1. Office of Research Oversight 1 Office of Research and Development Local Accountability Meeting January 2009

2. Office of Research Oversight 2 Mission and Challenges VHA Handbook 1058.01: Reporting Research Events

3. Office of Research Oversight 3 Advise Under Secretary for Health Monitor / Review / Investigate Compliance – Protection of Human Subjects – Laboratory Animal Welfare – Research Safety & Research Security – Research Information Security – Research Misconduct

4. Office of Research Oversight 4 Regional Offices Northeastern Bedford, MA VISNs 1, 2, 3 Midwestern Hines, IL VISNs 11, 12, 15, 19, 23 Western Loma Linda, CA VISNs 18, 20, 21, 22 Southern Atlanta, GA VISNs 7, 8, 16, 17 Mid-Atlantic Washington, DC VISNs 4, 5, 6, 9, 10

5. Office of Research Oversight 5 Trends in Research Compliance Increasing Challenges for Program Oversight (CY2006  Present) – Facility Director Leadership – Facility-Level Program Oversight – Auditing and Monitoring to Enhance Compliance – Aging Infrastructure – Relationships with Academic Affiliates

6. Office of Research Oversight 6 Action Plans: Meeting Current Challenges Facility Director Leadership  Leadership & Accountability Training (ORD) – Mandatory Attendance (January 2009)  Annual Certification of Research Oversight (ORO) – Began July 1, 2007 (ORO)

7. Office of Research Oversight 7 Action Plans: Meeting Current Challenges Facility-Level Program Oversight  Research Administrative Review (ORD) – Define Roles & Accountability for ACOS/R, AO/R, R&D Committee  Leadership & Accountability Training (ORD) – Mandatory Attendance (January 2009)  Facility Investigator Training Program Required

8. Office of Research Oversight 8 Action Plans: Meeting Current Challenges Auditing & Monitoring  Facility Research Compliance Officer Required – Effective December 31. 2008 (detailed or permanent) – Must Report to Facility Director (Mandatory) – Direct Reporting of Non-Compliance to ORO  Annual 100% Audit of Informed Consent  Tri-Annual Regulatory Audit of all Protocols  Audit Results Reported to ORO  Add Audit Monitoring to ORO On-Site Reviews  Research Compliance Officer Training (ORO)

9. Office of Research Oversight 9 Aging Infrastructure  Infrastructure Review (ORD)  Research Allocation Review (ORD, Finance, 10N)  ORD Research Administration IT Solution Work Group Action Plans: Meeting Current Challenges

10. Office of Research Oversight 10 Action Plans: Meeting Current Challenges Relationships with Academic Affiliates  AAMC – VA Working Group  VHA – OGC – OI&T Working Group – Use of Oversight Committees – Research Service Responsibilities – Data Ownership – Data Storage and Use

11. Office of Research Oversight 11 ORO On-Site Program Reviews (Human, Animal, Safety, Info Sec, etc) CY03 CY04 CY05 CY06 CY07 CY08 100 75 50 25 1922 45 33 95 97

12. Office of Research Oversight 12 Facility-Identified Noncompliance CY03 CY04 CY05 CY06 CY07 CY08 200 150 100 50 68 90 49 177 66 201

13. Office of Research Oversight 13 Replaces All Previous ORO Reporting Requirements – Human Research – Animal Research – Research Safety – Research Laboratory Security – Research Information Protection Includes Reporting: – Within the Facility – To ORO New Definitions and Reporting for Human Research – Unanticipated Problems / Serious Adverse Events – Serious of Continuing Noncompliance VHA Handbook 1058.01: Reporting Research Events

14. Office of Research Oversight 14 New Definitions Administrative Hold. A voluntary interruption of research enrollments and/or ongoing research activities. Does not apply to interruptions of research related to concerns regarding: – The safety, rights, or welfare of human research subjects, research investigators, research staff, or others; or – The safety or welfare of laboratory animals. VHA Handbook 1058.01: Reporting Research Events

15. Office of Research Oversight 15 New Definitions Serious Noncompliance. Failure to adhere to the laws, regulations, or policies governing VA research that: –Results in substantive harm or damage (or risk of substantive harm or damage) to the safety, rights, or welfare of human subjects, research staff or others; or –Results in substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals; or –Substantively compromises the integrity or effectiveness of research protections, either systemically or relative to a particular protocol or project. VHA Handbook 1058.01: Reporting Research Events

