Successful Grant Writing for NIH Cheryl Anne Boyce, Ph.D. Chief, Behavioral and Brain Development Branch Associate Director, Child and Adolescent Research Division of Clinical Neuroscience and Behavioral Research National Institute on Drug Abuse Houston Baker, Ph.D. Program Director Imaging Technology Development Branch Cancer Imaging Program National Cancer Institute 1

“Anatomy” of Grant Process Researcher Idea Institution Program Staff Program Announcement or RFA Collaborators Grant Application (R01, R03, R21, K01, K08, etc.) Revision $ National Advisory Council CSR Referral and Review Program Staff 2

Grant Writing for Success Writing the Application Start early Seek advice from colleagues Start with a good idea Talk to your NIH Program Official(s) Use the NIH webpage (www.nih.gov) Remember review criteria Follow instructions carefully Transition to Electronic Submission (http://era.nih.gov/ElectronicReceipt/) 3 3

What Determines Which Grants Are Funded? Impact Score—Scientific merit Program considerations Availability of funds 4

NIH Award Mechanisms Grants Cooperative agreements Contracts Numerous grant mechanisms R01s, R21s, R03s, K99’s, etc. Multi-project grants- P01, P30, P41, P50, etc. Investigator initiated (PA or PAR) or solicited (RFA) Cooperative agreements “U” grants, used for most clinical trial and other networks Substantial NIH staff involvement Solicited—Request for Applications (RFA) Contracts N01s Solicited—Request for Proposals (RFP)

Three Ways to Work with an IC Submit an application for a grant or contract Apply for grant funding for your research project grant at any time or for specific opportunities (PA, PAR, PAS) Apply to a specific competition for grant set-asides (RFA) or a specific contract competition (RFP, BAA) Indirectly through someone who has funding from the IC Collaborate with an extramural awardee as a subcontractor Collaborate with our Intramural Research Program through material transfer agreements, etc. Gain access to IC sponsored resources Get help and in-kind materials from our specimen resources, etc.

Applying for Grants (e-Submission)

Grant Submission Dates http://grants. nih

Electronic Submission Most NIH grant applications require electronic submission via http://Grants.Gov eRA Commons: secure web-based information exchange between NIH and applicant organization (PI and Business Official) http://commons.era.nih.gov Applicant business office and PI must establish personal eRA Commons accounts to track review progress and to retrieve scores and summary statements eRA: electronic Research Administration

You must register for e-submission Register on Grants.gov (may take 4-8 weeks) Register with US CCR (Central Contractor Registration) Obtain DUNS number (Data Universal Numbering System) Obtain Grants.gov credentials Assign an AOR to submit grants (Authorized Organizational Representative); SO (Signing Official) Non-US organization: may require registration with North Atlantic Treaty Organization Commercial and Government Entity (NCAGE) Register on eRA Commons Both applicant and organization must register One-time registration Enables you to receive and transmit application or information electronically

Applying for an NIH Grant

“I don’t really care about that administrative stuff “I don’t really care about that administrative stuff!” But it is IMPORTANT: To understand how NIH works! Easy to disengage and only focus on the lab Network with NIH staff Talk to us at meetings, on the phone, by email The squeaky wheel gets the oil If I don’t know you, how can I help you? Understand how NIH peer review works Learn what works and what doesn’t in peer review AND funding

Are You a “New Investigator”? NIH fosters research independence of new investigators Definition: Has not previously served as PI on any NIH grant Except R03, R15, R21, R42, R43 or mentored K awards Gets special consideration during peer review and IC funding decisions See web site for details: grants1.nih.gov/grants/new_investigators 13

Are you an Early Stage Investigator (ESI)? NIH fosters research independence of early career investigators Definition: Has completed his or her terminal research degree or medical residency—whichever date is later—within the past 10 years and has not yet been awarded a substantial, competing NIH research grant Get special consideration during peer review and IC funding decisions

Where are applications reviewed? CSR Study Sections Research Project Grants (R01s) AREA Grants (R15s) Fellowships (F32s & F31s) SBIRs Shared Instrumentation Grants Small Grants (R03s) Exploratory/Developmental Grant (R21s) INSTITUTES Scientific Review Groups Contract Review Ctees. Program Project Grants (P01s) Center Grants (P30s) Training Grants (T32s) K Grants RFAs (some of which will be for R01s) Contracts

Who are the Peer Reviewers? Established Investigators - few assistant professors Demonstrated scientific expertise Mature judgment Breadth of perspective Impartiality Adequate representation of women and minority scientists Diversity of expertises represented The typical reviewer: Associate Professor or Professor with active publication record and history of NIH grant support Record of prior participation on IRGs preferred. Conflicts of interest are carefully assessed. Specific assignments selected based upon SRA evaluation of reviewer experience and reviewer designated level of comfort with specific subject areas. If we don’t have the right expertise on the panel, we get it (ad hoc, telephone, write-in)

Peer Review: Evaluation Criteria Review of applications based on NIH standard review criteria Significance Investigators Innovation Approach Environment Also initiative specific review criteria, when applicable Different criteria for training related applications

Peer Review: New NIH Scoring System Score Descriptor Additional Guidance on Strengths/Weaknesses 1 Exceptional Exceptionally strong with essentially no weaknesses 2 Outstanding Extremely strong with negligible weaknesses 3 Excellent Very strong with only some minor weaknesses 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 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

Peer Review: Process The SRO prepares an order of review that clusters New Investigator (NI) applications, Early Stage Investigator applications (ESIs) and clinical applications if feasible. NI and ESI applications are identified for reviewers so there can be appropriate review in context of career stage. Expectations of preliminary data and publication track record less than for established investigators.

