Office of Research and Development

1

• Office of Research and Development
• Local Accountability Meeting
• January 2009

2

• Mission and Challenges
• VHA Handbook 1058.01 Reporting Research Events

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

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Regional Offices
Midwestern Hines, IL VISNs 11, 12, 15, 19, 23
Northeastern Bedford, MA VISNs 1, 2, 3

• Western
• Loma Linda, CA
• VISNs 18, 20, 21, 22

Mid-Atlantic Washington, DC VISNs 4, 5, 6, 9, 10

• Southern
• Atlanta, GA
• VISNs 7, 8, 16, 17

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• 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

• 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)

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• Action Plans Meeting Current Challenges

• Facility-Level Program Oversight
• ? Research Administrative Review (ORD)
• Define Roles Accountability for ACOS/R,
• AO/R, RD Committee
• ? Leadership Accountability Training (ORD)
• Mandatory Attendance (January 2009)
• ? Facility Investigator Training Program
  Required

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• 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)

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Action Plans Meeting Current Challenges

• Aging Infrastructure
• Infrastructure Review (ORD)
• Research Allocation Review (ORD, Finance, 10N)
• ORD Research Administration IT Solution Work
  Group

10

• Action Plans Meeting Current Challenges

• Relationships with Academic Affiliates
• AAMC VA Working Group
• VHA OGC OIT Working Group
• Use of Oversight Committees
• Research Service Responsibilities
• Data Ownership
• Data Storage and Use

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• ORO On-Site Program Reviews
• (Human, Animal, Safety, Info Sec, etc)

100 75 50 25
95
97
45
33
19
22
CY03 CY04 CY05 CY06 CY07 CY08
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• Facility-Identified Noncompliance

200 150 100 50
201
177
90
68
66
49
CY03 CY04 CY05 CY06 CY07 CY08
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VHA Handbook 1058.01 Reporting Research Events

• 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

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VHA Handbook 1058.01 Reporting Research Events

• 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.

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VHA Handbook 1058.01 Reporting Research Events

• 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.

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VHA Handbook 1058.01 Reporting Research Events

• 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.

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VHA Handbook 1058.01 Reporting Research Events

• 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 RDC, IRB, IACUC, etc.
• For human research, may include the informed
  consent document, clinical investigators
  brochure, product labeling, etc.

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VHA Handbook 1058.01 Reporting Research Events

• 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

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VHA Handbook 1058.01 Reporting Research Events

• 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

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VHA Handbook 1058.01 Reporting Research Events

• 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

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VHA Handbook 1058.01 Reporting Research Events

• 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
• RD Committee

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VHA Handbook 1058.01 Reporting Research Events

• Report to ORO Regional Office
• Problems (including AEs) Involving Risks to
  Subjects or Other that are
• Serious and Unanticipated and Related (or
  Possibly 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

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VHA Handbook 1058.01 Reporting Research Events

• Report to ORO Central Office
• (Copy to ORO Regional Office)
• Assurance Changes
• IRB Changes
• MOU Changes
• Accreditation Problems

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VHA Handbook 1058.01 Reporting Research Events

• 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

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• http//www.1.va.gov/oro/
• 1717 H Street, NW, Suite 500 (10R)
• Washington, D.C. 20420
• PHONE [phone]