NIH Expedited Reporting • Requirements for reporting vary by institute Institute NCCAM: NCI: NEI: NHLBI: NIA: NIAID: NIAMS: NICHD: NIDA: NIDCR: NIDDK: NIMH: NINDS: Data and Safety Monitoring Policies http://nccam.nih.gov/research/policies/datasafety/ http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm http://www.nci.nih.gov/clinical_trials/conducting/ http://www.nei.nih.gov/funding/policy/policy6.htm http://www.nhlbi.nih.gov/funding/policies/dsmb_est.htm http://rover2.nhlbi.nih.gov/funding/policies/dsm-12.htm http://rover2.nhlbi.nih.gov/funding/policies/dataqual.htm http://www.nhlbi.nih.gov/funding/policies/dsmb_othr.htm http://www.nia.nih.gov/funding/policy/humint.htm http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf http://www.niams.nih.gov/rtac/clinical/dsmb3.html http://www.niams.nih.gov/rtac/funding/grants/datasafe.htm http://www.nichd.nih.gov/funding/datasafety.htm http://www.nida.nih.gov/Funding/DSMBSOP.html http://www.nidcr.nih.gov/research/ctp/data_safety_monitoring_boards.pdf http://www.niddk.nih.gov/patient/patient.htm#policy http://www.nimh.nih.gov/research/safetymonitoring.cfm http://www.ninds.nih.gov/funding/ninds_patient_safety_guidelines.htm
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Dual Review System for Grant Applications First Level of Review Scientific Review Group (SRG)  Provides Initial Scientific Merit  Review of Grant Applications  Rates Applications and Makes Recommendations for Appropriate Level of Support and Duration of Award Second Level of Review Council        Assesses Quality of SRG Review of Grant Applications Makes Recommendation to Institute Staff on Funding Evaluates Program Priorities and Relevance Advises on Policy
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It’s really not this bad! Office Officeofofthe theDirector Director National NationalInstitute Institute on onAging Aging National NationalInstitute Institute on onAlcohol AlcoholAbuse Abuse and andAlcoholism Alcoholism National NationalInstitute Institute ofofAllergy Allergyand and Infectious InfectiousDiseases Diseases National NationalInstitute Institute ofofArthritis Arthritisand and Musculoskeletal Musculoskeletal and andSkin SkinDiseases Diseases National NationalCancer Cancer Institute Institute Eunice EuniceKennedy Kennedy Shriver ShriverNational NationalInstitute Institute ofofChild ChildHealth Healthand and Human HumanDevelopment Development National NationalInstitute Instituteon on Deafness Deafnessand andOther Other Communication Communication Disorders Disorders National NationalInstitute Institute ofofDental Dentaland and Craniofacial Craniofacial Research Research National NationalInstitute Institute ofofDiabetes Diabetesand and Digestive Digestiveand and Kidney Diseases Kidney Diseases National NationalInstitute Institute on onDrug DrugAbuse Abuse National NationalInstitute Institute ofofEnvironmental Environmental Health Sciences Health Sciences National NationalEye Eye Institute Institute National NationalInstitute Institute ofofGeneral General Medical Sciences Medical Sciences National NationalHeart, Heart, Lung, Lung,and andBlood Blood Institute Institute National NationalHuman Human Genome GenomeResearch Research Institute Institute National NationalInstitute Institute ofofMental MentalHealth Health National NationalInstitute Institute ofofNeurological Neurological Disorders Disordersand and Stroke Stroke National NationalInstitute Institute ofofNursing NursingResearch Research National NationalCenter Center for forComplementary Complementary and Alternative and Alternative Medicine Medicine John JohnE. E.Fogarty Fogarty International International Center Center National NationalCenter Center for forResearch Research Resources Resources National NationalLibrary Library ofofMedicine Medicine National NationalInstitute Instituteofof Biomedical BiomedicalImaging Imaging and andBioengineering Bioengineering Clinical ClinicalCenter Center Understanding NIH Center Centerfor for Information Information Technology Technology Slide 10 National NationalInstitute Instituteon on Minority MinorityHealth Healthand and Health Disparities Health Disparities Center Centerfor for Scientific ScientificReview Review 8 November 2017
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Scientific Review Process Dual Review System for Grant Applications First Level of Review : CSR/Institute Review Scientific Review Group (SRG) (Study Section) Second Level of Review NIH Institute/Center Council
