Phil 7570 Case Studies in Research Ethics

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Phil 7570Case Studies in Research Ethics

• Fall 2006
• Bryan Benham
• Department of Philosophy

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Outline

• Course Objectives Overview
• Why be concerned?
• Ethical Framework
• Research Misconduct vs. RCR
• hum.utah.edu/bbenham
• www.research.utah.edu/integrity/index.html

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Course Objectives

• Increase ethical sensitivity to issues regarding
  RCR
• Based on ORIs 9 core areas, plus
• Aid in developing moral reasoning skills
• Case Studies
• Acquaint with relevant policies, procedures, and
  professional standards of ethical research.
• Lectures and Discussions

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Central Dogma

• The focus of the course is not merely
  understanding legal or explicit regulations, but
  identifying and employing the underlying ethical
  principles and values that guide responsible
  research, so that one can (ideally) navigate the
  rocky shoals and murky waters of daily research
  practice.

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Faculty

• Course Director
• Bryan Benham (Philosophy)
• Faculty Fellows (Fall/Spring)
• Kathi Mooney (Nursing)
• Kim Korinek (Sociology)
• Rachel Hayes-Harb (Linguistics)
• Frank Whitby (Biochem)
• Tom Richmond (Chemistry)
• Leslie Francis (Phil Law)

• Additional Faculty (Fall)
• David Grunwald (Genetics)
• Dana Carroll (Biochem)
• Michael Kay (Biochem)
• Jim Metherall (Genetics)
• Marty Rechsteiner (Biochem)
• Alice Schmid (Genetics)
• Matt Williams (Pathology)
• Jody Rosenblatt (OncSci)

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Course Requirements

• Course Structure
• Ten Week Course (Thursdays, 400-530)
• Lecture and Small Group Discussion of Case
  Studies
• Requirements
• Attendance no less than 8 of 10
• Readings Case Studies (Available Online)
• Final Paper Case Study Analysis and Evaluation
• hum.utah.edu/bbenham
• www.research.utah.edu/integrity/index.html

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Fall 2007 Schedule
Aug. 30 RCR and Misconduct Sept. 6 Data
Management and Ownership Sept. 13 Authorship and
Peer Review Sept. 20 Mentoring Issues   Sept.
27 Human Participants Oct. 4 Animal
Subjects Oct. 11 Fall Break - No Meeting Oct.
18 Conflicts of Interest Oct. 25 Commerce
Research Nov. 1 Issues in Biomedical
Research Nov. 8 Social Responsibility
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Outline

• Course Objectives Overview
• Why be Concerned?
• Ethical Framework
• Research Misconduct vs. RCR
• hum.utah.edu/bbenham
• www.research.utah.edu/integrity/index.html

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Central Dogma

• The focus of the course is not merely
  understanding legal or explicit regulations, but
  identifying and employing the underlying ethical
  principles and values that guide responsible
  research, so that one can (ideally) navigate the
  rocky shoals and murky waters of daily research
  practice.

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Why Research Ethics? (RCR)
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Success

• Seoul National University
• 1999 announced cow cloning(s)
• But, not confirmed.
• Science, March 12, 2004
• somatic cloning
• Science, June 17, 2005
• 11 hESC lines
• August, 2005
• Cloned dog, Snuppy
• Leader of World Stem Cell Hub

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Not so successful

• Accused of paying for donated eggs,
• some from lab techs.
• Gerald Schatten (U Pitt.) ceased collaborations,
  and withdrew name from 2005 Science paper.
• Both Science papers found to have fabricated
  data subsequently retracted.
• Also, charges of embezzlement and government
  collusion.
• Removed from SNU and WSCH.

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Misconduct

• Breach of international legal and
• ethical codes re egg donation.
• Finding of misconduct, re Science papers.
• Authorship issues, re Gerald Schatten.
• Set back international cooperation on stem cell
  research, plus raised public concern about stem
  cell research.
• Financial Conflict of Interest and Govt
  involvement.

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But, Snuppy is real
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Also, Parthenogenesis

• Review of Hwang Woo Suks research shows his
  embryonic stem cells were the product of
  parthenogenesis.
• It could have been a seminal finding if they
  hadnt had their blinders on. (Kent Vrana, Penn
  State University)
• New York Times, Aug. 3, 2007
• Scientific American, Aug. 2, 2007
• Cell Stem Cell, Aug. 2, 2007

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Not-So-Big-Science, too

• A professor publishes ideas and experiments
  developed by her graduate student, without giving
  credit to the student.
• A researcher presents a paper that shows 33 data
  points that are consistent with his hypothesis,
  but doesnt report the other 12 data points that
  are significantly inconsistent with his
  hypothesis.
• An experimenter recruits subjects for his study
  on cognitive effects of stress on children, but
  advertises it as a study on the role of social
  interactions in child learning.

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Not so Big science, too

• While waiting to hear from a journal about her
  latest paper submission, a new assistant
  professor hears from the editor that the paper is
  held up by a reviewer who has been extremely
  busy, but professor suspects the reviewer may be
  delaying her paper in order to publish first with
  similar findings.
• A researcher published favorable results for a
  new memory enhancing drug, without disclosing
  that she serves as a consultant and holds stocks
  in the company that is developing this new drug.

