Transitioning to Independence: Tips for Writing NIH Career (K) Award Applications

Transitioning to independence: Tips For Writing NIH Career (K) award applications

Brenda Fredericksen, PhDScientific Review Officer

NIAID, [email protected]

240-669-5052

1. Various award mechanisms available to junior investigators

2. The review process

3. Review criteria for R series and K series award applications• Common problems• New review criteria regarding rigor and transparency

Preparing an Application: Overview

• Submit via your organizational representative

• Use eRA Commons to track application

Identify a FOA that fits your career stage and research

your research interests

• Read the FOA

• Follow Application Instructions

Prepare ApplicationSubmit, Track & View

Application

Develop research topic

• Needs to align with an IC mission.

• Should be of high impact.

Find Opportunities

•Talk to your mentor and other NIH funded researchers.•Talk with NIH staff about your idea and where it fits.•Use NIH’s Research Portfolio Online Report Tool (RePORT). http://RePORT.nih.gov/

Developing research ideas

• Organizational funding information• NIH staff contacts• Success rates• Award trends• Which ICs fund research like yours• Projects similar to yours• NIH-funded workforce data• Potential collaborators• NIH grantees in your area

Career Stages of Funding Programs

Type of FOA Description

Program Announcements (PA) examples: PAR, PAS

• Identifies areas of increased priority and/or emphasis on particular funding mechanisms for a specific area of science.

• Usually ongoing (3 yrs)• Often use standard receipt dates

Parent Announcements • Type of program announcement• Generally span the breadth of NIH mission• By activity code (R01, R03, K awards, etc.)• For “investigator initiated” or “unsolicited” research

ideas• Eligibility criteria explained in the FOA

Requests for Applications (RFA)

• Narrowly defined scope• Usually single receipt date • Set aside funds• IC usually convenes review panel

Funding Opportunity Announcements (FOAs) Are Used to Fund Extramural Research

Where to find FOAs

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• Grants.gov (Home | GRANTS.GOV)• NIH Guide for Grants and Contracts website:

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

http://www.niaid.nih.gov/researchfunding/newsletter/pages/subscribe.aspx

Decide which K mechanism is best for you: NIAID Career Development Awards (K) or NIH K Kiosk.

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Ph.D./M.D.

Research training Phase

K25

K01-Research Scientist Development Award: Research or health-professional doctoral degree. Development plans must be in epidemiology, modeling techniques, and outcomes research.

NIAID Career Awards-Support by Career Stage

K25

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NIAID Career Awards-Support by Career Stage

PH.D./M.D.

Research training Phase

K25

K08-Mentored Clinical Scientist Research: Clinical doctoral degree (M.D., D.V.M.,O.D, PharmD), professional license to practice in the United States, and current work in biomedical or behavioral research.

K23-Mentored Patient-Oriented Research Career Development Award: Clinical doctorate, completed specialty or subspecialty training and the research requires direct interaction with patients.

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K25 Mentored Quantitative Research Development Award: Candidate must have an advanced degree in engineering or quantitative science, such as Ph.D. or M.S.E.E.

Ph.D./M.D.

Research training Phase

K25K25

NIAID Career Awards-Support by Career Stage

K22-NIAID Career Transition Award: Postdoctoral scientist with no more than five years with plans to apply for an assistant professorship at an academic institution. (non-mentored).

K99/R00-NIH Pathway to Independence Award: Clinical or research doctorate and no more than four years of postdoctoral research. (NIAID supports 2+2)

K99/R00 Pathway to IndependencePA-16-193: http://grants.nih.gov/grants/guide/pa-files/PA-16-193.html

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Eligibility• No more than 4 years of total aggregate postdoctoral experience at

the time of submission. • Physician-scientists: Time spent in clinical training during

residency or clinical specialty is not counted towards K99/R00 eligibility

• No prior or current Career Development (K) awards or NIH research grant (R01, R03 or R21).

• No current or previous position as an independent research faculty. Clinical faculty member who does not hold an independent research faculty position is eligible for the K99/R00 award

• Non-citizens with appropriate visa may apply

•NIAID limits the budget to 4 years of support: Mentored phase (2 years) + Independent phase (2 years).

K22 Career Transition AwardPAR-14-341: http://grants.nih.gov/grants/guide/pa-files/PAR-14-341.html

• Not a mentored award.• Postdoctoral fellow to PI transition.• Goal: obtain & begin Asst. Prof position• Eligibility

• No more than 5 years of related postdoctoral experience. • No prior or current Career Development (K) awards, R01 or

equivalent funding.• No current or prior position as an independent research

faculty.

