Grant Writing, Grantsmanship, & Grant Submission

Jared B Jobe, PhD, FABMR

Division of Cancer Control and Population SciencesNational Cancer InstituteNational Institutes of HealthDepartment of Health and Human Services

Acknowledgements

Susan Czajkowski, PhD, NHLBI Ellen Werner, PhD, NHLBI William Elwood, PhD, CSR Mary Horlick, MD, NIDDK Tom Pearson, MD, MPH, PhD, Univ of Rochester Charlotte Pratt, PhD, NHLBI Julia Rowland, PhD, NCI Lorraine Silsbee, MS, NHLBI

Learning Objectives

Understand new NIH policies on New & Early Stage PIs.

Understand the increased importance of the Specific Aims page.

Consider steps needed in organizing and writing an effective research grant application.

Initial Step: Become Familiar with Relevant NIH Institutes

Identify the several most likely Institutes for funding based on your specialty/scientific interests . See who funds your mentor’s research. See what Institutes are issuing FOAs in your area. See what Institute staff attend the same meetings you do. Become familiar with the websites of those Institutes who might

fund you. Review funding agencies priorities and review FOAs.

Next Steps in Applying for an NIH Grant

Sign up for the NIH Guide ListServe The Guide is emailed once a week, and contains Table of

Contents with ‘links’ to PAs, Notices, and RFAs http://grants1.nih.gov/grants/guide/listserv.htm

Review recently funded grants (RePORTER) http://projectreporter.nih.gov/reporter.cfm http://nexus.od.nih.gov/all/DiscNIHReport/index.htm

Review model grants on the NIH website Discuss your ideas with colleagues. Consider a consultant.

Next Steps in Applying for an NIH Grant (continued)

Contact program officers (POs) to obtain info on: Mechanisms supported by that Institute; Institute-specific policies & procedures; and Other relevant program information. Write a concept paper with your specific aims (1-2 pages). Send concept paper to a Scientific Review Officer (SRO) at the Center for Scientific Review

to discuss possible study section assignment.

Determine the Institute’s Interest and Receive Feedback on Your Idea

Share your concept paper/prospectus with an NIH Institute program officer(s) & request feedback: Is your Institute interested in funding research like

this? Are others currently funded doing similar work? Does this fall within a priority area of research for your

institute? What study section group would likely review the

application? How can I improve this concept?

Institute Specific Policies and Procedures

Payline (the percentile at which an Institute will provide funds for an application)

New Investigator payline at NHLBI Paylines vary across institutes Budgetary policies

Grants> $500 K direct costs/year require prior Institute approval

Across the board funding cuts, decreases in duration of funding

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New NIH Policies:New & Early Stage Investigators

NIH Definition of New Investigator (NI) A principal investigator (PI) is considered a New Investigator (NI)

if he/she has not previously competed successfully as a PI for a significant NIH independent research award

May have received funding as PI on small, early stage, training and mentored career awards including: Small Grant (R03) Academic Research Enhancement Award (R15) Exploratory/Developmental grant (R21) Training & Research Career Awards (F awards, K awards)

If multiple PIs, to obtain “New Investigator” status, all PIs must conform to New Investigator criteria

New NIH Policies: New & Early Stage Investigators (cont’d)

NIH Definition of Early Stage Investigator (ESI) A PI who qualifies as a New Investigator is considered an

Early Stage Investigator (ESI) if, at the time of submission, he/she is: within 10 years of completing his/her terminal research

degree or within 10 years of completing medical residency (or the

equivalent)

NIH Approach to New/Early Stage Investigators - 1

Applications will be more effectively evaluated when judged against applications from individuals at the same career stage.

Whenever possible, CSR will cluster applications from New Investigators for discussion during initial peer review.

Reviewers are asked to focus more on the research proposed and less on the track record and preliminary studies of the New Investigators.

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NIH Approach to New/Early Stage Investigators - 2

Priority processing and release of summary statements have been established for New Investigators.

Special Receipt dates have been established for New Investigators who resubmit their applications in consecutive rounds (see NOT-OD-07-083 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html)

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NIH Approach to New/Early Stage Investigators - 3

Small Grant (R03) and the NIH Exploratory/ Developmental Research Grant (R21) applications have increased over the last few years.

A smaller proportion of individuals with initial R21 or R03 grant support subsequently apply for and obtain R01-equivalent funding than those who first apply for an R01.

The initial success rate for R21 applications often is lower than for R01 applications.

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NIH Approach to New/Early Stage Investigators - 4

Because R03 and R21 grants are limited in scope and period of support, they may not be the most effective way to launch an independent research career.

NIH encourages New Investigators, particularly ESIs, to apply for R01 grants when seeking first-time funding from the NIH (excepting mentored career awards of course).

