1 OHRP: Activities, OHRP: Activities, Staffing, and Budget Staffing, and Budget Ivor Pritchard, Ph.D. Ivor Pritchard, Ph.D. Senior Advisor to the Senior Advisor to the Director Director Office for Human Research Office for Human Research Protections (OHRP) Protections (OHRP) [email protected][email protected]October 27, 2008 October 27, 2008
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1 OHRP: Activities, Staffing, and Budget Ivor Pritchard, Ph.D. Senior Advisor to the Director Office for Human Research Protections (OHRP) [email protected].
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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)
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
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
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