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NIH Review Process NIH Center for Scientific Review (CSR) Application DRR Funding Institute(s ) Scientific Review Group • Scientific Focus & Mission Relevance • Program Officials Council • Initial review groups • Scientific review groups IC Director DRR – CSR Division of Receipt and Referral Council – Advisory Council/Board of the funding institute IC Director – Institute/Center Director Understanding NIH Slide 16 8 November 2018
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The NIH Peer Review Process To Request a Scientific Review Group • Cover letter of application Not all requests – Application title can be honored. – 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 SRG rosters are posted 30 days before the SRG meeting: http://era.nih.gov/roster/index.cfm http://www.csr.nih.gov/committees/rosterindex.asp 6 6
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National Institutes of Health Office Officeof ofthe theDirector Director National NationalInstitute Institute on onAging Aging National NationalInstitute Institute on onAlcohol AlcoholAbuse Abuse and andAlcoholism Alcoholism National NationalInstitute Institute of ofAllergy Allergyand and Infectious InfectiousDiseases Diseases National NationalInstitute Institute of ofArthritis Arthritisand and Musculoskeletal Musculoskeletal and andSkin SkinDiseases Diseases National NationalCancer Cancer Institute Institute National NationalInstitute Institute of ofChild ChildHealth Health and andHuman Human Development Development National NationalInstitute Instituteon on Deafness Deafnessand andOther Other Communication Communication Disorders Disorders National NationalInstitute Institute of ofDental Dentaland and Craniofacial Craniofacial Research Research National NationalInstitute Institute of ofDiabetes Diabetesand and Digestive Digestiveand and Kidney KidneyDiseases Diseases National NationalInstitute Institute on onDrug DrugAbuse Abuse National NationalInstitute Institute of ofEnvironmental Environmental Health HealthSciences Sciences National NationalEye Eye Institute Institute National NationalInstitute Institute of ofGeneral General Medical MedicalSciences Sciences National NationalHeart, Heart, Lung, Lung,and andBlood Blood Institute Institute National NationalHuman Human Genome GenomeResearch Research Institute Institute National NationalInstitute Institute of ofMental MentalHealth Health National NationalInstitute Institute of ofNeurological Neurological Disorders Disordersand and Stroke Stroke National NationalInstitute Institute of ofNursing NursingResearch Research National NationalInstitute Instituteof of Biomedical BiomedicalImaging Imaging and andBioengineering Bioengineering National NationalCenter Center for forComplementary Complementary and andAlternative Alternative Medicine Medicine Fogarty Fogarty International International Center Center National NationalCenter Center for forResearch Research Resources Resources National NationalLibrary Library of ofMedicine Medicine National NationalCenter Centeron on Minority Health Minority Healthand and Health HealthDisparities Disparities Clinical ClinicalCenter Center Center Centerfor for Information Information Technology Technology Center for Scientific Review
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National Institutes of Health Office of Extramural Research Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke Fogarty International Center National Center for Research Resources National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine NIH Clinical Center Center for Information Technology National Library of Medicine Center for Scientific Review National Institute of Nursing Research National Institute of Biomedical Imaging and Bioengineering No funding authority3
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NSU’s NSU’s 17 17 Academic Academic Institutes Institutes  Brief Therapy Institute  Lifelong Learning Institute  Community Resolution Services  National Coral Reef Institute  Criminal Justice Institute Brief Therapy Institute   The Eye Institute Community Resolution Services  Options National Coral Reef Institute  Guy Harvey Research Institute Criminal Justice Institute     Hudson The EyeInstitute Instituteof Entrepreneurship and Executive Education Guy Harvey Research Institute  Institute of Trauma and Victimization Hudson Institute of International Institute Franchise Entrepreneurship andfor Executive  Education Education  Southeast Rumbaugh-Goodwin Institute for Institute for Cross-  Institute of Trauma and Victimization   Tyler Institute Institute The Language  International Institute for Franchise Education   Women’s Tyler Institute Resource       National Lifelong Learning Institute Institute for Educational Rumbaugh-Goodwin Institute for National Institute for Educational Cancer Research Options CancerCounseling Research Cultural Southeast Institute for Cross South Florida Ocean Cultural Counseling Measurement Center  South Florida Ocean The LanguageCenter Institute Measurement Institute Women’s Resource Institute