MOST IMPORTANT SLIDE! Most common reasons for not receiving funds: Lack of new or original ideas Diffuse, superficial or unfocused research plan Lack of knowledge of published relevant work Lack of experience in the essential methodology Uncertainty concerning the future directions Questionable reasoning in experimental approach Absence of acceptable scientific rationale Unrealistically large amount of work Lack of sufficient experimental detail Uncritical approach Common reviewer criticisms: The work proposed is not hypothesis driven / is a fishing expedition. The data generated will be correlative at best, and will offer no progress in understanding mechanisms. The proposal is overly ambitious and unrealistic. The investigator has a lack of recent research productivity. There are not adequate preliminary data to support an investment of this magnitude in the project proposed.

Formula for Successful Applications

Start with a Good Idea Does it address an important problem? Will scientific knowledge be advanced? Does it build upon or expand current knowledge? Is it feasible … to implement? to investigate?

Good Grantsmanship Contact NIH program staff early Assess IC interest & “goodness of fit” Are there related FOAs? Searching web sites is good start … but follow up with personal contact Send a 2 – 3 page concept paper to a program contact

Good Grantsmanship What’s a Concept Paper? Facilitates productive discussion with Program Official Study Goals You want support from which IC to do what? Problem/Background Why does this topic need study? Significance Why this is important to the field? Research Question What hypotheses will you test? Design/Analysis What study design and statistical approach do you propose? Team Who will be the key participants and collaborators?

Good Grantsmanship grants1.nih.gov/grants/multi_pi Collaborate with other investigators Fill gaps in your expertise and training Add critical skills to your team “Team Science” is the new direction Support for multidisciplinary research projects Consider the Multiple-PI Model Talk to NIH program contact if the project involves multiple PIs grants1.nih.gov/grants/multi_pi

Good Grantsmanship Ask a colleague to review your draft Ask a colleague who does not already know what you intend to do Ask a colleague who is not your best friend Your draft reviewers need to understand What you intend to do Why you believe it is important to do Exactly how you are going to do it Leave enough time to make revisions

Good Presentation 3 Simple Steps: Read the application instructions carefully Don’t forget … ... read the application instructions carefully http://enhancing-peer-review.nih.gov/restructured_applications.html

Alignment of Application Format with Scored Review Criteria Significance Research Strategy a. Significance Investigator(s) Biosketch Personal Statement Innovation b. Innovation Approach c. Approach Environment Resources

Application Changes Changes to three parts of application: Biographical sketch Research Plan Resources Changes in page limits and format

Application Changes: Biographical Sketch (4 pages) Personal Statement – why experience and qualifications make the applicant particularly well-suited for role in the project Publications limited to 15 5 most recent 5 best 5 most relevant to the application

Restructured Research Plan: Significance, Innovation, Approach Previous Application New Application Background and Significance Research Strategy Significance Innovation Approach Preliminary Studies for New Applications Progress Report for Renewal/Revision Research Design and Methods Preliminary Studies/Progress Report Review Criteria now aligned with Application Format

Application Changes: Resources Facilities and Other Resources (in 424 part of the R&R Other Project Information; in 398 the Resources Format Page) Environment - New instruction to address how scientific environment will contribute to probability of success, unique features of environment, etc. For ESIs, provide description of institutional investment in success of the investigator.

Good Presentation Title Abstract Capture essence of goals and objectives Abstract Present your project Concisely State significance Clearly State Hypotheses, Research Problem, Solution Methods and Rationale Write direct, active text: Read aloud. Snooze? Fix!

Good Presentation Organize the Research Strategy to answer 4 essential questions: What do you intend to do? Why is the work important? What has already been done? How are you going to do the work?

