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NIH Peer Review & Grant Writing for Success Michael A. Sesma, Ph. D. National NIH Peer Review & Grant Writing for Success Michael A. Sesma, Ph. D. National Institute of Mental Health Roger G. Sorensen, Ph. D. , M. P. A. National Institute on Drug Abuse with inspiration from Coelho, Perl, Frascella & Levitin 2008 NIH Mini-Regional, Albany 1

“Anatomy” of Grant Process Program Staff Researcher Revision Collaborators Program Announcement or RFA Idea “Anatomy” of Grant Process Program Staff Researcher Revision Collaborators Program Announcement or RFA Idea Institution Grant Application (R 01, R 03, R 21, K 08, etc. ) $ Program Staff National Advisory Council CSR Referral and Review 2

The NIH Peer Review Process Division of Receipt and Referral (DRR), Center for Scientific The NIH Peer Review Process Division of Receipt and Referral (DRR), Center for Scientific Review (CSR) Application received by CSR DRR Assignments made Initial peer review Funding considerations SRG (CSR or IC) IC(s) – duals possible Second level of review National Advisory Council/Board IC Director (funding decisions) 3

The NIH Peer Review Process Division of Receipt and Referral, CSR • Checks for The NIH Peer Review Process Division of Receipt and Referral, CSR • Checks for completeness • Determines area of research • Assigns an identification number • Assigns a grant number • Assigns application to specific NIH IC for possible funding • Assigns a Scientific Review Group NIH receives ~ 80, 000 applications per year Central receiving point for all competing applications 4

The NIH Peer Review Process Receipt and Referral CSR Review n Most R 01 The NIH Peer Review Process Receipt and Referral CSR Review n Most R 01 s, fellowships, and small business applications n Some Program Announcements (PAs, PARs), Requests for Applications (RFAs) Institute/Center Review n IC-specific features n Program projects n Training grants n Career development awards n RFAs 5

The NIH Peer Review Process First level of review Scientific Review Group (SRG) - The NIH Peer Review Process First level of review Scientific Review Group (SRG) - Provides initial scientific merit review of grant applications - Rates applications and makes recommendations concerning level of support and duration of award Second level of review Advisory Council - Makes recommendations to IC staff concerning funding - Evaluates program priorities and relevance 6 - Advises on policy

The NIH Peer Review Process Scientific Review Officer (SRO) An Extramural Scientist responsible to The NIH Peer Review Process Scientific Review Officer (SRO) An Extramural Scientist responsible to NIH for the scientific and technical review of applications n Designated Federal Official manages SRG, ensures fair and unbiased evaluation of scientific and technical merit of applications for grants, contracts, cooperative agreements n Identifies and assigns reviewers to the SRG n 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) 7

The NIH Peer Review Process Scientific Review Groups (SRGs) Make recommendations: • Scientific and The NIH Peer Review Process Scientific Review Groups (SRGs) Make recommendations: • Scientific and technical merit • Budget and project duration • Bars to award – human subjects, vertebrate animals, biohazards • Resource Sharing Plans • Other administrative factors Study Sections ü Priority scores or UN do not make ü Written critiques funding decisions! (summary statements) 8

Who are the Peer Reviewers? ■ ■ ■ ■ Demonstrated Scientific Expertise Doctoral Degree Who are the Peer Reviewers? ■ ■ ■ ■ Demonstrated Scientific Expertise Doctoral Degree or Equivalent Mature Judgment Work Effectively in a Group Context Breadth of Perspective Impartiality Interest in Serving Adequate Representation of Women and Minority Scientists 9

The NIH Peer Review Process Reviewer Assignments • ≥ Three qualified reviewers (2 + The NIH Peer Review Process Reviewer Assignments • ≥ Three qualified reviewers (2 + 1) • Based on scientific content of application • Expertise of reviewer • Suggestions from PI on types of expertise – not names! • Suggestions from Program staff • Conflicts of interest Telephone reviewers – discuss and score Mail-in reviewers – do not discuss, do not score 10

The NIH Peer Review Process Remember Review Criteria • Included in the Funding Opportunity The NIH Peer Review Process Remember Review Criteria • Included in the Funding Opportunity Announcement (FOA) • Sent to reviewers with applications • Guide discussion at the meeting • Format for critiques in summary statement • Standardized across NIH by type of mechanism 11

