What to Report to

1

• What to Report to
• The Office of Research Oversight
• Revised November 22, 2005

2

• What to Report to ORO
• September 8, 2005 Guidance
• Basic Guidance
• Human Research Protections
• Laboratory Animal Welfare
• Research Safety Security
• Research Misconduct

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What to Report to OROSept 8, 2005 Guidance

• Revises / Replaces 11.12.2003 Memorandum
• Incorporates New VHA Handbooks
• Adverse Events, 1058.1
• Research Misconduct, 1058.2
• Clarifies Current Practice
• Harmonizes Across Reporting Areas

4
What to Report to OROSept 8, 2005 Guidance

• Report in Writing to ORO Regional Office (unless
  otherwise indicated)
• Report Promptly (as soon as possible)
• Describe Issue
• Describe Actions to Address Issue
• Provide Preliminary Report Where Appropriate
• Copy VISN Director

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What to Report to OROSept 8, 2005 Guidance

• Problems related to
• Human Subject Protections
• Report FWA MOU Changes to ORO Central Office
• Laboratory Animal Welfare
• Research Safety and Security
• Research Misconduct
• Report to ORO Central Office

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What to Report to OROSept 8, 2005 Guidance

• Does Not Address Reporting Requirements to Other
  Offices or Agencies
• OHRP
• FDA
• OLAW
• ORI

7
What to Report to OROBasic Guidance

• Report in Writing from Facility Director
• Fax / E-Mail and Hard Copy
• Report Promptly (as soon as possible)
• Within 10 working days after issue comes before
  responsible official or oversight committee (eg,
  IRB, IACUC, SRS)
• File preliminary report if necessary
• Report to ORO Regional Office unless otherwise
  indicated

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What to Report to OROBasic Guidance

• Descriptive Information and Actions
• Facility Name / Assurance Number
• Title of Project
• PI Name (except for animal research)
• IRB / IACUC Project Number
• Name of External Sponsor (if any)
• Funding Source
• Detailed Description of Situation
• Detailed Description of Action Plan

9
What to Report to OROBasic Guidance

• Serious Problems or Injuries
• For-Cause Suspension or Termination of Research
• Serious or Continuing Noncompliance
• Findings of Noncompliance from ORD or other VA
  Offices
• Findings of Noncompliance from External Oversight
  Agencies

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What to Report to OROBasic Guidance

• Changes in MOUs with Affiliate Institutions or
  other VA Facilities
• Human Subject Protections
• Laboratory Animal Welfare
• Changes in Assurance Status
• Changes in Accreditation Status
• Research Misconduct

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What to Report to OROHuman Subject Research

• Adverse Events Resulting in Substantive IRB
  Action (see VHA Handbook 1058.1)
• Written report within 10 working days of IRBs
  action determination
• Report via express mail and either e-mail or FAX
• Within 4 weeks provide copy of minutes of all IRB
  meetings in which the AE and subsequent actions
  were discussed, ratified, or summarized

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What to Report to OROHuman Subject Research

• Unexpected Deaths (see VHA Handbook 1058.1)
• Report within 24 hours of IRB determination of
  unexpected death
• Report within 10 days if IRB determination not
  yet made
• Unanticipated Problems Involving Risks to
  Subjects or Others Resulting in Substantive IRB
  Action

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What to Report to OROHuman Subject Research

• For-Cause Suspension or Termination of Research
• Does not include suspension/termination due
  solely to expiration of approval period
• Serious or Continuing Noncompliance with Federal
  Regulations or VHA Policies Including
• 38 CFR 16 VHA Handbook 1200.5
• 45 CFR 46 21 CFR 50, 56, 312, 812
• Serious or Continuing Noncompliance with IRB
  Requirements or Determinations

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What to Report to OROHuman Subject Research

• Findings of Noncompliance from ORD or Other VA
  Offices
• Include copy of official finding
• Provide copies of subsequent correspondence until
  issue resolved
• Findings of Noncompliance from External Oversight
  Agencies (eg, OHRP, FDA)
• Provide copy of official finding (eg, FDA Form
  483, Inspectional Observations)
• Provide copies of subsequent correspondence until
  issue resolved

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What to Report to OROHuman Subject Research

• Change in Facilitys Human Research Protection
  Accreditation Status, or that of Affiliate
  Institution or Other VA Facility on Which the
  Facility Relies
• Change in Facilitys FWA or Designated IRB(s)
• Report directly to ORO Central Office and copy
  ORO Regional Office
• Significant Change in Facilitys Memorandum of
  Understanding (MOU) with Affiliate Institution or
  Other VA Facility on Which the Facility Relies
• Report directly to ORO Central Office and copy
  ORO Regional Office

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What to Report to OROAnimal Research

