1. A Day with NIH at UTEP February 19, 2010 Michael A. Sesma, PhD National Institute of Mental Health National Institutes of Health A Peer into the NIH Review Process

2. Mission NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. 2

3. Fulfilling Our Mission Foster communication of medical and health sciences information Foster communication of medical and health sciences information Support research by non-Federal scientists across U.S. and abroad Help train research investigators Conduct research in our own laboratories (intramural) 3

4. 4 Research and Training Grant Award Mechanisms − Individual Fellowships (NRSA) (F30/F31/F32) − Institutional Research Training Grants (T32) − Career Development Awards (K-awards) − Research Grants (R01/R03/R21/R34) − Program Project & Centers Grants (P01/P50) − Small Business Awards (SBIR/STTR) (R41/R42/R43/R44)

5. “Anatomy” of Grant Application Process Program Staff ProgramAnnouncement or RFA ProgramAnnouncement Grant Application (R01, R03, R21, K01, K08, etc.) Grant Application (R01, R03, R21, K01, K08, etc.) NationalAdvisoryCouncilNationalAdvisoryCouncil Program Staff Program Staff $ RevisionRevision ResearcherIdeaINSTITUTIONResearcherIdeaINSTITUTION CSRReferral and Review CSRReferral CollaboratorsCollaborators 5

6. Institutional and NIH Team Players in the Grant Application Process

7. Principal Investigator Authorized Organizational Reps Research Administrator Grantee Institution Team Grants are awarded to institutions as represented by AORs. Grants are awarded to institutions as represented by AORs. PD/PIs manage and perform the science PD/PIs manage and perform the science Research Administrators support business aspects of the grant Research Administrators support business aspects of the grant Successful grants require close coordination between all members of the grantee team. 7

8. Responsibilities of the Principal Investigator(s) (PIs) Designated by the grantee institution Responsible for the scientific and technical aspects of project Responsible for the scientific and technical aspects of project Directly manages the project on a day-to-day basis Directly manages the project on a day-to-day basis Assures scientific compliance by maintaining contact with the NIH Program Officer Assures scientific compliance by maintaining contact with the NIH Program Officer Coordinates with other PDs/PIs on projects with multiple Principal Investigators Coordinates with other PDs/PIs on projects with multiple Principal Investigators 8

9. Program Staff Review Staff Grants Management The NIH Extramural Team 9

10. Review Staff: Scientific Review Officer (SRO) An Extramural Scientist responsible to NIH for the scientific and technical review of applications Reviews applications for completeness and conformance with application requirements Reviews applications for completeness and conformance with application requirements Ensure fair and unbiased evaluation of the scientific and technical merit of the proposed research Ensure fair and unbiased evaluation of the scientific and technical merit of the proposed research Provide accurate summaries of the evaluation to aid funding recommendations made by National Advisory Councils to Institute Directors Provide accurate summaries of the evaluation to aid funding recommendations made by National Advisory Councils to Institute Directors Point of contact for applicants during the review process (i.e., after submission, until review is completed) 10

11. Program Staff: Program Administrator (aka Program Officer, Program Director or Program Official) An Extramural Scientist responsible for the programmatic, scientific, and/or technical aspects of a grant Role in Pre-submission, Review, Post- Review, Pre-Award, Award and/or Resubmission, Post-Award 11

12. Why your Scientific Review Officer or Program Officer Doesn’t Answer E-Mails or the Phone So, keep trying! ARRA Overload!

13. WOW! What a great idea The NIH Grant Process Investigator initiated research is core to the NIH grant process 13

14. 14 Getting Started: Why Contact a Program Official ? ■ The program official can : ■ Provide direction to the appropriate Institute ■ 24 institutes have granting authority ■ Provide direction to the appropriate Division/Office ■ Basic, clinical, behavioral, translational ■ Provide direction to the appropriate Program Official ■ Extramural research portfolio ■ Help navigate the Review process ■ Provide “application technical assistance”

15. 15 Program Official Principal liaison between investigators and the NIH Your most important contact Call us early … Contact us often!

16. 16 Must I contact NIH before applying? Usually it’s just a smart idea Usually it’s just a smart idea When RFA’s request Letter of Intent When RFA’s request Letter of Intent If you have questions about grant mechanisms or budget limitations or eligibility or... If you have questions about grant mechanisms or budget limitations or eligibility or... When you are considering applying for any grant, if you are a new or experienced investigator -- contact with program staff is always highly recommended When you are considering applying for any grant, if you are a new or experienced investigator -- contact with program staff is always highly recommended Prior contact with a program officer will always save you time!

