Phil 7570 Case Studies in Research Ethics

1. Phil 7570Case Studies in Research Ethics Fall 2006 Bryan Benham Department of Philosophy

2. Outline • Course Objectives & Overview • Why be concerned? • Ethical Framework • Research Misconduct vs. RCR hum.utah.edu/~bbenham www.research.utah.edu/integrity/index.html Phil 7570: Case Studies in Research Ethics

3. Course Objectives • Increase ethical sensitivity to issues regarding RCR • Based on ORI’s 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 Phil 7570: Case Studies in Research Ethics

4. 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. Phil 7570: Case Studies in Research Ethics

5. 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) Faculty Phil 7570: Case Studies in Research Ethics

6. Course Requirements • Course Structure • Ten Week Course (Thursdays, 4:00-5:30) • 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 Phil 7570: Case Studies in Research Ethics

7. 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* Phil 7570: Case Studies in Research Ethics

8. Outline • Course Objectives & Overview • Why be Concerned? • Ethical Framework • Research Misconduct vs. RCR hum.utah.edu/~bbenham www.research.utah.edu/integrity/index.html Phil 7570: Case Studies in Research Ethics

9. 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. Phil 7570: Case Studies in Research Ethics

10. Woo Suk Hwang Why Research Ethics? (RCR) Phil 7570: Case Studies in Research Ethics

11. 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 Phil 7570: Case Studies in Research Ethics

12. 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. Phil 7570: Case Studies in Research Ethics

13. 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 Gov’t involvement. Phil 7570: Case Studies in Research Ethics

14. But, “Snuppy” is real… Phil 7570: Case Studies in Research Ethics

15. Also, Parthenogenesis Review of Hwang Woo Suk’s research shows his embryonic stem cells were the product of parthenogenesis. “It could have been a seminal finding if they hadn’t 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 Phil 7570: Case Studies in Research Ethics

16. 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 doesn’t 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. Phil 7570: Case Studies in Research Ethics

17. 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. Phil 7570: Case Studies in Research Ethics

18. 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. Phil 7570: Case Studies in Research Ethics

19. 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. Phil 7570: Case Studies in Research Ethics

20. 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 Phil 7570: Case Studies in Research Ethics

21. 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. Phil 7570: Case Studies in Research Ethics

22. 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. Phil 7570: Case Studies in Research Ethics

23. Outline • Course Objectives & Overview • Why be concerned? • Ethical Framework • Research Misconduct vs. RCR hum.utah.edu/~bbenham www.research.utah.edu/integrity/index.html Phil 7570: Case Studies in Research Ethics

24. 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. Phil 7570: Case Studies in Research Ethics

25. 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 balancingact… Phil 7570: Case Studies in Research Ethics

26. 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 don’t 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. Phil 7570: Case Studies in Research Ethics

27. What should you do? • Return the wallet, with the money. • Return the wallet, but keep the money. • Don’t return the wallet, keep the money. • Don’t return the wallet, but donate the money to a charity. Phil 7570: Case Studies in Research Ethics

28. Why? • It’s 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. • “Finder’s Keeper’s” Phil 7570: Case Studies in Research Ethics

29. Ethical In accord with an ethical principle. Leads to good consequences. Weighs everyone’s interests. Unethical Violates an ethical principle. Leads to bad consequences. Doesn’t weigh everyone’s interests. What is the difference between an ethical and unethical action? Phil 7570: Case Studies in Research Ethics

30. Balancing Three Questions • What rules or principles apply? • What are the consequences? • Whose interests are involved? Phil 7570: Case Studies in Research Ethics

31. P C I Ethical Framework Principles Consequences Interests Phil 7570: Case Studies in Research Ethics

32. 1. What rules or principles apply? • General: don’t kill, steal, etc. • Specific: accuracy, openness, etc. • Source: Law, Religion, Social/Prof., etc. Phil 7570: Case Studies in Research Ethics

33. 2. What are the consequences? • Short-term • Long-term • To whom? Phil 7570: Case Studies in Research Ethics

34. 3. Whose interests are involved? • Individuals • Groups or Institutions • Society at large • Past, Present or Future Phil 7570: Case Studies in Research Ethics

35. P C I Ethical Framework Principles Consequences Interests Phil 7570: Case Studies in Research Ethics

36. P C I 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. Phil 7570: Case Studies in Research Ethics

37. Outline • Course Objectives & Overview • Why be concerned? • Ethical Framework • Research Misconduct vs. RCR hum.utah.edu/~bbenham www.research.utah.edu/integrity/index.html Phil 7570: Case Studies in Research Ethics

38. Research Misconduct • Generally, research that is done in an unethical or unprofessional manner. • Technically… Phil 7570: Case Studies in Research Ethics

39. 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. Phil 7570: Case Studies in Research Ethics

40. Other recommendations "questionable research practices, such as unethical or sloppy scientific conduct that is not fabrication, falsification or plagiarism.” QRP Phil 7570: Case Studies in Research Ethics

41. 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." Phil 7570: Case Studies in Research Ethics

42. 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. Phil 7570: Case Studies in Research Ethics

43. P C I 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 Phil 7570: Case Studies in Research Ethics

44. How to determine FFP? A researcher presents a paper that shows 33 data points that are consistent with his hypothesis, but doesn’t 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? Phil 7570: Case Studies in Research Ethics

45. 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? Phil 7570: Case Studies in Research Ethics

46. 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? Phil 7570: Case Studies in Research Ethics

47. 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. Phil 7570: Case Studies in Research Ethics

48. Frederick Grinnell Science is ambiguous • Discovery - at the edge of knowledge • Credibility - publication of findings Phil 7570: Case Studies in Research Ethics

49. 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 one’s expectation, is it because one’s original idea was wrong, or because the methods used to test the idea were wrong? Scientists have a saying: Don’t give up a good idea just because the data don’t fit.” Phil 7570: Case Studies in Research Ethics

50. F. Grinnell, 2002. “…when it comes to distinguishing data from experimental noise, heuristic principles can be helpful, but an investigator’s 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.” Phil 7570: Case Studies in Research Ethics