Norris CTSI K Award Workshop
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Transcript of Norris 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
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.
hdp://grants.nih.gov/grants/guide/no<ce-‐files/NOT-‐OD-‐04-‐007.html
K12: Op@ons for Ins@tu@ons
• 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