The University of Virginia Charlottesville, Virginia

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The University of VirginiaCharlottesville,
Virginia
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Ethics in Research

• Definitions
• Strategies for Avoidance of Research Misconduct
• Responsibilities of team members
• Communication and timeliness
• Authorship responsibilities and importance
• Research Ethics Committee
• Inquiry
• Investigation
• Implications of a Breech
• Hints for Staying Squeaky-clean

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UVa Conflict of Interestand Related Policies
This institution will be based on the illimitable
freedom of the human mind. For here we are not
afraid to follow truth wherever it may lead, not
tolerate error as long as reason is left free to
combat it. Thomas Jefferson, 1820
All University conflict of interest policies are
aimed at minimizing vested interests, thus
optimizing the environment for pursuing truth.
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UVa Conflict of Interestand Related Policies

• Objectivity in Research

• Identify personal interests that might be
  affected by grant
• Must declare interests 3 equity or 10,000
• Must sign for all members of research team
  (Goldenrod form)

• Faculty Endorsement of Industry

• Objectivity and appearance of neutrality
  essential to University mission.
• Must declare that funds not associated with
  product endorsement.
• Cannot use University appointment or name in
  endorsing industry.

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UVa Conflict of Interestand Related Policies

• Objectivity in Research

• Identify personal interests that might be
  affected by grant
• Must declare interests 10,000
• Must sign for all members of research team

• Faculty Endorsement of Industry

• Objectivity and appearance of neutrality
  essential to University mission.
• Must declare that funds not associated with
  product endorsement.
• Cannot use University appointment or name in
  endorsing industry.

• Commonwealth of Virginia Policy

• No Va. employee may receive personal benefit in
  performance of official
• duty (e.g., purchasing, contracts, promotions,
  etc.).

• Continuing Medical Education

• Any personal interest must be declared to
  audience.
• Detailed disclosure forms required by ACCME

• Research Ethics

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Regulations RegardingInvestigation of Research
Misconduct
Office of Science and Technology Policy Executive
Office of the President
Federal Register, Vol. 65, No. 235, pp.
76260-76264 December 6, 2000
Applies to all federally-funded research and
proposals submitted to Federal agencies for
research funding.
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Definition of Research
includes all basic, applied, and demonstration
research in all fields of science, engineering,
and mathematics. This includes, but is not
limited to, research in economics, education,
linguistics, medicine, psychology, social
sciences, statistics, and research involving
human subjects or animals.
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Definition of Research Misconduct
Research misconduct is defined as fabrication,
falsification, or plagiarism in proposing,
performing, or reviewing research, or in
reporting research results.
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Fabrication
Fabrication is making up data or results and
recording or reporting them.
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Falsification
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.
Includes research proposals, laboratory records
(both physical and electronic), progress reports,
abstracts, theses, oral presentations, internal
reports, and journal articles.
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Plagiarism
Plagiarism is the appropriation of another
persons ideas, processes, results, or words
without giving appropriate credit.
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Technically not Research Misconduct

• Poor planning
• Sloppy record keeping
• Erroneous calculations
• Drawing faulty conclusions
• Failing to communicate

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Other Forms of Research Misconduct

• Unethical treatment of human research subjects
• Mistreatment of laboratory animals
• Authorship disputes, other than plagiarism
• Misallocation of funds
• Sexual harassment
• Discrimination

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Ethics in Research

• Definitions

• Strategies for Avoidance of Research Misconduct
• Responsibilities of team members
• Communication and timeliness

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Avoidance of Research Misconduct
Responsibilities of team members

• 1. The investigator
• Continuously reassess role and communicate

• 2. The laboratory group
• Work is not owned by any individual member

• 3. The laboratory director (mentor)
• Investigators responsibility to inform and
  update
• Mentors responsibility to advise, correct,
  approve
• All releases from lab should go through him/her

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Avoidance of Research Misconduct
Responsibilities of team members

• 4. The department Chair
• Must review and approve all protocols and
  grants
• Large departments may delegate to research
  director

• 5. The institution
• Technically the owner, but investigator its
  agent

• 6. The funding agency
• Avoid accepting funds for research which cannot
  be fully
• disclosed
• Must disclose research for which you will
  receive direct
• benefit (Objectivity in Research policy)

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Avoidance of Research Misconduct
Communication among team members

• Establish authorship when project conceived

• Have regularly-scheduled lab meetings

• Have regularly-scheduled career-planning
• sessions

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Ethics in Research

• Definitions
• Strategies for Avoidance of Research Misconduct
• Responsibilities of team members
• Communication and timeliness

• Authorship responsibilities and importance

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Authorship
Define authorship as early as possible order can
be changed during the course of the project.

