slide1 n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Office for Protection from Research Risks (OPRR) PowerPoint Presentation
Download Presentation
Office for Protection from Research Risks (OPRR)

Loading in 2 Seconds...

play fullscreen
1 / 27
wynn

Office for Protection from Research Risks (OPRR) - PowerPoint PPT Presentation

114 Views
Download Presentation
Office for Protection from Research Risks (OPRR)
An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.

- - - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript

  1. Office for Protection from Research Risks (OPRR) Department of Health and Human Services National Institutes of Health OPRR Dissolved June, 2000

  2. Office for Human Research Protections (OHRP) Department of Health and Human Services Office of Public Health and Science Director: Greg Koski, Ph.D. M.D.

  3. OHRP Responsibilities • Implementation and interpretation of federal regulations and policy • Educational programs • Negotiation of assurances • Evaluation of compliance

  4. OHRP Electronic Access • E-mail: ohrp@osophs.dhhs.gov • Web Site: http://ohrp.osophs.dhhs.gov

  5. Federal Regulations and Policy 45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects - Subpart A Originally adopted January 13, 1981 Revised June 18, 1991 “The Common Rule” - Federal Policy for the Protection of Human Subjects June 18, 1991 Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and HHS. NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission.

  6. Food and Drug Administration Regulations: • IRB - 21 CFR 56 • Informed Consent - 21 CFR 50

  7. OHRP Organization • Office of the Director • Greg Koski – Director • Melody Lin – Deputy Director • Division of Education • Jeffrey Cohen – Director • Division of Assurance Support & Quality Improvement • George Gasparis – Acting Director • Division of Compliance Oversight • Michael Carome - Director

  8. Education

  9. Education • Presentations and Training Programs • Workshops and Town Meetings • For further information on both of the above contact Darlene Ross (dr20a@nih.gov) • Educational Materials • “IRB Guidebook” http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm • Videotape Series: "Protecting Human Subjects“ http://ohrp.osophs.dhhs.gov/references/resource.htm

  10. OHRP/FDA/VA Workshops • "Current Human Research Issues & Solutions: Regulatory Overview & Investigator/Institutional Sponsor Partnerships ", May 10-11, 2001, Newark, NJ. • "Evolving Concern for Protection of Human Subjects“, June 8, 2001, St. Louis MO. (Town Meeting) • "Current Human Research Issues & Solutions: Regulatory Overview & Hot Topics", June 21-22, 2001, Charleston, SC • "Current Human Research Issues & Solutions: Regulatory Overview & Social/Behavioral Research" July 16-17, 2001, Los Angeles, CA. • "Current Human Research Issues & Solutions: Regulatory Overview & TBD", September 20-21, 2001, Minneapolis, MN.

  11. Assurance Support & Quality Improvement

  12. OHRP Federalwide Assurance • Single Assurance Document - Federalwide Assurance (FWA) • MPAs, CPAs, SPAs, CAs, IIAs, AIIs, NIAs eliminated • FWAs will cover all of the institution’s Federally-supported human subject research. • No OHRP review of individual applications, protocols, consent documents http://ohrp.osophs.dhhs.gov/irbasur.htm

  13. OHRP Federalwide Assurance • Each legally separate institution will need its own FWA • International Standards OK • All Institutions Eligible – no longer limited to those receiving Federal funds • Web-Based Application Process • IRB Registration • Rely on own institutional IRB, other institutional IRB, commercial

  14. OHRP Federalwide Assurance • Current Status • Currently in pilot phase • FWA is voluntary • OHRP will continue to accept SPAs and CPAs • All MPAs extended until FWA becomes mandatory

  15. OHRP Federalwide Assurance • Required completion of OHRP Assurance Training Modules • The Institutional Signatory Official • The Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person) • IRB Chairperson(s) • Institutions must establish education programs for IRB members and investigators • Completion by investigators must be documented

  16. URL: ohrp-ed.nih.gov

  17. IRB/Investigator Education Recommended Features: • Ongoing • One-time presentations inadequate • Broad based • Institutional Officials • IRB members • Investigators • Staff • Not voluntary

  18. IRB/Investigator Education Content: • Ethical principles of human subject research • Requirements of the Federal regulations • Applicable state law • Provisions of Institutional Assurance • Institutional policies and procedures for the protection of human subjects

  19. Quality Improvement • Consultation to improve institutional programs of human subjects protections • Voluntary • Separate from Compliance Oversight • Multiple methodologies • Self evaluation tools • Teleconference/Videoconference consultations • Site visits

  20. Compliance Oversight

  21. Compliance Process • OHRP discovers or receives an allegation or indication of non-compliance • COMPLAINT(S) • PI, IRB MEMBER, SUBJECT, PRIVATE CITIZEN, ETC. • SELF REPORTING • INSTITUTION, PI • MEDIA • OTHER INCIDENT REPORT • FDA INSPECTION • NIH PSV REPORT • COOPERATIVE GROUP AUDIT

  22. Compliance Process • OHRP determines if it has jurisdiction • OHRP notifies institution and requests institutional response (may include additional documentation, institutional investigation and report, etc.) • OHRP may take immediate action if protection of human subjects warrants

  23. Compliance Process • OHRP evaluates institutional response • OHRP issues a report of findings OR • OHRP performs site visit

  24. Compliance Process Most compliance oversight evaluations can be resolved through correspondence with the institution and do not require an on-site review or a formal report of findings.

  25. Compliance Concerns OPRR Compliance Activities: Common Findings and Guidance http://ohrp.osophs.dhhs.gov/references/findings.pdf

  26. Overarching Concerns Does the institution support and respect the IRB and its mission? Is there a “culture of compliance”? Are IRB members and investigators knowledgeable about regulatory requirements? Is there adequate documentation of IRB findings and actions?