Pluses and Pitfalls

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SRA Annual Meeting (SN37) October 12, 2008
Joint Research Misconduct Investigations
Pluses and Pitfalls
Peter N. Poon, JD, MA Office of Research
Oversight, Dept. of Veterans Affairs
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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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Research Misconduct
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I. Research Misconduct Defined Research
misconduct is defined as fabrication,
falsification, or plagiarism in proposing,
performing, or reviewing research, or in
reporting research results. Fabrication is
making up data or results and recording or
reporting them. Falsification is
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
is the appropriation of another persons ideas,
processes, results, or words without
giving appropriate credit. Research misconduct
does not include honest error or differences
of opinion.
Federal Policy on Research Misconduct
65 Fed. Reg. 76262
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Fabrication
Falsification
Plagiarism
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F
F
P
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Research Misconduct Cases

• William Summerlin (1974)
• John Darsee (1981)
• Stephen Breuning (1983)
• Robert Slutsky (1985)

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Research Misconduct Cases

• Eric Poehlman (2005)
• Paul Kornak (2005)

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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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Department of Veterans Affairs
Secretary
Under Secretary for Health VHA
Under Secretary for Benefits VBA
Under Secretary for Memorial Affairs NCA
21 Veterans Integrated Service Networks (VISNs)
Director VISN 1
Etc.
Director VISN 2
Director VISN 3
VA Medical Centers (VAMCs)
VAMC A
VAMC B
VAMC C
Etc.
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12d(1). Inquiry and Investigation by a
Local VA Medical Center. In most instances, the
local VA medical center that receives a research
misconduct allegation is responsible for
conducting an Inquiry, and if warranted, a
further Investigation. The Investigation
Committees findings and recommendations for
corrective actions, if applicable, are set forth
in an Investigation Report. 12d(3).
Adjudication by VISN Director. The appropriate
VISN Director reviews the final Investigation
Report and renders a decision regarding the
findings and recommendations for corrective
actions. 12d(5). Appeal to the Under
Secretary for Health. The Respondent may appeal
a finding of research misconduct and proposed
corrective actions (including debarment, if
applicable) to the Under Secretary for Health
who makes a ruling on the Respondents appeal
which constitutes VAs final agency action.
Sequence of Review
VA Policy and Procedures for Handling Research
Misconduct Allegations
VHA Handbook 1058.2
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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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When More Than One Agency is Involved. A lead
agency should be designated to coordinate
responses to allegations of research
misconduct when more than one agency is
involved in funding activities relevant to
the allegation. Each agency may
implement administrative actions in
accordance with applicable laws,
regulations, policies, or contractual procedures.
Federal Policy on Research Misconduct
65 Fed. Reg. 76263
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12c. Joint Jurisdiction Other non-VA
agencies or entities (e.g., academic affiliates
of the VA) may have concurrent jurisdiction over
the same research project, or parts thereof that
is the subject of a VA research misconduct
Inquiry and Investigation. In such cases, VA
must coordinate its response to allegations of
research misconduct with the relevant non-VA
agencies and/or entities, in order to maximize
procedural uniformity and minimize duplication
while recognizing institutional autonomy.
VA Policy and Procedures for Handling Research
Misconduct Allegations
VHA Handbook 1058.2
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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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Joint Jurisdiction Examples

• VA study funded by the NIH through the VAs
  academic affiliate
• VA study funded by the NIH through a nonprofit
  corporation (NPC)
• VA study using non-VA facilities, equipment, or
  personnel (by agreement)
• VA study with non-VA collaborators
• Joint oversight by agreement (e.g., MOU regarding
  researchers with joint appointments)

