Keith C. Norris, MD, FASN, FACPProfessor and Executive VP for Research and Health Affairs, Charles R. Drew UniversityAssistant Dean for Clinical and Translational Science, Geffen School of Medicine, UCLA
Perspectives from the NIH Study SectionUCLA CTSI K Award Workshop
Perspectives from the NIH Study Section
NIH Career Award (K) Programs
UCLA CTSI K Award Workshop
Keith C. Norris, MD, FASN, FACPProfessor and Executive VP for Research and Health Affairs, Charles R. Drew UniversityAssistant Dean for Clinical and Translational Science, Geffen School of Medicine, UCLA
• Overview of K Awards
• The Review of K awards
• General NIH Reviewer Guidelines
NIH Career Award (K) Programs
• Support mechanisms that provide mentored research experiences to gain additional expertise in a new research area or in an area that will significantly enhance research capabilities.
Mentored K Awards: What are they?
• It is expected that the mentored research and career development experience will lead to an independent and productive research career
Mentored K Awards: Objective
• K01: Mentored Research Scientist Development Award
• K08: Mentored Clinical Scientist Development Award
• K23: Mentored Patient-Oriented Research Development Award
• K99/R00: NIH Pathway to Independence (PI) Award
• K12: Institutional Mentored Research Scientist Development Program
Mentored K Awards: Which One?
Common K Award Features
• Must have a full-time appointment at applicant organization
• Duration: three, four, or five years• Salary – legislative cap * • Research/development – usually 25K
*Amounts vary by participating NIH Institute
Common K Award Features (cont’d)
• Level of Effort: – generally >75 percent toward K12 activities and
the remainder toward other clinical and teaching pursuits consonant with the award objectives.
– In final 2 years may now reduce effort on K if replaced by effort as a PD/PI or subproject PD/PI provided they remain in mentored situation.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html
K12: Options for Institutions
• K12: Institutional Mentored Research Scientist Development Program – Enhance research career development for
individuals, selected by the institution, who are training for careers in specified research areas
– Provides institutions with a greater capacity for mentoring junior investigators
– Not transferable to another institution– Usually solicited by a Funding Opportunity
Announcement (FOA)
Mentored Clinical Research Scholar Program Award (K12)
• Train and retain clinicians in clinical research investigation
• Provide clinicians with both didactic experience and supervised research training in more than one discipline
• Accommodate candidates with varying levels of research experience
• Allow clinicians engaged in patient-based or basic biomedical research to bring a clinical dimension to the research enterprise
Candidate
Mentor
Career Development Plan
Research Plan
Institutional Environment
Mentored K Awards: Review
Mentored K Awards: Review
Candidate Prior Research Experiences
• Potential for conducting research. • Evidence of originality
Publications (first-author); productivity Likelihood of research independence Justification of need for additional research
mentoring Letters of Reference
MentorTrack record in mentoringAppropriate scientific expertiseResearch funding and publicationsCommitment to mentoring
candidate (letter of support)
Mentored K Awards: Review
Institutional Environment Necessary resources for proposed research
and career development Interactions with other investigators Detail opportunities for research and career
development Institutional commitment to candidate
assurances that the institution intends the candidate to be an integral part of its research program
commitment to protect at least 75% of the candidate’s effort for proposed career development activities
Mentored K Awards: Review
Career Development Plan Activities other than research alone that
will facilitate transition to independence Additional coursework to fill-in gaps? Grant-writing workshops? Seminars, journal clubs Participation in K30 program?
Mentored K Awards: Review
Research Plan Should include new research training Hypothesis- vs. discovery-driven Provide a logical path to research independence
(away from mentor) Detailed experimental plan with potential pitfalls,
expected outcomes, alternative approaches (K99/R00:distinct research phases)
Mentored K Awards: Review
Helping Candidates Develop a Strong Career Development Training Plan
• Understand the intent of the mentored K award is to help new investigators achieve independence (i.e., R01-level funding).– Preparing for the R01 grant application that the
candidate will submit at the end of the K award should be the organizing principle of the K grant application, which includes both a training plan and a research plan.
