AGENDA

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AGENDA

• Background
• Overview of VHA Handbook 1058.2
• Handling Allegations of Research Misconduct
• Q A

Refer to VHA Handbook 1058.2 for complete policy
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I. Background
VA Policy (1993) M-3, Pt. I, Ch. 15

• 15.04 DEFINITION
• Misconduct is defined as
• a. Serious deviation, such as fabrication,
  falsification, or plagiarism, from accepted
  practice, in carrying out research, or in
  reporting the results of research or
• b. Material failure to comply with Federal
  requirements affecting specific aspects of the
  conduct of research e.g., the protection of human
  subjects and the welfare of laboratory animals.

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I. Background
Federal Policy on Research Misconduct (2000)

• Applies to all federally-funded research
• Uniform definition of research misconduct
• fabrication, falsification, or plagiarism in
  proposing, performing, or reviewing research, or
  in reporting research results
• Procedural requirements and guidelines
• e.g., clear separation of Inquiry/Investigation,
  Adjudication, and Appeal phases

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I. Background
VHA Handbook 1058.2 (2005)

• Effective May 4, 2005
• VHA Manual M-3, Part I, Chapter 15 rescinded
• Developed by ORO, with input from ORD, OGC, OIG,
  and field representatives
• Implements Federal Policy on Research Misconduct
• All VHA facilities are required to follow the new
  Handbook for research misconduct allegations

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II. Overview of VHA Handbook 1058.2
Paragraph 1. Purpose

• To establish procedures for reporting,
  investigating, and resolving allegations of
  misconduct involving VA research

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II. Overview of VHA Handbook 1058.2
Paragraph 2. Background

• The procedures in the Handbook
• protect the publics confidence in the integrity
  of VA research by
• minimizing the incidence of research misconduct
• providing a fair and timely manner of responding
  to allegations.
• maintain appropriate safeguards for Respondents
  and Informants
• RESEARCH MISCONDUCT IS PROHIBITED
• The Handbook conforms to the Federal Policy on
  Research Misconduct (2000)

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II. Overview of VHA Handbook 1058.2
Paragraph 3. Definition of Research Misconduct

• Fabrication, Falsification, or Plagiarism in
  proposing, performing, or reviewing research, or
  in reporting research results
• Fabrication making up data or results and
  recording or reporting them
• Falsification manipulating research materials,
  equipment, or processes, or changing or omitting
  data or results such that the research is not
  accurately represented in the research record
• Plagiarism the appropriation of another
  persons ideas, processes, results, or words
  without giving appropriate credit

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II. Overview of VHA Handbook 1058.2
Paragraph 3. Definition of Research Misconduct

• Research misconduct does not include honest error
  or differences of opinion
• To constitute research misconduct, the behavior
  must
• represent a significant departure from accepted
  practices of the relevant research community and
• be committed intentionally, knowingly, or with
  reckless disregard for the integrity of the
  research
• The allegation must be proven by a preponderance
  of the evidence (i.e., MORE LIKELY THAN NOT TO BE
  TRUE)

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II. Overview of VHA Handbook 1058.2
Paragraph 4. Scope

• Applies to all VA employees
• includes WOC, contractors, IPA personnel engaged
  in VA research
• scientists, trainees, technicians, students,
  collaborators, etc.
• Other ethical improprieties are not covered by
  Handbook
• Special examples
• Misrepresentation of ones qualifications in a
  merit review application falls within definition
  of research misconduct
• Authorship disputes other than plagiarism do not
  fall within definition of research misconduct

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II. Overview of VHA Handbook 1058.2
Paragraph 5. Definitions

• Informant. The person who makes an allegation or
  cooperates with an Inquiry or Investigation of
  research misconduct.
• Respondent. The person against whom an
  allegation of research misconduct is directed or
  whose actions are the subject of an Inquiry or
  Investigation.
• Research Record. The record of data or results
  that embody the facts resulting from scientific
  inquiry, including, but not limited to, research
  proposals, physical and electronic laboratory
  records, abstracts, theses, oral presentations,
  internal reports, and journal articles.
• VA Research. All research (1) funded in whole or
  in part by VA (2) conducted by VA employees
  within the scope of their VA employment and/or
  (3) using VA facilities, equipment, personnel, or
  patients.

