VHA Handbook 1058.2

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VHA Updates in Research Regulatory
Compliance Workshop 28
VHA Handbook 1058.2 Research Misconduct
Society of Research Administrators
International Sunday, October 16, 2005 130 to
500 pm Peter Poon
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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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VHA Handbook 1058.2 (2005)

• Effective May 4, 2005
• VHA Manual M-3, Part I, Chapter 15 rescinded
• All VHA facilities are required to follow the new
  Handbook for research misconduct allegations

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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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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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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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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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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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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

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Inquiry

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

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Inquiry

• 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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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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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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Investigation Committee

• May be a standing or ad hoc Committee
• Composed of 3 to 5 individuals
• 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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Investigation

• Sequestration of physical evidence
• Administrative Investigation Board procedures (VA
  Handbook 0700)
• Except where Handbook 1058.2 has contrary
  provision
• Interview Respondent and Informant, other
  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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Investigation Report

• 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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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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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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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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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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Departmental Review

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

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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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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