17. 17 Program Officers... Program Officers... Give advice and encouragement! The cape, Larry! Go for the cape!

18. 18 In recent years the use of Small Grants (R03) and the NIH Exploratory /Developmental Research Grant (R21) has increased : New Investigator policies are limited to applications for Traditional Research project grant (R01) support. Accordingly, the NIH is strongly encouraging New Investigators, particularly ESIs, to apply for R01 grants when seeking first-time NIH funding. % First-Time Investigators New NIH Policy Encourage New Investigator Applications for the R01

19. Are You a “New Investigator”? Definition: New Investigator (NI) is a PD/PI who has not yet competed successfully for a substantial NIH research grant ( Except for R03, R15, R21 or mentored K awards) Definition: New Investigator (NI) is a PD/PI who has not yet competed successfully for a substantial NIH research grant ( Except for R03, R15, R21 or mentored K awards) Definition: Early Stage Investigator (ESI) is a NI who is within 10 years of completing the terminal research degree or is within 10 years of completing medical residency (or equivalent) Definition: Early Stage Investigator (ESI) is a NI who is within 10 years of completing the terminal research degree or is within 10 years of completing medical residency (or equivalent) Get special considerations during peer review and IC funding decisions Get special considerations during peer review and IC funding decisions Resource web site with further information Resource web site with further information grants1.nih.gov/grants/new_investigators grants.nih.gov/grants/guide/notice-files/NOT-OD-08-121.html 19

20. 20 New/Early Stage Investigators ESI/NI Applications will be identified to reviewers so that appropriate consideration of career stage can be applied during review. ESI/NI Applications will be identified to reviewers so that appropriate consideration of career stage can be applied during review. Apprise NIH staff of ESI/NI status, which will be considered when applications are selected for award Apprise NIH staff of ESI/NI status, which will be considered when applications are selected for award Support New Investigators (majority expected to be ESIs) at success rates equivalent to that of established investigators submitting new applications Support New Investigators (majority expected to be ESIs) at success rates equivalent to that of established investigators submitting new applications For multiple PD/PI applications, all PD/PIs must meet requirements for ESI status to receive consideration during review For multiple PD/PI applications, all PD/PIs must meet requirements for ESI status to receive consideration during review ESIs/NIs are eligible for the Shortened Review Cycle option ESIs/NIs are eligible for the Shortened Review Cycle option (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html ) New and Early Stage Investigator Policies

21. The NIH Peer Review Process NIH Peer Review System Two-tiered: Two-tiered:  Initial peer review  Scientific Review Groups (SRGs)  I/C Advisory Council or Board (Council) Per year: Per year:  Nearly 80,000 applications  Over 18,000 reviewers 21

22. The NIH Peer Review Process Overview Application received Assignments made   Initial peer review Funding considerations Scientific Review Group Institutes or Centers (ICs) (Study section, SRG) (Dual assignment possible) Scientific Review Group Institutes or Centers (ICs) (Study section, SRG) (Dual assignment possible) Scientific Review Officer Program Officer     Second level of review Advisory Council  Funding decisions IC Director  Award! IC Director  Award! 22

23. The NIH Peer Review Process Division of Receipt and Referral - CSR Check for completeness Check for completeness Determine area of research Determine area of research Assign an identification number Assign an identification number Assign a grant number Assign a grant number Assign application to specific Assign application to specific NIH IC for possible funding NIH IC for possible funding Assign a Scientific Review Group Assign a Scientific Review Group The Center for Scientific Review = Central receiving point for all competing applications 23

24. The NIH Peer Review Process CSR Review Most R01s, fellowships, and small business applications Some Program Announcements (PAs, PARs), Requests for Applications (RFAs) Institute/Center Review IC-specific features Program projects/Centers Training grants Career development awards RFAs Referral for Review Can I influence the Referral Process? 24

25. The NIH Peer Review Process To Request a Scientific Review Group Cover letter of application Cover letter of application – Application title – FOA # and title – Request: – Assignment to particular SRG or study section – Assignment to particular IC for funding consideration – Disciplines involved, if multidisciplinary – Explanation for late application Not all requests can be honored. 25

