Writing an Effective �K Application

P. Kay Lund, PhD kay.lund@nih.gov

Division of Biomedical Research Workforce

Office of the Director

National Institutes of Health

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NIH includes 27 �Institutes and Centers

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FY 2018 NIH Operating Budget: $36,388,000

NIH Budget Office: http://officeofbudget.od.nih.gov/index.htm

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Postdoctoral and Early �Research Career Training

R00

Established Investigator

Early Research Career

Postdoctoral Training/�Clinical Residency

K01, K07, K25

K99

Graduate/�Clinical�Training

K08, K23

• K25 is currently to support career development of

investigators with quantitative/engineering

backgrounds in biomedical research

• New K25 to provide biomedical researchers

with quantitative skills is under discussion

Diversity Supplements: PA-20-222 

Loan Repayment Programs

https://www.lrp.nih.gov/

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NIH Research Training Website

• Launched in 2015,one stop for funding opportunities
• Useful resource for trainees, postdocs, potential K award applicants and early stage faculty

https://researchtraining.nih.gov

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Career (K) Kiosk

Active FOAs (Parent & IC specific) can be found at: https://researchtraining.nih.gov/programs/

career-development

At that website click on each

K award type to view active FOAs

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Pathway to Independence Award

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October 27, 2020

Supports protected time (75%) in 2 distinct phases:

K99/R00: Goal to facilitate transition from a mentored postdoctoral research position to an independent research position with independent NIH research support at an earlier stage than the current norm

K99 – Phase 1- 2 years

• Mentored: must be affiliated with an institution
• Within 4 years of attaining PhD or completing clinical training
• 2007 awardees: 94.7% transition to R00; 2014 awardees 87.6% transition to R00.

R00 – Phase 2 (3 years)

• Independent (tenure-track or equivalent),own lab limited teaching and/or clinical responsibilities to assist pathway to next independent award.
• ‘Quality’ of tenure-track offer administratively reviewed by NIH staff before R00 awarded

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No U.S. citizenship requirement for applicants to the parent K99 (PA-20-187; PA-20-188; PA-20-189)

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NIAID Physician Scientist K99-R00: PAR-20-209; PAR-20-210; NOT-AI-19-034; Requires 50% effort; no U.S. citizenship requirement

NIDCR Dual Degree Dentist Scientist K99-R00 (PAR-18-432; PAR-19-144; PAR-19-141) no U.S. citizenship requirement.

Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative K99-R00 to promote diversity (RFA-NS-19-043  RFA-NS-19-044) requires citizenship/permanent resident status.

Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity K99-R00 requires citizenship/permanent resident status; first due date February 12^th 2020 (PAR-19-343); Institutional UE5 Co-operative Agreement due date November 15^th 2019 (PAR-19-342) provides courses for skills development & mentoring.

Due to COVID two cycle extension of eligibility announced for Parent K99 NOT-OD-20-158; NIDCR K99 NOT-DE-20-031; Mosaic K99 NOT-GM-20-051

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K01, K08 and K23 FOAs with different requirements

Require PD/PI to conduct an independent clinical trial

• PA-20-176 (K01;14 IC)
• PA-20-202 (K08;15 IC)
• PA-20-206 (K23;17 IC)

K applicant/awardee has primary or lead responsibility for conducting & executing the trial (Funding is from the K award & may be an ancillary or feasibility study)

Permit clinical trial research experience but will NOT permit an independent clinical trial

• PA-20-190 (K01;16 IC)
• PA-20-203 (K08; 20 IC)
• PA-20-205 (K23; 19 IC)

K applicant/awardee may propose research experience in a clinical trial led by the K award mentor or co-mentor.

Funding Opportunity Announcements (FOAs) for K Awards will :

Permit Basic Experimental Studies with Humans (BESH)

• PA-20-191 (K01; 9 IC)
• PA-20-201 (K08; 13 IC)
• PA-20-204 (K23; 12 IC)

K applicant/awardee may propose basic science experimental studies involving humans which can be “prospective basic science studies involving human participants.”

