The AUCD Council on Research and Evaluation (CORE) Presents:

Strategic Grant Writing: NIH Funding Mechanisms, Proposal Preparation & Review Process February 18, 2013 11:00am-12:00pm EST Recording will be available at www.aucd.org/webinars

Strategic Grant Writing: NIH Funding Mechanisms, Proposal

Preparation & Review Process

Judith S. Gordon, PhD Associate Professor

Associate Head for Research

Family & Community Medicine

Affiliated Faculty Sonoran UCEDD

Objectives

• Understand the process of strategic grant writing

• Learn which NIH institutes to target for disability-related research

• Describe the various NIH funding mechanisms

• Learn how to prepare the components of an NIH application

• Understand the NIH review process

Strategic Grant Writing

Funding Mechanism

Expertise/ Resources

Research Idea

Proposal

Planning for NIH Applications

• Review Institutes & Centers (IC) priorities and goals. Each IC has a research training and career development program.

• Identify the grant programs offered by each IC

• Make early contact with program officers

• Find innovative, well-respected mentors and collaborators

• Study successful grant applications- talk to your mentor

• Propose your best and most creative ideas

• Apply (After all, this is the only way to get a grant.)

National Institutes of Health • 27 Institutes and Centers (ICs)

with specific research agendas

• World’s largest source of funding for basic, biomedical, and behavioral research

• ~$31 Billion ▫ ~12% career and training

▫ ~53% for research projects

▫ ~35% on intramural projects

• Support >300,000 research personnel, and >3,000 universities and research institutions

Institutes to Target

DISABILITY RELATED

• NICHD (child and human development)

• NIMH (mental health)

• NICDC (deafness/communication)

ISSUE RELATED

• NIA (aging)

• NCCAM (alternative therapies)

• NIMHD (health disparities)

• OBSSR (health disparities)

• NCI (cancer)

• PARs and RFAs (e.g., dissemination and implementation)

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

Funding Mechanisms

• Career development (K Awards)

• Small Grants (R03)

• Developmental Grants (R21, R34)

• Research Grants (R01)

Career Development Awards

Overview

• Individual awards known as Ks

• Opportunities for basic and clinical investigators

• Mix of mentored and independent mechanisms

• Some designed as awards for faculty investigators

• Newer programs (K22 and K99/R00) are transition awards for MDs and PhDs

Review Criteria

1. Candidate

2. Career Development Plan; Career Goals & Objectives and Plan to Provide Mentoring

3. Research Plan

4. Mentor(s), Consultants(s) and Collaborator(s)

5. Environment and Institutional Commitment to the Candidate

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

K01 Mentored Research Scientist

Development Award

Overview

• Supports development experiences leading to research independence & training in a new field

• May also be awarded following a research hiatus (varies by IC).

• Some ICs use K01 for junior faculty development. Other ICs use K01s for other purposes.

• Opportunities for MDs and PhDs.

• Salary Cap varies by IC and fringe benefits (determined by your institution; generally at 28% level)

Benefits

Term: 3 to 5 years

Research Support: up to $50,000/year (varies by IC)

Facilities & Administrative Allowances = 8%

IC contacts and policies: http://grants2.nih.gov/grants/guide/pa-files/PA-10-056.html

K02 Independent Scientist Award

Overview

• Must have independent grant support as Principal Investigator, e.g. R01

• Most K02s go to PhDs.

• Salary cap varies by IC + fringe benefits for up to 5 years

• Relatively few applicants.

Benefits Salary support only Facilities &

Administrative Allowances = 8%

Recipient must give up salary support from all other NIH grants!

Small Grant Program (R03)

• Provides limited funding for a short period of time to support a variety of types of projects, including:

▫ Pilot or feasibility studies

▫ Collection of preliminary data

▫ Secondary analysis of existing data

▫ Small, self-contained research projects

▫ Development of new technology, etc.

• Limited to two years of funding

• Limited to new investigators

• Direct costs generally up to $50,000 per year

• Not renewable

• Used by more than ½ of NIH ICs

Exploratory/Developmental

Research (R21) • Encourages new, exploratory and developmental

research projects by providing support for the early stages of project development

• Sometimes used for pilot and feasibility studies • Preliminary data are not required but may be

included if available • Limited to up to two years of funding • Combined budget for direct costs for the two year

project period usually may not exceed $275,000 • No preliminary data is generally required • Most Institutes and Centers utilize the R21 program

Exploratory/Developmental

Research (R34) • Encourages new, exploratory and developmental

research projects by providing support for the early stages of project development

• Used solely for pilot and feasibility studies

• Limited to up to three years of funding

• Combined budget for direct costs are variable

• No preliminary data is generally required

• Few but growing number of ICs have R34s

Research Project Grant Program (R01)

• Supports a discrete, specified, circumscribed project in an area representing the investigator's specific interest and competencies