26. The NIH Peer Review Process Cover Letter of Application List one request per line List one request per line Place SRG & IC review requests on separate lines Place SRG & IC review requests on separate lines Place positive & negative requests on separate lines Place positive & negative requests on separate lines Include name of IC or SRG, Include name of IC or SRG, followed by a dash and acronym followed by a dash and acronym Provide explanations for each request Provide explanations for each request in a separate paragraph in a separate paragraph Inclusion of a Cover letter is not required. Be proactive! 26

27. The NIH Peer Review Process Information on Review Groups Center for Scientific Review: Center for Scientific Review:http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/http://www.csr.nih.gov/committees/rosterindex.asp Institutes and Centers: Institutes and Centers: http://era.nih.gov/roster/index.cfm http://era.nih.gov/roster/index.cfm Areas of IC interest: Areas of IC interest:http://www.nih.gov/icd/index.html 27

28. The NIH Peer Review Process Scientific Review Officer (SRO) Designated Federal Official for the review Designated Federal Official for the review Extramural scientist Extramural scientist Identifies and recruits reviewers Identifies and recruits reviewers Manages conflicts of interest Manages conflicts of interest Oversees arrangements for review meetings Oversees arrangements for review meetings Presides at review committee meetings Presides at review committee meetings Prepares and releases summary statements Prepares and releases summary statements 28

29. The NIH Peer Review Process Scientific Review Group (SRG) “Study Section” Reviewers: “Study Section” Reviewers: Expertise Expertise Stature in field Stature in field Mature judgment Mature judgment Impartiality Impartiality Managed conflicts of interest Managed conflicts of interest Balanced representation Balanced representation Gender Gender Geography Geography Diversity Diversity Seniority Seniority 29

30. The NIH Peer Review Process Scientific Review Group (SRG) Membership Membership – Sometimes includes lay members – May include foreign reviewers – Not more than one-quarter may be federal staff Types of SRGs Types of SRGs – “Chartered”  Multiyear terms  Formal appointment process – Special Emphasis Panel (SEP)  Ad hoc membership  Often meet only once 30

31. For each application: For each application: Score (10-90) Score (10-90) Human subject concerns Human subject concerns Inclusion criteria Inclusion criteria Vertebrate animal concerns Vertebrate animal concerns Budget/duration recommendation Budget/duration recommendation First level of review: SRG Meeting A standing study section has 15- 20 members primarily from academia A standing study section has 15- 20 members primarily from academia Each study section will review 60- 100 applications at a meeting 3X/yr Each study section will review 60- 100 applications at a meeting 3X/yr The NIH Peer Review Process Scientific Review Group (SRG) Meeting 31

32. The NIH Peer Review Process Reviewer Assignments ≥ Three qualified reviewers (2 + 1) ≥ Three qualified reviewers (2 + 1) Assigned based on scientific content of applicationAssigned based on scientific content of application Expertise of reviewer Expertise of reviewer Suggestions from PI on types of expertise – not names! (cover letter)Suggestions from PI on types of expertise – not names! (cover letter) Suggestions from Program staff Suggestions from Program staff Managing conflicts of interest Managing conflicts of interest Balancing workload Balancing workload 32

33. The NIH Peer Review Process Conflicts of Interest (COI) Financial Financial Employment Employment Personal Personal Professional Professional SRG membership SRG membership Other interests Other interests Two COI vouchers submitted by each SRG member Pre-meeting Pre-meeting Post-meeting Post-meeting 33

34. The NIH Peer Review Process Scientific Review Groups (SRGs) Recommendations: Scientific and technical merit Scientific and technical merit Budget and project duration Budget and project duration Bars to award – human subjects, Bars to award – human subjects, vertebrate animals, biohazards vertebrate animals, biohazards Resource Sharing Plans Resource Sharing Plans Other administrative factors Other administrative factors Impact/priority scores Impact/priority scores Criterion scores Criterion scores Written critiques Written critiques Study Sections do not make funding decisions! 34

35. The NIH Peer Review Process Scientific Review Groups (SRGs) Confidentiality All materials, discussions, documents All materials, discussions, documents (except those in the public domain) (except those in the public domain) Reviewers sent guidance with applications Reviewers sent guidance with applications All questions referred to SRO All questions referred to SRO Closed to the public Closed to the public Program staff may observe Program staff may observe Reviewers must sign two Confidentiality Certifications! 35