NIH’s partners--Institutions--must continue to look for ways to reduce the duration of graduate and postdoctoral training and to find new ways to enable new investigators to compete successfully for extramural funding.

For more details, see: http://grants.nih.gov/grants/new_investigators/

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Allowable Grants for New PIs

Pathway to Independence Award-Research Phase (R00)

Small Grant (R03) Academic Research Enhancement Award (R15) Exploratory/Developmental Grant (R21) Research Education Grants (R25, R90, RL9, RL5) Clinical Trial Planning Grant (R34) Dissertation Award (R36) Shannon Award (R55)

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Allowable Grants for New PIs (Cont)

Small Business Technology Transfer Grant-Phase I (R41) Small Business Innovation Research Grant-Phase I (R43) NIH High Priority, Short-Term Project Award (R56) Competitive Research Pilot Projects (SC2, SC3) Resource Access Award (X01) All Fellowships (F awards) All mentored individual and institutional career awards

(K awards). Some K grants are not mentored.

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Allowable Grants for New PIs (Cont)

Loan repayment contracts (L30, L32, L40, L50, L60) All training grants (T32, T34, T35, T90, D43) Instrumentation, Construction, Education, Health

Disparity Endowment Grants, or Meeting Awards G07, G08, G11, G13, G20 R13 S10, S15, S21, S22

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What Not to Do if You are an ESI

Never, ever agree to become a transition PI on an ESI-disqualifying grant.

Never agree to become a PI on a multiple-PI grant, if all the PIs are not ESIs.

NHLBI Policy for ESIs

The special payline policy for non-ESIs was phased out in FY 2010 as planned.

The NHLBI payline for ESI only is 5 percentile points above the regular R01 payline (i.e., 10%-tile) for FY 2012 (15th %-tile).

ESI applications on which all named principal investigators are ESI investigators that are >5 but <=10 percentile points above the regular R01 payline may undergo an expedited review to resolve comments in the summary statement (16-20th %-tile).

All awards to ESI applicants under this policy will be funded for all years recommended.

For NHLBI-specific policy:http://www.nhlbi.nih.gov/funding/training/redbook/newinvest.htm

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Submitting a Multi-PI Application

For investigators seeking support for projects or activities that require a team science approach

A contact PI is responsible for communication between the NIH and the leadership team

Awards managed using subcontracts, if have PIs at different institutions

NIH policies related to New Investigators will be applied to multi-PI applications only when all PIs involved are classified as New Investigators

Grantsmanship: The Idea Marketplace

Is the idea important?Your Good Can you do the work? ResearchIdea Support Is your plan feasible and well thought out?

Traits of a Successful Grant Getter

Research skills Salesmanship skills Communication skills Ingenuity and

flexibility Administrative skills Human relations

Persistence, dedication, patience

Ability to work hard Political awareness

and action Integrity

The research-grant application provides numerous opportunities to demonstrate qualifications and scholarly attributes, but it easily reveals faulty thinking, hasty preparation, superficiality, and inexperience.

‘I THINK YOU SHOULD BE MORE EXPLICIT HEREIN STEP TWO.”

Career Vision

It’s critical to have a research career vision! Don’t focus too much on what’s hot. Rather, focus on what you can do best. Don’t think just about the current application or

plans. Design a long-term program of research. Communicate that vision in your application.

Larson, G. The Complete Far Side. 2003.

Goals of Restructured Applications

Align the structure and content of the forms with review criteria.

To focus the applicants and reviewers on the same elements.

To help ensure a more efficient and transparent review process

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Overview of the Application Changes

Application forms have been revised in three sections (January, 2010): Research Plan Biographical Sketch Resources and Facilities

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Anatomy of a Research Grant: New Research Plan Components

Introduction (for revised or supplemental applications)Specific AimsResearch Strategy

-Background and Significance-Preliminary Studies/Progress Report -Research Design and Methods

Inclusion Enrollment ReportBibliography and References CitedHuman Subjects Sections - protections, women/minorities,

enrollment, childrenOther Research Plan Sections - animals, select agents, multi PD/PI,

consortium, support, resource sharingAppendix

Application Alignment with Review Criteria

Significance

Investigators Innovation

Approach

Environment

Research Strategy A. Significance

Biosketch Research Strategy

B. Innovation Research Strategy

C. Approach Resources

Review Criteria Application Sections

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Page Limit Summary

Section of Application Page Limits

Introduction to resubmission or revision applications

1

Specific Aims 1

Research Strategy 12

Biographical Sketch 4

Specific Aims: One Page

List the broad, long term objectives and what the proposed research is intended to accomplish

Often list 4-6 specific aims which are used to organize the background and significance preliminary studies, and design/methods sections

State hypotheses to be tested

Specific Aims Prototype

Text Overall goal of the project Hypothesis to be tested

Bullet Points Population/animal model to be studied Data to be collected or intervention used Endpoints to be measured Analysis of data Accomplishments expected at the end of the project

Research Strategy: 12 pages

Background and Significance

Preliminary Studies Research Design and Methods

Background and Significance

Why should this application be funded? Critically evaluate existing knowledge Specifically identify gaps that the project is

intended to fill Relate the specific aims to long term relevance Answer the “So what?” question

Background and Significance Prototype

What is known about the condition or disease in the population being studied?

