Responsible Conduct of Research

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Responsible Conduct of Research
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Learning Objectives

• This module will help you to
• Define research misconduct
• Describe general best practices for responsible
  authorship
• Identify good data integrity practices
• Define various types of conflicts of interest

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Integrity in Science

• For a scientist, integrity embodies above all
  the individuals commitment to intellectual
  honesty and personal responsibility
• -- Integrity in Scientific Research, National
  Academy of Sciences
• Trust and honesty are the cornerstones

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Why do we need to talk about responsible conduct
in research?

• Increase understanding and judgment
• Promote best practices
• Establish a culture of concern

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What can happen when research lacks integrity?

• Misdemeanors
• Unmerited authorship credit
• Not sharing data / materials
• Misleading statistics or graphics
• Breaking confidentiality in review
• Maintaining inadequate records
• Failing to disclose conflicts of interest
• Fragmentary publication
• Duplicate publication

• Questionable credibility
• Damaged reputation
• Tainted future research

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What can happen when research lacks integrity?

• Debarment from receipt of federal funding
• Supervision certification of future research
• Halt research
• Termination
• Rescission of degree
• Formal reprimand
• Formal apology
• Ethical training
• Suspension / probation
• Withholding pay

• High Crimes
• Research Misconduct
• Plagiarism
• Fabrication of data
• Falsification of data

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Research Misconduct Definition

• Research misconduct means fabrication,
  falsification, or plagiarism in proposing,
  performing, or reviewing research, or in
  reporting research results
• (a) Fabrication is making up data or results and
  recording or reporting them.

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Definition (continued)

• (b) 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.
• (c) Plagiarism is the appropriation of another
  persons ideas, processes, results, or words
  without giving appropriate credit.

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Definition (continued)

• (d) Research misconduct does not include honest
  error or differences of opinion.
• Federal Register, vol 70 (94)

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Why Research Integrity?

• Its not only about research misconduct its
  about the responsible conduct of research

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Responsible Conduct of Research

• Responsible authorship and peer review
• Data integrity
• Conflict of interest disclosure
• Collegial collaborative research
• Research mentoring
• Ethical conduct of research with humans or
  animals
• Intellectual property management
• Fiscal responsibility
• Proper handling of biohazardous materials

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Where Can You Learn About RCR?

• Research mentor
• PSU RAG16 Guidelines for the Responsible
  Conduct of Research
• Professional Society Codes of Ethics
• Journal authorship guidelines
• ORI Introduction to the Responsible Conduct of
  Research written by Nicholas Steneck
• Scientific Integrity written by Frank Macrina

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Why Research Ethics?

• Its not only about research misconduct its
  about the responsible conduct of research.
• Everyone is vulnerable regardless of status

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Causes of Misconduct or QRP

• Pressure to get results
• Pressure to obtain funding or tenure
• Increasing complexity of research environment
• Inadequate training in proper conduct

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Why Research Ethics?

• Its not only about research misconduct its
  about the responsible conduct of research.
• Everyone is vulnerable
• Its not always straightforward

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Research Integrity Responsible Authorship
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Responsible Authorship

• Research dissemination
• Proper citation
• Authorship credit and responsibility
• What to publish
• When to publish

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Guidelines for Publication
Widely cited guidelines for publication written
by the International Committee of Medical Journal
Editors. Guidelines can be found at
www.icmje.org
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Guidelines for Publication

• Disseminate research findings in a timely fashion
• Further knowledge in the field
• Avoid redundant work
• NSF 05-131 July 2005 (Grant Policy Manual)
• http//www.nsf.gov/publications/pub_summ.jsp?ods_k
  eygpm
• Part 734 Dissemination and Sharing of Research
  Results
• Promptly publish significant findings
• Share data, samples, software, or other
  materials, etc. resulting from supported research

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Good Citation Practices

• Adequately and accurately cite literature
• Include adequate references to document ideas
• Verify that referenced works are consistent with
  the ideas and information credited to them
• Cite original sources
• Check the accuracy of citations
• Do not plagiarize!

