Keith C. Norris, MD, FASN, FACP Professor and Execu<ve VP for Research and Health Affairs, Charles R. Drew University Assistant Dean for Clinical and Transla<onal Science, Geffen School of Medicine, UCLA Perspec<ves from the NIH Study Sec<on UCLA CTSI K Award Workshop
Perspectives from the NIH Study Section Keith C. Norris, MD, FASN, FACP Professor and Executive VP for Research and Health Affairs, Charles R. Drew University Assistant Dean for Clinical and Translational Science, UCLA
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Keith C. Norris, MD, FASN, FACP Professor and Execu<ve VP for Research and Health Affairs, Charles R. Drew University Assistant Dean for Clinical and Transla<onal Science, Geffen School of Medicine, UCLA
Perspec<ves from the NIH Study Sec<on UCLA CTSI K Award Workshop
Perspec<ves from the NIH Study Sec<on
NIH Career Award (K) Programs UCLA CTSI K Award Workshop
Keith C. Norris, MD, FASN, FACP Professor and Execu<ve VP for Research and Health Affairs, Charles R. Drew University Assistant Dean for Clinical and Transla<onal 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 addi<onal exper0se in a new research area or in an area that will significantly enhance research capabili0es.
Mentored K Awards: What are they?
• It is expected that the mentored research and career development experience will lead to an independent and produc0ve research career
Mentored K Awards: Objec@ve
• K01: Mentored Research Scien<st Development Award
• K08: Mentored Clinical Scien<st Development Award
• K23: Mentored Pa<ent-‐Oriented Research Development Award
• K99/R00: NIH Pathway to Independence (PI) Award • K12: Ins0tu0onal Mentored Research Scien0st Development Program
Mentored K Awards: Which One?
Common K Award Features
• Must have a full-‐<me appointment at applicant organiza<on
• Dura<on: three, four, or five years • Salary – legisla<ve cap * • Research/development – usually 25K
*Amounts vary by par<cipa<ng NIH Ins<tute
Common K Award Features (cont’d)
• Level of Effort: • generally >75 percent toward K12 ac<vi<es and the remainder toward other clinical and teaching pursuits consonant with the award objec<ves.
• 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 situa<on.
• K12: Ins<tu<onal Mentored Research Scien<st Development Program • Enhance research career development for individuals, selected by the ins@tu@on, who are training for careers in specified research areas
• Provides ins<tu<ons with a greater capacity for mentoring junior inves<gators
• Not transferable to another ins<tu<on • Usually solicited by a Funding Opportunity Announcement (FOA)
Mentored Clinical Research Scholar Program Award (K12)
• Train and retain clinicians in clinical research inves<ga<on
• Provide clinicians with both didac0c experience and supervised research training in more than one discipline
• Accommodate candidates with varying levels of research experience
• Allow clinicians engaged in pa<ent-‐based or basic biomedical research to bring a clinical dimension to the research enterprise
Candidate
Mentor
Career Development Plan
Research Plan
Ins<tu<onal Environment
Mentored K Awards: Review
Mentored K Awards: Review
Candidate Prior Research Experiences
• Poten<al for conduc<ng research. • Evidence of originality
Publica<ons (first-‐author); produc<vity Likelihood of research independence Jus<fica<on of need for addi<onal research mentoring
Leders of Reference
Mentor Track record in mentoring Appropriate scien<fic exper<se Research funding and publica<ons Commitment to mentoring candidate (leder of support)
Mentored K Awards: Review
Ins<tu<onal Environment Necessary resources for proposed research and career development
Interac<ons with other inves<gators Detail opportuni<es for research and career development
Ins<tu<onal commitment to candidate assurances that the ins<tu<on 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 ac<vi<es
Mentored K Awards: Review
Career Development Plan Ac0vi0es other than research alone that will facilitate transi0on to independence
Addi<onal coursework to fill-‐in gaps? Grant-‐wri<ng workshops? Seminars, journal clubs Par<cipa<on 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 poten0al piDalls, expected outcomes, alterna0ve approaches
(K99/R00:dis<nct 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 inves0gators achieve independence (i.e., R01-‐level funding). • Preparing for the R01 grant applica<on that the candidate will submit at the end of the K award should be the organizing principle of the K grant applica<on, 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. • Iden<fy cri<cal gaps or deficiencies in the mentee’s knowledge or skills.
• Explain how addi<onal 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 didac<c training and hands-‐on research experience that address the gaps or deficiencies in their knowledge or skills.
• Fully exploit the training opportuni<es 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 applica<on are achieved, how will scien0fic 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 poten0al problem areas and consider alterna0ve tac0cs?
• Is there an appropriate work plan included? • Does the project include plans to measure progress toward achieving the stated objec<ves? How will you know when you are half way there?
Innova@on
• Does the project employ novel concepts, approaches or methods?
• Are the aims original and innova<ve? • Does the project challenge or advance exis<ng paradigms or develop new methodologies or technologies?
Inves@gator
• Is the inves<gator appropriately trained and well suited to carry out this work?
• Is the work proposed appropriate to the experience level of the principal inves<gator and other significant inves<gator par<cipants?
• Is there a prior history of conduc<ng (fill in area) research? Does not fund empty aspira0ons!
Environment
• Does the scien<fic environment contribute to the probability of success?
• Do the proposed experiments take advantage of unique features of the scien0fic environment or employ useful collabora0ve arrangements?
• Is there evidence of ins<tu<onal support? • Is there an appropriate degree of commitment and coopera<on of other interested par<es as evidence by leOers detailing the nature and extent of the involvement?
Budget
• Are all requests jus<fied scien<fically • Do special items have quotes • Is the project feasible with the given budget • Low budget omen 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 applica<on scoring system
• 9-‐point ra<ng for the impact/priority score with 1 = Excep<onal and 9 = Poor.
• Ra<ngs 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 Instruc@ons in the PHS 398 applica@on kit! • Observe page limita<ons • Give yourself and your mentor enough <me • Give references and leders of support enough <me • 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 Boors<n
Career Development Programs
• K Kiosk at: hdp://grants.nih.gov/training/careerdevelopmentawards.htm
• Career Award Wizard at: hdp://grants.nih.gov/training/kwizard/index.htm