What is known about the independent variables being studied?

How well is the endpoint usually measured? What analyses have been performed by others

to date?

Preliminary Studies

Provide information that will help to establish the experience and competence of the investigator to pursue the proposed project.

Competing continuation grants should summarize the previous application’s specific aims and the progress made toward them

May list publications relevant to or supported by prior grant and submit up to 10 manuscripts in Appendix

Preliminary Studies Prototype

What is your experience with the proposed study population or animal model?

Can you precisely and accurately measure the endpoint variables?

Can you precisely and accurately measure the dependent (outcome) variables?

Can you manage and analyze the data?

Purpose of a Pilot Study

Demonstrate ability to recruit/access/retain study population.

Establish ability to perform assay reproducibility, validity, precision, accuracy.

Estimate prevalence/incidence of endpoints. Quantify variability and magnitude of change in

endpoint for purpose of sample size calculation.

Research Design and Methods

Overall Study Design Participant Population Data Collection Endpoint Definition Data Management Data analysis

Sample Size Calculation Study Strengths and Limitations Timeline

Issues in Research Design and Methods

Data management is often left out Involve biostatistical colleagues early and often

and have them write the analysis section Analysis of study design Sample size calculation

Provide a frank discussion of application’s limitations, including alternatives considered

Include a timeline either here or in the budget justification to demonstrate feasibility

Human Subjects Research

Deficiencies in human subjects research plan appear to account for most of the reduction in funding rates in clinical versus basic science applications.

Provide complete answers to required questions. Provide projections on recruitments of women,

underrepresented minorities, and children. Describe recruitment procedures in detail in the

research plan. Keep the community involved, so you have their

consent and approval throughout.

Components of a Research Career Development Award

Specific Aims Candidate Mentor(s) Institution Research Project

Page limits: http://grants.nih.gov/grants/forms_page_limits.htm#car

Candidate for an RCDA (part of the page limit) Background and Training: Potential for research career Scientific Bibliography: Commitment to research career Career Development Plan / Training Activities

Formal coursework/degree program Seminars/journal clubs Summer institutes/outside courses Annual scientific meetings Interactions with mentor(s) Publications, grant applications Timeline for career development

Training in Responsible Conduct or Research

Mentors(s) for an RCDA(not part of the page limit)

Primary mentor’s experience Background and training Experience and funding in area of mentee interest Track record and current involvement in research training

Mentorial committee (3-4 co-mentors encourage multidisciplinary research) Describe role of each co-mentor May have co-mentors from outside institutions, as needed Describe function of the mentorial committee

Mentoring plan should be detailed

Institutional Sponsorship of an RCDA (not part of the page limit)

Description of resources relevant to candidate’s career Education and training programs (e.g. K30) Research facilities

Institutional commitment signed by official Support of candidate for faculty career development

(e.g. tenure track) Promise to protect % effort as required by the RCDA Usually description of remainder of time not

supported by RCDA

Research Plan(part of the page limit)

Similar to an R01, except shorter due to candidate’s statement

Preliminary results need not be lengthy, may include mentor’s laboratory results if relevant

Describe expected results and transition to R01 type funding

Practical Tips for RCDA’s

K08/K23 have relatively good funding rates Submit K and then R01, not vice versa Understand NIH Institute’s guidelines about

submitting R01’s during K Award. Transition of K to R is a measure of K award’s success

Plan for prompt revision, if not immediately funded

Talk with current K Awardees, review their applications

Community Partnered Approaches

Understand the differences among the terms: CBPR, community research, community-based research.

CBPR requires community involvement in ALL phases of the project.

Don’t claim in your application that you will conduct CBPR if the community doesn’t partner in ALL of the areas.

Go with one of the other terms, and explain why. OBSSR definition on CBPR:

http://obssr.od.nih.gov/scientific_areas/methodology/community_based_participatory_research/index.aspx

Suggestions for Community Partnerships - I

Describe the scientific, logistic, and organizational responsibilities of each partner.

Describe the history of partnership collaboration. Submit evidence of strong scientific capabilities. Submit evidence of community involvement and support. Emphasize human subjects protections. Include a Data and Safety Monitoring Plan. Include a Community Advisory Board.

