Update from the Office of Research Oversight ORO Meeting of ACOSR

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Update from the Office of Research Oversight
(ORO)Meeting of ACOS/R Center
DirectorsThursday, January 22, 2004
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Office of Research OversightORO Formerly ORCA

• David A. Weber, Ph.D., FACNP
• Acting Chief Officer, ORO

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ORCA ????OHRO?ORO(1999 ???2003)

• Few changes in mission responsibilities
• Educational responsibilities transferred to ORD

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ORO OUTLINE

• Congressional Legislation
• Mission
• Areas of Responsibility
• Compliance Reviews
• Regional Offices
• Required Reporting to ORO
• New AE Reporting Policy
• Misconduct, Assurance Program

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Legislation in Support of ORO

• 11/19/2003 - S.1156 Passed Senate
• 11/21/2003 - Cleared for White House
• 11/25/2003 - Presented to President
• 12/6/2003 President Signs Pub. L. 108(170)

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S.1156- Veterans Health Care, Capital Asset, and
Business Improvement Act of 2003 Pub. L. 108(170)

• Title IV-OTHER MATTERS
• Sec. 401. Office of Research Oversight in
  Veterans Health Administration
• (a) Statutory Charter.-(1) Chapter 73 is amended
  by inserting after section 7306 the following new
  section

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7307. Office of Research Oversight(a)
Requirement for Office.-(1) There is in the
Veterans Health Administration an Office of
Research Oversight (hereinafter in this section
referred to as the Office). The Office shall
advise the Under Secretary for Health on matters
of compliance and assurance in human subjects
protection,..
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ORO
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ORO Mission

• Advise USH on matters of CA related to human
  subjects and animal welfare, research safety, and
  research misconduct.

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ORO Actions

• Office monitors, reviews, and investigates
  regulatory CA with respect to HSP, AW, RS, and
  RM in medical research

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ORO RESPONSIBILITIES

• Human Subjects Protections
• Oversee compliance with protections established
  by the Common Rule (38 CFR Part 16), other
  applicable federal regulations, and VHA policies.
• Manage VAMCs Assurances and MOUs Nationwide
• Review accreditation survey reports for
  regulatory compliance issues

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ORO RESPONSIBILITIES

• Animal Welfare
• Provide regulatory oversight of VHA Animal Care
  Use Programs.
• Investigate allegations of animal research
  non-compliance.
• Help ensure animal welfare in scientific
  research.

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ORO RESPONSIBILITIES

• Research Safety
• Help ensure safety of VHA research personnel and
  laboratory physical security.
• Oversee compliance with federal regulations, VHA
  policies and procedures, and all applicable
  NIH/CDC guidelines.

• Research Misconduct
• Oversee facilities' investigations into
  allegations of research misconduct (FFP in
  proposing, performing, or reviewing research, or
  in reporting research results).

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For Cause On-Site Reviews

• To investigate reported or alleged instances of
  noncompliance with the laws, regulations,
  policies, and/or procedures governing research
• May require either a focused or systematic
  on-site review
• Teams of 2-5 members for 2-4 days depending on
  the seriousness and scope of potential
  noncompliance

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Routine On-Site Reviews

• To assess CA with the laws, regulations,
  policies, and procedures governing research
• At all VHA facilities with research programs on a
  rotating basis
• To include HSP, AW, RS, and RM
• Remediation includes corrective actions
  recommended by ORO

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ORO REVIEWS

• Types of Reviews
• Routine and For-Cause

• Reviews Focus on Compliance
• Identify deficiencies

• End Product/Outcome
• Site visit report with recommendations
• Facility develops action plan
• Assurance Restricted/Suspended
• Continuous follow-up until remedial action
  complete

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What is OROs Organizational Structure ?

• Central Office Component
• Manage ORO
• Strategic guidance, coordination, and oversight
• Regional Offices
• Field operational units
• Geographically distributed
• 5 locations across the country
• Oversee RCA for 21 VISNs
• Oversee RCA for 115 VAMC Res. Prog. with
  Assurances VAMC affiliates

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ORO Regional Offices
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ORO Regional Offices

• Northeastern
• Bedford, MA
• VISNs 1, 2, 3
• Mid-Atlantic
• Washington, DC
• VISNs 4, 5, 6, 9, 10
• Southern
• Decatur, GA
• VISNs 7, 8, 16, 17

• Mid-Western
• Hines, IL
• VISNs 11, 12, 15, 19, 23
• Western
• March AFB, CA
• VISNs 18, 20, 21, 22

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Regional Office Directors

• Mid-Western RO
• Karen M. Smith, PhD
• [phone]
• Western RO
• Paul St. J. Hammond, MD, DPhil
• [phone]

• Northeastern RO
• Richard J. DAugusta, RPh, MPA
• [phone]
• Mid-Atlantic RO
• Min-Fu Tsan, MD, PhD
• [phone]
• Southern Regional Office
• David J. Miller, PhD, FAClinP
• [phone]

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ORO Regional Office

• Conducts routine and for cause reviews
• Answers questions about regulations, policies,
  directives, best practices.
• Assists with concerns about incidents that may
  pose compliance problems
• Helps locate information resources

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WHAT TO REPORT TO ORO

• Date November 12, 2003
• From Acting Chief Officer, Office of Research
  Oversight (ORO) (10R)
• Thru Deputy Under Secretary for Health (10A)
• Deputy Under Secretary for Health for Operations
  and Management (10N)
• To Institutional Officials of VHA Facilities
  Conducting or Supporting Research

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WHAT TO REPORT TO OROMEMORANDOM

• Identifies issues VHA facilities must report to
  ORO as required by various Federal regulations
  and VHA policies.
• http//www.va.gov/oro/

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REPORTING AEs in RESEARCH TO ORO

• Replaces previous procedures for reporting all
  SU AEs in research to ORO. New HB requires
  reporting to ORO RO all AEs that result in (1)
  an IRB taking substantive action(s) with respect
  to a protocol, ICF, or research personnel or (2)
  unexpected death of a research subject,
  regardless of IRB action.

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DEFINITIONS

• Substantive Action. Action taken by an IRB that
  materially alters the substance and meaning of a
  protocol, ICF or process, or research personnel,
  including, but not limited to, restriction,
  suspension or termination of a study or research
  personnel participation, and actions.

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DEFINITIONS

• Unexpected Death. The death of a research
  subject when high risk of death is not projected
  in the written protocol, ICF, and/or sponsor
  brochure. Does not include deaths associated
  with a terminal condition unless the research
  hastened the subjects death. A subject death
  that is not associated with research is not an
  unexpected death.

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IN PROGRESS

• Misconduct Handbook
• Assurance Handbook

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ORO TAKE HOME MESSAGE
ORO promotes enhances responsible conduct of
research advises USH on compliance
assurance ORO reviews focus on regulatory
compliance ORO is receptive to questions
(hypothetical or real) on research compliance ORO
requires reporting What to Report to ORO? ORO
facilitates/maintains assurances with
facilities ORO supports accreditation New ORO
Handbooks
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THE END