• Applications are generally awarded for 1 - 5 budget periods, each normally 12 months in duration

• Applications for an R01 award are not limited in dollars but most have a $500,000 per year cap

• Full IDC rates apply

• Applications can be renewed by competing for an additional project period

• Supplements and amendments are allowed

• Almost all ICs fund R01s

Definition of New Investigator

• A PD/PI who has not previously competed successfully for a significant NIH independent research award (e.g., R01), other than the following awards: ▫ Research Project Grants: R00, R03, R15, R21, R25, R90,

(RL9, RL5), R34, R36, (R41, R43), R55, R56, SC2, SC3

▫ All training Grants: T32, T34, T35, T90, D43

▫ All Fellowships: F awards

▫ Mentored Career Awards: All individual and institutional mentored K awards

▫ Loan repayment contracts: L30, L32, L40, L50, L60

▫ Instrumentation, Construction, Education, Health Disparity Endowment Grants, or Meeting Awards: G07, G08, G11, G13, G20, R13, S10, S15, S21, S22

Definition of Early Stage Investigator

• A PD/PI who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent)

• Can request an extension of the ESI Period

New and Early-Stage Investigators Increasing Time to Research Independence

Age at First R01 Equivalent Award from NIH, FY 1980-2009

Additional Resources

To learn more about NIH grants and training opportunities, visit

http://grants.nih.gov

Also, you may follow funding announcements at

http://twitter.com/nihforfunding

Applications Components

• Cover letter

• Project Narrative

• Abstract

• Specific Aims

• Research Strategy

• Literature Cited

• Human Subjects

• Appendices

• Biosketch

Cover Letter

• Application title • FOA # and title • Particular Study Section or study section

▫ Not all requests can be honored

• Reviewer conflicts with brief description • Reviewer expertise

▫ Do not name specific reviewers

• Approval from the agency: ▫ for a conference grant (R13 or U13) ▫ to submit over the $500K annual cap

Title, Project Narrative & Abstract

• Title and Narrative must convey scope of project and responsiveness to funding announcement

• Abstract

▫ 40 lines

▫ Clear, concise description of

Significance

Innovation

Approach IMPACT

Investigators

Environment

Specific Aims

• 1 page

• Compelling summary

• Project goals

• Specific hypotheses

Research Strategy

• 6 – 12 pages

• Significance ▫ Scope of problem

▫ Theoretical basis

▫ Gaps in science/health that this will fill

• Innovation ▫ Novel ideas & approaches

▫ Must advance science &/or health

Research Strategy

• Approach ▫ Design

▫ Methods

▫ Timeline

▫ Protocols & procedures

▫ Analyses

▫ Limitations

▫ Future directions

Biosketch

• 4 pages

• Personal statement

• Previous support

• 15 Publications

NIH Peer Review

• Partnership between NIH and the scientific community

• Per year: ~ 80,000 applications

~ 18,000 reviewers

• Standard mechanisms 2 – 3 cycles per year

Application Flow

• Center for Scientific Review

• Scientific Review Officer

• Manages all applications through scoring process

• Study Section

• Panel Members

• Review, score and recommendations

• Individual Agencies

• Program Officers

• Point of contact for scientific & administrative issues

Review Process

Prior to Meeting

▫ ≥ 3 reviewers are assigned to each application

▫ Read applications, prepare written critiques in templates, enter preliminary scores

▫ Read and consider critiques and preliminary scores from other Study Section members

▫ Streamline 50% of applications (ND)

At Study Section

▫ Discuss each application

▫ Members score after its discussion

Guidelines & Templates for Reviewers: http://grants.nih.gov/grants/peer/reviewer_guidelines.htm

Scored Review Criteria

• Individual, numerical scores for:

– Significance - Approach

– Investigator(s) - Environment

– Innovation

“Review Criteria at a Glance” (http://grants.nih.gov/grants/peer/reviewer_guidelines.htm)

Impact Score Descriptor

High Impact

1 Exceptional

2 Outstanding

3 Excellent

Moderate

Impact

4 Very Good

5 Good

6 Satisfactory

Low Impact

7 Fair

8 Marginal

9 Poor

NIH Scoring System

• Final impact scores

– Average of all votes multiplied by 10

– Range from 10 (exceptional) through 90 (poor)

– Percentiles for some

mechanisms

After the Review

• Receive a written summary statement

• If the outcome is not fundable:

• Consider scores, comments, talk to PO

• If concerns are addressable, revise and resubmit your application

• If not, consider major revision with different aims, different mechanism, etc.

• If the outcome is fundable, congratulations!

Additional Information

• Enhancing Peer Review Initiative http://enhancing-peer-review.nih.gov/

• Office of Extramural Research Peer Review

Process http://grants.nih.gov/grants/peer_review_process.htm

• Peer Review Policies & Practices

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

• Center for Scientific Review

http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/

Thank you!