National Institute of Health (NIH) Funding Funding Presented by: - - PowerPoint PPT Presentation

National Institute of Health (NIH) Funding Funding

Presented by: Samantha J. Taylor Senior Research Officer Wyss Institute for Biologically Inspired Engineering, Harvard University

• What is NIH’s primary mission?

– To improve the health of the Nation

• How is that mission accomplished?

– By supporting and conducting research

• How do they support extramural Research?

– By issuing grants and contracts

• How do you apply for grants?

– Grants.gov or paper applications (this is rare)

• Who is involved in the application process and what

are their roles?

– Applicant and NIH staff

What’s the Difference Between Grants and Contracts?

$ $ $ $ $ $

GRANT CONTRACT

• Assistance
• Acquisition
• Government is Patron or

Partner

• Government is Purchaser

$ $ $ $ $ $ $ $

• Purpose: support and

stimulate research

• Purpose: acquire goods
• r services
• Benefit a public purpose
• Benefit and use of the

government

• Investigator initiated
• Government initiated

Grants, First steps! ERA Commons USER name!

(Club Membership)

You Need the Goods!

• Good Idea
• Good Timing
• Good Presentation
• Good Reviewers
• Good Grantsmanship

Good Grantsmanship

• Knowing and Understanding: Who, what,

when, where, how.

• Willingness: Requires approximately 22 hours
• Willingness: Requires approximately 22 hours

to collate a grant (not including the science).

• Commitment: On the part of the PI first & his

team to get it done. (We can do it!)

Funding Opportunity Announcements (FOA) published through

NIH Guide (http://grants.nih.gov/grants/guide/) Grants.gov

Type of FOA General Description Parent Announcements

Investigator initiated for basic mechanisms

Program Announcements

highlights areas of focus – ideal institutional use of funds

Requests for Applications (RFA)

a one-time call with set-aside funds

What should I apply for?

• R01 – Too difficult!
• R03 – Too much work,

not enough funding!

• R21 – They’re saying

no!

• R01 – Time &Innovation
• R03 – Start somewhere!
• R21 – They never say

‘no’ when they’re excited! no! excited!

Developing the Application: NIH Interests

NIH Institute Program Priorities

– Search RePORTER to learn what research is supported

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

– Search Institute Web Sites

• www.nih.gov/icd/

– Contact Institute Staff

• http://ned.nih.gov/

– Identify Relevant RFA or PA in NIH Guide

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

WHO: Finding Your Way at NIH

National Institute

• n Alcohol Abuse

and Alcoholism National Institute

• f Arthritis and

Musculoskeletal and Skin Diseases National Cancer Institute National Institute

• n Aging

National Institute

• f Child Health

and Human Development National Institute

• f Allergy and

Infectious Diseases National Institute

• f Diabetes and

Digestive and Kidney Diseases National Institute

• f Dental and

Craniofacial Research National Institute

• n Drug Abuse

National Institute

• f Environmental

Health Sciences National Institute on Deafness and Other Communication Disorders National Eye Institute

Office of the Director

Kidney Diseases Research Health Sciences Disorders National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute

• f Mental Health

National Institute

• f Neurological

Disorders and Stroke National Institute

• f General

Medical Sciences National Institute

• f Nursing Research

National Library

• f Medicine

National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Institute

• f Biomedical

Imaging and Bioengineering

No funding authority

NIH Clinical Center Center for Information Technology Center for Scientific Review National Center on Minority Health and Health Disparities

NIH Research Programs

Institutes and Centers

• Divisions
• Divisions
• Branches
• Programs

Where do I find a guide?

Getting Started:

Contact a Program Official

Why? They can direct you to:

The appropriate Institute

• 24 institutes have granting authority

The appropriate Division/Office

• Basic, clinical, behavioral, translational

The appropriate Program Official

• Extramural research portfolio

Program Official Program Official

Officials you Should You

Scientific Review Officer Scientific Review Officer Grants Specialist Grants Specialist

Program Official [aka Program Director or Project Officer]

Responsible for the Responsible for the programmatic, scientific, and technical aspects of a grant

Who/What is a Program Official?