Good Presentation Address Scored Review Criteria Significance: Does the study address an important problem? How will scientific knowledge be advanced? Investigator: Is the investigator appropriately trained? Innovation: Are there novel concepts or approaches? Are the aims original and innovative? Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

Good Presentation Provide well-focused research plan Keep specific aims simple … and specific Link hypotheses to specific aims Explain method chosen to test every hypothesis Don’t wander from the main theme A conceptual model can clarify ideas

Good Presentation Be realistic … not overly ambitious Discuss potential problem areas Discuss possible solutions Explain rationale for your decisions Be explicit Reviewers cannot read your mind … Don’t assume they know what you intend

Good Presentation Prepare a reviewer-friendly application Be well organized and clear Use logical transitions between sections Add section headings -- major and minor Make tables and figures easy to view Eliminate all mispeelings and type-O’s

Good Presentation Prepare a reviewer-friendly application Be well organized and clear Use logical transitions between sections Add section headings -- major and minor Make tables and figures easy to view Eliminate all misspellings and typo’s

Good Review Get to the right review group Make sure your application goes to the right review group* Title, abstract, specific aims all point to the main goals of your project Include a Cover Letter suggest IC and review group assignment* Outline key expertise needed for appropriate review do not name specific reviewers * Consult with Program Officer

Good Review Good Presentation will keep your reviewers happy Reviewers often work late at night Help them stay alert and interested Make your application easy to read and easy to understand Convince reviewers to advocate for your idea Get reviewers on your side!

Good Luck Results from: Good Ideas Good Grantsmanship Good Presentation Good Review

Elements of an Outstanding Grant Application New or original ideas Pilot data (essential for R01/ less critical for Fs and Ks) Focused, incisive research plan Knowledge of published relevant work Experience in the essential methodology Future directions and contingency plans This slide describes good grantsmanship, but…..

Writing an R01 (Regular Research Grant) Directly from a senior reviewer Write Specific Aims section and discuss with mentor or an NIH grantee Give yourself four weeks to write first draft Full draft to mentor one month before submission date Read and follow the instructions (electronic 424) Prepare budget with budget person Write for a general scientific audience Simple is better Repetition is good

Writing an R01 (cont’d) You must have simple testable hypothesis that is supported by preliminary data Study Sections are conservative No preliminary data = No award Demonstrate medical significance Rationale, limitations of methods, controls, and back-up plans are critical Details of methods are unimportant (boring) but make sure the reviewers know you know the methods and say so Get collaborators and consultants- strong letters

R01 Common Errors Not discussing literature that is contrary to your ideas Not discussing strengths and limitations of your data- don’t let reviewer do it for you! Proposing too much for 3 or 5 years Common criticisms: “This Specific Aim could serve as an entire grant in and of itself” “Research is unfocused” “Study is overambitious” “Not clear investigator has needed experience”

R01 Common Errors (cont’d) Lack of relationship to disease Methodology over Biology is not good Descriptive vs Hypothesis-driven “Looking at” (bad) vs “testing” (good) “Fishing expedition” (bad) No biostatistical support Sample size (power) calculations for animal or human studies Inadequate control group

Specific Aims The most critical page in the application It is a one page summary of the application Describe Overall Impact expected Why is this problem significant? What are the exciting preliminary data? What hypotheses do the data support? Simple list of your Aims is good Be general Avoid long (laundry) list of things you are going to do 2-3 Specific Aims is sufficient (Focus: must fit together)

Research Strategy Assume you are not writing for an expert Emphasize general medical importance and then specific importance of your topic Avoid jargon Discuss controversies in the area Avoid selective citation of the literature Make your story interesting- make the reviewer want to read more! Correct English, grammar, and attention to typographical errors is important. Reviewers like a “pretty” application.

Preliminary Data Show primary data for critical methods Make figures or tables readable Progress Report- for renewals Restate Aims (avoid laundry list) Publication list MUST be very strong. No productivity- no grant Convince reviewer that you can do what you propose

Approach (Methods) Do you have the right tools and experience? Is this the right model system/preparation? Are there adequate controls? Are you discussing the pitfalls and alternatives? Avoid details (volumes, components of buffers) Show a time line - reviewers like them

Response to Critiques - When you resubmit an application You have 1 page to explain how you revised the application in response to issues identified by the reviewers - make it easy for reviewer to find your “answers” Misunderstandings are your fault- if they missed a key fact in a figure or table, maybe it wasn’t clear enough Be diplomatic and positive (most reviewer’s comments are good). Don’t argue with reviewers. Avoid tone that says “You (the reviewer) don’t know anything about this area” Address every single criticism Avoid overstating your data

Don’t give up!! Initial failure is common Understand which parts of the application process are under your control Learn from a failed submission and succeed - majority do Study criticisms in Summary Statement Discuss with program to decide if problems are repairable Attend diligently to each criticism Keep a positive tone and attitude Express gratitude to reviewers if you can muster any. Their criticisms are intended to help you. Even if you don’t agree with them, find a way to acknowledge their point and go on to explain yours.

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NIH OER NIH Guide for Grants and Contracts

NIH Guide for Grants and Contracts Official publication listing NIH funding opportunities and policy notices Published weekly List grants and contracts Request for Applications (RFA) Program Announcements (PA) (& PAR, PAS) Request for Proposals (RFP)

Research Portfolio Online Reporting Tool (RePORT) http://report. nih A Searchable database of federally supported biomedical research -- Replaces C.R.I.S.P. Access reports, data, analyses, expenditures, results of NIH supported research activities Identify, Analyze IC(s) research portfolios, funding patterns, funded investigators: Identify areas with many or few funded projects Identify NIH-funded investigators and their research Identify potential mentors/collaborators

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