Taking Responsibility for Responsible Conduct of Research

1. Taking Responsibility for Responsible Conduct of Research A course to guide postdoctoral fellows and junior faculty in teaching and mentoring others who look to them for guidance

2. Course leaders • Rick McGee, PhD – r-mcgee@northwestern.edu • Associate Dean, Faculty Affairs, FSM • David Schneeweis, PhD – d-schneeweis@northwestern.edu • Assistant Director, NUIN • Lew Smith, MD – ljsmith@northwestern.edu • Associate Vice President for Research • Ann Adams, JD – nu-ori@northwestern.edu • Associate Vice President, Office for Research Integrity • Course Administration • Robyn Mann, NUCATS – r-mann@northwestern.edu

3. Logistics • Tuesdays, 3:30-5:00, January 19 – March 23 • Except Monday, February 1, not Tuesday, February 2 • Chicago – Wieboldt Hall, Room 421 • Evanston – Tech MG51 • To receive Certificate of Completion (from NUCATS Institute) must attend or listen to/view all sessions • Web location of slides and audio of Chicago session will be communicated • You will self-certify that you have met the requirements at the end through NUCATS Online

4. Individual Situation and Case Study Discussions The final two sessions are set aside for discussions around your questions and experiences Each of you will be expected to submit a situation you have experienced in the past or have a concern you are likely to face in the future Especially as a mentor to others One that raises a dilemma or concern over how to act We will provide a template for the submissions As many as possible will be posed to the group anonymously for discussion OK to wait as sessions unfold as new questions and issues will arise each week

5. Why are we all here? • For most, NIH said you have to be here because you received some form of training award! • Those of us teaching it strongly believe the topics are important and often difficult to handle • A cheap insurance policy – NOTHING you do can consume more time and create more angst than conflicts over research practices! • A key goal is to help you ‘experience’ potential situations before you stumble on them for real • The practices that guide research conduct are not spelled out in detail and suffer from ambiguity, differing opinions within a field, and differences between fields • Very soon, if not already, you will become responsible for the behaviors of others

6. RCR Topics to be covered… • Introduction and Research Misconduct • The Role and Effectiveness of Mentoring in RCR • Conflicting Interests – Recognizing, Acknowledging, Managing, Eliminating • Data Acquisition, Management, Sharing and Ownership • Publication Practices and Responsible Authorship • Peer Review • Research with Human Subjects and Materials • Research with Animals • Collaborative Science and RCR – covering this within context of the other topic since it affects all of them • Your topics, issues and topics, especially as future mentors

7. Our starting points…. • How many of you are doing research with humans? Animals? Neither? • How many of you have had a formal course such as this on RCR? How many have had several? • Was it useful and/or a questionable use of your time? • How many of you have had planned conversations with a mentor on topics related to RCR? • How many of you have had episodic conversations? • If so, were these helpful? If not, why not? • To what degree do you feel you have heard consistent information/guidance from courses and/or mentors?

8. Past experiences… • Have any of you had first hand experience with something you think or know for sure was judged as research misconduct? • What experiences have you had with practices or situations where you were uncomfortable or had concerns about them, even if they might not reach the level of misconduct?

9. What would you like us to talk about? • What situations or issues would you like to get on the table to make sure we cover?

10. Will our approach be different than what you might have done in the past? • That depends….but for sure you are all starting from different sets of experiences and knowledge • The topics are likely to be similar – largely specified by NIH • Recent expansion of expectations of training • We will talk through basic principles of each topic • We will emphasize discussing/resolving different views people have and what they have seen • Much of our time will focus on ‘what if’ scenarios • The big difference will be our focus on how YOU will teach/mentor/lead others either in small ways or as the leader of your research team!!!

11. Research Conduct • Many terms get used. What’s the difference between • Moral Behavior • Ethical Behavior • Responsible Conduct • Accepted or Normative Behavior/Practices • Research Misconduct • Some similar behaviors, such as forms of harassment, are prohibited by legal mandate… • Why has research created a separate layer outside the legal system?

12. Research Misconduct – DHHS/NIH Definition (42 CFR Part 93) • 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.(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 person's ideas, processes, results, or words without giving appropriate credit.(d) Research misconduct does not include honest error or differences of opinion.

13. Research Misconduct – Proposed inclusion…. “…other serious deviation from accepted practices.” What do you think? Should this be an additional criterion?

14. What should you do if you suspect misconduct is occurring? • It depends somewhat on how sure you are – the really tricky part… • Try to get as clear a picture as you can WITHOUT becoming a CSI • Potentially discuss your concerns with A senior person if that is feasible, or go to NU ORI to discuss your concerns – that is what they are there for

15. What should you NOT do if you suspect misconduct is occurring? • Talk about your suspicions with a lot of people • Set a trap to try to catch someone or gather more evidence • Call or email NIH or the DHHS ORI • Call or email the Chicago Tribune • However, if you believe your concerns are not taken seriously by the institution where you work you do have the right to pursue other options….