Suggestions for Community Partnerships - II

Use community members as intervention staff and measurement staff—and remember that they must be different people.

Use a qualitative phase to work with the community to develop the specifics of the intervention.

Negotiate an agreement regarding ownership or control of research data and biological samples.

Negotiate an agreement regarding authorship, and the review and approval of research protocols, abstracts, and manuscripts.

Writing an Appealing Application - I

Read and follow all instructions in NIH Guide, PHS398/SF424 R&R, and related updates.

I said, “All instructions.” This means you! Conduct and demonstrate a thorough literature

review. Make reasonably detailed arguments! Provide a specific rationale for your proposed

investigation. Present a complete and organized research plan.

Writing an Appealing Application - II

Adherence to pitch, font, and margin rules and page limits

Correct spelling or grammatical errors Organize by headings Use spacing and indentation strategically Break-up text with well-designed and legible figures

and tables There is, in fact, no rule against using commas

Writing an Appealing Application - III

Your reviewers assume nothing! Propose realistic and detailed amounts of work. Include preliminary and/or related data whenever

possible. Obtain pre-submission feedback from your institutional

colleagues, other peers, or NIH program directors. Consider multiple Federal, state, and private funding

sources. Volunteer to review NIH, CDC, AHRQ, and other

applications!

Writing an Appealing Application - IVIt All Should Match

Specific aims Hypotheses Theory Pilot data Detail about methods Analysis plan

Power calculations Data and Safety Monitoring Plan Minority, women, children recruitment

Before Submitting

Do your homework in researching review groups. Choose an appropriate Review Group (locate listing of

Review Groups and rosters via NIH Webpage). Use key words in title & abstract that will ensure an

appropriate assignment for your application. Be sure to observe any Institute-specific requirements

when preparing your application. You should contact the Scientific Review

Administrators, just as you should contact institute program officers.

More New NIH Policies

Resubmission (Amended) Applications: NIH is now only allowing applicants to submit an application

twice rather than three times (the original and a single resubmission).

If applicants do not receive funding after 2 submissions, they must significantly re-design the project & submit as a new application.

Shorter Applications: Applicants now have shorter application page limits, as of

January, 2010 Keep informed of all new submission & review changes at:

http://enhancing-peer-review.nih.gov/

Biographical Sketch

Personal Statement added: “Briefly describe why your experience and

qualifications make you particularly well-suited for your role in the project”

Publications revised: Limit the list of publications or manuscripts to no

more than 15 Applicant is encouraged to make selections based on

recency, importance to the field, and/or relevance to the application

Resources and Facilities

Instructions added to Resources: Provide a description of how the scientific

environment will contribute to the probability of success of the project.

For Early Stage Investigators (ESIs), describe the institutional investment in the success of the investigator.

What Has Not Changed

You need to have a good idea about how to answer an important question

Reviewers need to be able to understand WHAT you want to do, WHY it is important, and can YOU do it?

You need to align YOUR goals with the funding agency goals, not vice versa.

Larson, G. The Complete Far Side. 2003.

A Strong ARA Letter – Awaiting Receipt of Application

Letter of intent – requests approval to submit application:

Title of grant Scientific impact Budget Cost reduction measures

Draft budget Abstract with specific aims

Submission Requirements

All applicant organizations must have a DUNS number.

http://www.grants.gov/applicants/org_step1.jsp All applicants must register with the federal

Central Contractor Registryhttp://www.grants.gov/applicants/org_step2.jsp Complete application instructions are at: http://www.grants.gov/CompleteApplication

Submission Requirements (continued)

All applications must be submitted electronically at grants.gov/apply

Use the FOA-specific application web site to apply. Obtain all application forms and instructions

Local sign-off forms Grant-making agency

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Typical Timeline for a New R01 Grant Application

–Submit in February (June, October)–Review in June (October, February)

–Council in September (January, May)–Earliest award in December (April, July)

Cycle 1--- Cycle 2--- Cycle 3---

There are three overlapping cycles per year:

Grants.gov Assistance

Applicant Contact Center Support available 24/7 Email: support@grants.gov Toll-Free Phone Number: 1-800-518-4726 Self-help iPortal: (http://grants.gov/iportal)

Additional Resources Animated Tutorials Brochures (Overview/Registration) (for applicants only) FAQs User Guides

For More Information:

NIH grants process:http://grants.nih.gov/grants/grants_process.htm

NIH grant eligibility:http://grants.nih.gov/grants/grant_basics.htm

New NIH Peer Review Systemhttp://enhancing-peer-review.nih.gov

Grants.gov help:http://grants.gov/agencies/grantors_help_resou.jsp

Thank You for Your Attention!

“You miss 100% of the shots you never take.”

Wayne Gretzky