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Timeline for K Applications

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Writing an Effective K Application

Start Early

Develop a Strategy

Plan Your Application

Application Requirements

Review Criteria

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Start Early

• Start at least 6 months prior to the application due date (or begin planning even sooner)
• Get an NIH Commons account at least a month before the application deadline
• New Requirement for ORCID ID for K award applicants effective with receipt dates after January 25^th 2020
• Know your organization's Authorized Organizational Representative (AOR) to assist with the application
• Notify your referees early and give them plenty of time to submit letters of reference (ensure they know you, have your current CV & if possible, aims of grant)

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Develop a Strategy

• Assess your career situation and needs. Is there added value to a K award? Why not another funding mechanism?
• Check which NIH Institute or Center (IC) funds K awards in your research area
• Schedule a phone call with an NIH Program Officer to discuss & confirm that your research area, training needs & career development plans fit with the IC.
• Assess the field & the competition. See what is being funded by NIH: Research Portfolio Online Reporting Tools (RePORT: https://report.nih.gov)

• Identify mentor(s) and collaborators
• Discuss with them your plans, project & career development needs early to be sure they are on board
• Consider your strengths & areas for growth
• Can you fill any gaps & gain essential experiences with proposed mentor, collaborators or consultants?
• Identify essential resources & support needed & consider if this is available within your organization – or must be obtained elsewhere

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Plan Your Application

• Coordinate with your mentor(s) – a K application is a collaboration between you & your mentor(s)
• Put together a review committee to assist planning & provide critical feedback
• Draft a short description of your specific aims �& discuss these with the committee – chalk talk, diagrams, central hypotheses, scope
• Do not write the entire grant before input received on aims
• Be sure the project is distinct from your mentor’s research (although can be related) & that the mentor is supportive of future independence

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Don’t Propose Too Much

• Avoid an “over-ambitious” project – but it should be novel & significant!
• Your hypothesis should be testable & aims doable with the resources you are requesting (& mentor support)
• The scope of your hypothesis & aims should match available time and resources
• Your research & career development objectives should be related/matched

New Research Direction

• RNA Sequencing
• Novel imaging approaches
• Take advantage of core facilities

Career Development

• Bioinformatics workshop & courses
• Expert collaborator
• May be at other institution

EXAMPLES

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Application Requirements

• Candidate Qualifications, Career Goals & Objectives

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• Mentor(s), Collaborators & Consultants

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• Institution’s Environment & Commitment to the Candidate

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• Specific Aims

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• Research Strategy

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A Few Tips �as You Write

Make Life Easy for Reviewers:

• Write clearly & concisely
• Label all components clearly
• Make sure figures & legends are readable
• Avoid TMI – a figure is worth a thousand words!
• Guide the reviewers with graphics as much as possible
• Edit & proofread

Know These Review Problems & Solutions:

• Write a compelling argument for why your career will be advanced to independence & enhanced by receiving a K award
• Write for both experts & non-experts in your field
• Cite the published work of experts with leading articles in the field

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Candidate’s Qualifications

Biographical Sketch:

• Education/training
• Contributions to science: background, findings, influence/impact, your specific role, cite publications or research products
• Personal statement: your research experience & other qualifications for this K award
• Research support: ongoing & completed research projects, accomplishments of you & your mentor(s)/colleague(s) attesting to qualifications of the research team

Candidates Background:

• Can coordinate with biosketch information
• Ensure key information is provided, even if it repeats the biosketch
• Commitment to academic research career
• Interactions, collaborations, Research achievements experience & potential
• Other relevant experience (leadership, teaching, mentoring)

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Career Goals & Objectives of the K Award

• New or enhanced research skills you will gain
• Other activities to enhance your research career, e.g. courses, workshops, techniques, teaching, mentoring (including ‘soft skills’ management, leadership)
• If you have changed research direction, discuss the reasons & justify how it will enhance research career development
• Provide a career development timeline, including plans to apply for subsequent grant support
• Career development can include a visit to another laboratory, to learn new technologies or approaches (network for the future!)

