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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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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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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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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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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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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UA Contacts Know Your Security and Privacy Officer: • University-wide Privacy Officer: Jan Chaisson • University-wide Security Officer: Ashley Ewing • University Medical Center Privacy Officer is Jan Chaisson • University Medical Center Security Officer is Amy Sherwood • Brewer Porch Privacy/Security Officer is Warren Williams • Speech and Hearing Privacy/Security Officer is JoAnne Payne • Autism Spectrum Disorders Clinic Privacy/Security Officer is Sarah Ryan • UA Group Health Plan/FSA Privacy Officer is Emily Marbutt • UA Group Health Plan/FSA Security Officer is Greg Gaddis • WellBAMA Program Privacy/Security Officer is Heather Clayton • Working on Womanhood Program (WOW) Privacy/Security Officer is Jill Beck • Center for Advanced Public Safety (CAPS) Privacy/Security Officer is Vaughn Poe • Institutional Review Board Compliance Officer is Tanta Myles • College of Education Alabama Medicaid Agency Project Privacy/Security Officer: Rick Houser INTERNAL USE ONLY 32
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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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UA Contacts Know Your Security and Privacy Officer • University-wide Privacy Officer: Jan Chaisson • University-wide Security Officer: Ashley Ewing • University Medical Center Privacy Officer: Jan Chaisson • University Medical Center Security Officer: Amy Sherwood • Brewer Porch Privacy/Security Officer: Warren Williams • Speech and Hearing Privacy/Security Officer: JoAnne Payne • Autism Spectrum Disorders Clinic Privacy/Security Officer: Sarah Ryan • UA Group Health Plan/FSA/WellBama Privacy Officer: Emily Marbutt • UA Group Health Plan/FSA/WellBama Security Officer: Greg Gaddis • Working on Womanhood Program (WOW) Privacy/Security Officer: Jill Beck • Center for Advanced Public Safety (CAPS) Privacy/Security Officer: Vaughn Poe • Institutional Review Board Compliance Officer: Tanta Myles • College of Education Alabama Medicaid Agency Project Privacy/Security Officer: Rick Houser INTERNAL USE ONLY
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UA Contacts Know Your Security and Privacy Officer • University-wide Privacy Officer: Jan Chaisson • University-wide Security Officer: Ashley Ewing • University Medical Center Privacy Officer: Jan Chaisson • University Medical Center Security Officer: Amy Sherwood • Brewer Porch Privacy/Security Officer: Warren Williams • Speech and Hearing Privacy/Security Officer: JoAnne Payne • Autism Spectrum Disorders Clinic Privacy/Security Officer: JoAnne Payne • UA Group Health Plan/FSA Privacy Officer: Emily Marbutt • UA Group Health Plan/FSA Security Officer: Greg Gaddis • Working on Womanhood Program (WOW) Privacy/Security Officer: Jill Beck • Center for Advanced Public Safety (CAPS) Privacy/Security Officer: Vaughn Poe • Institutional Review Board Compliance Officer: Tanta Myles INTERNAL USE ONLY 32
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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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WHOM DO I CONTACT?  Before review, contact the Scientific Review Officer in CSR  After review, contact your Program Officer in the NIH funding institute or center
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NIH Funding A n n u al A p p ro p r iat o n s % G ro w t h After years of slow growth or reductions in funding, total NIH appropriations increased 7% from 2015 to 2016. Competition for funding remains high, however, with applicant success rates under 20%.  Sequestration mandated the National Institutes of Health (“NIH”) cut $1.6 B of its federal grant budget for the 2013 fiscal year; NIH appropriations did not exceed 2012 levels until 2016  Over the past 10 years, research applications have increased 14.2% to 54,220, while awards have only increased 2.7% to 10,372 35% $25,000,000 25% $15,000,000 15% $(5,000,000) 5% 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 $5,000,000 Appropriations % Growth -5% 100% 80% 40,000 60% 40% 20,000 20% 0 19 0% 97 19 99 20 Awards 01 20 03 20 05 20 07 Applications 20 09 20 11 20 13 20 15 Success Rate (%) As a result of decreasing federal funding, research departments have been forced to begin seeking alternate sources of funding, such as private industry and foundations. Source: NIH Data Book 9 © 2016 HURON CONSULTING GROUP INC. Source: NIH 2016 Data book Success Rates (%) $35,000,000 60,000 Applicatons/Awards NIH Program Funding Research Project Grants
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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/peer.htm • Center for Scientific Review http://cms.csr.nih.gov/AboutCSR/Welcome+to+CSR/ 46 46
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