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ORD Local Accountability Meetings

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Office of Research Oversight ORD Local Accountability Meetings 2007 2008 Tom Puglisi, PhD, CIP Joan P. Porter, MSc, DPA, MPH, CIP, CIPP/G Office of Research ... – PowerPoint PPT presentation

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Title: ORD Local Accountability Meetings


1
Office of Research Oversight
  • ORD Local Accountability Meetings
  • 2007 2008
  • Tom Puglisi, PhD, CIP
  • Joan P. Porter, MSc, DPA, MPH, CIP, CIPP/G

2
Office of Research Oversight
  • Thank you to everyone here for helping to ensure
    compliant research contributing to quality
    research for the health and welfare of our
    veterans!

3
Office of Research Oversight
  • PART I
  • OROs Mission
  • Areas of Concern
  • Common Problems in Compliance
  • Case Studies

4
Office of Research Oversight
  • PART II
  • Engagement in Human Research
  • VHA Handbook 1058.03 Assurance Requirements
  • What Constitutes Engagement
  • Reporting AEs UPRs in Human Research
  • To the IRB
  • To ORO
  • Other Reporting to ORO

5
OROs Mission
  • Advise Under Secretary for Health
  • Monitor / Review / Investigate Compliance
  • Protection of Human Subjects
  • Laboratory Animal Welfare
  • Research Safety Security
  • Research Misconduct
  • Research Information Security
  • Governmentwide Debarment Suspension (VHA
    Handbook 1058.04)

6
OROs Mission Areas of Concern
  • Use of Affiliate IRBs
  • ORO directed to
  • review VA use of university IRBs
  • conduct targeted on-site reviews of effectiveness
    of university IRBs for VA research programs
  • strengthen facility research program assessments
    and Facility Director certification of research
    oversight to include use of university IRBs
  • ORO and ORD directed to
  • review accreditation standards and findings for
    VA use of university IRBs
  • review effectiveness of oversight by VA Research
    and Development Committees
  • ORD directed to develop and implement education
    programs addressing VA use of university IRBs.
    ORO will help.

7
OROs Mission Areas of Concern
  • Privacy, Confidentiality, Information Security
  • ORO responsibilities under VHA Directive 1058
    (revised February 2008)
  • Information Security Routine On-site Reviews
  • Checklists on ORO website
  • Effectiveness of Facility Oversight Roles of
    Director, RD Committee, and ACOS/R
  • Facility Director Certification of Research
    Oversight
  • Facility Director Checklist
  • RD Committee Annual Program Evaluations
  • Implementation of ACOS/R Responsibilities

8
OROs Mission Areas of Concern Just a reminder
  • Access to Protected Health Information (PHI) for
    recruitment of research subjects
  • VHA is more restrictive than HIPAA, HHS, and NIH
  • VHA requires
  • Prospective IRB Review and Approval
  • Documented Waiver of HIPAA Authorization
  • Documented Waiver of Informed Consent under
    Common Rule
  • Approval of RD Committee
  • see OROs website at
    http//vaww1.va.gov/oro/

9
ORO Checklists Available on ORO Website
  • Facility Director Research Oversight
    Certification Checklist
  • Human Research Protection Program Checklist
  • Institutional Review Board (IRB) Checklist
  • Research Development Committee Checklist
  • Laboratory Animal Welfare Checklist
  • Research Laboratory Safety Checklist
  • Security Checklist for BSL-1 BSL-2 Research
    Laboratories
  • Security Checklist for BSL-3 Research
    Laboratories
  • Research Data Security Checklist
  • Research Privacy Checklist
  • Checklists for Memoranda of Understanding

10
Directors Certification
11
Facility Director Research Oversight
Certification and Checklist
  • Detailed Checklist of Facility Directors
    Specific Responsibilities (4 pages, single
    spaced)
  • Provided Annually
  • Action Plans with Timelines
  • Monitoring of Action Plan Implementation by ORO
    Regional Offices
  • 43 No Action Plan Required
  • 57 Action Plan in Progress
  • Annual Assessment or Reports
  • Written Operating Procedures