36. The NIH Peer Review Process NIH Scoring System Private scoring at SRG meeting Private scoring at SRG meeting Numerical scores – new system Numerical scores – new system – 1.0 (exceptional) to 9.0 (poor) – Final impact/priority score = average of individual scores x 10 average of individual scores x 10 – New feature - individual criterion scores – Ranked by percentile for certain mechanisms Not Discussed - streamlining Not Discussed - streamlining Other designations (NR, DF, AB, NP, etc.) Other designations (NR, DF, AB, NP, etc.) 36

37. The NIH Peer Review Process Streamlining Allows discussion of more meritorious applications Allows discussion of more meritorious applications – Research projects ~ 50% – Shared instrumentation ~ 40% – Fellowship applications ~ 30% – RFAs – pre - arranged limits Requires full concurrence of SRG Requires full concurrence of SRG Not discussed at SRG meeting, designated “ND” Not discussed at SRG meeting, designated “ND” Streamlined applications receive a Summary statement: Streamlined applications receive a Summary statement: – Reviewer critiques – Individual criterion scores – No final overall impact/priority score 37

38. The NIH Peer Review Process SRG Meeting Procedures Call to Order - Chairperson Policy and instructions - SRO Policy and instructions - SRO Discuss each application, where feasible: Discuss each application, where feasible: – In score order – Cluster New Investigator applications – Cluster clinical applications Scoring Scoring Discuss other considerations Discuss other considerations – Budget – Resource Sharing Plans – Foreign institutions 38

39. The NIH Peer Review Process SRG Meeting Procedures Discussion format Discussion format Members with conflicts excused Members with conflicts excused Initial levels of enthusiasm stated Initial levels of enthusiasm stated (assigned reviewers and discussants) (assigned reviewers and discussants) Primary reviewer - explains project, strengths, Primary reviewer - explains project, strengths, weaknesses weaknesses Other assigned reviewers and discussants follow Other assigned reviewers and discussants follow Open discussion (full panel) Open discussion (full panel) Levels of enthusiasm (assigned reviewers) re-stated Levels of enthusiasm (assigned reviewers) re-stated Individual SRG members vote Individual SRG members vote Other review considerations discussed (budget) Other review considerations discussed (budget) 39

40. The NIH Peer Review Process SRG Meeting Procedures Reviewer workload ~ 6 – 8 as “reviewer” ~ 6 – 8 as “reviewer” ~ 2 – 3 as “discussant” ~ 2 – 3 as “discussant” HINT: Don’t assume reviewers will See the unstated See the unstated Grasp nuances Grasp nuances Understand your lingo Understand your lingo Look things up Look things up Read your mind! Read your mind! 40

41. If 60 applications/SRG meeting If 60 applications/SRG meeting ~ 50% streamlined ~ 50% streamlined 30 applications to discuss and score 30 applications to discuss and score If 9 hour SRG meeting (8:00 AM – 5:00 PM) If 9 hour SRG meeting (8:00 AM – 5:00 PM) ~ ½ hour introduction, streamlining ~ ½ hour introduction, streamlining ~ 1 hour lunch, 2 x 15 minute breaks ~ 1 hour lunch, 2 x 15 minute breaks Review Implications: Review Implications: ~ 14 minutes/application ~ 14 minutes/application ~ 3 - 4 minutes/reviewer ~ 3 - 4 minutes/reviewer Clarity and brevity are essential! The NIH Peer Review Process SRG Meeting Procedures 41

42. The NIH Peer Review Process SRG Meeting Procedures Internet Assisted Review (http://era.nih.gov/nih_and_grantor_agencies/review_and_decisi on_making/internet_assisted_review.cfm) Internet Assisted Review (http://era.nih.gov/nih_and_grantor_agencies/review_and_decisi on_making/internet_assisted_review.cfm) – Reviewer critiques/preliminary scores – Due several days before SRG meeting Acceptance of supplementary material at discretion of SRO Acceptance of supplementary material at discretion of SRO – Correcting errors or omissions – New data or newly accepted publications – Additional letters of commitment Cannot modify application Cannot modify application 42

43. The NIH Peer Review Process eRA Commons http://era.nih.gov/commons/index.cfm Final Impact/Priority Score available three days Final Impact/Priority Score available three days after conclusion of SRG meeting after conclusion of SRG meeting Summary statement available 4 – 8 weeks after meetingSummary statement available 4 – 8 weeks after meeting – Available to Program Officers at that time – Confidential document Available to Available to – PD/PIs – NIH officials – Advisory Council members 43

