RESEARCH MISCONDUCT in Academic Institutions

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RESEARCH MISCONDUCT in Academic Institutions
Presented at the Sociedad de Administradores de
Investigación Annual Meeting March 14, 2008

• Delia M. Camacho, PhD
• Dean for Academic Affairs
• University of Puerto Rico
• Medical Sciences Campus

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Board of TrusteesCertification 45 2006-2007

• University of Puerto Rico
• System-Wide Policy and Procedures for Responding
  to Allegations of Possible Research Misconduct

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General Policy

• Research misconduct
• Fabrication, falsification, or plagiarism in
  proposing, performing, or reviewing research, or
  in reporting research results
• Institutional policy
• Safeguard research against actions that undermine
  its integrity and public trust
• Discourage misconduct
• Address effectively allegations of misconduct in
  research and research-related activities
• Report to pertinent agencies, when required

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Funding Agencys Policy

• When Public Health Service (PHS) support,
  National Science Foundation (NSF) funding or
  other federal funding is involved, the funding
  agencys policy on research misconduct will
  apply in addition to the system-wide policy.

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Scope

• Allegations of research misconduct involving any
  institutional member
• Noncompliance with federal, state, or
  institutional regulations concerning
• Human subjects
• Animal care and use
• Recombinant DNA
• Other types of regulations governing research

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Definitions

• Allegation disclosure of possible research
  misconduct
• Applicable agencies
• Office of Research Integrity (ORI) if PHS support
  is involved
• NSF
• Other agencies
• Complainant person who in good faith makes an
  allegation

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Definitions

• Evidence document, tangible item, testimony
• PHS support
• Intramural research
• PHS grants
• Cooperative agreements
• Contracts, subgrants, subcontracts
• Salaries

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Definitions

• Research Integrity Officer (RIO) official on
  each campus who is responsible for assessing
  allegations of research misconduct and
  determining when such allegations warrant
  inquiries, and for overseeing inquiries and
  investigations
• Research misconduct fabrication, falsification
  or plagiarism in proposing, performing or
  reviewing research or in reporting research
  results

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Process

• Allegation
• Chancellor / Chancellors designee
• Research Integrity Officer

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• Research Integrity Officer
• Assessment
• 42 CFR 93.103
• Potential evidence of misconduct
• Inquiry No Inquiry

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Inquiry

• Purpose
• to conduct an initial review of the available
  evidence to determine whether to conduct an
  investigation.
• It is not to decide whether misconduct definitely
  occurred, determine who committed the misconduct,
  or to conduct exhaustive interviews and analysis.

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Inquiry

• RIO will notify respondent at the time of, or
  before beginning an inquiry.
• Draft of inquiry report will be sent to
  respondent for comments
• Final Inquiry Report copy to respondent
• Respondent may appeal findings(Cert. 44
  1984-85, as amended by Cert. 94, 1989-90 CHE,
  Board of Trustees)

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Inquiry

• Interim administrative actions (based on ongoing
  inquiry findings)
• Additional monitoring of research process and
  handling of federal funds and equipment
• Reassignment of personnel or of responsibility
  for handling federal funds and equipment
• Additional review of research data and results
• Delaying publications

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Conducting the Inquiry

• Assessment of allegations
• Notice to respondent
• Sequestration of research records
• Appointment of the Inquiry Committee
• Three members or as appropriate
• Charge to the Inquiry Committee
• Inquiry process
• Time for completion
• 60 days

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Inquiry Report

• Notification to respondent and opportunity to
  comment
• Institutional decision and notification
  (Chancellor or designee)
• Notification to respondent,complainant,
  applicable Federal Agency

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• Institutional Decision
• Investigation is warranted
• Decision not to investigate

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Institutional Decision

• Investigation is warranted
• Copy of report to ORI or applicable federal
  agency
• Notify institutional officials
• Documentation of decision not to investigate
• Report and documentation retained for 7 years

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Investigation WarrantedConducting an
investigation

• Investigation must be initiated 30 days after
  decision to investigate
• Notify ORI and respondent
• Purpose
• Develop a factual record by exploring the
  allegations in detail and examining the evidence
  in depth, leading to recommended findings on
  whether research misconduct has been committed,
  by whom and to what extent

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Investigation WarrantedConducting an
investigation

• Sequestration of research records
• Appointment of Investigation Committee by
  Chancellor
• Members may have served in Inquiry Committee
• Members may be from outside UPR
• Respondent will be notified of committee
  composition
• Respondent may object to a committee member
  within10 days of notification

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Standard for making a finding of Research
Misconduct

• Misconduct occurred as defined in policy or
  applicable federal agency policy
• Is a significant departure from accepted
  practices of the relevant research community and
• Respondent committed the research misconduct
  intentionally, knowingly or recklessly

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Time for completion of investigation

• 120 days from its initiation
• If delayed, RIO may submit written request for
  extension

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Research MisconductInstitutional Administrative
Actions

• Restitution of funds to the sponsor, as
  appropriate
• Withdrawal or correction of all pending or
  published abstracts and papers arising from
  research in which misconduct was found
• Notification of institutions and sponsoring
  agencies with which the individual has been
  affiliated if there is reason to believe that the
  validity of previous research may be questionable

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Research MisconductInstitutional Administrative
Actions

• Prohibition to act as a principal investigator
  for a period usually not exceeding 5 years
• Special monitoring of future research activities
  and/or
• Disciplinary or other administrative action,up to
  and including termination of employment, in
  keeping with personnel and/or student
  regulations, in proportion to the magnitude of
  the misconduct

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Research MisconductInstitutional Administrative
Actions

• The Chancellor may be obliged to notify
• Puerto Rico Office of Governmental Ethics
• Office of the Comptroller of the Commonwealth of
  Puerto Rico
• Puerto Rico Department of Justice
• (Funding sponsor may impose own sanctions)

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Summary
ALLEGATION
NO MISCONDUCT Report and documentation retained
for 7 years
NO INQUIRY
MISCONDUCT Institutional administrative actions
INVESTIGATION
INQUIRY
NO INVESTIGATION
Report and documentation retained for 7 years