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OHRP: Activities, Staffing, OHRP: Activities, Staffing, and Budget and Budget
Ivor Pritchard, Ph.D.Ivor Pritchard, Ph.D.Senior Advisor to the Director Senior Advisor to the Director
Office for Human Research Protections Office for Human Research Protections (OHRP)(OHRP)
[email protected]@hhs.gov
October 27, 2008October 27, 2008
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Office for Human Research Protections Office for Human Research Protections (OHRP)(OHRP)
Director
Education and
Development
Compliance Oversight
Policy and
Assurances
Secretary’s Advisory Committee
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Education and DevelopmentEducation and DevelopmentFY 2008FY 2008
Regional Conferences (3)Regional Conferences (3) Quality Assurance Meetings (8 full-day, 9 half-Quality Assurance Meetings (8 full-day, 9 half-
day)day) Other Meeting Presentations (~45)Other Meeting Presentations (~45) Information/Clarification Requests (~1200 Information/Clarification Requests (~1200
calls, ~1200 email direct replies, ~400 referred calls, ~1200 email direct replies, ~400 referred emails)emails)
Educational Video DevelopmentEducational Video Development
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Education and Development StaffEducation and Development Staff
Elyse Summers - Acting Division DirectorElyse Summers - Acting Division Director Lyndi Lahl - Education/Quality ImprovementLyndi Lahl - Education/Quality Improvement Freda Yoder - Education/Quality Improvement Freda Yoder - Education/Quality Improvement Kevin Nellis - Education/Quality ImprovementKevin Nellis - Education/Quality Improvement Michelle Feige - Education/Quality ImprovementMichelle Feige - Education/Quality Improvement Darlene Ross – Executive Secretary, Human Darlene Ross – Executive Secretary, Human
Subjects Research SubcommitteeSubjects Research Subcommittee Lannette Myers (Division Support)Lannette Myers (Division Support)
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Policy and AssurancesPolicy and Assurances
Assurances and IRB registrationAssurances and IRB registrationRegulatory ActivityRegulatory ActivityGuidance ActivityGuidance ActivityOther ActivitiesOther Activities
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Assurances and Assurances and IRB RegistrationIRB Registration
Active Federalwide Assurances: Active Federalwide Assurances: 10,419 (10/18/08)10,419 (10/18/08)
Active Registered IRBs: 6,190 Active Registered IRBs: 6,190 (10/18/08)(10/18/08)
Meeting Information Collection Meeting Information Collection Requirements (4 Notices)Requirements (4 Notices)
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Policy and Assurances: Policy and Assurances: Pending GuidancePending Guidance
EngagementEngagement Definition of “Research”Definition of “Research” Conditional ApprovalConditional Approval IRB FAQsIRB FAQs Discontinuation of Subject ParticipationDiscontinuation of Subject Participation Other ProjectsOther Projects
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Regulatory ActivityRegulatory Activity IRB Registration RuleIRB Registration Rule Educational RequirementEducational Requirement Accountability of External IRBsAccountability of External IRBs Expedited Review CategoriesExpedited Review Categories Adults with Impaired Decision-Adults with Impaired Decision-
making Capacitymaking Capacity Other Projects….Other Projects….
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Other Activities (FY2008)Other Activities (FY2008) Prisoner Research Certifications (~120)Prisoner Research Certifications (~120) 407 Children’s research review panels 407 Children’s research review panels
(0)(0) OHRP CorrespondenceOHRP Correspondence Information/clarification requestsInformation/clarification requests Media Contacts/Interviews (>100)Media Contacts/Interviews (>100) Meeting presentations (14)Meeting presentations (14)
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Policy and Assurances StaffPolicy and Assurances Staff Irene Stith-Coleman - Division DirectorIrene Stith-Coleman - Division Director Harold Blatt - Assurances/IRB RegistrationsHarold Blatt - Assurances/IRB Registrations Charmaine Anderson - Assurances/IRB RegistrationsCharmaine Anderson - Assurances/IRB Registrations Jean Makle - Assurances/IRB RegistrationsJean Makle - Assurances/IRB Registrations Billy Miller - Assurances/IRB RegistrationsBilly Miller - Assurances/IRB Registrations Julie Kaneshiro – Policy Team LeaderJulie Kaneshiro – Policy Team Leader Glen Drew - PolicyGlen Drew - Policy [Vacancy] – Policy[Vacancy] – Policy Patricia El-Hinnawy – Public AffairsPatricia El-Hinnawy – Public Affairs Barry Bowman – Division SupportBarry Bowman – Division Support Gail Carter – Division SupportGail Carter – Division Support
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Compliance OversightCompliance Oversight
Site VisitsSite Visits New CasesNew Cases Restrict/Suspend AssurancesRestrict/Suspend Assurances FY 08 ActivitiesFY 08 Activities
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OHRP Compliance Oversight ActivitiesOHRP Compliance Oversight ActivitiesSite Visits – 1990-2007Site Visits – 1990-2007
0123456789
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90 93 96 99 O2 O5
Site Visits
Year