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Plagiarism - Definition

• Plagiarism is the appropriation of another
  person's ideas, processes, results, or words
  without giving appropriate credit, including
  those obtained through confidential review of
  others' research proposals and manuscripts.
• Federal Register
• Vol 64, No 198

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Plagiarism Definition

• PSU English department definition
• Verbatim plagiarism
• Plagiarism by paraphrasing
• Mosaic plagiarism

On Plagiarism http//www.courses.psu.edu/engl/eng
1030_jth/Plagiari.html
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Avoiding Plagiarism

• Take careful notes
• Always credit the work of others
• Be sure to cite sources
• Include all cited sources in the reference list
  and vice versa
• Obtain permission to include figures, models,
  graphs, etc.

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Authorship Credit Responsibility

• Substantial contribution to
• Conception design of study, OR
• Acquisition of data, OR
• Analysis interpretation of data
• Drafting the article OR revising it critically
  for important intellectual content
• Final approval of the version to be published
• Authors should meet all 3 conditions

International Committee of Medical Journal
Editors (ICMJE) Uniform Requirements for
Manuscripts. http//www.icmje.org/
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Authorship Credit - Summary

• Each author should have participated sufficiently
  in the work to take public responsibility for
  appropriate portions of the content. (ICMJE)
• Avoid honorary and ghost authorship
• Acknowledge contributors who do not merit
  authorship

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CASE STUDY From Game, A. and West, M.A. (2002).
Principles in publishing. Psychologist, 15(3),
126 130. David, Carol, Peter and Ann have
worked on a project on the predictors of nurse
job satisfaction in hospitals for two years.
Anns role was as the research grant holder. She
designed the research initially but thereafter
had little day-to-day involvement. She attended
most of the monthly research meetings, at which
she made useful suggestions. Peter worked
part-time for the team (10 hours a week) for the
whole two years to support his study as an
undergraduate in the Psych Department. He played
a major role in the research in getting
questionnaires printed, distributing them,
entering the data and performing some basic
quantitative data analyses the team directed him
to perform (descriptive data and some one-way
analyses of variance). He also helped transcribe
many of the open comments on the questionnaire
on to a single file that could be used in
conjunction with a qualitative analysis package.
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CASE STUDY CONTINUED David is one of the three
professors in the department and was named on the
original grant proposal, though he has played no
role in the development of the research from
design through to writing up. However, his
measure of job satisfaction was the central scale
used in the study. Finally, Carol supervised the
project throughout the two years, and was closely
involved throughout. She wrote the complete
first draft of the paper reporting the results of
the study. Who should get authorship and in what
order?
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CASE STUDY From Game, A. and West, M.A. (2002).
Principles in publishing. Psychologist, 15(3),
126 130. Joe, a Psychology graduate student,
and his advisor, Emma, together developed the
ideas for a project in Emmas area of expertise
(bullying in schools). Emma, helped Joe get
access, discussed the research ideas with Joe,
and gave him copies of her papers so he could
design the research appropriately. He wrote the
project up for his masters thesis. It was
examined and awarded a good mark. Emma then
undertook to use the thesis as the basis for
partially reanalyzing the data and writing the
article up for publication in a BPS journal.
In what order should the authors be listed?
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Good Publication Practices

• Avoid misrepresentation in publications
• Publish accurate, complete, clear, and unbiased
  work
• Avoid fragmentary publication
• Publish manuscripts that represent substantial
  findings

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Good Publication Practices

• Avoid duplicate manuscript submission
  publication
• Publish research that will add new contributions
  to the field
• Acknowledge prior publications
• A suitable footnote might read This article is
  based on a study first reported in the title of
  journal, with full reference. ICJME
  guidelines

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Responsible Authorship Principles

• Research is not complete until it has been
  reported
• Integrity in publication depends on objectivity
  and avoiding misrepresentation
• Authorship implies both credit and responsibility
• Research publications should impart new and
  substantial findings

