1 OHRP: Activities, Staffing, and Budget Ivor Pritchard, Ph.D. Senior Advisor to the Director Office...

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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

Transcript of 1 OHRP: Activities, Staffing, and Budget Ivor Pritchard, Ph.D. Senior Advisor to the Director Office...

Page 1: 1 OHRP: Activities, Staffing, and Budget Ivor Pritchard, Ph.D. Senior Advisor to the Director Office for Human Research Protections (OHRP) Ivor.Pritchard@hhs.gov.

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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

Page 2: 1 OHRP: Activities, Staffing, and Budget Ivor Pritchard, Ph.D. Senior Advisor to the Director Office for Human Research Protections (OHRP) Ivor.Pritchard@hhs.gov.

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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

18

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