help from Your Friends

  Before and After the Study Section Meets

  Is the Check in the Mail?

  The Check is Not in the Mail …

  The Check is in the Mail, But …

How an Application Becomes a Grant

  Develop idea, confirm it is of interest to IC(s), confirm it is not already being funded

  Identify appropriate funding mechanism & opportunity

  Identify appropriate reviewers

  Develop application with reviewers & review criteria in mind (it’s all about the sponsor & the reviewers, not you)

  Prepare clear, concise, compelling narrative

  Seek feedback from others

National Institutes of Health   27 semi-autonomous Institutes & Centers

(24 with grant-making authority)

  Congress both authorizes the NIH & appropriates NIH funding

  Review process is codified in Public Law (protects NIH from “earmarks”)

  ~80% funds extramural research, ~11% funds intramural research, rest for administration & training

Institutes and Centers   NIAID ≠ NCI ≠ NIGMS ≠ NIDCR ≠ NIEHS ≠ …

  Each IC has its own culture, organization, payline, processes, policies, etc.

  Advisory Council or Board conducts second level of review (& they really do review summary statements), considers appeals, closely reviews certain types of applications, & approves (“clear”) concepts for future research initiatives

  Scientific Councilors review intramural research

  Review committees for RFAs, contracts, and P, U, T, & K applications

Institutes and Centers   POs (program officers, not parole officers)

  Contact before applying, after receive summary statement (not with score only), after receive award

  Initial contact via email – ask about communication preferences

  Find via colleagues, IC Website, RePORTER, other POs

  Advice on funding opportunities, project, application, study section selection

  GMS (grants management specialists) – budget & policy questions

Institutes and Centers   Funding trend data

  #R01 applications scored at a given percentile vs #R01 applications funded at that percentile

  NCI, NIA, NIAID, NIAMS, NIDDK, NIDA, NIEHS, NIGMS, NIMH, NINDS (in book, some on Web)

  Only a handful of ICs publish interim and/or final paylines

  Some ICs set “post-award” paylines at end of FY

  Some ICs adjust payline throughout the year

CSR & Peer Review Process   ~90K applications, ~20K reviewers

  Pick the right reviewers   CSR

  RePORTER

  PO, colleagues

  Review criteria (scored for all applications)   Significance   Investigator(s)   Innovation   Approach   Environment

CSR & Peer Review Process   Limited time for review

  Make reviewers’ job as easy as possible   Write for reviewers (not all experts)

  Goal: motivate reviewers to advocate for your application, make them want to read the papers to come out of your research

  Hundreds of hours on research & application for <15 minute discussion

  Watch CSR peer review videos

Office of Extramural Research   Guide to NIH Grants & Contracts

  Parent Announcements   Program Announcements (PA, PAR, PAS)   Requests for Applications (RFA)   Notices (policy, changes in FOAs, RFPs/contracts,

Request for Information, research misconduct, etc.)

  RePORTER

  NIH Data Book

  eRA Commons

  NIH Grant Policy

Office of Extramural Research   Funding Facts, NIH Data Book, Budget & Spending

  Compare success rate among mechanisms & ICs

  Check to see # applications reviewed & funded

  Postdoc in DNA repair:   Institute

  NIGMS vs NIEHS vs NCI   Mechanism

  R (R01, R03, R21, R15)   F32   K (K99, K22, K01)

Federal/NIH Budget Process

  Fiscal year (FY) starts Oct 1

  If no appropriations bills passed, operate under continuing resolution (CR) at prior FY $ levels

  Debt ceiling, elections, fair & balanced differences of opinion all delay final federal budget

  Application timing   Cycle I (Feb-May) – review in summer, decision next

calendar year – can reapply in Nov   Cycle II (June-Sept) – review in fall, decision next year   Cycle III (Oct-Jan) – review in spring, decision by

summer

Telling Your Story Well

Telling Your Story Well   Specific Aims

  Research Strategy   Significance   Innovation   Approach

  Draft in order of importance:   Approach (0.82 correlation coefficient with Impact)   Significance (0.69)   Innovation (0.62)

Telling Your Story Well   Convey “likelihood for the project to exert a sustained,

powerful influence on the research field(s) involved”