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II. Overview of VHA Handbook 1058.2
Paragraph 6. The Office of Research Oversight

• ORO Central Office oversees VHAs research
  misconduct program in general
• ORO Central Office reviews all research
  misconduct cases

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II. Overview of VHA Handbook 1058.2
Paragraph 7. Research Integrity Officers (RIOs)

• Each VAMC with research involvement must have a
  RIO
• The RIO is responsible for overseeing all
  research misconduct allegations at that facility
• The RIO may be ACOS/RD, Research Coordinator,
  RD Committee Chair, or similar individual within
  the research program with sufficient
  institutional authority and experience to fulfill
  the required duties
• Responsibilities
• Receiving and reviewing research misconduct
  allegations, overseeing all Inquiries and
  Investigations, maintaining files of all
  documents and evidence, ensuring the
  confidentiality and security of those files,
  acting as a liaison with ORO
• Maintaining safeguards for Respondents and
  Informants
• Providing education and training to
  Inquiry/Investigation Committee members
• Informing VAMC staff of Handbook procedures and
  overseeing compliance
• Demonstrating objectivity in carrying out RIO
  duties
• Conflicts of Interest If the RIO has a COI in a
  particular case (significant relationship with
  Respondent, Informant, project or investigator),
  an acting RIO must be appointed

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II. Overview of VHA Handbook 1058.2
Paragraph 8. Informants

• VA employees have a responsibility to report
  suspicions of research misconduct if they
  honestly and reasonably believe there is credible
  evidence
• VAMC authorities must make diligent efforts to
  protect good faith Informants from retaliation
• Informants may provide testimony and be informed
  of the general outcome of a case, but do not
  otherwise have a right to participate in the
  determination of the case

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II. Overview of VHA Handbook 1058.2
Paragraph 9. Respondents

• Respondents must be given timely, written
  notification of allegations made against them
• Respondents must have the opportunity to be
  interviewed and present evidence
• Respondents are required to cooperate in good
  faith with any Inquiry or Investigation
• Respondents may obtain the advice of legal
  counsel or a personal advisor, but such advisor
  may not speak on behalf of the Respondent during
  the Inquiry or Investigation
• Respondents are prohibited from retaliating
  against good faith Informants
• Respondents may appeal any finding of research
  misconduct
• Respondents who are not found guilty of research
  misconduct must be given reasonable assistance in
  restoring their reputations

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II. Overview of VHA Handbook 1058.2
Paragraph 10. Privacy and Confidentiality

• All nonpublic information must be kept
  confidential
• Nonpublic information should only be made
  available to persons specifically authorized to
  review the research misconduct allegation
• Case files must be stored in a secure location

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II. Overview of VHA Handbook 1058.2
Paragraph 11. Record Retention and Access

• All research records related to a misconduct
  allegation may be inspected and sequestered by
  the RIO, Inquiry or Investigation Committee, or
  ORO, without notice
• Respondents may be given supervised access to or
  copies of original data to continue their
  research prior to completion of a misconduct
  proceeding
• After a case is closed, the RIO must retain all
  research misconduct records until the retention
  period has ended

7 year retention period has been proposed
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II. Overview of VHA Handbook 1058.2
Paragraph 12. General Procedures

• Joint Jurisdiction
• Other non-VA entities (e.g., academic affiliates)
  may have concurrent jurisdiction over the same
  research project
• Perform joint Inquiry/Investigation with
  representatives from both institutions
• Negotiate which entity will take the lead
• Single set of recommendations
• Each entity follows own procedures for
  adjudication and appeals
• Interim Actions
• Follow 38 CFR 1.200 1.205 for reporting
  criminal matters
• Refer to VA Inspector General or other
  appropriate investigative body
• Admissions
• An admission of guilt by itself is not grounds
  for terminating a case. Additional investigation
  may be necessary to discover the full extent of
  misconduct
• Admissions must be in writing and signed by the
  Respondent and a witness
• Employment Status
• Termination of a Respondents VA employment does
  not preclude an Investigation

