Norris CTSI K Award Workshop

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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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Norris CTSI K Award Workshop

  1. 1. 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  
  2. 2. 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  
  3. 3. •  Overview  of  K  Awards   •  The  Review  of  K  awards   •  General  NIH  Reviewer  Guidelines   NIH  Career  Award  (K)  Programs  
  4. 4. •  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?    
  5. 5. •  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    
  6. 6. •  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?  
  7. 7. 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  
  8. 8.    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    
  9. 9. 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)  
  10. 10. 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  
  11. 11.   Candidate       Mentor             Career  Development  Plan       Research  Plan       Ins<tu<onal  Environment     Mentored  K  Awards:  Review  
  12. 12. 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  
  13. 13.  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  
  14. 14.   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  
  15. 15.   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  
  16. 16.   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  
  17. 17. 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.  
  18. 18. 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.  
  19. 19. 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.  
  20. 20. 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).  
  21. 21. General  NIH  Reviewer   Guidelines  
  22. 22.  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!!!  
  23. 23. 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?  
  24. 24.  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?  
  25. 25. 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!  
  26. 26. 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?  
  27. 27. 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  
  28. 28. 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
  29. 29. 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).    
  30. 30. 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  
  31. 31. K  Award  Success  
  32. 32. "The  greatest  obstacle  to  discovery  is   not  ignorance  –                      
  33. 33. 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  

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