The NIH Peer Review Process Remember Review Criteria Standard criteria*: Factored into priority score The NIH Peer Review Process Remember Review Criteria Standard criteria*: Factored into priority score • Significance * Research projects and contracts • Approach • Innovation • Investigator(s) • Environment • Protection of human subjects from research risks • Vertebrate animal welfare • Biohazards 12

The NIH Peer Review Process n n n Significance: Does the study address an The NIH Peer Review Process n n n Significance: Does the study address an important problem? How will scientific knowledge be advanced? Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? Innovation: Are there novel concepts or approaches? Are the aims original and innovative? Investigator: Is the investigator appropriately trained? Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment? 13

The NIH Peer Review Process Review Criteria Additional considerations: Not factored into priority score The NIH Peer Review Process Review Criteria Additional considerations: Not factored into priority score • Budget • Foreign institutions • Resource Sharing Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http: //grants. nih. gov/grants/guide/notice-files/NOT-OD-07 -017. html) Encouraging Early Transition to Research Independence: Modifying the NIH New Investigator Policy to Identify Early Stage Investigators (http: //grants. nih. gov/grants/guide/notice-files/NOT-OD-08 -121. html) 14

The NIH Peer Review Process Research Plans • Introduction to Application (resubmission or revision The NIH Peer Review Process Research Plans • Introduction to Application (resubmission or revision only) • Specific Aims • Background and Significance • Preliminary Studies/Progress Report • Research Design and Methods • Inclusion Enrollment Report • (renewal or revision only) • Bibliography and References Cited 15

The NIH Peer Review Process Research Plans - continued • Protection of Human Subjects The NIH Peer Review Process Research Plans - continued • Protection of Human Subjects • Inclusion of Women and Minorities • Targeted/Planned Enrollment Table • Inclusion of Children • Vertebrate Animals • Select Agent Research • Multiple PD/PI Leadership Plan • Consortium/Contractual Arrangements • Letters of Support • Resource Sharing Plans 16

The NIH Peer Review Process SRG Meeting Procedures • Call to Order - Chairperson The NIH Peer Review Process SRG Meeting Procedures • Call to Order - Chairperson • Policy and instructions – SRO • Conflicts of Interest • Confidentiality • Streamlining • Discuss each application • Scoring • Discuss other considerations § Resource Sharing Plans § Foreign institutions 17

The NIH Peer Review Process SRG Meeting Procedures Discussion format • Members with conflicts The NIH Peer Review Process SRG Meeting Procedures Discussion format • Members with conflicts excused • Initial levels of enthusiasm (assigned reviewers) • Primary reviewer explains project, strengths/weaknesses • Other assigned reviewers follow • Open discussion (full panel) • Levels of enthusiasm (assigned reviewers) • Reviewer workload ~ 6 – 8 as “reviewer” ~ 2 – 3 as “discussant” 18

The NIH Peer Review Process SRG Meeting Procedures • If 60 applications/SRG meeting ~ The NIH Peer Review Process SRG Meeting Procedures • If 60 applications/SRG meeting ~ 50% streamlined 30 applications to discuss and score • If 9 hour SRG meeting (8: 00 AM – 5: 00 PM) ~ ½ hour introduction, streamlining ~ 1 hour lunch, 2 x 15 minute breaks Review Implications ~ 14 minutes/application ~ 3 - 4 minutes/reviewer Clarity and brevity are essential! 19

The NIH Peer Review Process SRG/Study Section Actions n Scored, Scientific Merit Rating (priority The NIH Peer Review Process SRG/Study Section Actions n Scored, Scientific Merit Rating (priority scores and percentiles) n Unscored (lower half) n Deferral 20

The NIH Peer Review Process e. RA Commons Post Review • Priority Score ü The NIH Peer Review Process e. RA Commons Post Review • Priority Score ü Three days after conclusion of SRG meeting • Summary statement ü 4 – 8 weeks after conclusion of SRG meeting ü Available to Program Officers at that time ü Confidential document • Available to ü PD/PIs ü NIH officials ü Advisory Council members 21

