Colleagues as a Defense Against Bad Science The Walter C. Randall Lecture on Biomedical Ethics April 12, 2011

1. Colleagues as a Defense Against Bad ScienceThe Walter C. Randall Lecture on Biomedical EthicsApril 12, 2011 Gerald P. Koocher, Ph.D., ABPP Simmons College www.ethicsresearch.com

2. Proximal Cause & Scientific Dishonesty • Researchers are most likely to intentionally engage in dishonest acts if: • their commitment to discovering the truth (to patient care, or to other core values) fails or becomes compromised through rationalization; • if the potential for reward (or perceived urgent need) exists; and • if they regard the chances of detection as low.

3. For example, an investigator justify falsifying data as acceptable because… • They believe the actual results would turn out as expected anyway; • taking a shortcut seems necessary to meet an important deadline; and • the chance of uncovering forged data seems nil. • What to do? • Create a situational constraint stands as the primary barrier to intentionally committing a dishonest act. • Colleagues in a position to observe or learn about the misbehavior constitute the principal source of such constraint. These same colleagues also provide the most readily available resource for preventing and correcting unintentional errors.

4. What do you mean by “Bad Science” ? • The big three are FF&P • Fabrication, Falsification, and Plagiarism • Fabrication is usually in the form of “dry lab” data that are simply invented. • Falsification can take several forms. • “Smoothing,” or “cooking” actual data to more closely approach the desired or expected outcome. • Dropping collected data points (“trimming”) to delete unwanted information.

5. Can we agree on plagiarism? • Use of another person’s words, ideas, or other intellectual and creative work without attribution, and representing it as one’s own. • But wait… • How about “self-plagiarism”? • How about cultural justifications? • I wanted to get it right… • I was just being efficient • My professor is lazy

6. The Bozo Factor • Sometimes ineptitude or incompetence can result in inappropriate design, poor or biased sampling procedures, misused or wrongly applied statistical tests, inadequate record-keeping, and just plain carelessness. Even though there may be no intent to deceive, inaccurate information can also seriously damage the research record.

7. Won’t the scientific record self-correct over time? • One might assume (or hope) that such inaccuracies, purposeful or not, will be discovered. But don’t cannot count on it. • The odds of correct errors through replication have declined as funding sources do not support replication research • Most scholarly journals do not normally publish replication studies. • As a result, researchers have little incentive to repeat projects, especially expensive and complex ones.

8. Difficulties in Detection • Most highly publicized data scandals have occurred in biomedical research laboratories. • No one knows for sure whether the incidence is higher in biomedical science than in the social and behavioral sciences, or whether it is simply easier to detect fraud in biomedicine.

9. Most social and behavioral research does not involve chemical analyses, tissue cultures, changes in physical symptoms, invasive procedures, or similar “hard” documentation. • Social science data often take the form of scores from questionnaires, psychological assessments, performance measures or qualitative data based on interviews or behavioral observations. • By the time data analysis takes place the participants have long since gone, taking their identities with them. Such data become relatively easy to generate, fudge, or trim.

10. NIH Grant No. R01 NS049573 [NINDS/ORI] Gerald P. Koocher, Principal Investigator Patricia Keith-Spiegel and Joan Sieber, Co-Investigators See: Koocher, G. P. & Keith-Spiegel, P. (2010). Opinion: Peers nip misconduct in the bud. Nature, 466, 438-440. Colleagues as a Defense Against Bad Science

11. NIH focuses on FF&P, but there’s more… • We surveyed more than 5,000 names in the NIH CRISP data base. • 2,599 respondents reported 3,393 accounts of suspected wrongdoing and other errors related to the conduct of research. • Only 406 of those responding stated that they had no incidents to share.

14. What Risks Materialized and Who Got Hurt? • In 1,169 (42%) of the incidents, participants experienced no negative consequences as a result of their intervention. • Another 296 participants (11%) reported an elevation in status. • Almost half of our interveners reported suffering to some degree; most recounting only emotional distress as opposed to career or social standing damage. • Some reported serious consequences, such as feeling shunned, forced to leave a job, or losing previously close friends or allies. A few feared law suits, although none ever materialized.