12
OROs Activities
  • For Cause Reviews Off and On-site
  • Routine (Not for Cause) Reviews
  • Frequency ? 50 Annually (previously 25-30)
  • End of 2007 ? 67 onsite visits to review 97
    programs for compliance
  • Focus
  • Research Information Security
  • Research Safety Security
  • Human Research Protection Program
  • Laboratory Animal Welfare
  • Technical Assistance
  • Research Misconduct
  • Federal-wide Assurances

13
  • Common Research
  • Non-Compliance Problems
  • Human Subjects
  • Animal Welfare
  • Research Safety
  • Research Security

14
  • Some Case Examples
  • of Systemic Compliance Failures
  • What went wrong?
  • Why?

15
Common Compliance Concerns
  • Oversight of Research Program
  • Lack of Program Oversight by Facility Director
  • Lack of Program Oversight by RD Committee
  • Role Confusion / Inappropriate Reliance on ACOS/R
    or AO/R
  • Lack of RD Committee Knowledge about VA and
    Federal Research Requirements
  • Lack of RD Committee Knowledge about
    Subcommittee Responsibilities, Procedures, and
    Current Issues of Concern
  • Uncritical RD Committee Reliance on
    Subcommittees
  • Lag in Meeting Information Security Requirements

16
Common Compliance Concerns
  • Human Research Protection Program
  • Initiating Research without IRB and/or RD
    Committee Approval
  • Enrolling Subjects with Absent or Deficient
    Informed Consent
  • Implementing Unapproved Protocol Changes /
    Deviations
  • Inadequate Procedures for Reporting to IRB and/or
    ORO
  • Serious / Related / Unexpected Adverse Events
  • Unanticipated Problems Involving Risks to
    Subjects/Others
  • Inadequate Procedures for Reporting to Privacy
    Officer and/or ISO
  • Unauthorized Use / Disclosure / Loss of
    Identifiable Patient Info
  • Violations of VA Information Security
    Requirements
  • Inappropriate Contingent Approval Requiring
    Substantive Changes
  • Lack of Procedures for Conducting Protocol and
    IRB Audits

17
Common Compliance Concerns
  • Animal Care and Use Program
  • Failure to Conduct Semi-Annual Program and
    Facility Review
  • Failure to Implement Occupational Health and
    Safety Program
  • Inadequate Review of Category D and E Protocols
  • Inadequate Post-Surgical Care and Monitoring
  • Use of Inappropriate Anesthesia Techniques
  • Use of Outdated and/or Non-Pharmaceutical Grade
    Drugs
  • Inadequate Tracking and Securing of Controlled
    Substance
  • Inadequate Population Management and Animal
    Tracking
  • Inadequate Training IACUC Members,
    Investigators, Caretakers
  • Implementation of Unapproved Protocol Changes
  • Inadequate Facility Maintenance and Temperature
    Control Testing

18
Common Compliance Concerns
  • Research Safety Program
  • Failure to Conduct Annual Reviews of the
    Research Areas and of the Chemical Hygiene Plan
  • Failure to Conduct Semi-Annual Reviews of
    Personnel Access, Hazardous Agent Inventory,
    Select Agent / Toxin Exempt Quantity Logs
  • Failure to Implement VHA Handbook 1200.06
    (October 2005)
  • Failure to Appoint a Research Safety Coordinator
  • Failure to Ensure Annual Research-Specific Safety
    Training
  • Failure to Comply with NIH rDNA and IBC
    Requirements
  • Failure to Comply with National Standards for
    Eyewash Stations, Storage of Flammable Chemicals,
    Labeling and Containment of Hazardous Chemical
    Wastes

19
Office of Research Oversight
  • ORO Suspensions Since April 30, 2006
  • Smoking Cessation Study
  • Animal Care and Use Program
  • Research Safety Program
  • Research Information Security (Birmingham)
  • Use of Affiliate IRB

20
? Smoking Cessation Study
  • Collaborative HSRD Project to
  • Increase use of care for smoking cessation
  • Ensure that a best practice (telephone care
    coordination for smoking cessation) becomes
    routine care throughout two VISNs
  • Concerns brought to ORO by one IRB

21
Smoking Cessation Study OROs Concerns
  • Veteran subjects and their local, referring VA
    providers not informed adequately that the
    program involved
  • Research comparing four separate approaches to
    intervention (intervention groups)
  • Assignment of participants to intervention groups
    based on geographic location rather than clinical
    factors.