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The NIH Peer Review Process Application received – CSR* Assignments made   Initial peer review Funding considerations SRG; study section Institutes or Centers (ICs) IC or CSR* Duals possible Scientific Review Officer Program Officer   Second level of review  Funding decisions Council or Board (IC) IC Director  Award! *CSR = NIH Center for Scientific Review 4 4
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RDA Responsibilities Post – Award / Compliance Obtain approval/signatures on all post-award grant documents through execution of LSC approval process Serve as primary point of contact for grant documents, negotiations and correspondence with grant funders and auditors In conjunction with Grants Accounting, monitor LSC subrecipients to ensure proper documentation of transactions and follow up of rules and regulations Ensure compliance of post-award documents with applicable rules and regulations as well as LSC policies and procedures Collect and submit audit documents prepared by the grant program team Work with the grant program team, RDA Development and all affected departments to design and submit continuation funding proposals Conduct mock interviews to prepare the grant program team for external audit meetings Summarize the approved grant proposal, grant contract, and applicable rules into Deliverables Worksheets that support and facilitate grant orientation and grant management Communicate to Grants Accounting the approved grant budget and relevant information to establish the grant budget in iStar Make formal applications for amendments, including no-cost extensions, budget revisions, and modification of terms of award Conduct internal checks to ensure grant programs adhere to grant management requirements (ie.: desk reviews, time & effort checks, etc.) Administer LSC IRB*applications and ensure LSC IRB has the required representation and maintains appropriate records *IRB: Institutional Review Board Provide technical assistance to the grant program team to review regulations, answer questions, and resolve issues related to their grants Retain post-award grant documents and applicable notes in ServiceNow for LSC records
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The NIH Peer Review Process Streamlining • Score order of review – SRG discusses most meritorious applications first – Entire SRG decides when to stop, which applications will not be discussed in panel • Other order of review (e.g., IC assignment, mechanism) – SRO prepares a list of average preliminary scores – Distributes to SRG – Entire SRG decides which applications to discuss 29 29
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Decision Making – An Example Performing Comparisons JavaScript, by Dr. Khalil 12
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Review System for Grants 1st level Scientific Review Group (SRG) • Independent outside review • Evaluate scientific merit, significance • Recommend length and level of Output: Priority Score and funding Summary Statement 3 - 7 months Output: Funding Recommendations 2nd level Advisory Council • • • • assess quality of SRG process offers recommendation to Institute Staff evaluates program priorities and relevance advises on policy 1 - 3 months Institute Director Output: Awards or Resubmission • makes final decision based on Council input, programmatic priorities • Must also Pass Administrative Review Attend “A Peer into the NIH Review Process” at 10:30am today. Data Source: NIH Office of Budget
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Review System for Grants 1st level Scientific Review Group (SRG) • Independent outside review • Evaluate scientific merit, significance • Recommend length and level of Output: Priority Score and funding Summary Statement 3 - 7 months Output: Funding Recommendations 2nd level Advisory Council • • • • assess quality of SRG process offers recommendation to Institute Staff evaluates program priorities and relevance advises on policy 1 - 3 months Institute Director Output: Awards or Resubmission • makes final decision based on Council input, programmatic priorities • Must also Pass Administrative Review Attend “A Peer into the NIH Review Process” at 10:30am today. Data Source: NIH Office of Budget