The Program Official is both: a Scientist and an Administrator

Responsibilities of the Program Official

• Manages scientific research portfolio of grants,

contracts, and cooperative agreements

• Identifies opportunities and needs of science

specific to an Institute’s mission specific to an Institute’s mission

• Stimulates interest in scientific areas of emphasis

for each Institute

• Communicates program priorities
• Program Announcements (PA)
• Request for Applications (RFA)

Responsibilities of the Program Official

• Provides technical assistance to applicants
• Observes scientific review meetings
• Discusses review issues with applicant
• Discusses review issues with applicant
• Evaluates the programmatic merit and mission

relevance of applications

• Prepares funding recommendations
• Reviews annual research progress of grantees
• Reports on scientific progress and program

accomplishments

Program Official

Principal liaison between investigators and the NIH

Your most important contact Call them early … Contact them often!

Must I contact NIH before applying?

Yes …under certain circumstances it is MANDATORY

• Applications with budgets >$500,000 (direct

cost) for any single year cost) for any single year

– IC must agree to accept the application – Request must be six weeks before receipt date – NIH Guide NOT-OD-02-004 (10/16/2001)

• R13 Conference Grant Applications

– IC must agree to accept the application

Must I contact NIH before applying?

Usually, it’s just a smart idea

• When RFA’s request Letter of Intent
• If you have questions about grant mechanisms or

budget limitations or eligibility or ... budget limitations or eligibility or ...

• When you are considering applying for any grant
• whether you are a new or experienced investigator -

contact with program staff is always highly recommended Prior contact with a program official will always save you time!

Contact before submission has benefits Two more important reasons:

• Develop a relationship with a potential

program official

• Assure that your application has a home

(appropriate Institute)

Your Program Official Can Help ...

During Application Development and Preparation

During Scientific Review After Peer Review After the Grant Award

Developing the Application: Your Idea

Your Research Needs and Interests

– My research interests focus on the link – My research interests focus on the link between A & B – My need is for additional research training or career development

Develop Your Application: For NIH

A Program Official can discuss Your ideas

• Match your scientific interests with the
• Match your scientific interests with the

mission and focus of NIH Institutes

NIH ideas

• Research initiatives and priorities already

established by ICs

Organize your thoughts for productive discussion with a Program Official

• Grant Purpose Briefly, you want a grant from which institute/agency to do

what?

• Problem/Background Explain why you to think this topic needs study.

Demonstrate you know the institute priorities….or ask!

• Significance Explain why this is important to the field.
• Question What hypotheses will you test and what model will guide your
• Question What hypotheses will you test and what model will guide your

hypotheses?

• Design/Analysis What is the study design that will enable testing your

hypotheses? What statistical approach?

• Team Who will be the key participants (co-investigators and organizations)
• n the project?
• Miscellaneous Other issues that may be relevant to your plans

Remember …

… the INSTITUTE DIRECTOR makes the … the INSTITUTE DIRECTOR makes the final funding decisions But…

Program Officials ...

Give advice and encouragement! The cape, Larry! Go for the cape!

Writing a Grant Application

• Research plan answers 4 essential questions

– What do you intend to do? – Why is the work important? – What has already been done? – What has already been done? – How are you going to do the work?

• Successful applications typically are:

– Well-focused and explicitly written – Not overly ambitious – Understandable by a naïve reader

Time to write!!!

• Cover Letter
• Science
• CV (Biosketch)

Personnel

• Personnel
• Budget (Along with your administrator)
• Subcontracts
• Resources (Institutional)
• Letters of Support

The NIH Peer Review Process – Cover Letter

Cover letter of application

– Application title – FOA # and title – Request: – Assignment to particular SRG or study section – Assignment to particular IC for funding consideration – Assignment to particular IC for funding consideration – Disciplines involved, if multidisciplinary – Explanation for late application Typically written last SRG rosters are posted 30 days before the SRG meeting:

http://era.nih.gov/roster/index.cfm http://www.csr.nih.gov/committees/rosterindex.asp

The NIH Peer Review Process - Science Scored Review Criteria

• Significance
• Investigator(s)
• Innovation
• Approach
• Environment
• Environment
• (FOA-specific criteria)

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

The NIH Peer Review Process - Science Scored Review Criteria

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability,

Significance

will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

The NIH Peer Review Process – Science Scored Review Criteria

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators,

• r in the early stages of independent careers, do

they have appropriate experience and training?