The NIH Peer Review Process Summary Statement • Program Officer, Contact information • Priority The NIH Peer Review Process Summary Statement • Program Officer, Contact information • Priority Score, Percentile (if applicable) • Description (provided by applicant) • Resumé and Summary of Discussion • Reviewer critiques – essentially unedited • Committee Recommendations ü Budget ü Human subjects ü Vertebrate animals ü Inclusion plans • Administrative Notes 22

The NIH Peer Review Process After the Review • Program Officer = Point of The NIH Peer Review Process After the Review • Program Officer = Point of Contact • Wait for summary statement • Read summary statement carefully, several times, take notes ………then contact program officer The score/percentile rank is not a guarantee of funding! 23

The NIH Peer Review Process After the Review • Consult Program Officer • Consider The NIH Peer Review Process After the Review • Consult Program Officer • Consider options if outcome unfavorable § Revise and resubmit application üConsider critiques in summary statement üAddress critiques in introduction and text § Appeal review outcome üProcedural deficiencies üFactual errors üMay result in re-review of same application by different SRG 24

The NIH Peer Review Process After the Review Consult Program Officer If an award The NIH Peer Review Process After the Review Consult Program Officer If an award is likely the program officer will • Discuss responses to issues raised by reviewers § Budget § Human subjects or animal welfare issues § Inclusion issues § Administrative requirements • Negotiate Funding Amounts • Study Section Recommendations • NIH and Institute Guidance 25

The NIH Peer Review Process Advisory Council/Board Second level of review • Advisory to The NIH Peer Review Process Advisory Council/Board Second level of review • Advisory to IC Director • Rosters: http: //www 1. od. nih. gov/cmo/committee/index. html • Schedule: http: //www 1. od. nih. gov/cmo/committee/index. html 26

The NIH Peer Review Process Advisory Council/Board Panel of scientific experts and lay members The NIH Peer Review Process Advisory Council/Board Panel of scientific experts and lay members provide advice to Institute Director on • Research priority areas • Funding • Policy and program development • Appeals of review recommendations • Quality of SRG review § Concur with SRG recommendations § Modify SRG recommendations § Deferral for re-review § Cannot change priority score from SRG 27

The NIH Peer Review Process Funding Considerations • Scientific and technical merit (initial peer The NIH Peer Review Process Funding Considerations • Scientific and technical merit (initial peer review) • Council recommendation • Relevance to IC program priorities • Availability of funds 28

Who Actually Makes the Funding Decisions? The Institute Director! n Factors Considered: n n Who Actually Makes the Funding Decisions? The Institute Director! n Factors Considered: n n n Scientific Merit Contribution to Institute Mission Advisory Council Recommendation Program Balance Availability of Funds 29

The NIH Peer Review Process Additional Information • Enhancing Peer Review Initiative http: //enhancing-peer-review. The NIH Peer Review Process Additional Information • Enhancing Peer Review Initiative http: //enhancing-peer-review. nih. gov/ • Office of Extramural Research Peer Review Process http: //grants. nih. gov/grants/peer_review_process. htm • Peer Review Policies & Practices http: //grants. nih. gov/grants/peer. htm • Center for Scientific Review http: //cms. csr. nih. gov/About. CSR/Welcome+to+CSR/ 30

Changes are coming to Peer Review 31 http: //enhancing-peer-review. nih. gov/ Changes are coming to Peer Review 31 http: //enhancing-peer-review. nih. gov/

The NIH Peer Review Process Enhancing Peer Review at NIH The preliminary implementation plans The NIH Peer Review Process Enhancing Peer Review at NIH The preliminary implementation plans for 2009 -2010 calendar years are: • Engage the Best Reviewers • Recruit and retain the best reviewers; enhance reviewer training • Increase flexibility for reviewers through virtual reviews • Improve the Quality and Transparency of Review • Improve scoring transparency and scale • Score streamlined applications • Shorten and restructure applications – e. g. , 12 page R 01 research plan • Ensure balanced and fair reviews across scientific fields and career stages, and reduce administrative burden • Fund the best science earlier, reduce resubmissions • Review like applications together, e. g. , ESI or clinically focused projects http: //www. nih. gov/news/health/sep 2008/od-30 a. htm 32

Grant Writing for Success Writing the Application • Start early • Seek advice from Grant Writing for Success Writing the Application • Start early • Seek advice from colleagues • Start with a good idea • Talk to your NIH Program Official(s) • Use the NIH webpage (www. nih. gov) • Remember review criteria • Follow instructions carefully Transition to Electronic Submission (http: //era. nih. gov/Electronic. Receipt/) 33

