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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)

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Presentation on theme: "1 OHRP: Activities, Staffing, and Budget Ivor Pritchard, Ph.D. Senior Advisor to the Director Office for Human Research Protections (OHRP)"— Presentation transcript:

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

2 2 Office for Human Research Protections (OHRP) Director Education and Development Compliance Oversight Policy and Assurances Secretary’s Advisory Committee

3 3 Education and Development FY 2008 Regional Conferences (3) Regional Conferences (3) Quality Assurance Meetings (8 full-day, 9 half- day) Quality Assurance Meetings (8 full-day, 9 half- day) Other Meeting Presentations (~45) Other Meeting Presentations (~45) Information/Clarification Requests (~1200 calls, ~1200 direct replies, ~400 referred s) Information/Clarification Requests (~1200 calls, ~1200 direct replies, ~400 referred s) Educational Video Development Educational Video Development

4 4 Education and Development Staff Elyse Summers - Acting Division Director Elyse Summers - Acting Division Director Lyndi Lahl - Education/Quality Improvement Lyndi Lahl - Education/Quality Improvement Freda Yoder - Education/Quality Improvement Freda Yoder - Education/Quality Improvement Kevin Nellis - Education/Quality Improvement Kevin Nellis - Education/Quality Improvement Michelle Feige - Education/Quality Improvement Michelle Feige - Education/Quality Improvement Darlene Ross – Executive Secretary, Human Subjects Research Subcommittee Darlene Ross – Executive Secretary, Human Subjects Research Subcommittee Lannette Myers (Division Support) Lannette Myers (Division Support)

5 5 Policy and Assurances Assurances and IRB registration Assurances and IRB registration Regulatory Activity Regulatory Activity Guidance Activity Guidance Activity Other Activities Other Activities

6 6 Assurances and IRB Registration Active Federalwide Assurances: 10,419 (10/18/08) Active Federalwide Assurances: 10,419 (10/18/08) Active Registered IRBs: 6,190 (10/18/08) Active Registered IRBs: 6,190 (10/18/08) Meeting Information Collection Requirements (4 Notices) Meeting Information Collection Requirements (4 Notices)

7 7 Policy and Assurances: Pending Guidance Engagement Engagement Definition of “Research” Definition of “Research” Conditional Approval Conditional Approval IRB FAQs IRB FAQs Discontinuation of Subject Participation Discontinuation of Subject Participation Other Projects Other Projects

8 8 Regulatory Activity IRB Registration Rule IRB Registration Rule Educational Requirement Educational Requirement Accountability of External IRBs Accountability of External IRBs Expedited Review Categories Expedited Review Categories Adults with Impaired Decision- making Capacity Adults with Impaired Decision- making Capacity Other Projects…. Other Projects….

9 9 Other Activities (FY2008) Prisoner Research Certifications (~120) Prisoner Research Certifications (~120) 407 Children’s research review panels (0) 407 Children’s research review panels (0) OHRP Correspondence OHRP Correspondence Information/clarification requests Information/clarification requests Media Contacts/Interviews (>100) Media Contacts/Interviews (>100) Meeting presentations (14) Meeting presentations (14)

10 10 Policy and Assurances Staff Irene Stith-Coleman - Division Director Irene Stith-Coleman - Division Director Harold Blatt - Assurances/IRB Registrations Harold Blatt - Assurances/IRB Registrations Charmaine Anderson - Assurances/IRB Registrations Charmaine Anderson - Assurances/IRB Registrations Jean Makle - Assurances/IRB Registrations Jean Makle - Assurances/IRB Registrations Billy Miller - Assurances/IRB Registrations Billy Miller - Assurances/IRB Registrations Julie Kaneshiro – Policy Team Leader Julie Kaneshiro – Policy Team Leader Glen Drew - Policy Glen Drew - Policy [Vacancy] – Policy [Vacancy] – Policy Patricia El-Hinnawy – Public Affairs Patricia El-Hinnawy – Public Affairs Barry Bowman – Division Support Barry Bowman – Division Support Gail Carter – Division Support Gail Carter – Division Support