  Generate excitement & enthusiasm & desire to see your work in the literature

  Draft Specific Aims first, revise as prepare Approach

  Specific Aims most important page in application   May be only page read by all study section members   Must capture attention & generate excitement

  Must tell entire story

Telling Your Story Well   Have colleagues & PO review aims

  Complementary, not conditional   Generate useful knowledge whether hypothesis

supported   SMART: specific, measurable, attainable, relevant,

time-based

  No “right” number, so long as they are SMART

  Conclude with statement of Overall Impact

Telling Your Story Well   Approach needs to achieve the aims – organize by

aim to help the reviewer

  Focus on overall design & knowledge gained rather than procedural details

  Discuss analysis & interpretation, including potential pitfalls & alternative approaches

  Can consolidate common methods, clinical trial description, animal models, etc. in one section

  Convey this project as part of larger ongoing body of research (“sustained, powerful influence”)

Telling Your Story Well   Significance = why the work is important to do

  Not a background section, not a review paper, not a tutorial

  Goal: build desire for your project   Length depends on complexity of project

  Innovation = why your aims & approach are better than what has been/is being done   Tricky to write & review   Can divide into “Conceptual Innovation”, “Technical

Innovation”, “Translational Innovation”   Length depends on creativity of project

Telling Your Story Well   Preliminary data go wherever they strengthen the

story:   Approach if demonstrating feasibility of method &

establishing starting point for proposed experiments   Significance if establishing why the work is important

  Innovation if highlighting a novel method or concept   Integrate into narrative rather than separate out

  Cite published data rather than repeat all details but include key figures & summary

  Progress Report for competing renewals does not need to include all your preliminary data (but it can if appropriate)

Telling Your Story Well   Introduction

  Tell reviewers what you really think – then run this draft through the shredder (repeat as many times as needed)

  Not a rebuttal or debate   Skip repeating what prior reviewers liked   Focus on Resume & Summary of Discussion points   If room, address concerns from individual critiques   Cite critique verbatim in quotes (not paraphrased)   If no discussion, cite concerns shared by 2 or more

reviewers, then major individual concerns   PO can help, especially if attended review meeting

Telling Your Story Well   Research subject protection

  Vertebrate animals – stats for calculating sample size   Human subjects – key details must be in narrative

  Conveys to reviewers your comfort & competence in conducting this type of research

  Project Summary (abstract)   Use for referral if no cover letter

  Used by public & Congress (RePORTER)   Project Narrative = public health benefits in lay terms

Telling Your Story Well   Biosketch

  Personal statement can explain anything not covered in narrative – prior work with collaborators, specific experience with methods, breaks in training, etc.

  15 publications not a requirement but best to stay within that limit

  Can cite relevant non-publication peer-reviewed listings (patents, conference poster/presentation abstract, etc.)

  Include start-up package details in Facilities & Other Resources (new/ESI)

Telling Your Story Well   Facilities & Other Resources

  Multiple PD/PI Plan

  Biohazards

  Resource Sharing

  Letters of Support

  Budget

  Reviewers pay attention to conflicting details

Telling Your Story Well   Cover letter

  Request IC assignment   Request SRG assignment

  Identify areas of expertise needed to review (no names)

  Identify reviewers to whom your application should not be assigned (by name)

  Name PO with whom you are working

  Indicate intent to submit video   Document IC acceptance of R13/U13 application,

application with budget >$500K, late or corrected application

Telling Your Story Well   Format for readability

  Ragged right margin easier to read than full justification

  Plenty of white space to help application breathe   Use bold, italics, underline, color, etc. sparingly   Mark changes in revised A1 application by vertical

line in margin or change in font type (serif vs sans-serif)

Telling Your Story Well   Science of communication

  Use active tense, first-person voice   Keep sentences concise & clear

  Avoid use of modifiers (except scientifically descriptive), jargon, abbreviations

  Avoid empty phrases, omit needless words

  Important information (new, exciting) at end of sentence in stress position vs buried in middle

  Do not overstate: puts reader on guard, diminishes the piece

Telling Your Story Well   Videos (current policy)