Career Development Training Plans
• Make a compelling argument why the mentee needs a K award.– Identify critical gaps or deficiencies in the
mentee’s knowledge or skills. – Explain how additional training or mentored
research experience in these areas will enable the mentee to compete successfully for R01 funding.
– Be specific; provide examples.
Career Development Training Plans
• Develop a career development training plan that is uniquely suited to the mentee.– Given their previous training and research
experience, mentees should propose a mix of didactic training and hands-on research experience that address the gaps or deficiencies in their knowledge or skills.
– Fully exploit the training opportunities available. – The training plan should be as carefully thought
out and presented as the research plan.
Helping Candidates Develop a K Award Research Plan
• The research plan is a training vehicle. Should be well integrated with the candidate’s training plan and provide an opportunity to acquire new skills
• The research plan is a means to achieve independence. Should be viewed as a precursor for the next state of research – ideally, an R01.
• Mentored K awards provide limited funding. The scope needs to be appropriate and feasible ($25K-$50K/year).
General NIH Reviewer Guidelines
Significance
• Does this study address an important problem? Do you make a compelling case?
• If the aims of the application are achieved, how will scientific knowledge be advanced??
• What will be the effect of these studies on the concepts or methods that drive this field? How might this change the field? Be convincing!!!
Approach• Are the conceptual framework, design, methods,
and analyses adequately developed, well-integrated, and appropriate to the aims?
• Does the applicant acknowledge potential problem areas and consider alternative tactics?
• Is there an appropriate work plan included? • Does the project include plans to measure
progress toward achieving the stated objectives? How will you know when you are half way there?
Innovation
• Does the project employ novel concepts, approaches or methods?
• Are the aims original and innovative? • Does the project challenge or advance existing
paradigms or develop new methodologies or technologies?
Investigator
• Is the investigator appropriately trained and well suited to carry out this work?
• Is the work proposed appropriate to the experience level of the principal investigator and other significant investigator participants?
• Is there a prior history of conducting (fill in area) research? Does not fund empty aspirations!
Environment
• Does the scientific environment contribute to the probability of success?
• Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?
• Is there evidence of institutional support? • Is there an appropriate degree of commitment
and cooperation of other interested parties as evidence by letters detailing the nature and extent of the involvement?
Budget
• Are all requests justified scientifically• Do special items have quotes• Is the project feasible with the given
budget – Low budget often viewed worse than high budget,
• Low budget - applicant does not understand what is need to do the work - may worsen the score
– -High budget -: will get cut but usually not worsen score, unless really high
Other Key areas
• Protection of human subjects (closely reviewed)– HIPAA plan– data and safety monitoring plan– inclusion of women, minorities & children – recruitment plan– evidence (not plan) of proposed partnerships
• Animal welfare• Biohazards• Evaluation
NIH grant application scoring system
• 9-point rating for the impact/priority score with 1 = Exceptional and 9 = Poor.
• Ratings in whole numbers only (no decimal).
Helpful Hints for K Awards Read the FOA; contact program staff to discuss your
eligibility and proposed plan! Read the Instructions in the PHS 398 application kit! Observe page limitations Give yourself and your mentor enough time Give references and letters of support enough time Career Development Plan should be appropriate considering
previous experience Capable and experienced mentor? Co-mentor? Project should have merit as research and as career
development mechanism Arrange for pre-review
K Award Success
"The greatest obstacle to discovery is not ignorance –
it is the illusion of knowledge -Daniel Boorstin
Career Development Programs
• K Kiosk at: http://grants.nih.gov/training/careerdevelopmentawards.htm
• Career Award Wizard at: http://grants.nih.gov/training/kwizard/index.htm