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Bad Grad

• A FORMER GRADUATE STUDENT at Michigan State
  University was sentenced on Monday to 10 months
  in prison for faking the theft of his own
  research materials. The student, Scott M. Doree,
  was supposed to be working on a vaccine to
  prevent a pneumonialike disease in pigs, but he
  apparently had not done any research for several
  years, authorities say.
• http//chronicle.com/daily/2003/08/2003082102n.htm
  .

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Scientists Behaving BadlyBC Martinson, MS
Anderson, R de Vries. (2005). Nature, 435
737-38

• NIH funded survey
• 3,247 early/mid career
• (47 rr)
• Engaged in
• Top 10 Behaviors
• Early 28
• Mid 38
• Overall 33
• plus expect an underreporting bias.

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Why be concerned?

• What results from a culture of irresponsible
  research or unreflective research practice?
• History of Research Ethics
• Human Participation Nazis, Willowbrook,
  Tuskegee, etc.
• Misconduct Baltimore Affair, S. Korean
  Debacle, etc.
• COI Commercial Interests Political Influence

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Why be concerned?

• Research is a Social Activity
• No researcher is an island collaboration on
  rise
• Research is funded by public funds for public
  good
• Research has serious consequences for society
• Research is a Profession
• Accepted Standards of Behavior (Codes of Ethics)
• Professional Integrity Reputation
• Interest in Self-regulation
• Public Trust
• Wuchty, Jones, Uzzi. 2007. The Increasing
  Dominance of Teams in Production of Knowledge.
  Science 316, May 18 1036-39.

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So far

• Both big and not-so-big-science exhibit unethical
  (and/or unreflective) research practices.
• Both big and not so big science are professional
  and social activities that have profound
  consequences for future research, individuals,
  and society.
• (and it is required for grant support)
• Hence, we should be concerned with responsible
  conduct of research.

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Outline

• Course Objectives Overview
• Why be concerned?
• Ethical Framework
• Research Misconduct vs. RCR
• hum.utah.edu/bbenham
• www.research.utah.edu/integrity/index.html

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Central Dogma

• The focus of the course is not merely the legal
  or explicit regulations, but identifying and
  employing the underlying ethical principles and
  values that guide responsible research, so that
  one can (ideally) navigate the rocky shoals and
  murky waters of daily research practice.

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What is Ethics?

• Determining what one should do
• Right/wrong, good/bad, better/worse
• Principled and Practical
• Promotion and Prevention
• Not mysterious, subjective, arcane practice of
  analysis or deliberation,
• but a balancing act

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A Simple Case?

• Imagine you are waiting at a bus stop. A bus
  pulls over an opens the door, but since it is not
  your bus, you dont get on. Suddenly, from out of
  the blue, a stranger runs by you and leaps on the
  bus. As the bus pulls away you notice that the
  stranger must have dropped his wallet. You
  examine the wallet finding 100, but no
  identification.

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What should you do?

1. Return the wallet, with the money.
2. Return the wallet, but keep the money.
3. Dont return the wallet, keep the money.
4. Dont return the wallet, but donate the money to
   a charity.

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Why?

• Its the right thing to do.
• The wallet/money is not yours.
• It would make stranger happy (or unhappy)
• More people would benefit.
• Too much trouble.
• I (or the charity) could use the money.
• Finders Keepers

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What is the difference between an ethical and
unethical action?

• Ethical
• In accord with an ethical principle.
• Leads to good consequences.
• Weighs everyones interests.

• Unethical
• Violates an ethical principle.
• Leads to bad consequences.
• Doesnt weigh everyones interests.

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Balancing Three Questions

• What rules or principles apply?
• What are the consequences?
• Whose interests are involved?

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Ethical Framework
Principles
Consequences
Interests
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1. What rules or principles apply?

• General dont kill, steal, etc.
• Specific accuracy, openness, etc.
• Source Law, Religion, Social/Prof., etc.

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2. What are the consequences?

• Short-term
• Long-term
• To whom?

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3. Whose interests are involved?

• Individuals
• Groups or Institutions
• Society at large
• Past, Present or Future

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Ethical Framework
Principles
Consequences
Interests
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So far

• We should be concerned with responsible conduct
  of research because research is a social and
  professional practice with consequences.
• Ethical Framework includes balancing answers to
  three questions in the analysis and deliberation
  of ethical cases.

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Outline

• Course Objectives Overview
• Why be concerned?
• Ethical Framework
• Research Misconduct vs. RCR
• hum.utah.edu/bbenham
• www.research.utah.edu/integrity/index.html

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Research Misconduct

• Generally, research that is done in an unethical
  or unprofessional manner.
• Technically

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Defining Research Misconduct

• Office of Science and Technology Policy (Dec.
  2000)
• "fabrication, falsification, or plagiarism in
  proposing, performing, or reviewing research, or
  in reporting research results."
• This is not meant to include honest mistake or
  error in research. But a finding of misconduct
  does require "that there be a significant
  departure from accepted practices of the relevant
  research community" proven by the preponderance
  of evidence.