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II. Overview of VHA Handbook 1058.2
Paragraph 13. Allegations

• Allegations of research misconduct must be made
  in good faith and must be reasonable
• The informant must believe in the substance of
  his/her allegation and
• The allegation must be one which a person in the
  Informants situation could reasonably make.
• An allegation is not made in good faith nor
  reasonable if made with reckless disregard for or
  willful ignorance of facts that would negate the
  allegation.

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II. Overview of VHA Handbook 1058.2
Paragraph 13. Allegations

• Informants are not required to prove good faith
  in order for an Inquiry to be opened.
• However, an allegation that is not made in good
  faith may result in the waiver of certain
  protection privileges (i.e., protection from
  retaliation).

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II. Overview of VHA Handbook 1058.2
Paragraph 14. Inquiry

• Sole purpose to determine whether sufficient
  evidence exists to open a formal Investigation.

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II. Overview of VHA Handbook 1058.2
Paragraph 15. Investigation

• Purpose to determine
• whether and to what extent research misconduct
  has occurred
• who is responsible and
• what corrective actions are appropriate.

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II. Overview of VHA Handbook 1058.2
Paragraph 16. Adjudication

• VA determination based on recommendations from
  the Investigation
• Adjudication by the Network Director
• review of Investigation Report and all supporting
  documents
• may consult with ORO, ORD, OGC
• May adopt all, some, or none of the
  Investigations recommendations

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II. Overview of VHA Handbook 1058.2
Paragraph 17. Departmental Review

• ORO CO reviews each case for procedural
  conformance
• Timeliness
• Objectivity
• Preservation of safeguards
• Thoroughness
• Competence

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II. Overview of VHA Handbook 1058.2
Paragraph 17. Departmental Review
ORO Disposition

• Inquiry/Investigation and adjudication
  substantially adhered to procedures

Uphold Network Directors decision

• Inquiry/Investigation did not substantially
  adhere to procedures so as to materially affect
  outcome of the case

Reopen VAMC Investigation, or open ad hoc ORO
Investigation
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II. Overview of VHA Handbook 1058.2
Paragraph 18. Corrective Actions

• Examples
• Government-wide debarment
• Removal from a particular project or suspension/
  termination of an active award
• Restitution of funds or civil penalties
• Prohibition from receiving VA research funds for
  a period of time
• Correction or retraction of published article
• Monitoring or supervision of future work
• Required certification of data or sources
• Remedial education and/or mentoring

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II. Overview of VHA Handbook 1058.2
Paragraph 18. Corrective Actions

• Considerations
• Extent of the misconduct (amount, duration,
  scope)
• Degree to which misconduct was knowing,
  intentional, or reckless
• Presence or absence of pattern of misconduct
• Consequences of the research misconduct
• Respondents position and responsibility
• Cooperation of Respondent
• Likelihood of rehabilitation
• Type of corrective actions imposed in past cases

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II. Overview of VHA Handbook 1058.2
Paragraph 19. Appeals

• All final research misconduct findings and
  proposed corrective actions may be appealed
• Only named Respondents may appeal
• Reviewed by the Under Secretary for Health
• Must appeal within 30 days of receiving notice
• Document review only
• Exception Debarment hearing (38 CFR 44, Subpart
  H)
• Final decision uphold, reverse, or modify

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II. Overview of VHA Handbook 1058.2
Paragraph 20. References

• Federal Policy on Research Misconduct (65 FR
  76260)
• Administrative Investigations (VA Handbook 0700)
• Employee/Management Relations (VA Handbook 5021)
• Whistleblower Protection Act of 1989 (5 USC
  1201)
• Governmentwide Debarment/Suspension (38 CFR Part
  44)
• Criminal Referrals (38 CFR 1.200-1.205)