11 11 Compliance Oversight Site Visits Site Visits New Cases New Cases Restrict/Suspend Assurances Restrict/Suspend Assurances FY 08 Activities FY 08 Activities

12 12 OHRP Compliance Oversight Activities Site Visits – Year

13 13 OHRP Compliance Oversight Activities New Cases Initiated – Year

14 14 OHRP Compliance Oversight Activities Suspend/Restrict Assurance – Year

15 15 Compliance Oversight FY 2008 New For-Cause Cases Opened (9) New For-Cause Cases Opened (9) New Not-for-Cause Evaluations (1 Site Visit, 3 Paper Evaluations) New Not-for-Cause Evaluations (1 Site Visit, 3 Paper Evaluations) Determination Letters (38) Determination Letters (38) Processed and Closed Incident Reports (922) Processed and Closed Incident Reports (922) Meeting Presentations (14) Meeting Presentations (14)

16 16 Compliance Oversight Staff Kristina Borror, Division Director Kristina Borror, Division Director Lisa Rooney – Compliance Oversight Lisa Rooney – Compliance Oversight Paul Andreason – Compliance Oversight Paul Andreason – Compliance Oversight Lisa Buchanan – Compliance Oversight Lisa Buchanan – Compliance Oversight Carol Weil – Compliance Oversight Carol Weil – Compliance Oversight Jamie Gulin – Compliance Oversight Jamie Gulin – Compliance Oversight

17 17 SACHRP FY 2008 SACHRP meetings (3) SACHRP meetings (3) Subcommittee on Subpart A – Common Rule Meetings (3) Subcommittee on Subpart A – Common Rule Meetings (3) Subcommittee on the Inclusion of Individuals with Impaired Decision-making Capacity in Research Meetings (3) Subcommittee on the Inclusion of Individuals with Impaired Decision-making Capacity in Research Meetings (3) Ex-officio Meetings (6) Ex-officio Meetings (6) Teleconferences Teleconferences

18 18 SACHRP Staff Julia Gorey – Executive Director Julia Gorey – Executive Director Cecilia Chirinos – Administrative Support Cecilia Chirinos – Administrative Support

19 19 Office of the Director Budget and Management Oversight Budget and Management Oversight International Program (3 workshops, International Laws/Rules Compilation) International Program (3 workshops, International Laws/Rules Compilation) Interagency Human Subjects Research Subcommittee Interagency Human Subjects Research Subcommittee Meeting Presentations (~60) Meeting Presentations (~60)

20 20 Office of the Director Staff Jerry Menikoff - Director Jerry Menikoff - Director Melody Lin - Deputy Director Melody Lin - Deputy Director Michael Carome - Associate Director Michael Carome - Associate Director Ed Bartlett - International Ed Bartlett - International Toni Goodwin – Administrative Support Toni Goodwin – Administrative Support Carla Brown – Administrative Support Carla Brown – Administrative Support Ivor Pritchard – Senior Advisor to the Director Ivor Pritchard – Senior Advisor to the Director

21 21 Non-OHRP Staff Laura Odwazny – Office of the General Counsel Laura Odwazny – Office of the General Counsel Shirley Beckford – Office of Public Health and Science Administrative Resource Center Shirley Beckford – Office of Public Health and Science Administrative Resource Center Annephia Proctor - Office of Public Health and Science Administrative Resource Center Annephia Proctor - Office of Public Health and Science Administrative Resource Center

22 22 OHRP Budget Fiscal Year S & B OverheadProgramTotal FY ,100,000800,000900,0005,800,000 FY ,946,2861,649,9361,406,1487,002,370 FY ,672,1031,382,8001,450,0977,505,000 FY ,085,2521,372,0001,817,4957,274,748 FY ,424,5461,450,0001,466,9907,341,536 FY ,164,8741,360,0001,388,6886,913,560 FY ,431,0001,372,5001,035,5006,839,000 FY ,245,7001,289,2001,128,1006,663,000 FY ,686,0001,390,000625,0006,701,000

23 23 OHRP Dollars Over Time

24 24 OHRP Budget Over Time


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