Grant Writing for Success Urban Myth of Grantsmanship It is not a process by Grant Writing for Success Urban Myth of Grantsmanship It is not a process by which bad ideas get transformed into good ones … … rather, it is more often the case of a good idea disguised as a bad one. 34

Principles of Success n n Understand the peer review process Understand the agency mission Principles of Success n n Understand the peer review process Understand the agency mission n n Secure collaborators (mentors) to complement your expertise and experience n n Every IC is different! Don’t compete … collaborate! Learn and practice the skills of writing applications for grant funds 35

Remember … Before you start n n Talk to Program Staff at appropriate IC Remember … Before you start n n Talk to Program Staff at appropriate IC Read instructions for application form n n Know your audience n n SF 424 R & R or PHS 398 Which review committee is most likely to get your application? Propose research about which you are passionate and totally committed to doing 36

The Formula for Writing a Successful Grant Application 37 The Formula for Writing a Successful Grant Application 37

Good Idea n n Does it address an important problem? Will scientific knowledge be Good Idea n n Does it address an important problem? Will scientific knowledge be advanced? Does it build upon or expand current knowledge? Is it feasible … n n to implement? to investigate? 38

Good Grantsmanship u Grant writing is a learned skill –Writing grant applications, standard operating Good Grantsmanship u Grant writing is a learned skill –Writing grant applications, standard operating protocols and manuals of procedures that get approved are learned skills –Writing manuscripts that get published in peer reviewed journals is a learned skill u Grantsmanship is a full time job –Learn about the grant application process 39

Good Grantsmanship n n Contact NIH program staff early Assess IC interest & “goodness Good Grantsmanship n n Contact NIH program staff early Assess IC interest & “goodness of fit” Are there related FOAs? Searching NIH web sites is good start … but follow up with personal contact 40

Good Grantsmanship n n n Show your draft application to a colleague who does Good Grantsmanship n n n Show your draft application to a colleague who does not already know what you intend to do Show your draft application to a colleague who is not your best friend 41

Good Grantsmanship n Your draft reviewers need to understand n n n What you Good Grantsmanship n Your draft reviewers need to understand n n n What you intend to do Why you believe it is important to do Exactly how you are going to do it If they don’t get it, you must revise your application Leave enough time to make revisions 42

Good Presentation 3 Simple Steps: Read the application instructions carefully n Don’t forget …. Good Presentation 3 Simple Steps: Read the application instructions carefully n Don’t forget …. . . read the application instructions carefully n 43

Good Presentation Organize the Research Plan to answer 4 essential questions: n What do Good Presentation Organize the Research Plan to answer 4 essential questions: n What do you intend to do? n Why is the work important? n What has already been done? n How are you going to do the work? 44

Good Presentation Address the 5 review criteria n Significance n Approach n Innovation n Good Presentation Address the 5 review criteria n Significance n Approach n Innovation n Investigator n Environment 45

Good Presentation n Provide well-focused research plan n Keep specific aims simple … and Good Presentation n Provide well-focused research plan n Keep specific aims simple … and specific n Link hypotheses to specific aims n Explain method to test every hypothesis n Don’t wander from the main theme n A conceptual model can clarify ideas 46

Good Presentation n Be realistic … not overly ambitious Discuss potential problem areas Discuss Good Presentation n Be realistic … not overly ambitious Discuss potential problem areas Discuss possible solutions n n n Explain rationale for your decisions Be explicit Reviewers cannot read your mind … Don’t assume they know what you intend 47

Good Review Get to the right review group n Title, abstract, specific aims all Good Review Get to the right review group n Title, abstract, specific aims all point to the main goals of your project n Attach a cover letter n n n suggest IC and review group assignment* outline areas of key expertise needed for appropriate review do not name specific reviewers 48 * Consult with Program Officer

Good Luck Results from: n Good Ideas n Good Grantsmanship n Good Presentation n Good Luck Results from: n Good Ideas n Good Grantsmanship n Good Presentation n Good Review 49

50 50

Grant Writing for Success 51 Grant Writing for Success 51

Top 10 Common Reviewer Concerns …. . or How Not To Get DINGED! 52 Top 10 Common Reviewer Concerns …. . or How Not To Get DINGED! 52