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Shawn Gaillard, Ph.D.Research Training Officer

Office of Research Training and Special ProgramsNational Institute of Allergy and Infectious Diseases, NIH

5601 Fishers Lane, Rm 4F-30Rockville, MD 20892-9823

Email: [email protected]

Office of Research Training and Special Programs

https://www.niaid.nih.gov/researchfunding/traincareer/pages/career.aspx

Review Process for a Research Grant

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Performs the Research

Institution

Submits Application

Allocates Funds

Center for Scientific Review (CSR)

CSR

Evaluates for Scientific Merit (1st

level)

Advisory Councils & Board

Recommends Action (2nd level)

Institute DirectorMakes Funding

Decision

Grants.gov

eRA Commons

Division of Receipt and Referral Assigns for review

Institute (IC)

Principal Investigator

(PI)

3 Overlapping Funding Cycles Per YearFunding

CycleReceiptDates

ReviewMeetings

AdvisoryCouncil

PotentialStart Date

Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec1

Jan Feb Mar AprMay June July Aug Sept Oct Nov Dec2

Jan Feb Mar Apr May June July AugSept Oct Nov Dec3Stan

dard

revi

ew c

ycle

Except for K99/R00: Receipt Dates and Review schedule apply. Funding decisions are made once a year at May/June council.

AIDS

/HIV

revi

ew c

ycle

FundingCycle

ReceiptDates

ReviewMeetings

AdvisoryCouncil

PotentialStart Date

May June July Aug Sept Oct Nov1

2

3

Jan Feb MarSept Oct Nov Dec

Jan Feb Mar Apr May June July

On-time Submission

• Important reminders:• NIH recommends submitting early (days, not minutes!) to allow

time for correcting any errors found during the application viewing window prior to the due date.

• NIH’s late policy does not allow corrections after the due date.• All registrations must be completed before the due date.

Error-free applications must be accepted by Grants.gov with a time stamp on or before 5:00 p.m. local time of the submitting organization on the due date

15NOT-OD-15-039: Simplifying the NIH Policy for Late Application Submission:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-039.html

The NIH-specific Scoring System• Reviewers give numerical scores for:

Overall impact score Individual criterion scores

Overall impact Career development (K) awards: Likelihood for the candidate to maintain a strong research program.

Evaluation Criteria (Ks)5 Scored Review Criteria: (Considered in the Impact score) Candidate Career Development Plan/Plan to Provide Mentoring Research Plan Mentors, Co-Mentors, Consultants, Collaborators Environment and Institutional Commitment to the Candidate

Additional Review Criteria: (Considered in the Impact Score) Animal Welfare, Human Subjects Protections, Biohazards,

Resubmission (A1), and Renewal (K24)

Additional Review Considerations: (Does not affect impact score) Authentication of Key Resources, Training in the

Responsible Conduct of Research, Budget, Select Agents, Resource Sharing

Candidate’s Background• Research record/Productivity:

• Publications: Recently accepted manuscripts are acceptable post-submission material. - See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-030.html#sthash.RSibaCYn.dpuf(http://grants.nih.gov/grants/funding/post_submission_faq.htm). Must be submitted with concurrence from the Authorized Organization Representative (AOR) of the applicant organization.

• Awards• Fellowships

• Clear commitment to independent research career

• Letters of Reference

Reference Letters• Submitted directly by the referees.• Allow adequate time for the referees to put together

a well-tailored reference letter.• Minimum: 3 letters of reference; 5 maximum.• Individual directly involved in the research project

can not provide a letter of reference.

Referees• Must be received by the application submission

deadline.• Make sure to attach the correct letter.

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Career Development Plan and Career Goals and Objectives

•Be specific; individualize your plan.•Align career development goals with research plan.

•Understand your strengths and deficiencies.• Justify areas of training needed.•Provide a specific timeline and pathway for independence (R01 submission/goals).

• Involve your mentor. Plan for evaluation of progress (with mentors).

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Research Plan• Strong significance to an important problem in public

health: IMPACT is high• High degree of novelty and innovation

• Clear goals and approaches• Feasibility• Innovation • Independent from Mentor’s research• Timeline• Pitfalls and alternative strategies• Long term scope and plans for an independent

R0121

Common Problems in Research Plans• Lack of new or original ideas• Absence of an acceptable scientific rationale• Lack of experience in the essential methodology• Questionable reasoning in experimental approach• Diffuse, superficial, or unfocused research plan• Over ambitious research plan• Lack of sufficient experimental detail• Lack of knowledge of published relevant work• Uncertainty concerning future directions• Grantsmanship

GET INPUT FROM NIH FUNDED INVESTIGATORS

Statements of Support

•Mentor(s):•Mentor’s research expertise.•Research support.•Mentor’s training record.•Clear plan for meeting with mentees, evaluation.

*K22 applications require a statement of support from the current mentor.

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Letters of Support

Collaborators:Include letters from collaborator(s) outlining their specific role in the project.

Institutional Environment/Commitment

• Institutional environment:•List relevant research resources/logistics.•Opportunities for collaboration and training.

• Institutional commitment (one page) •Commitment to candidate and his/her independent research career.