44. The NIH Peer Review Process Alternate Styles of Review Teleconferences Teleconferences Editorial-style review Editorial-style review Video-enhanced discussions Video-enhanced discussions Asynchronous electronic Asynchronous electronic discussions discussions 44

45. The NIH Peer Review Process Summary Statement First page First page Program Officer (upper left corner) Program Officer (upper left corner) – Name – Contact information Final Impact/Priority Score or ND Final Impact/Priority Score or ND Percentile (if applicable) Percentile (if applicable) Codes Codes – Human subjects – Vertebrate animals – Inclusion plans Budget request Budget request 45

46. The NIH Peer Review Process Summary Statement - continued Subsequent Pages Subsequent Pages Description (provided by applicant) Description (provided by applicant) Resumé and Summary of Discussion (if discussed) Resumé and Summary of Discussion (if discussed) Reviewer critiques – essentially unedited Reviewer critiques – essentially unedited – Follow review criteria for mechanism – Now formatted in bullet points – Protections for Human Subjects – Inclusion Plans – Vertebrate Animals – Biohazards – Budget Administrative Notes Administrative Notes 46

47. The NIH Peer Review Process After the Review Program Officer = Point of ContactProgram Officer = Point of Contact Wait for summary statementWait for summary statement Read summary statement carefully, several times before calling!Read summary statement carefully, several times before calling! Remember: A favorable score is not a guarantee funding! 47

48. The NIH Peer Review Process Appeals Process Consider options program if outcome is unfavorable Consider options program if outcome is unfavorable Revise and resubmit application Revise and resubmit application – Consider critiques in summary statement – Address critiques in introduction and text Appeal review outcome Appeal review outcome – Lack of reviewer expertise – Procedural deficiencies – Factual errors – May result in re-review of same application by different SRG different SRG Discuss with your Program Officer first! 48

49. The NIH Peer Review Process Advisory Council/Board Second level of review Second level of review Advisory to NIH or IC Director Advisory to NIH or IC Director Rosters: http://www1.od.nih.gov/cmo/committee/index.html Rosters: http://www1.od.nih.gov/cmo/committee/index.html Schedule: http://www1.od.nih.gov/cmo/committee/index.html Schedule: http://www1.od.nih.gov/cmo/committee/index.html 49

50. The NIH Peer Review Process Advisory Council/Board Make recommendations to IC Director: Make recommendations to IC Director: Research priority areas Research priority areas Policy Policy Appeals Appeals Funding Funding Quality of SRG review Quality of SRG review  Concur with SRG recommendations  Modify SRG recommendations  Deferral for re-review  Cannot change final impact/ priority score from SRG 50

51. The NIH Peer Review Process Advisory Council/Board Scientists from the Scientists from the extramural research community Public representatives Public representatives Appointed to terms Appointed to terms Appointed as Special Appointed as Special Government Employees Expertise Expertise Stature in field Stature in field Mature judgment Mature judgment Impartiality Impartiality Managed conflicts of interest Managed conflicts of interest Balanced representation Balanced representation – Gender – Geography – Diversity – Seniority 51

52. The NIH Peer Review Process The NIH Peer Review Process Funding Considerations The Institute director will consider Scientific and technical merit (initial peer review) Scientific and technical merit (initial peer review) Council recommendationCouncil recommendation Relevance to IC program prioritiesRelevance to IC program priorities Number of meritorious applications receivedNumber of meritorious applications received Availability of fundsAvailability of funds 52

53. The NIH Peer Review Process Enhancing Peer Review Initiative Enhancing Peer Review Initiative http://enhancing-peer-review.nih.gov/ http://enhancing-peer-review.nih.gov/ Office of Extramural Research Peer Review Process Office of Extramural Research Peer Review Process http://grants.nih.gov/grants/peer_review_process.htm http://grants.nih.gov/grants/peer_review_process.htm Peer Review Policies & Practices Peer Review Policies & Practices http://grants.nih.gov/grants/peer/peer.htm http://grants.nih.gov/grants/peer/peer.htm Center for Scientific Review Center for Scientific Review http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/ http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/ Additional Information 53