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OHRP Compliance Oversight ActivitiesOHRP Compliance Oversight Activities
New Cases Initiated – 1990-2007New Cases Initiated – 1990-2007
0102030405060708090
100
90 93 96 99 O2 O5
New Cases
Year
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OHRP Compliance Oversight ActivitiesOHRP Compliance Oversight ActivitiesSuspend/Restrict Assurance – 1990-2007Suspend/Restrict Assurance – 1990-2007
0102030405060708090
100
90 93 96 99 O2 O5
SuspendAssuranceRestrictAssurance
Year
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Compliance Oversight FY 2008Compliance Oversight FY 2008
New For-Cause Cases Opened (9) New For-Cause Cases Opened (9) New Not-for-Cause Evaluations (1 New Not-for-Cause Evaluations (1
Site Visit, 3 Paper Evaluations)Site Visit, 3 Paper Evaluations) Determination Letters (38)Determination Letters (38) Processed and Closed Incident Processed and Closed Incident
Reports (922)Reports (922) Meeting Presentations (14)Meeting Presentations (14)
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Compliance Oversight StaffCompliance Oversight Staff
Kristina Borror, Division DirectorKristina Borror, Division Director Lisa Rooney – Compliance OversightLisa Rooney – Compliance Oversight Paul Andreason – Compliance OversightPaul Andreason – Compliance Oversight Lisa Buchanan – Compliance OversightLisa Buchanan – Compliance Oversight Carol Weil – Compliance OversightCarol Weil – Compliance Oversight Jamie Gulin – Compliance OversightJamie Gulin – Compliance Oversight
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SACHRP FY 2008SACHRP FY 2008 SACHRP meetings (3)SACHRP meetings (3) Subcommittee on Subpart A – Common Rule Subcommittee on Subpart A – Common Rule
Meetings (3)Meetings (3) Subcommittee on the Inclusion of Individuals Subcommittee on the Inclusion of Individuals
with Impaired Decision-making Capacity in with Impaired Decision-making Capacity in Research Meetings (3)Research Meetings (3)
Ex-officio Meetings (6)Ex-officio Meetings (6) TeleconferencesTeleconferences
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SACHRP StaffSACHRP Staff
Julia Gorey – Executive DirectorJulia Gorey – Executive Director Cecilia Chirinos – Administrative SupportCecilia Chirinos – Administrative Support
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Office of the Director Office of the Director
Budget and Management OversightBudget and Management Oversight International Program (3 workshops, International Program (3 workshops,
International Laws/Rules Compilation)International Laws/Rules Compilation) Interagency Human Subjects Research Interagency Human Subjects Research
Subcommittee Subcommittee Meeting Presentations (~60)Meeting Presentations (~60)
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Office of the Director StaffOffice of the Director Staff
Jerry Menikoff - DirectorJerry Menikoff - Director Melody Lin - Deputy DirectorMelody Lin - Deputy Director Michael Carome - Associate DirectorMichael Carome - Associate Director Ed Bartlett - InternationalEd Bartlett - International Toni Goodwin – Administrative SupportToni Goodwin – Administrative Support Carla Brown – Administrative SupportCarla Brown – Administrative Support Ivor Pritchard – Senior Advisor to the DirectorIvor Pritchard – Senior Advisor to the Director
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Non-OHRP StaffNon-OHRP Staff
Laura Odwazny – Office of the General Laura Odwazny – Office of the General CounselCounsel
Shirley Beckford – Office of Public Health Shirley Beckford – Office of Public Health and Science Administrative Resource Centerand Science Administrative Resource Center
Annephia Proctor - Office of Public Health Annephia Proctor - Office of Public Health and Science Administrative Resource Centerand Science Administrative Resource Center
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OHRP BudgetOHRP Budget
Fiscal Fiscal YearYear S & BS & B OverheadOverhead ProgramProgram TotalTotal
FY 2001FY 2001 4,100,0004,100,000 800,000800,000 900,000900,000 5,800,0005,800,000
FY 2002FY 2002 3,946,2863,946,286 1,649,9361,649,936 1,406,1481,406,148 7,002,3707,002,370
FY 2003FY 2003 4,672,1034,672,103 1,382,8001,382,800 1,450,0971,450,097 7,505,0007,505,000
FY 2004FY 2004 4,085,2524,085,252 1,372,0001,372,000 1,817,4951,817,495 7,274,7487,274,748
FY 2005FY 2005 4,424,5464,424,546 1,450,0001,450,000 1,466,9901,466,990 7,341,5367,341,536
FY 2006FY 2006 4,164,8744,164,874 1,360,0001,360,000 1,388,6881,388,688 6,913,5606,913,560
FY 2007FY 2007 4,431,0004,431,000 1,372,5001,372,500 1,035,5001,035,500 6,839,0006,839,000
FY 2008FY 2008 4,245,7004,245,700 1,289,2001,289,200 1,128,1001,128,100 6,663,0006,663,000
FY 2009FY 2009 4,686,0004,686,000 1,390,0001,390,000 625,000625,000 6,701,0006,701,000
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OHRP Dollars Over Time
8879
7476
6975 75 8182
122119
2525312426
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0%
20%
40%
60%
80%
100%
FY2001
FY2002
FY2003
FY2004
FY2005
FY2006
FY2007
FY2008
FY2009
Salary/Benefit Program
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OHRP Budget Over Time
Program
Salary & Benefits
Overhead
0
1,000,000
2,000,000
3,000,000
4,000,000
5,000,000
6,000,000
7,000,000
8,000,000
FY2001
FY2002
FY2003
FY2004
FY2005
FY2006
FY2007
FY2008
FY2009