Grant 1 Hypothesis: The proposed research seeks to examine the relationship between neurotransmitter A Grant 1 Hypothesis: The proposed research seeks to examine the relationship between neurotransmitter A and neurotransmitter B signaling in Brain Region of Interest and in vivo electrophysiological measures of Brain ROI output during the transition from chronic morphine exposure to morphine withdrawal…. . additionally seeks to determine whether putative Brain ROI projection neurons exhibit altered basal and behaviorally-correlated firing profiles during these states……. . finally seeks to determine whether the observed behavioral, neurochemical, and neurophysiological indices associated with morphine dependence and withdrawal are dependent on Neurotransmitter A projections to the Brain ROI. 53

Grant 1 SA #1: Examine alterations in Brain ROI neurotransmitter A and neurotransmitter B Grant 1 SA #1: Examine alterations in Brain ROI neurotransmitter A and neurotransmitter B efflux in response to acute morphine challenge and withdrawal in morphine-dependent rats SA #2: Examine alterations in Brain ROI single-unit neuronal activity in response to acute morphine challenge…. SA #3: Determine the sensitivity of withdrawal-associated neurotransmitter A efflux, single unit neuronal activity, and withdrawal-associated behaviors to lesions of the neurotransmitter A afferent inputs 54

Grant 1 Reviewer Comments: 1. 2. 3. 4. This application appears to lack a Grant 1 Reviewer Comments: 1. 2. 3. 4. This application appears to lack a hypothesis driven from a specific mechanism. Enthusiasm … dampened by the lack of a specific mechanism …. . the proposal begins to look more like a collection of experiments where the applicants are simply listing experiments according to their expertise in specific techniques …. overambitious nature of the project 55

# 1 Concern There is not a CLEAR HYPOTHESIS, or WELL DEFINED GOALS Ø # 1 Concern There is not a CLEAR HYPOTHESIS, or WELL DEFINED GOALS Ø Ø Ø Provide a focused hypothesis, objectives Describe the importance and relevance of your problem Be clear on how your project will move the field forward 56

Grant 2 Hypothesis: The increase in brain receptor subunits after chronic morphine is an Grant 2 Hypothesis: The increase in brain receptor subunits after chronic morphine is an adaptation to reduced tonic neurotransmitter release in the brain region of interest and elevates the threshold for opioid analgesia. Objective: Study is to design opioid-based pain relief paradigms with extended analgesic efficacy and reduced risk of abuse. Purpose: To determine whether these brain receptors are good targets for “anti-tolerance” drugs 57

Grant 2 n n SA #1: Determine the anatomical location(s) of chronic morphine-induced changes Grant 2 n n SA #1: Determine the anatomical location(s) of chronic morphine-induced changes in brain receptor subunit levels SA #2: Examine the role of brain receptor subunits in opioid-induced behaviors other than analgesia R 01 Requested $225, 000 direct costs / 5 years 58

Grant 2 Reviewer Comments: 1. 2. 3. 4. 5. Unfortunately, several of the experiments Grant 2 Reviewer Comments: 1. 2. 3. 4. 5. Unfortunately, several of the experiments proposed do not directly test the hypothesis and may or may not aid in our further understanding of opioid tolerance. . . it is not clear whether such changes would correlate with antinociceptive function. . there is a lack of preliminary data determining whether such studies can be accomplished and whether any significant changes can be measured. . the literature reports 15 to 20 different mechanisms demonstrating the inhibition of opioid anti-nociceptive tolerance, yet none of these are addressed …. . studies proposed in aim 2 lack rationale 59

# 2 Concern The SPECIFIC AIMS do NOT TEST the Hypothesis, The SPECIFIC AIMS # 2 Concern The SPECIFIC AIMS do NOT TEST the Hypothesis, The SPECIFIC AIMS DEPEND on results from previous aims Ø The best proposals are those with independent specific aims that address your hypothesis using different approaches 60