22
Smoking Cessation Study OROs Concerns
  • Local VA providers not given adequate information
    regarding medications prescribed to their
    patients
  • Nicotine
  • Bupropion (entails risks)
  • Serious contraindication MAO inhibitors
  • Dose-related seizures in a small number of
    patients, especially patients suddenly stopping
    regular use of sedatives (e.g., benzodiazepines)
    or alcohol

23
Smoking Cessation Study ORO Suspension
  • Suspension of New Enrollments
  • June 15, 2006
  • Notification of all referring providers
  • Evaluation of risks to each subject by referring
    provider
  • Resumption of Research
  • VISN A December 13, 2006
  • Local investigator at each site
  • Local IRB RD Committee approval
  • VISN B January 22, 2007
  • No local site investigators
  • Permission of Facility Director and COS at each
    site

24
? Animal Care and Use Program OROs Findings
  • Relatively new Facility Director had delegated
    all oversight of ACUP to long-time ACOS/R
  • IACUC meeting tapes demonstrated that former
    ACOS/R had inappropriately
  • Influenced IACUC deliberations
  • Made IACUC decisions without IACUC input
  • IACUC members uninformed about
  • Specific regulatory and policy requirements
  • Program oversight responsibilities

25
Animal Care and Use Program OROs Findings
  • Breakdown of communications and respect between
    research community and VMO
  • Semi-Annual Program Review and Facility
    Self-Assessment still not completed as of ORO
    site visit
  • Investigators perceived VMO to be
  • Unavailable for consultation pre/post IACUC
    meetings
  • Arbitrary in enforcing regulatory compliance
  • Disrespectful in investigator communications
  • VMO perceived investigators to be
  • Disrespectful of regulatory requirements
  • Subjecting animals to danger and harm

26
Animal Care and Use Program OROs Findings
  • VMO lacked
  • Access to copies of approved protocols
  • Access to certain animal research labs
  • Control over animal procurement
  • Any input into budgetary decisions, including per
    diem charges
  • ACUP lacked
  • Comprehensive Occupational Safety Health
    Program
  • Mechanisms to ensure proper training prior to
    handling animals
  • Mechanisms for tracking animal census and linking
    to protocols
  • Population management mechanisms

27
Animal Care and Use Program OROs Findings
  • ORO inspections revealed
  • OSH and training requirements for access to
    animals not enforced
  • Controlled substances obtained outside VA
    pharmacy
  • Controlled substances not properly locked and
    tracked
  • Widespread use of expired drugs
  • Widespread use on non-pharmaceutical grade drugs
  • Lack of investigator and IACUC awareness of above
    requirements
  • Investigator failure to obtain IACUC approval for
    protocol changes
  • Widespread violations of veterinary standards,
    especially surgical
  • Lack of periodic HVAC temperature testing
  • Lack of monitoring of cage wash temperatures

28
Animal Care and Use Program OROs Findings
  • ORO inspections revealed
  • Lack of primate technician and primate enrichment
    program
  • Lack of security for back entrance to animal
    facility
  • Chronic problems with mouse hepatitis virus
    (MHV), pinworms, and mouse parvovirus (MPV) such
    that affiliate would not accept animals transfers
    from VA facility
  • Multiple safety deficiencies in both animal and
    non-animal laboratories
  • Systemic lack of RD Committee oversight
  • Complex remedial action plan in multiple areas
  • Resumption of ACUP January 19, 2007