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Sponsor/Mentor(s),Collaborators, �Consultants

• Primary/Key Sponsor/Mentor(s) must explain how they will tangibly contribute to the applicant’s career development
• Discuss research & career development activities:
• Regular interactions with applicant, how interactions & proposed activities advance applicant’s research and career
• Document sources/amounts of anticipated support for the applicant’s research project
• Mentor(s) should discuss the plans for transitioning the candidate to independence by the end of the K award & convey clear support for the pathway to independence
• Provide details of previous experience as a mentor & outcomes of mentees

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Institutional Environment & Commitment

• Document a strong, well-established research program related to the candidate's interests
• Experienced faculty, facilities & resources
• Opportunities for intellectual interactions, e.g., journal clubs, seminars & presentations
• Research Centers or Program Projects which may provide resources & interactions to promote candidate’s success
• Commitment to the candidate’s career development
• Adequate office space, lab space, time & support to the candidate for the period of K award

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Specific Aims �of the Project

• Test a central hypothesis & sub-hypotheses
• Solve a specific problem & address a critical barrier to progress in the field
• Challenge an existing paradigm or develop new technology
• All members of the review panel may read this page
• State the problem, why you can solve it, what’s new & the hypothesis and sub-hypotheses related to each aim
• End with why completing the aims will be a major contribution to the biomedical field or clinical practice and to your career development
• A summary figure helps (now immediately after not in the specific aims)!

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A Few Tips on the Hypothesis

• Strong, testable hypotheses rather than simple advance in technology or ‘collecting’ information
• Aim 2 should still be doable/meaningful if aim 1 does not pan out
• Ask questions that prove or disprove a hypothesis rather than use a method to search for a problem or simply collect information
• Methods are the means to perform your experiments. Your experimental results & appropriate statistical analyses will prove or disprove your hypothesis
• The hypothesis must be testable during the K award & with the level of available resources

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Research Strategy

1. Significance:

• The importance of the problem you are trying to solve
• How your study & anticipated results will improve scientific knowledge, technical capability, or clinical practice in one or more fields
• How existing concepts, methods, technologies, treatments, or interventions may be impacted if the proposed aims are achieved

2. Innovation:

• How your proposed research will challenge or improve current research or clinical practice paradigms
• Novel theoretical concepts, approaches, methodologies, or interventions that may be developed or used
• Advantages over existing approaches, methodologies, instrumentation, or interventions

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Research Strategy

3. Approach:

• Methods & analyses to test the hypotheses and accomplish the specific aims (attention to positive & negative controls or randomization where appropriate).
• Benchmarks for success anticipated to achieve the aims.
• Potential problems & alternative strategies.
• For early stages of development, describe strategies to establish feasibility & manage high-risk aspects of the proposed work.
• Rigorous experimental design, power calculations, sufficient N, biological variables, appropriate statistical tests & authentication of reagents.

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Career Award Scored Review Criteria

1. Candidate:

• Research, academic and/or clinical record
• Commitment & potential to develop as an independent & productive researcher
• Quality of letters of reference (referees should know you!)�

2. Career Development Plan, Goals, Objectives:

• Contribute substantially to the scientific development of candidate
• Content, scope, phasing, & duration of the plan in the context of prior experience

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Career Award Scored Review Criteria

3. Research Plan:

• Scientific & technical merit of the research question, design & methodology
• Strong premise, rigorous experimental design & statistical analyses, unbiased approach, addresses relevant biological variables
• Relevance of the proposed research to the candidate‘s career objectives
• Is the research plan appropriate to the stage of research development & developing the research skills described in the career development plan?

