Download - 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


 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)


  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


 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?


 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)


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