Recognizing, Reporting and Avoiding Scientific Misconduct

1. CIPP 907 Research Ethics January 12, 2005 Recognizing, Reporting and AvoidingScientific Misconduct Joe Giffels Director UMB Research Integrity Office Academic Affairs jgiff001@umaryland.edu

2. Dept of Health and Human Services – Office of the SecretaryFindings of Scientific Misconduct Federal Register: December 2, 2003 (Volume 68, Number 231) SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Sheila Blackwell, University of Maryland, Baltimore: Based on the report of an investigation conducted by the University of Maryland, Baltimore (UMB Report), the respondent’s admission of responsibility, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Sheila Blackwell, former contractual employee, Department of Pediatrics at UMB, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant 2 R01 MH54983, entitled “Effectiveness of Standard versus Embellished HIV Prevention.” Specifically, PHS found that Ms. Blackwell engaged in scientific misconduct by fabricating interview records for the Focus on Teens HIV Risk Prevention Program for nine interviews that had not been performed over the period of May through July 2001…

3. Conscience is the inner voicewhich warns us thatsomeone may be looking. -H L Mencken

4. Research Integrity • Further knowledge • Benefit society • Responsible science

5. What are we protecting?

6. Total U.S. R&D • $284 billion in CY 2003

7. NIH Funding Increase • FY 1998: $14 billion • FY 2004: $29 billion

8. UMB Funding Increase • FY 1998: $146 million • FY 2004: $290 million

9. University of Maryland SOURCES & USES OF FUNDS FY 2004 Total Dollars: $629 Million Sources of Funds Uses of Funds

10. University of Maryland School of Medicine Scientist Receives Prestigious Presidential Award

11. Responsible Conduct of Research • Data acquisition, management, sharing, and ownership • Mentor/trainee responsibilities • Publication practices and responsible authorship • Peer review • Collaborative science • Human subjects • Research involving animals • Conflict of interest and commitment • Research misconduct

12. Responsible Research Scientific Misconduct Irresponsible Research

13. Case Study • Protocol • Role of Interviewers

14. Categories of Scientific Misconduct • Fabrication: making up experiments, data • Falsification: changing results, data without statistical justification • Plagiarism: appropriating the words or ideas of another and presenting them as one’s own

15. What Scientific Misconduct Is Not • Example 1: Simply illegal, improper or unacceptable behavior • Example 2: Honest error • Example 3: Disagreement based on honest differences of opinion • Example 4: Simply authorship disputes • Example 5: Arguably unethical behavior • Example 6: Sloppy science

16. Case Study • Allegations

17. UMB Definition(academic misconductmisconduct in scholarly work) • Means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research or other scholarly work; also includes any form of behavior, including the making of allegations that involve frivolous, mischievous or malicious misrepresentation, whereby one’s work or the work of others is seriously misrepresented; does not include honest error or honest differences in interpretations or judgments of data.

18. Case Study • Application of Misconduct In Scholarly Work Policy: What is the Misconduct (F? F? P?)

19. Definitions • Allegations • Complainant (whistleblower) • Respondent

20. Case Study • Who is the Respondent? • Who is the Complainant? • Must the NIH be notified?

21. Process • Inquiry • Investigation • Consequences

22. Case Study • Process • Committee • Evidence • Proceedings

23. To ensure that the scientific record is correct (science & society) To comply with regulations (individual) To prevent future misconduct (science & society) To protect one’s own reputation (individual) or the reputation of another (science & society) To punish wrongdoer (individual) Allegations are not borne out (individual) Time, effort and emotion intensive (individual) Retaliation by respondent or respondent’s institution (individual) Gain reputation as a trouble-maker (individual) Whistleblowing Benefits Risks

24. Case Study • Findings • Report • ORI Oversight of Investigation

25. How To Avoid Becoming Involved • Maintain good records • Collaborate with co-investigators • Don’t take that first step

26. Case Study • ORI Findings and Actions

27. Case Study • Washington Times Article • UMB Response

28. Examples(yes, these are true stories)

29. A Few Good URLs • www.ori.dhhs.gov • www.iom.edu • www.aamc.org • http://rcr.ucsd.edu • www.umaryland.edu/PPM

30. CIPP 907 Research Ethics January 12, 2005 Recognizing, Reporting and AvoidingScientific Misconduct Joe Giffels Director UMB Research Integrity Office Academic Affairs jgiff001@umaryland.edu