54. http://enhancing-peer-review.nih.gov/ Changes in Peer Review are here 54

55. The NIH Peer Review Process has changed New Aspects in Review Enhanced review criteria New scoring system Criterion scoring Structured critiques Clustering of New Investigator Applications Score order of review No more A2 submissions (2 nd revision) * These changes were implemented for applications considered for FY2010 funding and for ARRA FOAs 55

56. Review has Changed: Enhanced Review Criteria Overall Impact/Priority Score Reflects the reviewers’ assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved In consideration of: Core criteria Core criteria Additional review criteria (RFA or PAR) Additional review criteria (RFA or PAR) Additional review criteria – as applicable Additional review criteria – as applicable 56

57. Enhanced Review Criteria Core review criteria order: Core review criteria order: Significance* Significance* Investigator(s)* Investigator(s)* Innovation* Innovation* Approach* Approach* Environment* Environment* Additional review criteria & considerations expanded Additional review criteria & considerations expanded Side-by-side comparison available Side-by-side comparison availablehttp://grants.nih.gov/grants/peer_review_process.htm Overall Impact  Overall Impact/Priority Score *Will receive individual criterion scores 57

58. Enhanced Review Criteria Core review criteria for Career Award: Core review criteria for Career Award: Candidate* Candidate* Career Development Plan/Career Goals & Objectives/Plan to Provide Mentoring * Career Development Plan/Career Goals & Objectives/Plan to Provide Mentoring * Research Plan* Research Plan* Mentor(s), Consultant(s), Collaborator(s)* Mentor(s), Consultant(s), Collaborator(s)* Environment and Institutional Commitment* Environment and Institutional Commitment* Additional review criteria & considerations Additional review criteria & considerations Side-by-side comparison available Side-by-side comparison availablehttp://grants.nih.gov/grants/peer_review_process.htm Overall Impact  Overall Impact/Priority Score *Will receive individual criterion scores 58

59. Enhancing Peer Review at NIH: Enhanced Review Criteria Additional Review Criteria Protections for Human Subjects Inclusion of Women, Minorities, and Children Vertebrate Animals Resubmission Applications Renewal Applications Revision Applications Biohazards Budget and Period Support Select Agent Research Applications from Foreign Organizations Resource Sharing Plans As applicable for the project proposedAs applicable for the project proposed Reviewers will consider in the determination of scientific and technical merit Reviewers will consider in the determination of scientific and technical merit Reviewers will not give separate scores for these items.Reviewers will not give separate scores for these items. 59

60. Enhancing Peer Review at NIH: New Scoring System 1 = Exceptional 9 = Poor Reduces number of rating discriminationsReduces number of rating discriminations Provides rating descriptorsProvides rating descriptors –To improve reliability –To encourage use of the entire range Scores rounded to fewer digitsScores rounded to fewer digits 9-Point Scale 60

61. Enhancing Peer Review at NIH: New Scoring System New Score Descriptors Phases of Process ImpactScoreDescriptor High Impact 1Exceptional 2Outstanding 3Excellent Moderate Impact 4 Very Good 5Good 6Satisfactory Low Impact 7Fair 8Marginal 9Poor 61

62. Enhancing Peer Review at NIH Structured Critiques Phases of Process Bullet comments on Strengths/WeaknessesBullet comments on Strengths/Weaknesses Decrease variability of review Decrease variability of review Increase quality of information in critiques Increase quality of information in critiques More succinct, better organized More succinct, better organized Encourage evaluative statements Encourage evaluative statements Scores for five review criteriaScores for five review criteria Ensure that reviewers address all review Ensure that reviewers address all review criteria and considerations criteria and considerations Required comments:Required comments: –Protections for Human Subjects –Inclusion Plans –Vertebrate Animal Welfare –Biohazards –Budget 62

63. Enhancing Peer Review at NIH Clustering of New Investigator Applications Where feasible, NI applications will be clustered Where feasible, NI applications will be clustered NI and ESI applications will be identified for reviewers NI and ESI applications will be identified for reviewers Expectations for preliminary data or track record should not be the same as for established investigators Expectations for preliminary data or track record should not be the same as for established investigators Where feasible, discussion order based on: Where feasible, discussion order based on: – Clustering of New Investigator applications – Clustering of clinical applications – Clustering of similar activity codes – Preliminary overall impact/priority scores 63