Investigator(s)

If established, have they demonstrated an

• ngoing record of accomplishments that have

advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

The NIH Peer Review Process – Science Scored Review Criteria

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies,

Innovation

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field

• f research or novel in a broad sense?

Is a refinement, improvement, or new application

• f theoretical concepts, approaches or

methodologies, instrumentation, or interventions proposed?

The NIH Peer Review Process - Science Scored Review Criteria

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?

Approach

and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

The NIH Peer Review Process – Science Scored Review Criteria

Approach

If the project involves clinical research, are the plans for: 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of

Approach

sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

The NIH Peer Review Process - Science Scored Review Criteria

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and

• ther physical resources available to the

Environment

• ther physical resources available to the

investigators adequate for the project proposed? Will the project benefit from unique features

• f the scientific environment, subject

populations, or collaborative arrangements?

The NIH Peer Review Process - Science Additional Review Criteria

As applicable for the

• FOA-specific criteria
• Protections for Human Subjects
• Inclusion of Women, Minorities,

and Children

• Vertebrate Animals
• Resubmission Applications

As applicable for the project proposed, reviewers:

• Consider in

determining scientific and technical merit

• Do not give separate

scores for these items.

• Resubmission Applications
• Renewal Applications
• Revision Applications
• Biohazards

The NIH Peer Review Process - Other Additional Review Considerations

• As applicable for the
• FOA-specific considerations
• Select Agent Research
• Applications from Foreign

Organizations

• Resource Sharing Plans
• Budget and Period Support
• As applicable for the

project proposed, reviewers:

• Address each item
• Do not give scores

for these items

• Should not consider them

in providing an overall impact/priority score…but!!!!

• Budget and Period Support

The NIH Peer Review Process SRG Meeting Procedures

• If 60 applications/SRG meeting

~ 50% streamlined, 30 applications to discuss and score

• If 9 hour SRG meeting
• Leaves

~ 14 minutes on average/application ~ 3 - 4 minutes/reviewer ~ ½ hour introduction, streamlining ~ 1 hour lunch, 2 x 15 minute breaks

Clarity and brevity are essential!

New Investigator Definition New Investigator: A Program Director or Principal Investigator (PD/PI) is considered a New Investigator if he/she has not previously competed successfully as a PD/PI for a previously competed successfully as a PD/PI for a “significant independent” NIH research grant (like an R01).

New Investigator Definition

Significant independent NIH research grant: Any NIH research project grant

• ther than the following small or early stage research grants:

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) Small Business Technology Transfer Grant-Phase I (R41) Small Business Innovation Research Grant-Phase I (R43) Shannon Award (R55) NIH High Priority, Short-Term Project Award (R56) Competitive Research Pilot Projects (SC2, SC3)

Additionally, the PD/PI is not excluded from consideration as a “New Investigator” if he/she has been the PD/PI of, or received an award from, any of the following classes he/she has been the PD/PI of, or received an award from, any of the following classes

• f awards:

Training-Related and Mentored Career Awards All Fellowships (F awards) All individual and institutional career awards (K awards) 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 S10, S15, S21, S22 R13

Note regarding grants with Multiple PD/PIs: In the case of a grant application that involves more than one PI, all PD/PIs must meet the definition of New Investigator to check “Yes” in the “New Investigator” box

Early Stage Investigators

NIH created a new ‘Early Stage Investigator’ (ESI) category designed to accelerate the early transition of new scientists to research independence by receiving their first R01 earlier.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html

A Program Director/Principal Investigator 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).

• The NIH modified the collection of information on degree dates and

medical residency within the personal profile of the eRA Commons.

• PD/PIs must update their personal profile in the eRA Commons in order

to be considered for the ESI classification. Investigators who enter degree and residency completion dates will be notified of their ESI status by email.

Implementation of ESI definition

by email.

• A procedure and guidelines for requesting an extension of the period of

ESI eligibility is in place to accommodate individuals with various medical concerns, disability, pressing family care responsibilities, or active duty military service (instructions in Commons).

