Norris CTSI K Award Workshop

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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

description

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

Transcript of Norris CTSI K Award Workshop

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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  

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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  

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•  Overview  of  K  Awards  

•  The  Review  of  K  awards  

•  General  NIH  Reviewer  Guidelines  

NIH  Career  Award  (K)  Programs  

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•  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?    

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•  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    

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•  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?  

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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  

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   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    

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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)  

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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  

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  Candidate    

 Mentor          

  Career  Development  Plan    

  Research  Plan    

  Ins<tu<onal  Environment    

Mentored  K  Awards:  Review  

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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  

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 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  

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  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  

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 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  

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 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  

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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.  

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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.  

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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.  

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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).  

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General  NIH  Reviewer  Guidelines  

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 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!!!  

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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?  

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 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?  

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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!  

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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?  

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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  

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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

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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).    

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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  

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K  Award  Success  

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"The  greatest  obstacle  to  discovery  is  not  ignorance  –                      it  is  the  illusion  of  knowledge    

       -­‐Daniel  Boors<n  

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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