Grant 3 Hypothesis: Sustained electrical activity enhances neuronal process X activity, targeting select proteins Grant 3 Hypothesis: Sustained electrical activity enhances neuronal process X activity, targeting select proteins essential for synaptic vesicle neurotransmitter release and downregulating presynaptic output in neurotransmitter A neurons Objective: To define the cellular pathways initiated during periods of increased electrical activity to induce subsequent decreases in synaptic output Propose: Signal Transduction pathway 1 acts ultimately to phosphorylate and protect the key presynaptic targets of the process X structure 61

Grant 3 n n SA #1: Investigate the interplay between process X function and Grant 3 n n SA #1: Investigate the interplay between process X function and Signal Transduction 1 signaling in persistent neuronal plasticity SA #2: Validate roles for the presynaptic proteins ABC 1 and ABC 2 in persistent neuronal plasticity R 01 Requested $225, 000 direct costs / 5 years 62

Grant 3 Reviewer Comments: 1. 2. 3. 4. 5. . . the investigator presents Grant 3 Reviewer Comments: 1. 2. 3. 4. 5. . . the investigator presents an unrealistically simplistic picture of Signal Transduction 1 signaling in neurons The general experimental design relies on correlative studies of signaling systems that are highly complex, and which act at multiple levels. The anticipated outcomes are discussed only superficially and assume only that the experiments will turn out to support the investigator’s hypothesis…many outcomes can be imagined The paradigms still place the neurons in unnatural (non-physiological) environments for extraordinarily long periods of time. . this model system (cultured cells) reduces the significance of the project because the relevance to more realistic neuronal networks remains unclear. . experiments have been added which are outside the technical 63 expertise of the investigator and for which preliminary data are not in hand

Grant 4 Hypothesis: Combined Treatment A/B group will have a greater reduction in substance Grant 4 Hypothesis: Combined Treatment A/B group will have a greater reduction in substance use and better outcomes three months after study entry, and lower HIV risk from drug or sexual behaviors Purpose: Examine the utility of a Combined Treatment A/B protocol in the [hospital] emergency department with persons at risk for drug addiction and its associated health consequences SA #1: Determine the impact of a Combined Treatment A/B protocol on substance use, HIV risk reduction, health care utilization, and health status among persons at moderate or high risk for substance abuse seeking treatment in a [hospital] 64 emergency department

Grant 4 Reviewer Comments: 1. 2. 3. The initial model of care is not Grant 4 Reviewer Comments: 1. 2. 3. The initial model of care is not different from the current practice…. thus, it is not clear that this Combined Treatment A/B protocol will have an impact of identifying new patients who need counseling. . . the significance of this Combined Treatment A/B application is compromised by the failure to integrate the intervention into existing practice. The recruitment process is not based on a uniform screening protocol (lack of specifics on subject recruitment, interview process, support personnel, follow-up strategy). 65

# 3 Concern The Proposal is: NOT MECHANISTIC, or NOT SCIENTIFICALLY RELEVANT Ø Ø # 3 Concern The Proposal is: NOT MECHANISTIC, or NOT SCIENTIFICALLY RELEVANT Ø Ø Do not propose correlative studies, propose strong associations Do not propose general observations, propose specific manipulations 66

Grant 5 Hypothesis: Amphetamine-induced Behavior A targets Transcription Factor X to dendritic structures such Grant 5 Hypothesis: Amphetamine-induced Behavior A targets Transcription Factor X to dendritic structures such as the spines of pyramidal cells or the dendrites of interneurons of the Brain ROI SA #1: Amphetamine-induced Behavior A alters Transcription Factor X immunoreactivity in pyramidal neurons and/or interneurons SA #2: Amphetamine-induced Behavior A targets Transcription Factor X to dendrites and spines that receive excitatory synapses 67

Grant 5 Reviewer Comments: 1. This proposal ……is somewhat novel, although mainly in the Grant 5 Reviewer Comments: 1. This proposal ……is somewhat novel, although mainly in the sense that no one previously has examined this issue before in the Brain ROI. However, in essence this question reflects more of an incremental advance in our knowledge as opposed to the novel ideas targeted by the R 21 mechanism. 68

# 4 Concern This Application is not Appropriate for the Grant Mechanism Ø Ø # 4 Concern This Application is not Appropriate for the Grant Mechanism Ø Ø A R 21 is NOT a R 01 A Career Development Award (K) is NOT a Research Project Grant (R) 69

# 5 Concern The Proposal is OVERLY AMBITIOUS Ø Set realistic goals for the # 5 Concern The Proposal is OVERLY AMBITIOUS Ø Set realistic goals for the budget and project period you propose 70