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Organizational Structure of NIH Office of the Director http://www.nih.gov/ic d National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering No funding authority 18 18
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The NIH Peer Review Process NIH Scoring System • Preliminary scores (before the SRG meeting) – Entered by assigned reviewers and discussants in secure website – Made available to other SRG members • Final overall impact/priority scores (at the SRG meeting) – Voted by private ballot – All eligible SRG members vote Reviewers are instructed to revise their criterion scores after the meeting. 26 26
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RDA Responsibilities Obtain approval/signatures to develop grant programs as per LSC policies Submit completed grant programs to the funders and execute LSC approval process Work collaboratively with all stakeholders to develop grant budgets that support the program design and meet RFP requirements Provide technical advise to the grant program team regarding rules, regulations and requirements as per grant RFP and other documents Pre – Award / Grant Development Transform data, research, and program team discussion into a proposal that meets grantor’s specifications Facilitate the development of grant program evaluation plans in conjunction with the grant program team, as per RFP guidelines Work with the grant program team, RDA Compliance and all affected departments to design and submit continuation funding proposals Provide support and technical guidance on LSC policies and procedures for grant partnerships Inform the grant program team of costs-share requirements, and document/obtain approvals of costshare sources when applicable Facilitate the screening and identification of qualified external evaluators based on RFP guidelines and LSC policies and procedures Provide technical support to the grant program team with the development of all components of the grant application and supplemental documents Work with the grant program team in the draft of letters of support for designated partners when applicable Retain pre-award grant documents and applicable notes in ServiceNow for LSC records
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A Mock Student “Learning” Schedule incorporating the Study Cycle Your Practice Schedule Time M T W T F 6:00 AM Wake up Wake up Wake up Wake up Wake up Sat Sun Wake up Wake up Vol Church Vol Church 7:00 AM 8:00 AM English 9:00 AM Math Biology Math 10:00 AM Review Biology Review 11:00 AM English Review English Math Biology Review Review 12:00 PM Lunch Lunch Lunch Lunch Lunch Lunch Church 1:00 PM History Chemistry History Chemistry History Study Lunch 2:00 PM Lab1 Chemistry Lab2 Chemistry Review Study Study 3:00 PM Lab1 Review Lab2 Review Study Study Study 4:00 PM Lab1 Lab2 Study Study Study 5:00 PM Review Review Study Fun Study 6:00 PM Dinner Dinner Dinner Dinner Dinner Fun Dinner 7:00 PM Study Study Study Study Fun Fun House 8:00 PM Study Study Study Study Fun Fun House 9:00 PM Study Study Study Study Fun Fun House 10:00 PM Preview Preview Preview Preview Fun Fun Preview 11:00 PM Sleep Sleep Sleep Sleep Sleep Sleep Sleep
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The NIH Peer Review Process Pre-Meeting SRG Procedures • SRO – Performs administrative review of applications – Recruits reviewers, arranges for meeting date and site – Assigns 3 SRG members to each application – Makes applications available to reviewers • Internet Assisted Review (IAR) site or on CDs • Usually about six weeks before the SRG meeting – Instructs reviewers in review procedures – Monitors posting of initial scores and critiques in IAR Documents for Reviewers are available at: http://grants.nih.gov/grants/peer/reviewer_guidelines.htm#general_guidelines 30 30
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After submission, at NIH grant receipt, referral, and review  Center for Scientific Review (CSR) reviews & triages grants  Grant is assigned an Institute  Then assigned a Peer review committee that may be organized through CSR or IC  Grant given a number that will stay with the project (1 HL number-01)  Once assigned to a Review Committee, the Scientific Review Officer (SRO), an NIH employee, reviews applications & selects pertinent reviewers
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