15. Glass 2/3rds full • Despite personal risks, 2/3 of participants claimed to have attempted to prevent or correct a wrong in progress, or to minimize damage that had already occurred. • Very few participants initially reported their concerns to another entity, opting to attempt informal corrective steps or achieve damage control on their own or in partnership with other colleagues. • The most common reasons offered for acting included a commitment to research integrity, to avoid damaging the reputation of oneself, one’s lab, or institution, or to prevent an associate from making a mistake. • Almost all respondents took direct action if the questionable act was perpetrated by their own post docs or assistants.

16. Who Takes Action, and Does It Work? • A binary logistic regression analysis profiled characteristics of researchers who intervene: Most likely to take action were those who • held a higher professional or employment status than the suspected wrongdoer • had less regular interaction or involvement with the suspected wrongdoer • based their suspicions on strong evidence (i.e., direct observation or direct disclosure the transgressor rather than second-hand accounts or hearsay) • perceived the transgression as unintentional, and • held a belief that individuals have a primary responsibility to become actively involved in maintaining scientific integrity. • The vast majority of those who felt victimized or who believed that they might suffer blame also proved likely to intervene individually or by reporting the matter, suggesting that acts involving direct threat to oneself will likely lead to taking some type of action. • The highest rates of intervention occurred for projects described as taking place in the context of high stress that compromised research quality.

17. Those Who Did Not Act • About a third of participants did not take action regarding any incident they shared with us. • The largest group revealed that they felt too remotely involved or knew that others were already taking action. • Another third claimed they simply did not know what to do. • Reluctance to deal with a suspected offender perceived of as difficult person or who was their superior were other common reasons for inaction, as was an unwillingness to act when evidence seemed insufficient.

18. Social relationships, job security, and status become more salient in close working conditions. So perhaps understandable, but also disappointing – we found that those who worked closely with suspected wrongdoers were less likely to take any action. • Thus, the best opportunity to observe wrongs and stop or correct them appears to also be less likely to be utilized. • We asked if those who took no action on their suspicions experienced lingering reservations. Forty percent of those who did not get involved, even though they had direct evidence of wrongdoing, still felt misgivings, sometimes even after many years had since passed.

19. Rogues Gallery

20. Rogues’ Gallery • Dr. Eric Poehlman (University of Vermont) became the first academic scientist in the United States to serve prison time for misconduct (not involving fatalities) and received a lifetime ban on federal research funding. Poehlman published articles containing bogus data and submitted falsified grant applications that brought in almost 3 million dollars in federal grant money since the early 1990s.

21. Eric Poehlman • Plead guilty to acting alone in falsifying and fabricating research data and filing false grant applications, for which the National Institutes of Health paid $542,000. • Agreed to pay $180,000 to settle a civil complaint related to numerous false grant applications he filed while at UVM. • Paid $16,000 in attorney's fees to counsel for Walter F. DeNino, a research assistant whose complaint of scientific misconduct spurred an investigation by UVM. • Agreed to a lifetime bar from seeking or receiving funding from any federal agency and to submit numerous letters of retraction and correction to scientific journals related to his misconduct. • Agreed to a permanent exclusion from participation in all Federal health care programs.

22. Paul Kornak • Paul Kornak pled guilty to criminally negligent homicide for falsely representing results of blood chemical analyses in a chemotherapy study. • One participant who should have been excluded from the study died as a result.

23. Paul H. Kornak In August 2000, he applied for employment to the VA, submitting a false Declaration for Federal Employment form, denying any conviction or probation history, despite having been convicted and sentenced to 3 years probation for mail fraud in 1992. By October of 2000, Kornak was responsible for organizing, coordinating, implementing, and directing all research elements in the Stratton VA Medical Center oncology research program.

24. Paul H. Kornak From May 14, 1999, to July 10, 2002, Kornak defrauded the sponsors of the clinical studies by repeatedly submitting false documentation regarding study participants and enrolled people who did not qualify under the study protocols. He caused the death of a participant when he falsely represented the results of the patient’s blood chemistry analysis to suggest the participant met the criteria for participation in one study, when the actual results showed impaired kidney and liver function. The patient was administered the chemotherapeutic drugs docetaxel, cisplatin, and 5-FU in connection with the studt protocol on or about May 31, 2001, and died as a result on or June 11, 2001.

