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OHRP: Activities, Staffing, and Budget

OHRP: Activities, Staffing, and Budget. Ivor Pritchard, Ph.D. Senior Advisor to the Director Office for Human Research Protections (OHRP) Ivor.Pritchard@hhs.gov October 27, 2008. Office for Human Research Protections (OHRP). Education and Development FY 2008. Regional Conferences (3)

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OHRP: Activities, Staffing, and Budget

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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) Ivor.Pritchard@hhs.gov October 27, 2008

  2. Office for Human Research Protections (OHRP)

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

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

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

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

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

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

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

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

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

  12. OHRP Compliance Oversight ActivitiesSite Visits – 1990-2007 Year

  13. OHRP Compliance Oversight ActivitiesNew Cases Initiated – 1990-2007 Year

  14. OHRP Compliance Oversight ActivitiesSuspend/Restrict Assurance – 1990-2007 Year

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

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

  17. SACHRP FY 2008 • SACHRP 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) • Ex-officio Meetings (6) • Teleconferences

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

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

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

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

  22. OHRP Budget

  23. OHRP Dollars Over Time

  24. OHRP Budget Over Time

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