  Do not embed in application or include as appendix   Do include stills from video & brief description in

narrative   Declare intention to submit video in cover letter   Only acceptable use is to demonstrate devices or data

with temporal component or movement-change   ≤ 2 minutes & ≤ 25 Mb (embedded in PDF file)   SRO accepts & distributes to reviewers at his/her

discretion   http://grants.nih.gov/grants/guide/notice-files/NOT-

OD12-141.html

Before & After Study Section

  Prior to study section meeting   PO cannot comment on or help with application

  Communicate with assigned SRO

  Post-submission materials must be submitted at least 30 days prior to scheduled review meeting

  News of manuscripts accepted for publication (not manuscript itself) and promotion/tenure

  Revised application materials due to change in investigator(s) and/or institutions due to natural disaster

  No new data or additional application materials   http://grants1.nih.gov/grants/guide/notice-files/NOT-

OD-13-030.html

Before & After Study Section

  At study section meeting   Applications discussed in order of preliminary impact

scores

  Reviewers in conflict with your application leave meeting

  Primary & secondary reviewers and reader give preliminary scores

  Primary reviewer presents strengths & weaknesses of application

  Other reviewers add comments, then open for discussion

  Assigned reviewers give final impact scores, which sets scoring range for other SRG members eligible to score

  Internet-assisted review has discussion via threaded messages (no body language)

Before & After Study Section

Before & After Study Section

  Review week   Study section meeting date in eRA Commons   Wait at least a day, then commence with Web browser

window refresh every 10 minutes until score posted   Wait to contact PO until receive summary statement

  Council meeting   Members review the quality of the review & whether

the project fits the IC mission & current scientific priorities

  Some concurrence voting occurs electronically before scheduled meeting

  Other Council activities (cleared concepts etc.)

Before & After Study Section

  Percentile ≠ Payline ≠ Success Rate   Percentile is linked to the study section & activity

code for 3 most recent review cycles

  Payline is linked to the IC & activity code for FY   Success rate (funded applications) is linked to IC,

activity code, & application type & status for FY

  Percentile   (100 ÷ # applications) x (relative rank – 0.5)   Relative rank from table of scores from applications

reviewed at past 3 SRG meetings

  Not all scored applications receive percentile

Is the Check in the Mail?

  Paylines   Set after budget determined   Important question for POs is whether your

application is on the paylist   Not mandatory, not made for all mechanisms, may be

adjusted during the year

  From final appropriation   Subtract intramural, administrative, evaluation, set-

aside   Subtract noncompeting renewals (~80% of what is left)

  Remainder for competing awards (~20%)   5-10% for select pay

Is the Check in the Mail?

  Success Rate   Percentage of submitted applications that receive

funding

  Varies by submission type and status   FY12 R01 success rates – reflects shrinking

denominator:   Type 1 A0 = 8.6%

  Type 1 A1 = 37.2%

  Type 2 A0 = 28.4%

  Type 2 A1 = 49.7%

Is the Check in the Mail?

Check is Not in the Mail   Appeals are rarely a good idea

  If borderline, ask about select pay/pay by exception, negotiated smaller award, 1-year award (R56)

  If A0, prepare & submit A1 – both applications considered for funding   Rapid resubmission if minimal concerns readily addressed

  Lack of significance or modest impact difficult to address

  Usually best to stick with same study section

  If A1, consider repurposing (different mechanism, RFA)

When an Application Becomes a Grant

  Submit application in Feb 2013

  Reviewed in June – score in June (13th percentile), summary statement in July

  Contact PO after receiving summary statement – Council in Oct, but under CR, so no decision on funding

  Submit A1 in November – reviewed in Feb 2014 – now 15th percentile – still no federal budget

  April – federal budget & NIH appropriation passed – A0 at 13th percentile on paylist

  July 2014 – award processed!

Long-Term Grant Strategy   Research that appeals to multiple ICs

  Research that can be reviewed (well) by different study sections

  Research that can also fit into program applications

  Research of interest to other sponsors   Department of Defense   National Science Foundation   Department of Energy   Foundations   Professional societies

Resources   Project RePORTER:

http://projectreporter.nih.gov/reporter.cfm

  OER (FOAs, data book, grants policy): http://grants1.nih.gov/grants/oer.htm

  CSR (study section search & videos, review criteria): http://public.csr.nih.gov/Pages/default.aspx

  NIAID grant tutorials: http://www.niaid.nih.gov/researchfunding/grant/pages/aag.aspx

  Payline & other NIH discussions: http://writedit.wordpress.com/nih-paylines-resources/