64. Enhancing Peer Review Website:Enhancing Peer Review Website:(http://enhancing-peer-review.nih.gov/index.html) NOT-OD-09-025:NOT-OD-09-025:(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-025.html) Side-by-side comparison of enhanced and former Side-by-side comparison of enhanced and former review criteria review criteria(http://grants.nih.gov/grants/peer_review_process.htm) Guidelines for ReviewersGuidelines for Reviewers(http://grants.nih.gov/grants/peer/reviewer_guidelines.htm) Additional Information Enhancing Peer Review at NIH 64

65. 65 Enhancing Peer Review at NIH Major Changes in the Application (Implemented with Submissions after January 25, 2010*, FY2011 funding) Alignment of applications & review criteria Alignment of applications & review criteria Restructured Applications Restructured Applications Shorter Research Plans: new page limits Shorter Research Plans: new page limitshttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-149.htmlhttp://enhancing-peer-review.nih.gov/restructured_applications.html *Stay Tuned for updates 65

66. Alignment of Application with Review Criteria 66

67. Restructuring the Research Plan: Significance, Innovation, Approach 67

68. Revisions to Biographical Sketch: Investigator(s) Personal Statement added: Personal Statement added: Briefly describe why your experience and qualifications make you particularly well- suited for your role in the project Briefly describe why your experience and qualifications make you particularly well- suited for your role in the project Publications revised: Publications revised: Limit the list of publications or manuscripts to no more than 15 Limit the list of publications or manuscripts to no more than 15 Make selections based on recency, importance to the field, and/or relevance to the application Make selections based on recency, importance to the field, and/or relevance to the application Page limit remains at 4 (except DP1/DP2) Page limit remains at 4 (except DP1/DP2) 68

69. Revisions to Application: Environment  Instructions added to Resources: Provide a description of how the scientific environment will contribute to the probability of success of the project Provide a description of how the scientific environment will contribute to the probability of success of the project For ESIs describe the institutional investment in the success of the investigator For ESIs describe the institutional investment in the success of the investigator  Instructions added to Research Plan In Select Agent Research section, describe the biocontainment resources available at all performance sites In Select Agent Research section, describe the biocontainment resources available at all performance sites 69

70. 70 Page Limit Revisions Shorter Research Plans *FOA page limits should be followed if they differ from application instructions.

71. What do the changes mean for the Applicants and Grant Administrators? Applicants must check for new or reissued FOA or Parent Announcement to download new forms. Forms will be available by December 1. Applications submitted using incorrect forms will be delayed and may not be reviewed! A SINGLE UPLOAD for the Research Strategy (previously a 3-file upload) increases applicant control over the look and feel of the application Simpler preparation for applicants Simpler preparation for applicants Easier reading for reviewers Easier reading for reviewers 71

72. Identifying New Application Forms New forms are required for both paper PHS 398 and electronic SF 424 (R&R) New forms are required for both paper PHS 398 and electronic SF 424 (R&R) Funding opportunity announcement (FOA) or Parent Announcement Funding opportunity announcement (FOA) or Parent Announcement NIH Forms & Applications Page: NIH Forms & Applications Page:http://grants.nih.gov/grants/forms.htm Be sure to choose the correct application package: Be sure to choose the correct application package: SF 424 (R&R): ADOBE_FORMS_B SF 424 (R&R): ADOBE_FORMS_B PHS 398: Revision date “June 2009” PHS 398: Revision date “June 2009” 72

73. General Information Sources Enhancing Peer Review at NIH Webpages http://enhancing-peer-review.nih.gov/index.html Overview of Peer Review Enhancements Video http://enhancing-peer-review.nih.gov/video_overview.html 73

74. Who Actually Makes the Funding Decisions? The Institute Director! Factors Considered: Factors Considered: Scientific Merit Scientific Merit Contribution to Institute Mission Contribution to Institute Mission Advisory Council Recommendation Advisory Council Recommendation Program Balance Program Balance Availability of Funds Availability of Funds 74

75. Yippee!! Now I only have to worry about getting tenure. 75

76. The NIH Peer Review Process Enhancing Peer Review Initiative Enhancing Peer Review Initiative http://enhancing-peer-review.nih.gov/ http://enhancing-peer-review.nih.gov/ Office of Extramural Research Office of Extramural Research Peer Review Process Peer Review Process http://grants.nih.gov/grants/peer_review_process.htm http://grants.nih.gov/grants/peer_review_process.htm Peer Review Policies & Practices Peer Review Policies & Practices http://grants.nih.gov/grants/peer/peer.htm http://grants.nih.gov/grants/peer/peer.htm Center for Scientific Review Center for Scientific Review http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/ http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/ Additional Information 76