• First author
• Co-author
• Senior author

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First Author
Should have ...

• adapted a hypothesis
• defined precise methods
• participated in a major way in analysis
• and interpretation of results
• written the paper

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Co-Author
Should have made significant contributions to the
planning and execution of the research, the
methods and procedures, the collection and
analysis of the data, etc.
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Senior Author
Should have ...

• formulated the original hypothesis or provided
• significant intellectual resources
• and
• provided constructive criticism of the
  manuscript
• and
• accepted responsibility for the findings and
  the
• authorship

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Authors Statement - JAMA
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Authors Statement - JAMA(continued)
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Authors Statement - JAMA(continued)
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Promotions and Publications

• Important considerations
• Quality more than quantity
• Peer review and prestige of journal
• Reprints of 5 of your best and most
• representative publications will be
• requested.

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Ethics in Research

• Definitions
• Strategies for Avoidance of Research Misconduct
• Responsibilities of team members
• Communication and timeliness
• Authorship responsibilities and importance

• Research Ethics Committee
• Inquiry
• Investigation

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Research Ethics Committee

• John Kattwinkel, MD Professor of Pediatrics
• Carlos Ayers, MD Professor of Medicine
• David Hudson, PhD Associate Vice President
• for Research
• Jonathan Moreno, MD Director, Center for
• Biomedical Ethics
• Richard Murphy, PhD Professor of Physiology
• Elizabeth Scott, JD Professor of Law

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Response to Allegations of Research Misconduct
1. Discussion of allegation with accuser

• Immediate supervisor
• Division chief
• Department Chair
• Chairs HIC, ARC, GCRC, RSC
• Chair REC
• Dean

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Response to Allegations of Research Misconduct
2. Activation of informal inquiry

• Notification of accused
• Securing of data records
• Possible appointment of experts
• Hearing of evidence
• Development of recommendations

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Response to Allegations of Research Misconduct

• 3. Activation of formal investigation
• More in-depth than inquiry
• Recruitment of outside expert(s)
• May involve legal counsel

4. Acceptance or investigation by ORI
5. Appeal to Office of Inspector General
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Ethics in Research

• Definitions
• Strategies for Avoidance of Research Misconduct
• Responsibilities of team members
• Communication and timeliness
• Authorship responsibilities and importance
• Research Ethics Committee
• Inquiry
• Investigation

• Implications of a Breech

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Ethics in Research

• Definitions
• Strategies for Avoidance of Research Misconduct
• Responsibilities of team members
• Communication and timeliness
• Authorship responsibilities and importance
• Research Ethics Committee
• Inquiry
• Investigation
• Implications of a Breech

• Hints for Staying Squeaky-clean

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How to Avoid Allegations of Research Impropriety
1. Conduct responsible research

• Plan experiments carefully

• Maintain equipoise when conducting experiments
• (keep blinded wherever possible)

• Dont let enthusiasm for hypotheses affect
  results

• Be honest about data

• Dont let publish-or-perish dictate experiments

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How to Avoid Allegations of Research Impropriety
2. Keep good records.

• Lab notebooks, computer files, patient records,
  
• graph tracings, etc.

• Keep for at least 5 years.

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How to Avoid Allegations of Research Impropriety
3. Communicate!

• With colleagues regarding authorship.

• With lab team regarding progress and
  inter-related
• projects.

• With supervisors and mentors regarding
• Career development
• Evolving independence
• Ownership of intellectual property

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Ethics in Research

• Definitions
• Strategies for Avoidance of Research Misconduct
• Responsibilities of team members
• Communication and timeliness
• Authorship responsibilities and importance
• Research Ethics Committee
• Inquiry
• Investigation
• Implications of a Breech
• Hints for Staying Squeaky-clean