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Career Award Scored Review Criteria

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

• Qualifications, funding, & statement by Mentor(s), Collaborators, and/or Consultants
• Clear commitment & plan for career development & pathway to independence
• Mentors & collaborators must have real roles, i.e. be clearly involved & have the time to commit

5. Environment and Institutional Commitment to the Candidate:

• Assurance that minimum 75% effort will be devoted to research & related activities
• Capable faculty & research facilities
• Assurance that the candidate is considered an integral part of the institutional research program

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Additional Review Criteria & Review Considerations

Additional Review Criteria:

• Study Timeline for Clinical Trials
• Protection of Human Subjects
• Inclusion of Women, Minorities, and Children
• Vertebrate Animals
• Biohazards�

Additional Review Considerations:

• Training in the Responsible Conduct of Research
• Select Agent Research
• Resource Sharing Plans
• Authentication of Key Biological and/or Chemical Resources
• Budget and Period of Support

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Rigor in K Award Application and Review

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THANK YOU!�

QUESTIONS?

Keep the Joy in Research �Writing a Grant is Fun (really!)

Trainees and Mentees Provide a

Scientific Family Forever

Websites:

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https://grants.nih.gov/grants/oer.htm

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Contact us:

NIHTrain@mail.nih.gov

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�ORCID iD Requirement for Trainees, Fellows & Career Development (K) Appointees or Awardees: �NOT-OD-19-109� �

• To enhance career tracking, NIH will require Open Researcher & Contributor Identifiers (ORCID iDs) for trainees, fellows & career development (K) appointees/awardees, beginning in FY 2020
• Required as part of the appointment process for trainees, scholars, and participants supported by the following activities, beginning in October 2019:
• T15, T32, T34, T35, T37, T90/R90, TL1, TL4, TU2, K12/KL2, R25, R38, RL5, RL9
• Required at the time of application for fellowship and career development (K) awards, beginning with receipt dates after January 25, 2020:
• F05, F30, F31, F32, F33, F37, F38, F99/K00, FI2, K01, K02, K05, K07, K08, K18, K22, K23, K24, K25, K26, K38, K43, K76, K99/R00

https://era.nih.gov/erahelp/commons/PPF_Help/8_2_orcid.htm

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About Grants

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

Grants Basics

Grants Process Overview

Plan Your Application

How to Apply

Receipt & Referral

Peer Review

Pre-Award Process

Post-Award Monitoring and Reporting

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K-Awardees or Appointees

• Must be citizens, non-citizen nationals, or lawfully admitted for permanent residence in the U.S. at the time of award/appointment (except for some K99-R00 awards)
• Must have a research or clinical doctoral degree from an accredited domestic (U.S.) or foreign institution
• Must have a full-time appointment at the institution, and commit a minimum of 9 person-months (75% of full-time professional effort) to research career development
• Cannot be former PD/PIs on major NIH research grants (e.g. R01 equivalent), or other individual career development (K) awards.
• Appointees to institutional K12/KL2 awardees are eligible to apply for individual K

K-Kiosk: https://researchtraining.nih.gov/programs/career-development

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Brief Overview of Grant Process

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Responsible Conduct of Research

• Discuss the five components outlined in the NIH Policy:
• (1) Format, (1) Subject Matter, �(3) Faculty Participation, (4) Duration, and (5) Frequency
• Is the plan appropriate for your career stage, and will it enhance your understanding of ethical issues related to research?
• Document any prior participation in RCR training and/or propose plans to receive additional instruction

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Diversity Supplement

Administrative supplement to an existing, actively funded �research grant designed to:

• Support candidates from diverse diverse backgrounds, including those from underrepresented groups, who “wish to develop research capabilities…participate in…career development experiences”
• Support many career stages from undergraduate to faculty
• Could be a bridge to a K for postdoctoral researchers or early stage faculty
• Add to ongoing research & career development
• Expectation of a subsequent application for NIH support
• Enhance workforce diversity

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 PA-20-222: https://grants.nih.gov/grants/guide/pa-files/PA-20-222.html.

• Administratively reviewed by the Institute or Center (IC) funding the original grant
• Note: different ICs have different deadlines and policies
• https://grants.nih.gov/grants/guide/contacts/Diversity-Supp_contacts.html

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