Scientific Misconduct and How to Prevent It

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Scientific Misconduct(and How to Prevent It)

• Edith Paal
• UAMS Office of Research Compliance

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What is Scientific Misconduct?

• Research misconduct means fabrication,
  falsification, or plagiarism in proposing,
  performing, or reviewing research, or in
  reporting research results. 42 CFR 93.103

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What it is, continued

• Fabrication -making up results and recording or
  reporting them.
• Falsification - manipulation of research
  materials, equipment or processes or changing or
  omitting data or results such that the research
  is not accurately represented.
• Plagiarism - using another persons ideas,
  processes, results, or words without proper
  attribution.

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What is Isnt

• Honest error or differences of opinion are NOT
  scientific misconduct.

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What it is (cont.)

• UAMS Faculty Handbook expounds upon the federal
  definition, and adds
• Material failure to comply with federal
  requirements that uniquely relate to the conduct
  of research. This would include, but not be
  limited to, failure to comply with federal
  requirements for the protection of human
  subjects .

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How Big is the Problem?

• The Office of Research Integrity (ORI)
• Involved in federally funded research
• 200 allegations received every year
• 142 findings of misconduct in the past 10 years
• 90 percent for falsification/fabrication
• 10 percent for plagiarism

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Who is interested in the conduct of your study?

• Various federal agencies ORI, ORO, OIG, OHRP,
  FDA
• The people paying for it
• The institution
• The journals in which you publish it
• The people who use its findings to determine
  treatments for their patients
• The people who cite it in their own work

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FDA Guidance on Clinical Hold for Sponsor or
Investigator Misconduct

• Recent FDA guidance outlines agencys ability and
  intent to take faster action to protect subjects
• Examples cited as misconduct
• Failure to monitor subjects for serious toxicity
• Falsified eligibility data
• Repeated or deliberate failure to obtain informed
  consent
• Failure to obtain IRB approval for significant
  protocol changes
• http//www.fda.gov/cber/gdlns/clinholdinvest.pdf

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Who might suspect and report misconduct?

• Study monitors
• Auditors
• Study staff or other contributors
• Peer reviewers/journal readers
• Subjects and their families

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Who Can Be Cited For Misconduct

• Primary Investigator (ultimately responsible for
  all study activities)
• Sub Investigators
• Research Staff
• Both FDA and NIH are citing Research Associates
  more frequently

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Handling an Allegation

• Referred to the Vice Chancellor for Academic
  Affairs/Research Administration
• Others as required by law, regulation or contract
  might be notified
• UAMS has a 2-step process for investigating
• Source UAMS Faculty Handbook

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Two-Step Process, Part I

• Inquiry involves information gathering and
  initial fact-finding
• The accused must cooperate
• Report issued to ORI
• Investigation, if warranted, follows the
  inquiry
• Much more thorough review
• Investigations determination can be appealed

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Final Institutional Report to ORI

• Allegations and charge of misconduct
• Evidence
• Findings
• Federal Funding associated with study
• Final institutional actions
• Note if study involved VA ORO will also be
  notified

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ORI and us

• ORI expects the institution to take primary
  responsibility for any investigation.
• ORI may, however, do its own investigation.
• ORIs oversight can lead to Public Health Service
  findings and administrative actions

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How this Affects Research

• May be required to stop all activities on the
  study being questioned
• May have records sequestered
• May derail careers

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Possible Sanctions

• Externally ORI can ask an investigator or other
  staff person to enter a Voluntary Exclusion and
  Settlement Agreement
• Not apply for federal grant or contract funds
• Not work in the research field
• Not serve on PHS advisory committees, boards, or
  peer-review groups

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Possible Sanctions

• External
• Lose current funding
• Treble repayment of federal grant funds
• FDA disqualification
• Retraction of publications
• Get your name in print, and not in a good way.

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ORIs Hall of Shame
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Dr. Poehlmans case

• In addition to the usual ORI summary, his page
  contains 39-page university report and a press
  release
• Dr. Poehlman has offered a series of shifting,
  dodging and impossibly contradictory explanations
  for his actions.
• fanciful, the fraudulent, to the preposterous.
• wholly bankrupt value of Dr. Poehlmans
  credibility.
• contempt not just for the truth, but for this
  Panel, the University, and his profession.

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Prevention is a Good Idea

• Investigations are unpleasant and difficult to
  carry out.
• Sooner or later, itll catch up to you.
• Its easier to do it right up front than to have
  to deal with the aftermath later.

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How to Prevent It

• Training, training, and more training.
• Dont take shortcuts.
• Oversee staff on a regular basis.
• Have clean and complete source documentation for
  all research data.
• Make sure your source documentation is available
  for later review.

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Research Records

• The destruction, absence of, or respondents
  failure to provide research records adequately
  documenting the questioned research is evidence
  of research misconduct .
• 42 CFR 93.106

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How To Report Scientific Misconduct

• Written letter to Office of Research Compliance
  UAMS slot 813
• Phone call to ORC Director 526-6876

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For More Information

• ORI website http//ori.hhs.gov/
• UAMS Faculty Handbook (section titled,
  Maintenance of High Ethical Standards in the
  Conduct of Research)
• UAMS Administrative Guide (http//www.uams.edu/adm
  inguide)