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Research IntegrityData Management
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Data and Research Integrity

• Research integrity depends on responsible
• Selection
• Collection
• Handling
• Reporting
• Ownership
• Sharing
• of data

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Responsible Data Management

• Pre-Data Collection experimental design,
  protocol submission, approval by institutional
  committee(s)
• Data Collection ensuring quality avoiding
  bias, adequate recordkeeping
• Analysis Selection statistical analyses,
  criteria for including excluding data
• Data Ownership responsibility and rights for
  collection, use, and sharing
• Data Retention duration, security, and
  accessibility
• Sharing of Data what to share, when, and with
  whom

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Preparing for Data Collection

• Clearly identify a testable hypothesis
• Consider personal beliefs, social concerns, or
  regulatory restrictions that might place
  boundaries on the research
• Design the study to eliminate or minimize the
  effects of bias
• Enlist statistical expertise
• Proper choice of statistical methods can help
  eliminate wasted resources (e.g., too many or too
  few subjects/tests, misrepresentations in
  reporting)

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Data Collection Record Keeping

• Maintain adequate records
• Practice good laboratory practices
• To verify results
• To enable replication
• Record keeping best practices vary by discipline
  lab

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Data Collection Record Keeping

• Generally accepted standards
• Bound notebook
• Numbered pages
• Dated entries
• Written in ink
• Document when, who, what
• Line through deletions, still readable
• Corrections dated and initialed
• References to locations of supporting materials
  or records

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Analysis Selection
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Data Management Principles

• Integrity of research depends on the integrity of
  the data
• Research records document the process and
  products of the research
• Integrity of the data is a shared responsibility
  among all members of the research team
• Sharing of research data is in the best interest
  of knowledge advancement

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Conflicts of Interest
A conflict of interest is when ones actual or
imputed interest compromises or appears to
compromise ones ability to impartially perform
ones duty.
Stokes, L. Key Issues in Conflict of Interest for
Scientific, Engineering, and Educational
Research. The Journal of Research
Administration/Theme Issue Conflict of Interest,
v. XXXIII (II), 2002.
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Conflicts of Interest

• Issue of public trust
• The public expects University research to be
  objective and unbiased

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Financial Conflict of Interest

• Potential for bias in experimental results based
  on financial gains from
• Grants and contracts
• Consulting
• Advisory boards membership
• Speakers bureaus
• Patent/Royalty arrangements
• Expensive gifts/trips
• Equity interest

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Scientific Conflicts of Interest

• Scientific
• Unfairly inhibiting competitors manuscripts or
  proposals
• Unfairly implementing experimental techniques
  gained from competitors manuscripts or proposals
• Unfairly promoting friends manuscripts or
  proposals

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Judicial/Legislative Conflicts of Interest

• Potential for bias or appearance of bias when
• Testifying before legislative committees that
  appropriate funds for research
• Testifying before legislative committees that
  will influence public policy
• Engaging in paid expert testimony
• Serving on advisory board of executive agencies

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Conflict of Commitment
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Conflicts of Interest

• Ethical challenge be cognizant of outside
  influences and personal biases and disclose,
  disclose, disclose

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Why Research Ethics?

• Its not only about research misconduct its
  about the responsible conduct of research.
• Everyone is vulnerable
• Its not always straightforward
• Its survival skills

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Its Survival Skills

• Equally important as knowledge skill
• Follow guidelines for professional ethics
  societal institutional
• Learn the rules
• Be on the lookout for ethical situations
• If you are unsure, consult with colleagues
• Try the NYT Test

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Why Research Ethics?

• Its not only about research misconduct its
  about the responsible conduct of research.
• Everyone is vulnerable
• Its not always straightforward
• Its survival skills
• Ethics is integral to good research. (Michael
  Zigmond, co-director, Survival Skills and Ethics
  Program at the University of Pittsburgh)