•Research support: space, equipment, technician, supplementary funds for research.

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K22 Specific IssuesCareer Development plan:

• Describes plan for transition to independent investigator.• Includes lab management, teaching, research skills, etc.

Research Strategy:• How to gain independence from postdoctoral advisor and

achieve separation of the research program.

Statement of support from current mentor• Required attachment that allows the current postdoctoral

advisor to provide information about their respective future role and support to the candidate during the early phase as an independent investigator.

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Review Questions Regarding Rigor and Transparency

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Research plan

• Is there a strong scientific premise for the project?

• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the propose work?

• Has the candidate presented adequate plans to address relevant biological variable, such as sex, for studies in vertebrate animals or human subjects?

Examples of Scientific Premise•Fundamental scientific principles or related work

•Existing literature or prior work in the field

•Broad gaps in the field that the research will fill

•Research to be supported or facilitated

•Needs to be addressed

Examples of Scientific Rigor• Statistical procedures to determine appropriate group

sizes, numbers of animals, etc.• Plans for data analysis• Methods to reduce bias• Procedures to ensure independent, blinded

measurements• Procedures to improve precision and minimize

variability• Criteria for subject inclusion or exclusion• Addressing loss of experimental units or observations

• Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

• The expectation is to study both sexes; strong scientific justification needed to use a single sex.

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Examples include:• Sex • Age• Source• Weight• Genetic strain

Relevant Biological VariablesApproach – Review Questions

Authentication of Key Biological and/or Chemical Resources

•Reviewers should comment on the plans presented for authenticating key resources.

• In many cases, standards do not exist now.• Data is not expected in the resource authentication plan.

Examples:Cell linesSpecialty chemicalsAntibodiesBiologicsNot standard laboratory reagents

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html& Award Process

Training RCR:

• Plan to develop scholarly understanding of ethical issues of individual’s research

• Must have Acceptable plan. Unacceptable means bar to funding

• 5 parts:• Format: face-to-face• Subject matter: comprehensive• Faculty participation: formal & informal• Duration: 8+ hours• Frequency: once every 4 years

General tips• Start early

• Involve your mentor(s).• Discuss your research idea with your Program Officer.• Have NIH-funded colleagues read the application.

• Read Program Announcements• Pay particular attention to eligibility requirements and

submission guidelines.

• Grantsmanship• Submit early

• check for errors and completeness, • contact eRA/Commons help desk right away if there are

problems with submission.34

After the Review

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Check eRA Commons (next slide) (http://era.nih.gov/commons/index.cfm)

• Final Impact Score are available within 3 days after the review meeting

• Summary statement available within 4 – 8 weeks to:– PD/PI – NIH Officials – Advisory Council members – NIH Program Officer (Point of Contact)

Summary statement example

Summary Statement (I)

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• First page– NIH Program Officer (upper left corner)

– This is your point of contact to discuss the outcome of the review meeting

– Final Impact Score or other designation– Percentile (if applicable)– Codes (human subjects, vertebrate animals, inclusion) 44 = bar to funding 10 = no human subjects or vertebrate animals 30 = involves human subjects or vertebrate animals

but the SRG had no concerns – Budget request

•

Summary Statement (II)

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• Subsequent Pages– Resumé and Summary of Discussion (Discussed

applications only)– Description (provided by applicant)– Reviewer critiques Administrative Notes– Meeting roster

Program Officials’ Role:Funding Decisions

•At and After Review Meeting•Note reviewer enthusiasms and concerns•Discuss Summary Statements with applicants•Advise on resubmission process

•At Advisory Council•Report and address any unresolved review concerns•Address requirements for foreign applications

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After Peer Review

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If the applications is funded, congratulations! May need to resolve 44 codes May need to submit Just-in-time information

Not Funded. Now What?

Regroup• Take a deep breath• Read summary statement• Read it again• Talk with your NIH program official• Evaluate your options

• Revise & submit again?• Choose a new research direction?• Appeal the review outcome

• Acceptable reasons (NOT-OD-11-064):http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html

• Differences of scientific opinion cannot be appealed

There is no amount of Grantsmanship that will turn a bad idea into a good one . . . .

. . . but there are many ways to disguise a good idea.

Dr. William RaubPast Deputy Director, NIH

Grantsmanship

NIH Policy on Post-Submission Application Materials:https://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-030.html

Use NIH’s Research Portfolio Online Report Tool (RePORT). http://RePORT.nih.gov/

NIAID Training and Careerhttps://www.niaid.nih.gov/researchfunding/traincareer/Pages/default.aspx

March 9, 2016 NIAID Funding NewsPostdocs' Guide to Gaining Independence: Writing a Strong Grant Application

Grants.Gov>About Grants> How to Apply-Application Guide: http://grants.nih.gov/grants/funding/424/index.htm

Helpful links

Contact informationBrenda Fredericksen

[email protected]