77. Strategies for “Breaking In” to the NIH System Understand the NIH process including the review process Understand the NIH process including the review process Understand the ICs and their goals Understand the ICs and their goals Get to know your program officers Get to know your program officers Bounce ideas off established investigators Bounce ideas off established investigators Look at successful grant applications Look at successful grant applications Find Collaborators Find Collaborators Put forward your best, creative ideas Put forward your best, creative ideas Appropriate number of goals Appropriate number of goals Impact – now more important than ever Impact – now more important than ever Preliminary data if you have it Preliminary data if you have it 77

78. Step #1: Do your homework; learn a bit about the grant process and the options. Step #2: Contact us because… We’re from the Government, we’re here to help you! Path to Success at NIH Office of Extramural Research: Basics - http://grants.nih.gov/grants/grant_basics.htm Basics - http://grants.nih.gov/grants/grant_basics.htm Overview - http://grants.nih.gov/grants/grants_process.htm Overview - http://grants.nih.gov/grants/grants_process.htm IC priorities: http://www.nih.gov/icd/index.html NIH Guide Provides Weekly Updates on Funding Opportunities: http://grants.nih.gov/grants/guide/ http://grants.nih.gov/grants/guide/ 78

79. 79

80. 80 New/Early Stage Investigators NOT-OD-08-121 (09/26/2008) - Encouraging Early Transition to Independence: Identifying ESIs NOT-OD-08-121 (09/26/2008) - Encouraging Early Transition to Independence: Identifying ESIshttp://grants1.nih.gov/grants/guide/notice-files/not-od-08-121.html NOT-OD-09-013 (09/31/2008) – Revised New and Early Stage Investigator Policies NOT-OD-09-013 (09/31/2008) – Revised New and Early Stage Investigator Policieshttp://grants1.nih.gov/grants/guide/notice-files/NOT-OD-09-013.html NOT-OD-09-034 (12/31/2008) – ESI Policies: Requesting an Extension of the ESI Period NOT-OD-09-034 (12/31/2008) – ESI Policies: Requesting an Extension of the ESI Period http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html FAQs: http://grants.nih.gov/grants/new_investigators/investigator_policies_ faqs.html FAQs: http://grants.nih.gov/grants/new_investigators/investigator_policies_ faqs.html Information Sources

81. 81 Other NIH Award for New Investigators Fund exceptionally innovative research with potential for significant impact Fund exceptionally innovative research with potential for significant impact Launched in 2007 Launched in 2007 Open to new investigators within ten years of their terminal degree Open to new investigators within ten years of their terminal degree Appointment at US institutions Appointment at US institutions Commit at least 25% effort Commit at least 25% effort Up to $1.5 million over 5 years (direct costs) Up to $1.5 million over 5 years (direct costs) Abbreviated application Abbreviated application Preliminary data optional Preliminary data optional Review focus on innovation and creativity, scientific impact Review focus on innovation and creativity, scientific impact Number of Applications and awards Number of Applications and awards 2007 215030 2007 215030 2008 579 31 2008 579 31 2009 419 ? + ARRA 2009 419 ? + ARRA http://grants.nih.gov/grants/guide/rfa- files/RFA-RM-09-011.html

82. Human Subjects Protection Safeguarding the rights and welfare of individuals who participate as subjects in research based on DHHS regulations and established, internationally recognized ethical principles Safeguarding the rights and welfare of individuals who participate as subjects in research based on DHHS regulations and established, internationally recognized ethical principles DHHS Office of Human Subjects Research Protections (OHRP) oversees all issues for Federally-funded research involving people DHHS Office of Human Subjects Research Protections (OHRP) oversees all issues for Federally-funded research involving people Refer to website for information and resources Refer to website for information and resources www.hhs.gov/ohrpOHRP Office of Human Research Protections 82

83. Humane Animal Research Grantees are responsible for the humane care and treatment of animals under NIH- supported activities. Grantees are responsible for the humane care and treatment of animals under NIH- supported activities. NIH Office of Laboratory Animal Welfare (OLAW) oversees policies for humane animal care and use. NIH Office of Laboratory Animal Welfare (OLAW) oversees policies for humane animal care and use. Refer to website for information and resources Refer to website for information and resources grants.nih.gov/grants/olaw 83