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III. Handling Allegations of Research Misconduct
ALLEGATION

• Good faith and reasonable
• In writing, if possible
• Submitted to Respondents supervisor
• Forwarded to RIO (or direct submission)
• May be anonymous
• Required Threshold

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III. Handling Allegations of Research Misconduct
REQUIRED THRESHOLD

• Before an Inquiry is opened, the RIO must
  determine that the allegation meets all of the
  following requirements
• The allegation involves VA research
• The allegation is of research misconduct
• The allegation on its face contains the elements
  of a finding of research misconduct
• Significant departure from accepted practices
• Committed intentionally, knowingly, or with
  reckless disregard
• Deficient Allegations
• Notify Informant of the particular threshold
  requirement(s) that the allegation fails to meet

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III. Handling Allegations of Research Misconduct
INQUIRY

• VAMC Director convenes within 5 days after
  allegation received
• Written notification to Respondent, Informant,
  VISN, ORO CO
• Sequestration of physical evidence
• Inquiry conducted by RIO or an Inquiry Committee
• Interview Respondent and Informant
• Written transcripts
• Inquiry Report (summary format)
• Determine whether sufficient evidence exists to
  open Investigation
• Complete within 30 days

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III. Handling Allegations of Research Misconduct
OPENING AN INVESTIGATION

• Evidence that would raise a significant suspicion
  of research misconduct to a reasonable person is
  sufficient to justify opening a formal
  Investigation
• Termination of VA Case
• Available evidence is insufficient to justify
  opening an Investigation
• Retain case file for authorized retention period
• Forward Inquiry Report VISN, ORO CO
• If VAMC Director disagrees, must open an
  Investigation

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III. Handling Allegations of Research Misconduct
INVESTIGATION

• VAMC Director convenes Investigation Committee
  within 10 days of recommendation to open
  Investigation
• Written notification to Respondent, Informant,
  VISN, ORO CO
• Sequestration of physical evidence
• Administrative Investigation Board procedures (VA
  Handbook 0700)
• (Except where Handbook 1058.2 has contrary
  provision)
• Interview Respondent and Informant other
  relevant witnesses
• Written transcripts
• Determine whether, what extent research
  misconduct has occurred, who is responsible, and
  what corrective actions are appropriate
• VAMC Director sends Investigation Report to
  Network Director, with any added recommendations
  and proposed disciplinary actions
• Complete within 90 days

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III. Handling Allegations of Research Misconduct
INVESTIGATION COMMITTEE

• May be a standing or ad hoc Committee
• Composed of 3 to 5 individuals
• Members of Inquiry Committee may serve
• Members selected by the VAMC Director
• Chair must be VAMC employee with 5/8ths or
  greater appointment, involved in VA research
• Representative of agency/entity with concurrent
  jurisdiction
• No actual or apparent conflict of interest
• Respondent and Informant may submit objections to
  Committee membership based on COI, but Director
  makes final decision

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III. Handling Allegations of Research Misconduct
INVESTIGATION REPORT

• VA Handbook 0700, Chapter 6
• Standard Format
• Appendix N
• Investigation Report summarizes
• the allegation
• the evidence reviewed
• Recommendation about whether research misconduct
  occurred, the type/extent of misconduct, who is
  responsible, corrective actions
• Draft reviewed and commented on by
• Respondent
• Informant (only the portion related to
  Informants role and testimony)

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III. Handling Allegations of Research Misconduct
ORO Investigation

• Conducted in lieu of a VAMC investigation in
  exceptional circumstances
• as determined by ORO CO within its discretion
• Exceptional circumstances
• the VAMC is not prepared to handle the allegation
  in a manner consistent with Handbook 1058.2
• the VAMC cannot complete an investigation for any
  reason
• ORO involvement is needed to protect the public
  interest

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IV. Questions and Answers
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