29
? Research Safety Program OROs Findings
  • Unsafe storage of chemicals
  • Improper containers
  • Co-storage of incompatible chemicals
  • Flammable chemicals in unsafe cabinets
  • Outdated chemicals
  • Crystallized picric acid
  • Perchloric acid
  • Inoperable eyewash stations
  • Use of Bunsen burners in unsuited biosafety
    cabinets
  • Often placed adjacent to warning label on cabinet

30
Research Safety Program OROs Findings
  • Chemical fume hoods with clutter impeding air
    flow
  • Improper inspection of biosafety cabinets and
    fume hoods
  • Outdated chemical inventories
  • Fire code violations
  • Obstruction of exits
  • Exposed electrical wiring
  • Blocked sprinklers
  • Use of extension cords
  • Inconsistent temperature regulation and
    ventilation

31
Research Safety Program OROs Findings
  • Failure to label equipment, supplies, and waste
    as radioactive
  • Failure to decontaminate abandoned labs
  • Lack of coordination with Occupational Safety and
    Health Program
  • Laboratory personnel poorly trained/supervised
    about standard and specific safety precautions
  • Shorts and flip flops
  • Systemic failure of SRS and RD Committee
    Oversight
  • Failure to correct chronic observed deficiencies

32
? Use of Affiliate IRB OROs Findings
  • ORO involvement began with FDA termination 3
    collaborative studies involving VA, affiliate,
    and FDA
  • VA facility audits identified serious
    deficiencies in a number of studies
  • University IRBs
  • Not cognizant of VA requirements
  • Failed to inform facility systemically of SAEs /
    noncompliance
  • Unresponsive to audit reports
  • Facility RD Committee
  • Inadequate review of individual protocols
  • Inadequate oversight of research program

33
Use of Affiliate IRB OROs Findings
  • Facility Research Service
  • Extreme reliance on affiliate
  • Inadequate written policies and procedures
  • Absence of infrastructure and internal controls
    for research
  • Lack of complete protocol records in Research
    Service
  • Deficient protocol inventory and tracking
  • Failure to identify VA research vs Affiliate
    research
  • Lack of COI monitoring and management procedures
  • Lack research credentialing procedures
  • Lack of enforcement of training requirements

34
Restriction of Research August 30, 2007
  • Under Secretary for Health
  • Cease use of Affiliate IRBs
  • Establish VA IRB
  • ORO
  • Cease initiation of new studies
  • Cease enrollment of subjects in existing research
    unless necessary for health of individual subject
    and approved by COS

35
Restriction of Research August 30, 2007
  • ORO
  • Continue already enrolled subjects in ongoing
    research where necessary for health of individual
  • Transfer oversight to another VA IRB ASAP
  • Negotiate procedures with affiliate for transfer
    of ongoing research to VA IRB
  • Establish appropriate RD Committee review and
    oversight procedures

36
Status as of Jan 29, 2008
  • Facility amended FWA to permit use of another
    VAs IRB
  • In Fall 2007, 10-12 high priority protocols were
    reviewed and approved by this IRB
  • Facility established its own IRB, including
  • IRB and RD Committee member training
  • Individual and group investigator training
    program
  • COI review mechanisms
  • IRB administration and protocol tracking systems
  • Training and COI tracking systems

37
Status as of Jan 29, 2008
  • Facility amended FWA to include its own IRB
  • Facility IRB began reviewing protocols in
    priority order in late December 2007
  • Facility IRB has reviewed 20-25 protocols with
    10-12 fully approved
  • A few low priority protocols halted when approval
    period lapsed
  • Other protocols remain suspended to new
    enrollments pending IRB review and approval

38
PART II
  • Assurances
  • Engagement in Research
  • Reporting to ORO AEs and UPRs

Unanticipated problems involving risks to
subjects or others.
39
When an Assurance is Needed for the Protection of
Human Subjects
  • Each entity engaged in human research conducted
    or supported by VA
  • must provide a written Assurance to comply with
    the Federal Policy for the Protection of Human
    Subjects (38 CFR Part 16)
  • VA Facilities / VA Investigators
  • Non-VA Institutions
  • VHA Handbook 1058.03 2b(1)(2)