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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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12c(1). For every research misconduct
allegation received, the VA medical center
Research Integrity Officer must determine
whether and what other non-VA agencies or
entities have joint jurisdiction over the
underlying research. 12c(2). The VA medical
center RIO must notify all non-VA agencies or
entities that have joint jurisdiction over a
research project of any misconduct allegation
regarding such research. 12c(3). Wherever
possible, the VA medical center and the non-VA
agencies or entities with concurrent jurisdiction
are encouraged to perform a joint Inquiry, and if
warranted, a joint Investigation. Each agency or
entity with jurisdiction must designate at least
one representative to participate in the Inquiry
and Investigation.
12c. Joint Jurisdiction
VA Policy and Procedures for Handling Research
Misconduct Allegations
VHA Handbook 1058.2
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The Alternative to Joint Investigation
JOINT Investigation
Separate Investigation
Separate Investigation
Recommendation
Recommendation
Research Misconduct ?
No Research Misconduct ?
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12c(4). Through informal negotiation between
the VA medical center and the non-VA agencies or
entities with concurrent jurisdiction, a mutual
determination must be made as to which agency or
entity will take the lead in conducting the joint
Inquiry and Investigation. Factors to
consider in making this determination include,
but are not limited to, which agency or entity
(a) Is the primary sponsor or funder of the
underlying research (b) Approved the
underlying research (c) Is the primary
employer of the Respondent (d) Operates
the facilities that were used to conduct the
underlying research and (e) Has the
resources and personnel best suited to conducting
a timely and thorough Inquiry and Investigation.
12c. Joint Jurisdiction
VA Policy and Procedures for Handling Research
Misconduct Allegations
VHA Handbook 1058.2
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12c(5). The applicable procedures for
conducting an Inquiry and Investigation are those
of the agency or entity that takes the lead, as
determined by subparagraph12c(4). The VA medical
center and other non-VA agencies or entities are
encouraged to make, to the extent possible,
their respective research misconduct procedures
compatible in carrying out the joint Inquiry and
Investigation. 12c(7) Each Inquiry and
Investigation must result in a single set of
recommendations, although a minority opinion may
be produced if the lead agencys or entitys
procedures so specify.
12c. Joint Jurisdiction
VA Policy and Procedures for Handling Research
Misconduct Allegations
VHA Handbook 1058.2
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When More Than One Agency is Involved. A lead
agency should be designated to coordinate
responses to allegations of research
misconduct when more than one agency is
involved in funding activities relevant to
the allegation. Each agency may
implement administrative actions in
accordance with applicable laws,
regulations, policies, or contractual procedures.
Federal Policy on Research Misconduct
65 Fed. Reg. 76263
24
12c(8). Each agency or entity with
concurrent jurisdiction must follow its own
procedures for adjudicating and appealing
research misconduct cases. No agency or entity
is bound by anothers adjudication or appeal
decision. Each agency or entity may implement
administrative actions in accordance with its own
laws, regulations, policies, or contractual
procedures, although non-procurement debarments
and suspensions are applied across the Federal
government pursuant to Executive Order 12549.
12c. Joint Jurisdiction
VA Policy and Procedures for Handling Research
Misconduct Allegations
VHA Handbook 1058.2
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Separate Adjudication and Appeal
JOINT Investigation
Recommendation
Separate Adjudication
Separate Adjudication
Research Misconduct ?
No Research Misconduct ?
APPEAL
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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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Joint Investigations Pluses

• Single set of recommendations
• ? likely to have the same ultimate outcome
• Minimize duplication of effort
• Procedural uniformity
• Best institutional resources, experience
• Shared evidence, witnesses
• Sharing of institutional perspectives

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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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Joint Investigations Pitfalls

• Determining joint jurisdiction may be tricky
• Disagreement on which agency/entity leads
• Procedures may not be harmonized
• Conflicting institutional interests
• Imbalance of Committee membership
• Reduced oversight by non-lead agency/entity
• Mixture of joint and solo jurisdiction issues

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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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Potential Solutions

• Prior to any research misconduct allegation
• Be familiar with your institutions research
  misconduct policy and procedures
• Be familiar with your affiliates research
  misconduct policy and procedures
• Harmonize the two sets of procedures as much as
  possible be aware of the differences
• Establish key contacts at the other agency/entity

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Potential Solutions

• At the outset of a research misconduct case
• Determine jurisdiction
• For VA cases, consult ORO as necessary
• Weigh all benefits/risks of taking or ceding the
  lead in joint investigations
• Ensure adequate representation on committee
• Communicate institutional interests and concerns

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Potential Solutions

• During a joint research misconduct investigation
• Emphasize collaboration, but respect
  institutional autonomy
• Maintain adequate oversight regardless of which
  institution is leading the investigation
• Frequent communication between institutions
• Report all important issues (procedural and
  substantive) to both institutions officials
• Consider bifurcating the investigation only as a
  last resort

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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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Broader Application of Joint Investigation
Principles and Solutions

• Between other Federal Agencies
• Between other Federal Agencies and non-Federal
  entities
• Between non-Federal entities
• Other than research misconduct investigations

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Session Outline

• Research Misconduct Background
• Research Misconduct Investigations Solo
  Jurisdiction
• Joint Jurisdiction Policy
• Examples of Joint Jurisdiction
• Research Misconduct Investigations Joint
  Jurisdiction
• Joint Investigations Pluses
• Joint Investigations Pitfalls
• Potential Solutions
• Broader Application
• Remaining Concerns Discussion and Exchange of
  Ideas

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(No Transcript)
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Peter N. Poon, JD, MAAssociate Director for
Research Integrity Assurance

• Office of Research Oversight
• Veterans Health Administration
• Department of Veterans Affairs
• peter.poon_at_va.gov
• [phone]