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Other recommendations

• "questionable research practices, such as
  unethical or sloppy scientific conduct that is
  not fabrication, falsification or plagiarism.
• QRP

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Defining Research Misconduct

• University of Utah
• "fabrication, falsification, plagiarism, or
  other practices that seriously deviate from those
  practices that are commonly accepted within the
  research community for proposing, conducting, or
  reporting research. It does not include honest
  error or honest difference in interpretations or
  judgments of data."

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FFP?

• Fabrication is making up results and recording or
  reporting the fabricated results.
• 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
  person's ideas, processes, results, or words
  without giving appropriate credit and without
  specific approval, including those obtained
  through confidential review of others' research
  proposals and manuscripts.

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Why FFP?

• Principles
• Honesty and accuracy
• Preservation of Research Record
• Give Credit where Credit is Due
• Consequences
• Undermines other research and collaborations
• Undermines public trust
• Interests
• Researchers
• Individuals affected by the research
• Social Implications

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How to determine FFP?

• A researcher presents a paper that shows 33 data
  points that are consistent with his hypothesis,
  but doesnt report the other 12 data points that
  are significantly inconsistent with his
  hypothesis.
• Is this falsification of data? Why or why not?
• Does it make a difference if his results are
  reproducible? Or fail to be exactly reproduced?
• Why is this important for research?

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How to determine FFP?

• In order to help his promising post-doc, Prof.
  Nice lets the post-doc look at some older,
  already funded grant proposals on a similar
  topic. Pressed for time the post-doc incorporates
  large segments of the methods section into her
  own grant proposal.
• Is this plagiarism? Why or why not?
• Why is this important for research?

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How to determine FFP?

• Dr. Brown's research group recently published an
  important paper in a leading journal.  Several
  months after the publication of the manuscript,
  Dr. Brown is contacted by two colleagues who are
  not able to reproduce the findings reported. Dr.
  Brown meets with Adam Green, the postdoctoral
  fellow who did the experiments in question to
  review the results from the lab notebook. Once in
  Dr. Brown's office, Adam confesses that he has
  been remiss in keeping his data book. All of his
  experiments were recorded on computer and other
  electronic media. Adam transcribed many of these
  experiments into his lab book. However, there was
  a period of several days when his computer was
  infected by a virus was not working properly.
   Although Adam fixed the problem much of his data
  was gone. He relied on his memory to transcribe
  the results of those particular experiments into
  his lab book.  After completing the figures for
  the manuscript, Adam was pleased to find that his
  data supported Dr. Brown's hypothesis.
• Is this fabrication of data? Why or why not?
• Why is this important for research?

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Misconduct

• FFP and other practices that seriously deviate
  from those practices that are commonly accepted
  within the research community for proposing,
  conducting, or reporting research.

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Frederick Grinnell

• Science is ambiguous
• Discovery - at the edge of knowledge
• Credibility - publication of findings

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F. Grinnell, 2000

• Discovery takes place at the edge of knowledge,
  an ambiguous place where no one has been before.
  At the edge, one must make risky choices and
  address hard questions What should be done
  first? How does one recognize data, especially
  when one is searching for something never seen
  before? And when experimental results do not meet
  ones expectation, is it because ones original
  idea was wrong, or because the methods used to
  test the idea were wrong? Scientists have a
  saying Dont give up a good idea just because
  the data dont fit.

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F. Grinnell, 2002.

• when it comes to distinguishing data from
  experimental noise, heuristic principles can be
  helpful, but an investigators experience and
  intuition -- in short, his or her creative
  insight -- will determine the final
  interpretation. To some, the selection of results
  might appear arbitrary and self serving, or even
  an example of misconduct. The case of Nobel
  laureate Robert A. Millikan, who selected 58 out
  of 140 oil drops from which he calculated the
  value of the charge of the electron, provokes
  precisely that kind of debate.

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Robert A. Millikan

• Studied the nature of electronic charge.
• Following years of inconclusive research,
  Millikan publishes major paper on the results of
  a series of experiments on liquid droplets.
• In the paper he stated that the results based on
  all droplets observed over 60 days.
• But in his laboratory notebooks the observations
  were in fact only 58 out of 140 observations the
  82 discarded observations did not fit his
  predictions or were instrumentation errors.

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Robert A. Millikan

• Is this misconduct? (Falsification or dishonesty)
• Does it matter that in fact he was right, or that
  the totality of his research would still have
  great scientific importance, even if he had
  reported the discarded 82 observations? (Cf.
  Ptolemy, Galileo, Newton, etc.)
• Was it just good scientific intuition or
  dogmatic insistence on his hypothesis?

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Central Dogma, again

• The focus of the course is not merely the legal
  or explicit regulations, but identifying and
  employing the underlying ethical principles and
  values that guide responsible research, so that
  one can (ideally) navigate the rocky shoals and
  murky waters of daily research practice.

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Next Time

• Data Management and Ownership