• REPORTS ON ANIMAL RESEARCH SHOULD NOT INCLUDE
  NAME(S) OF INVESTIGATOR(S) UNLESS SPECIFICALLY
  REQUESTED BY ORO
• Incidents Seriously Affecting Health or Safety of
  Laboratory Animals
• Loss of Animal Life Due to Physical Plant
  Deficiencies and/or Engineering Failures or
  Mishaps
• Work Related Injuries to Animal Facility
  Personnel Requiring More Than Minor Medical
  Intervention or Leading to Serious Complications
  or Death

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What to Report to OROAnimal Research

• For-Cause Suspension or Termination of Research
• Serious or Continuing Noncompliance with
• Public Health Service (PHS) Policy on Humane
  Care and Use of Laboratory Animals
• VHA Animals in Research Handbook 1200.7
• Serious Deviation from Requirements of the Animal
  Welfare Act under 9 CFR Parts 1, 2, 3
• Serious Deviation from the Guide on Care and Use
  of Laboratory Animals

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What to Report to OROAnimal Research

• Any Findings of Noncompliance from ORD or Other
  VA Offices
• Include copy of official finding
• Provide copies of subsequent correspondence until
  issue resolved
• Any Findings of Noncompliance from External
  Oversight Agencies (eg, APHIS, OLAW)
• Provide copy of official finding
• Provide copies of subsequent correspondence until
  issue resolved

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What to Report to OROAnimal Research

• Change in Facilitys Animal Welfare Accreditation
  Status (ie, AAALAC), or that of Affiliate
  Institution or Other VA Facility on Which the
  Facility Relies
• Change in Facilitys Animal Welfare Assurance, or
  that of Affiliate Institution or Other VA
  facility on Which the Facility Relies
• Significant Change in Facilitys Memorandum of
  Understanding (MOU) with Affiliate Institution or
  Other VA Facility on Which the Facility Relies

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What to Report to OROResearch Safety Security

• Work-Related Injuries to Research Personnel
  Requiring More Than Minor Medical Intervention or
  Leading to Serious Complications or Death
• Significant Work-Related Exposures of Research
  Personnel to Hazardous Materials
• For-Cause Suspensions or Terminations of Research
  by the Subcommittee on Research Safety (SRS) or
  Other Institutional Safety Committee

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What to Report to OROResearch Safety Security

• Serious or Continuing Noncompliance with Federal
  Regulations or VHA Policies on Research Safety
  and Security, including

• 7 CFR 331
• 9 CFR 121
• 29 CFR 1910
• 29 CFR 1960

• VHA Handbook 1200.6
• VHA Handbook 1200.8
• VHA Directive 2003-030
• VHA Directive 2005-003

• Exposure, Release, Loss, or Theft of Hazardous
  Materials, Including Select Agents Toxins

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What to Report to OROResearch Safety Security

• Any Findings of Noncompliance from ORD, the
  National Health Physics Program, the Office of
  Inspector General, or other VA offices
• Provide copy of official finding
• Provide copies of subsequent correspondence until
  issue resolved

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What to Report to OROResearch Safety Security

• Any Findings of Noncompliance from External
  Oversight Agencies for Research Safety Security
• Such as OSHA NRC CDC or USDA (for hazardous
  agents / select agents / toxins) NIH (for
  recombinant DNA)
• Provide copy of official finding
• Provide copies of subsequent correspondence until
  issue resolved

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What to Report to OROResearch Misconduct

• REPORT RESEARCH MISCONDUCT DIRECTLY TO ORO
  CENTRAL OFFICE CO WILL NOTIFY REGIONAL OFFICE
• During Misconduct Proceeding, Notify ORO
  Immediately of
• Harm or threatened harm to research subjects
• Harm or threatened harm to persons involved in a
  misconduct inquiry or investigation
• Serious violations of animal welfare requirements
• Research safety or security compromises
• Risks to public health or safety
• Loss or destruction of VA funds or property
• Possible violations of Civil or Criminal law
• Administrative Actions to minimize resultant
  damage

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What to Report to OROResearch Misconduct

• Requests for Pre-Approval (REQUIRED) of
  Significant Changes or Departures from VHA
  Research Misconduct Handbook 1058.2
• Opening of Research Misconduct Inquiry
• Requests for Approval (REQUIRED) of Extensions to
  30-day Inquiry Period
• Closure of Research Misconduct Inquiry without
  Further Investigation (Include Copy of Inquiry
  Report and Concurrence of Facility Director)

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What to Report to OROResearch Misconduct

• Opening of Research Misconduct Investigation
• Requests for Approval (REQUIRED) of Extensions to
  60-day Investigation Period
• Closure of Research Misconduct Investigation
  (Include Copy of Investigation Report and
  Recommendations of Facility Director)
• Decision of Veterans Integrated Services Network
  (VISN) Director Regarding the Case

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• Office of Research Oversight
• http//www.1.va.gov/oro/
• 811 Vermont Avenue, N.W., Suite 574 (10R)
• Washington, D.C. 20420
• PHONE [phone]
• FAX [phone]