40
Assurances Needed by a Non-VA Entity
  • Intellectual contributions meriting publication
    authorship
  • VHA Handbook 1058.03 8a

41
Assurances Needed by a Non-VA Entity
  • Entities operated under a contract from a VA
    (eg, Contract CBOC)
  • VHA Handbook 1058.03 4i(1)

42
Engagement of VA Facilities In Human Research
  • VA is guided by, but does not completely follow,
    Office for Human Research Protections Guidance
    (January 1999)
  • If a VHA Facility is engaged in human research,
    the research needs review and approval from
  • The Facilitys IRB of Record
  • The Facilitys RD Committee

43
Engagement in Human Research
  • A VA facility is engaged in human subject
    research (and needs an Assurance) whenever its
    employees or agents
  • Intervene or interact with living individuals
    for research purposes, or
  • Obtain, release, or access individually-identifiab
    le private information (or individually-identifiab
    le specimens) for research purposes
  • VHA Handbook 1200.53.b.
  • (See also 38 CFR 16.102(f))

44
Examples of Engagement OHRP Guidance January
1999
  • (A)(1) Employees or Agents Intervene with Living
    Individuals for Research
  • Collecting biological specimens for research
  • Administering interventions for research
  • Dispensing drugs for research
  • Using invasive or non-invasive tests for research

45
Examples of Engagement OHRP Guidance January 1999
  • (A)(2) Employees or Agents Intervene with Living
    Individuals by Manipulating the Environment for
    Research
  • Manipulating light, sound, or temperature for
    research
  • Presenting sensory stimuli for research
  • Orchestrating environmental events or social
    interactions for research
  • Making voice, digital, or image recordings for
    research

46
Examples of Engagement OHRP Guidance January 1999
  • (A)(3) Employees or Agents Interact with Living
    Individuals for Research
  • Protocol-specified communication
  • Interpersonal contact for research
  • Surveys and interviews for research
  • Obtaining informed consent for research

47
Examples of Engagement OHRP Guidance January 1999
  • (A)(4) Institutions whose employees/agents
    release individually identifiable private
    information, or permit investigators to obtain
    individually identifiable private information,
    for research without subjects' explicit written
    permission
  • Releasing patient names to investigators for
    solicitation as research subjects
  • Permitting investigators to record private
    information from medical records in individually
    identifiable form
  • (VA departs from this guidance under certain
    circumstances)

48
Reporting to the IRB AEs vs Unanticipated
Problems (UPRs) 38 CFR 16.103(b)(5) 21 CFR
56.108(b)(1) 21 CFR 812.150(a)(1)
  • VHA Handbook 1058.1 requires detailed SOPs.
  • ORO has provided guidance (see ORO website).
  • Problems reportable to IRB should ensure that all
    UPRs are reported promptly to the IRB.
  • AEs that do not qualify as UPRs and to do not
    require prompt reporting to the IRB should at
    least be reported as part of the continuing
    review process.
  • Facilities have flexibilities in ensuring the
    required reporting
  • Algorithm for reporting to the IRB
  • Over-reporting may be desirable at the facility
    level to ensure that IRB is informed of all
    reportable UPRs

49
A problem occurs during a research project.
An Adverse Event (AE) occurs during a research
project.
Is the AE SERIOUS as defined by FDA? i.e., did
the AE result in (or need medical or surgical
intervention to prevent) death, a
life-threatening experience, inpatient
hospitalization, prolongation of
hospitalization, persistent or significant
disability or incapacity, congenital anomaly or
birth defect, or jeopardy to a subject rights,
safety, or welfare?
Algorithm for Reporting AEs UPRs to the IRB
NO
YES
Does the problem or event involve RISKS to
SUBJECTS?
NO
YES
  • Does the problem or event involve RISKS to ANYONE
    ELSE (e.g., subjects family members, research
    personnel, others)?