# 6 Concern Preliminary Data is lacking Ø Ø Ø Include preliminary data for # 6 Concern Preliminary Data is lacking Ø Ø Ø Include preliminary data for all aims Use preliminary data to show knowledge of methods and data analyses But DO propose more than just confirming preliminary results 71

# 7 Concern I’m not sure that the Investigator can do the PROPOSED EXPERIMENTS # 7 Concern I’m not sure that the Investigator can do the PROPOSED EXPERIMENTS Ø Ø Ø Don’t propose what you can’t do Include Collaborators and Consultants on your project Describe the value of datasets and experimental models 72

Grant 6 Objective: Study is designed to revise and evaluate Intervention Model A for Grant 6 Objective: Study is designed to revise and evaluate Intervention Model A for homeless adolescents Purpose: Intervention Model A has been thoroughly developed and standardized for adults, but not as well for adolescents, and certainly not within existing services. This will be a stage I, early treatment development project, with the aim of refining Intervention Model A for homeless adolescents 73

Grant 6 n n n SA #1: Refine the existing Intervention Model A [for Grant 6 n n n SA #1: Refine the existing Intervention Model A [for adults] program to develop an integrated Intervention A and Intervention B treatment program for homeless adolescents presenting symptoms of substance use disorders and self-injury/suicidality SA #2: Examine the feasibility of delivering the new Integrated Intervention program within the context of the [currently used] youth Intervention program recently developed …. for homeless adolescents SA #3: Conduct a pilot study, comparing the new Integrated Invention program to Treatment-as-Usual in a randomized two group repeated measures design, assessing clients enrolled in [the currently used] homeless adolescent Intervention program who are experiencing substance abuse disorder symptoms and suicidality/self-injurious behaviors 74

Grant 6 Reviewer Comments: 1. 2. 3. 4. 5. . . the application does Grant 6 Reviewer Comments: 1. 2. 3. 4. 5. . . the application does not provide a balanced, critical review of Intervention Model A with substance-abusing adults, and why this approach would, in turn, be promising with homeless youth. . there is an almost complete absence of focus on substance abuse or the integration of Intervention Model A [previously] adapted for this problem Other more serious design problems include different assessment schedules, attendance burden, and discharge rules between the two conditions. . inclusion criteria …are extremely broad…would seem to introduce enormous heterogeneity to the sample selected What is not well-specified in the application is how the team will decide if the results of the trial warrant the move to a 75 large efficacy trial.

# 8 Concern The Background section is missing key publications and experimental findings Ø # 8 Concern The Background section is missing key publications and experimental findings Ø Ø Ø Thoroughly describe the literature, especially controversies, but Support your views and ideas Be sure you have found key references 76

# 9 Concern Experimental Details, Alternative Approaches, or Interpretation of Data are Inadequately Described # 9 Concern Experimental Details, Alternative Approaches, or Interpretation of Data are Inadequately Described Ø Ø Ø Don’t assume the reviewers know the methods Provide other experimental directions you might use should you encounter problems Show the reviewers that you have thought about your research plan 77

# 10 Concern The Proposal is NOT RELEVANT to the MISSION of the INSTITUTE # 10 Concern The Proposal is NOT RELEVANT to the MISSION of the INSTITUTE Ø Don’t try to make your application FIT the Mission of a Particular Institute 78

Funded Applications 79 Funded Applications 79

Good Grant 1 Hypothesis: Chronic drug exposure upregulates the expression of Factor X, which Good Grant 1 Hypothesis: Chronic drug exposure upregulates the expression of Factor X, which triggers and sustains the exocytotic trafficking and surface expression of functional Receptor A Purpose: To investigate the molecular mechanisms for Factor X -induced Receptor A trafficking 80

Good Grant 1 n SA #1: Determine the signaling pathways mediating Factor Xinduced Receptor Good Grant 1 n SA #1: Determine the signaling pathways mediating Factor Xinduced Receptor A trafficking n SA #2: Determine Factor X involvement in drug-induced Receptor A trafficking n SA #3: Determine the synaptic sites of Receptor A trafficking and Receptor A-B interactions n SA #4: Determine the behavioral significance of emergent Receptor A and behavioral Receptor A-B interactions 81