16. Office of Research Oversight 16 New Definitions Serious AE (SAE) / Serious Problem. An AE or problem that involves or results in: –Death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect; or –Substantive harm or damage (or risk of substantive harm or damage) to the safety, rights, or welfare of research subjects, research staff; or –Substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals; or –The need for medical, surgical, behavioral, social, or other intervention to prevent any of the above. VHA Handbook 1058.01: Reporting Research Events

17. Office of Research Oversight 17 New Definitions Continuing Noncompliance. Persistent or repeated failure to satisfy VA or other federal research requirements, – Either in the past or extending into the present. Unanticipated Problem in Research. Any problem in research that is not expected – In terms of nature, severity, or frequency of occurrence – As documented in the protocol or other materials approved by the R&DC, IRB, IACUC, etc. – For human research, may include the informed consent document, clinical investigators’ brochure, product labeling, etc. VHA Handbook 1058.01: Reporting Research Events

18. Office of Research Oversight 18 General Requirements Facility Director must report to ORO: – Within 5 business days of being informed of a reportable event – Report must be in writing and signed – Report required whether or not event has been resolved – Followup reports as required by ORO VHA Handbook 1058.01: Reporting Research Events

19. Office of Research Oversight 19 Human Research Unanticipated Problems Involving Risks (Subjects/Others): Must be reported to the IRB and ACOS/R within 5 business days of discovery Unanticipated problems include: – Interruptions of research due to concerns about safety, rights, or welfare of subjects, research personnel, or others – Work-related injuries requiring more than minor medical intervention or lead to serious injury or death – Any PBM Alerts related to a facility research project – All Unanticipated Serious Adverse Events VHA Handbook 1058.01: Reporting Research Events

20. Office of Research Oversight 20 IRB Review of Unanticipated Problems and SAEs: Within 5 business days of report, a designated voting IRB Member/Reviewer (or the convened IRB) must: Determine and document whether event is related, possibly related, or unrelated to the research. If related or possibly related, must determine that event is: – Not Serious, No Action Required – Not Serious, But Minor Changes Needed via Expedited Review. – Serious, Immediate Action Needed to Prevent Harm, Report to Facility Director within 5 business days, Refer to Convened IRB Review for Resolution – Serious, but Immediate Action Not Needed to Prevent Harm, Report to Facility Director within 5 business days, Refer to Convened IRB Review for Resolution VHA Handbook 1058.01: Reporting Research Events

21. Office of Research Oversight 21 Serious or Continuing Noncompliance Must be reported to the IRB and ACOS/R within 5 business days of discovery If IRB determines serious or continuing noncompliance occurred, must be reported to Facility Director within 5 business days. If discovered during an RCO informed consent or regulatory audit, must be reported with 5 business days to: – Facility Director – ACOS/R – IRB for Review and Resolution – R&D Committee VHA Handbook 1058.01: Reporting Research Events

22. Office of Research Oversight 22 Report to ORO Regional Office Problems (including AEs) Involving Risks to Subjects or Other that are – Serious and Unanticipated and Related (or Possible Related) to the Research Serious or Continuing Noncompliance – If identified by an RCO informed consent or regulatory audit, must also be reported to VISN Director and CRADO Suspensions or Terminations of IRB approval VHA Handbook 1058.01: Reporting Research Events

23. Office of Research Oversight 23 Report to ORO Central Office (Copy to ORO Regional Office) Assurance Changes IRB Changes MOU Changes Accreditation Problems VHA Handbook 1058.01: Reporting Research Events

24. Office of Research Oversight 24 Comparable Reporting Required for: – Animal Welfare – Research Safety – Research Laboratory Security – Research Information Protection – Alleged Research Misconduct Handbook Includes Summary Tables and Decision Charts to aid in facility decision making Local SOPs Required for All Required Internal and External Reporting VHA Handbook 1058.01: Reporting Research Events

25. Office of Research Oversight 25 http://www.1.va.gov/oro/ 1717 H Street, NW, Suite 500 (10R) Washington, D.C. 20420 PHONE: (202) 266-4577