NO
YES
Was the problem or event ANTICIPATED as to
NATURE, SEVERITY, and FREQUENCY as described in
the protocol, consent document, or other
materials approved by the IRB?
YES
NO
Is the problem or event RELATED or POSSIBLY
RELATED to the research?
NO
YES
  • Facilities have flexibility in setting IRB
    reporting requirements.

? The problem or event MUST BE REPORTED PROMPTLY
to the IRB.
50
(No Transcript)
51
Reporting to ORO In Human Research Adverse
Events VHA Handbook 1058.1
  • An Adverse Event (AE) in research is
  • Any untoward occurrence in a human subject
    participating in research
  • (IRB of record for VA at affiliate does not
    report to ORO directly, but should have SOPs)
  • Physical, psychological, social, economic
  • Any unfavorable or unintended events, eg,
    abnormal laboratory findings, symptoms, disease,
    death
  • Not necessarily due to error or protocol
    deviation
  • Not necessarily caused by the research

52
Reporting to ORO In Human Research Adverse
Events VHA Handbook 1058.1
  • VHA facility must report to its ORO Regional
    Office
  • All AEs and imminent threats of AEs in on-site
    research that result in
  • An IRB taking substantive action(s) or
  • An unexpected death, regardless of IRB action

53
Reporting to ORO In Human Research Adverse
Events VHA Handbook 1058.1
  • The death of a research subject must be reported
    to ORO
  • Within 24 hours after IRB determines that it is
    unexpected, or
  • Within 10 working days if a determination has not
    yet been made

54
Reporting to ORO In Human Research Adverse
Events VHA Handbook 1058.1
  • Reporting of AEs to ORO must be
  • Separate for each AE
  • In writing
  • Initialed by the Facility Director
  • Sent by express mail and e-mail or fax
  • Accompanied by all relevant IRB meeting minutes
    (when available but no more than 4 weeks after
    the meeting)

55
Reporting to ORO In Human Research Adverse
Events VHA Handbook 1058.1
  • An Imminent Threat of an Adverse Event (AE) in
    research is
  • Any situation in which an AE has not yet occurred
    but is likely to occur without preventive
    measures
  • As determined by
  • An IRB member,
  • Research team member, or
  • Clinical team member

56
Reporting to ORO In Human Research Adverse
Events VHA Handbook 1058.1
  • An unexpected death
  • Is one where a high risk of death is not
    projected as indicated by
  • The protocol, or
  • Informed consent document, or
  • The clinical investigators brochure, or
  • Does not include deaths,
  • Associated with a terminal condition unless the
    research hastened the subjects death
  • Determined not to be associated with the research

57
Reporting to ORO In Human Research Adverse
Events VHA Handbook 1058.1
  • A substantive IRB action
  • Is an action taken by the IRB that materially
    affects the substance and meaning of
  • The protocol, or
  • The informed consent document or process, or
  • Investigator status
  • Includes, but is not limited to,
  • Restriction, suspension, or termination of a
    study
  • Restriction, suspension, or termination of
    investigator participation
  • Actions taken to prevent future occurrence of the
    AE

58
Reporting to the IRB AEs vs Unanticipated
Problems (UPRs) 38 CFR 16.103(b)(5) 21 CFR
56.108(b)(1) 21 CFR 812.150(a)(1)
59
Reporting to the IRB vs
REPORTING TO ORO
Substantive IRB
Action

Anticipated Deaths
  • Deaths

Adverse Events
60
Reporting to ORO In Human Research Other
Requirements
  • Any for-cause suspension or termination of human
    research by the IRB, VHA Facility, or VHA
    Affiliate
  • Any serious or continuing noncompliance with
    federal regulations or VA requirements
  • Any serious or continuing noncompliance with IRB
    requirements
  • Any finding of noncompliance by ORD, another VHA
    Office, OHRP, or FDA
  • Any change in accreditation status of VHA
    facility or affiliate
  • Any change in the VHA Facilitys FWA or
    designated IRB(s)
  • Any significant change in an MOU governing IRB
    oversight

61
Reporting to ORO In Human Research Other
Requirements
  • Calling a suspension an Administrative Hold is
    no excuse for not reporting non-compliance to
    ORO.
  • In other words
  • An Administrative Hold based on or involving
    research noncompliance must be reported to ORO.