16. DHHS Office of Research Integrity ORI maintains oversight of institutional handling of research misconduct allegations involving Public Health Service (PHS) funding ORI 2007 Statistics: • 217 allegations of scientific misconduct received • 10 closed cases resulted in misconduct findings and/or HHS administrative actions • All involved falsification, fabrication, or both • Results included debarment (in one case, lifetime) and voluntary exclusion

17. NU Office for Research Integrity: Mission Support and safeguard Northwestern’s research community by: • Identifying compliance risks in our research practices and communicating those risks to the research community; • Partnering with the research community to minimize and manage research risks; • Educating the research community with respect to appropriate business practices related to the conduct of research; and • Monitoring and correcting non-compliance in accordance with University and federal guidelines.

18. Guiding Principles in Handling Allegations of Scientific Misconduct Federal Office for Research Integrity Website http://ori.dhhs.gov/ Northwestern University Policy for Scientific Misconduct http://www.research.northwestern.edu/ori/misconduct/NUPolicySciMis.pdf

19. What Happens at NU When There’s an Allegation of Scientific Misconduct? • Step One: ORI Meets with Complainant • Does allegation meet definition of scientific misconduct? • Is there evidence to support allegation? • Consultation with Vice President for Research • Step Two: Inquiry Committee • Does allegation warrant investigation? • Federal funding? Notification to federal ORI? • Recommendation to VPR • Step Three: Investigation Committee • Did scientific misconduct occur? • Preponderance of evidence standard applies • Report to VPR, Provost

20. Thorny Issues • Are allegations brought in “good faith”? • Is complainant’s belief in the truth of the allegations reasonable? • Is allegation made with reckless disregard to information that would negate the allegation? • Allegation may lack sufficient credibility and specificity but still not be made in bad faith • Preventing Retaliation • Retaliation = taking adverse action against complainant, witness or committee member in response to good faith allegation or cooperation • Restoring Respondent’s Reputation • No finding of misconduct • Confidentiality is critical – but how to ensure?

21. Case Study: Eric Poehlman, M.D. • Tenured clinical researcher at University of Vermont specializing in menopause, aging and metabolism • Admitted to submitting false and fabricated research data in 17 federal grant applications and numerous published articles over almost a decade • Allegedly obtained $2.9 million in NIH and USDA funding based on fraudulent applications • Sentenced to 1 year in prison, 2 years probation • Agreed to pay $180,000 to settle civil complaint and attorney’s fees for research assistant who made complaint

22. Case Study: Eric Poehlman, M.D. Barred for life from seeking or receiving funding from any federal agency; permanently excluded from all federal health care programs Agreed to submit numerous letters of retraction and correction to scientific journals ORI and the U.S. Attorney’s Office “acknowledge the important role that individual scientists have in identifying and responding to research misconduct. . . Without their assistance, ORI and HHS would have great difficulty in taking appropriate actions to protect the public health.”

23. More Typical Findings of Misconduct • http://ori.dhhs.gov/

24. Situation #1 • You have a rapidly approaching grant deadline • Your grad student is feverishly working on an experiment to confirm a preliminary experiment • She comes to lab meeting and presents a figure with fantastic data you were hoping for • Looking more carefully, however, it seems the error bars are tighter than usual – perhaps too tight? • Should you be suspicious? If so, what do you do? • How much pressure have you put on to get the data? • How closely have you reviewed her primary data? How often? Most recently? • Have you ever talked with her or your group about when and how data can be excluded?

25. Situation #2 • Your grad student just came to you to raise a concern that he thinks your lab tech is using PhotoShop to make gel bands look better. What are the possibilities you need to consider? • The two of them don’t get along and it has escalated • Yes he is using PhotoShop but what he is doing is appropriate within the limits of image enhancement without altering results • Your tech is going through problems at home and cutting corners to make up for recent poor lab results • The tech is significantly altering the gels and the data from them • Other options?

26. Situation #2 • What do you do to sort out what is going on? • Try to stay neutral in listening to the ‘evidence’ presented – may depend on what is presented to you – but don’t jump to conclusions or dismiss the accusation • Create a non-threatening reason to review some gels and their processing • Look through primary data from your tech when others are not around • Response may depend on the amount of time the tech has worked for you and the amount of data you have seen/been involved with

27. Situation #3 • Your postdoc has just brought you the first draft of his first major paper since joining your lab • You start reading and are pleasantly surprised by the quality of the content and writing in the Introduction • The Methods section is ok but not nearly as good • When you get to Results, the form and content really go down hill which continues in the Discussion

28. Situation #3 - Continued • Should this cause you any concern? If so, what? • At what stage should you be concerned that the Introduction is not his own work? • Have you reviewed anything he has written before? Was it more like the good or poor aspects of the paper? • Should you go looking to see if you can find portions of the Introduction in references he used, or bluntly ask him if he has taken it from somewhere else? Are there other options?

29. What do you think you will do? • Now that we have talked through the issues, how do you see yourself guiding others to minimize the chances they will commit scientific misconduct? • Clear, non-threatening expression of what you expect • Reiterate and model that no pressure to obtain a certain result can trump the importance of accuracy & honesty • Especially at the start, establish a pattern of review of primary data • Open discussion about not dropping data that does not ‘look good’ or fit what is expected • Periodic discussion and/or modeling of how to avoid plagiarism and importance of giving credit to others • Other ways???

30. What have we not covered related to research misconduct you would like to talk about or know more about????