• Applications from ESIs and New Investigators are identified to reviewers

so that appropriate consideration of their career stage can be applied during review.

• Applications from ESIs and New Investigators are “clustered” during

review to enable evaluation as a group and distinguish from Established Investigators.

• An application with more than one Principal Investigator is identified for

consideration of ESI/NI by reviewers only if ALL of the listed Principal Investigators qualify as New Investigators.

Implementation of ESI definition (cont’d)

consideration of ESI/NI by reviewers only if ALL of the listed Principal Investigators qualify as New Investigators.

• Staff in the NIH institutes and centers are apprised of ESI and New

Investigator status and this factor is considered when applications are selected for award.

• New Investigators are eligible for the “Full Implementation to Shorten

the Review Cycle for New Investigator R01 Applications Reviewed in Center for Scientific Review (CSR) Recurring Study Sections”.

(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html )

NIH New Investigators

FY 2006

R01-Equivalent awards include R01, R23, R29, and R37 grants.

NIH New Investigator Results

FY 2009 FY 2006

R01-Equivalent awards include R01, R23, R29, and R37 grants.

Receipt and Referral of Applications

CSR Referral Office assigns the to an NIH Institute (IC) a unique identifier (application number) Electronic SF424 R&R submitted through grants.gov to Integrated Review Group (IRG) and then a study section (SRG) Office assigns the application… (application number)

Application assessed for completeness & eligibility Notice of assignment available in eRA Commons in 4 weeks.

Review System for Grants

Advisory Council

• assess quality of SRG process

Scientific Review Group (SRG)

• Independent outside review
• Evaluate scientific merit, significance
• Recommend length and level of funding

Output: Priority Score and Summary Statement

3 - 7 months

1st level 2nd level

• assess quality of SRG process
• ffers recommendation to Institute Staff
• evaluates program priorities and relevance
• advises on policy

Output: Funding Recommendations

Institute Director

• makes final decision based on Council

input, programmatic priorities

• Must also Pass Administrative Review

Output: Awards

• r Resubmission

1 - 3 months

Review

• Who Reviews Grant applications?

– Scientist peers with appropriate expertise -- recruited by the Scientific Review Officer – Assigned to specific applications based on content content – 4 year term typical – Temporary reviewers sought as needed

• 12-24 members: scientist peers
• 3 face-to-face meetings per year,

and a 4 year term of service.

Standing study sections typically have

1st Level Review

and a 4 year term of service.

• 60 – 100 applications to review at

each meeting

After 1st Level Review

• Priority Scores recorded
• Summary Statements prepared

– Overall Resume and Summary of Review Discussion – Essentially Unedited Critiques – Priority Score and Percentile Ranking – Budget Recommendations – Budget Recommendations – Administrative Notes

• Viewable 4-6 weeks after review meeting

– Only available through the eRA Commons

2nd Level Review

• National Advisory Council or Board assesses

quality of 1st level review

– Concurs with or modifies IRG recommended action action – Reads summary statements only

• Can also designate application as “High” or

“Low” program priority

Funding Decisions

• The Institute Director has the final funding

decision.

• Factors Considered in Funding Selections:

– Scientific Merit – Contribution to Institute Mission – Program Balance – Availability of Funds

Timeline: New Applications

Scientific Review Council Review Award Date Receipt Date

1.3 1.9 1.6

• –
• Review

July October March Review October January May Date December April July Date February 5 June 5 October 5

http://grants.nih.gov/grants/funding/submissionschedule.htm

• Write A Clear Introduction Section
• Address All Criticisms Thoroughly
• Respond Constructively

Revise and Resubmit

• Respond Constructively
• Acknowledge and Accept the Help of

Reviewer Comments

• Don’t Be Argumentative !
• Don’t be Abrasive or Sarcastic !

Revise and Resubmit

Prepare a REVISION COVER LETTER

• For Revisions, Indicate Review History
• Request Same or Different Study Section
• Request Same or Different Study Section
• Provide Justification for your request
• Don’t be Argumentative ! Never!
• Don’t be Abrasive ! Never!

Questions?

Thank you for attending… All the best with your applications! Samantha.taylor@wyss.harvard.edu