62
Laboratory Animal Welfare Requirements for
Reporting to ORO
  • Any incident that seriously affects the health or
    safety of lab animals
  • Any loss of animal life due to physical plant or
    engineering deficiencies
  • Any work related injury to personnel that
    requires more than minor medical intervention or
    leads to serious complications or death
  • Any for-cause suspension or termination of
    research by the IACUC
  • Any serious or continuing noncompliance with PHS
    Policy
  • Any serious deviation from the Animal Welfare Act
    or the Guide
  • Any finding of noncompliance by ORD, another VHA
    Office, USDA, or OLAW
  • Any change in the Animal Welfare Assurance or
    Accreditation status of the VHA facility or the
    entity on which the facility relies
  • Any significant change in an MOU governing Lab
    Animal Welfare

63
Research Lab Safety and Security Requirements for
Reporting to ORO
  • Any work related occupational injury to personnel
    that requires more than minor medical
    intervention or leads to serious complications or
    death
  • Any significant, work-related exposure to
    hazardous materials of personnel working with a
    research facility
  • Any for-cause suspension or termination of
    research by a Facility safety committee
  • Any exposure, release, loss, or theft of
    hazardous materials, including select agents and
    toxins
  • Any finding of noncompliance in research safety
    or security by ORD, the VA National Health
    Physics Program (NHPP), VA OIG, or another VHA
    Office
  • Any finding of noncompliance in research safety
    or security from external oversight agencies such
    as NIH OBA, CDC, USDA, OSHA, or the NRC

64
Research Misconduct Requirements for Reporting to
ORO
  • ORO should be notified immediately of
  • Any harm or threat of harm to research subjects
  • Any harm or threat of harm to those involved in
    an Inquiry or Investigation
  • Serious regulatory noncompliance
  • Risks to public health or safety
  • Loss or destruction of VA funds or property
  • Possible civil or criminal violations
  • Any request for pre-approval of significant
    changes or departures from the procedures or time
    frames required under VHA Handbook 1058.2
  • Any opening or closure of an research misconduct
    INQUIRY
  • Any opening or closure of an research misconduct
    INVESTIGATION
  • The Network (VISN) Directors decision on the
    merits of a research misconduct case

65
ORO 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
  • Duluth, GA
  • VISNs 7, 8, 16, 17

66
Office of Research Oversight http//www1.va.gov/or
o/
  • ORO (Central Office)
  • Department of Veterans Affairs
  • 811 Vermont Ave, NW, Suite 574 (10R)
  • Washington, DC 20420
  • 202.565.5184 ? fax 202.565.9194
  • ORO Mid-Atlantic Regional Office District of
    Columbia VAMC
  • 50 Irving Street, N.W. (10R) Washington, DC 
    20422 202.745.8110 ? fax 202.745-8538
  • ORO Midwestern Regional Office Hines VAMC
  • Building 1 (10R), Room B-103 5th Roosevelt
    Avenues Hines, IL  60141 708. 202.7254 ? fax
    708.202.7250

ORO Northeastern Regional Office Bedford VAMC 200
Springs Road (10R) Bedford, MA 
01730 781.687.3850 ? fax 781.687-3858 ORO
Southern Regional Office 3700 Crestwood Pkwy,
NW Suite210 (10R) Duluth, GA  30096 678.924.5762
? fax 678.924.5708 ORO Western Regional
Office P.O. Box 7360 Moreno Valley, CA 
92552-7360 Express Delivery 14560 2nd Street ,
Bldg. 2641, Suite B Riverside, CA 
92518 909.801.5164 ? fax 909.801.5176
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