25. Case Summary - Paul H. Kornak[Federal Register: February 24, 2006 (Volume 71, Number 37)] • Paul H. Kornak, Stratton VA Medical Center, Albany, New York pled guilty to: • making and using a materially false statemen • mail fraud and • criminally negligent homicide • (See United States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436 (FJS), U.S. District Court (N.D.N.Y.) (January 18, 2005). • In addition to 71-month prison term, he was directed to pay restitution to two pharmaceutical companies and the VA in the amount of approximately $639,000.

26. Too Good to be true: Stephen Bruning • By the age of 30 he had produced an influential body of work on treatment of the mentally retarded. But there was something odd about the work of Stephen Breuning, then an assistant professor of child psychiatry at the University of Pittsburgh. • His data seemed almost too orderly, too pat, and collected with remarkable speed. The doubts came to a head in 1983 when his supervisor, Robert Sprague, then director of the Institute for Child Behavior and Development at the University of Illinois, reported his suspicions to the NIMH.

27. Too Good to be true: Stephen Bruning • Between 1979 and 1984, said Sprague, Breuning, "produced one-third of the literature in the psychopharmacology of the mentally retarded.“ http://www.time.com/time/magazine/article/0,9171,964485,00.html#ixzz1Im1gTTtM • Dr. Stephen Breuning was convicted of "academic fraud-related charges" in the United States District Court of the District of Maryland on November 10, 1988.

28. Harvard Finds Scientist Guilty of Misconduct By Nicholas Wade, Published: August 20, 2010, Boston Globe • Harvard University said Friday that it had found a prominent researcher, Marc Hauser, “solely responsible” for eight instances of scientific misconduct. Marc Hauser worked in the field of cognition and morality. Hours later, Dr. Hauser, a rising star for his explorations into cognition and morality, made his first public statement since news of the inquiry emerged last week, telling The New York Times, “I acknowledge that I made some significant mistakes” and saying he was “deeply sorry for the problems this case had caused to my students, my colleagues and my university.”

29. Hauser’s Graduate Student

30. What can we do?

31. Witnesses of Research Wrong-DoingJoan E. Sieber and Ann Meeker O’Connell • Interviewed 135 of our participants and 125 provided first hand witnessing and respondeding to research wrongdoing. • Participants reported a variety of responses, including formal notification of institutional officials, peer shaming and one-on-one discussions with peers to address wrongdoing that ranged from improper attribution of authorship to falsification, fabrication and plagiarism. • Unexpectedly, administrative incompetence in handling allegations seemed the prevalent theme, exceeding all of forms of wrongdoing that were coded. Institutions may have neither effective nor efficient processes for managing even the most egregious cases of research wrongdoing.

32. Witnesses of Research Wrong-DoingJoan E. Sieber and Ann Meeker O’Connell • “My university admitted many very wealthy foreign students, most of whom plagiarized rampantly. When I spoke out about it, colleagues explained that if they cracked down on plagiarism, the students would simply leave and go to another expensive private university where they could submit plagiarized work.” • “Our research team recounted to our dean the bullying and dishonesty we had experienced. It seemed to us that the dean didn’t know how to confront the powerful perpetrator and didn’t confront the wrongdoing. He instructed all of us to relinquish any right to our data.”

33. Witnesses of Research Wrong-DoingJoan E. Sieber and Ann Meeker O’Connell • “I had just become a post doc for a PI who gave me data on 50 subjects to work with. However, the research coordinator, who was resigning, told me that fMRI scans had only been done on 6 of the 50 subjects and that the results did not support the PI’s hypotheses. I felt like I had just been handed a smoking gun, and wanted out immediately. But how?” • “The department had recently hired a nationally known superstar with tenure, who brought many grants with him. He was close to retirement and suffering from severe emotional problems, which manifested themselves as paranoia, self-aggrandizement, and extreme cruelty and ruinous abuse of post-docs and students in his lab, who were driven out of the laboratory or left science entirely.”

34. Culture shifting • Actively engaging colleagues with gentle alternatives to whistleblowing • Offering help • Expressing concern • The “Bullwinlke” approach • Encouraging reporting of near-miss situations • Apologizing when appropriate

35. Create a culture that encourages reporting of human error • Near-miss recognition and reporting systems (near-miss, zero cost) • Creating a safe climate for sharing concerns in a professional manner and context (engaged colleagues)