Good Grant 1 Reviewer Comments: 1. 2. 3. Strengths are numerous and include novel Good Grant 1 Reviewer Comments: 1. 2. 3. Strengths are numerous and include novel and innovative hypotheses, sound experimental design using multidisciplinary approaches, a highly qualified investigator and research team, and a high likelihood of meaningful findings Strengths include the significance of the central hypothesis, the well-designed experimental plan, supportive preliminary data …. . . the rationale for the studies are clearly delineated, appropriate controls are in place, scope of the studies is appropriate, and there is … complete discussion of possible limitations of some approaches and how findings will be interpreted 82

Good Grant 2 Objective: To use … conceptual and statistical models to address challenges Good Grant 2 Objective: To use … conceptual and statistical models to address challenges in the development of practical strategies for measuring the quality of community treatment programs Purpose: To extend previous approaches to casemix adjustment for performance measurement, and the feasibility of valid outcomes-based performance measurement systems for community treatment. 83

Good Grant 2 n SA #1: Test whether Treatment Program A demonstrates efficacy under Good Grant 2 n SA #1: Test whether Treatment Program A demonstrates efficacy under experimental conditions relative to communitybased care programs, can be translated to a set of communitybased care programs, and is effective relative to a set of community-based care programs n SA #2: Identify program features associated with good client outcomes which might serve as indicators of the quality of community-based treatment programs n SA #3: Identify candidate quality indicators appropriate for assessing the performance of community-based care programs in serving key client subgroups 84

Good Grant 2 Reviewer Comments: 1. 2. 3. 4. The evaluation of Treatment Program Good Grant 2 Reviewer Comments: 1. 2. 3. 4. The evaluation of Treatment Program A. . in real world settings, and the examination of efficacy, translational, and effectiveness outcomes in a single study represents a highly significant endeavor. . . the approach to aim 1 is elegant The study has the potential to address a major gap in treatment services research, and to guide diffusion of research-based practices to real world settings The solid design and measurement aspects of the study and the innovative analytical approach. . make this an exciting application with the potential for high impact on the field 85

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More Web Resources 87 More Web Resources 87

Funding Opportunities Sites with important information: http: //grants. nih. gov/grants/index. cfm http: //grants. nih. Funding Opportunities Sites with important information: http: //grants. nih. gov/grants/index. cfm http: //grants. nih. gov/grants/welcome. htm#introduction http: //deainfo. nci. nih. gov/funding. htm http: //deainfo. nci. nih. gov/extra/extdocs/grantrevprocess. htm http: //www. niaid. nih. gov/ncn/grants/default. htm http: //www. niaid. nih. gov/ncn/grants/charts/default. htm http: //www. niaid. nih. gov/ncn/glossary/default. htm 88

grants 1. nih. gov/grants/grant_tips. htm 89 grants 1. nih. gov/grants/grant_tips. htm 89

grants. nih. gov/grants/glossary. htm 90 grants. nih. gov/grants/glossary. htm 90

http: //www 3. cancer. gov/admin/gab/links. htm 91 http: //www 3. cancer. gov/admin/gab/links. htm 91

deainfo. nci. nih. gov/consumer. htm 92 deainfo. nci. nih. gov/consumer. htm 92

deainfo. nci. nih. gov/extra/extdocs/gntapp. htm 93 deainfo. nci. nih. gov/extra/extdocs/gntapp. htm 93

www. niaid. nih. gov/ncn/grants/ 94 www. niaid. nih. gov/ncn/grants/ 94

http: //era. nih. gov/ 95 http: //era. nih. gov/ 95

https: //commons. era. nih. gov/commons/ 96 https: //commons. era. nih. gov/commons/ 96

http: //era. nih. gov/virtualschool/ 97 http: //era. nih. gov/virtualschool/ 97

grants 2. nih. gov/grants/policy/nihgps_2003 98 grants 2. nih. gov/grants/policy/nihgps_2003 98

grants 2. nih. gov/grants/policy/nihgps_2003 99 grants 2. nih. gov/grants/policy/nihgps_2003 99

1 5 2 6 3 4 http: //era. nih. gov/Electronic. Receipt/ 100 1 5 2 6 3 4 http: //era. nih. gov/Electronic. Receipt/ 100

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