Responsible Conduct of Research

1. Responsible Conduct of Research Terrance L. Johnson, Ph.D. Professor and Chair Biological Sciences TSU Research Integrity Officer Director TSU MBRS-SCORE Program Director Title III Activity IV Program

2. Integrity in Science • Meaning • Science is knowledge derived from observation, study and experimentation; it provides an understanding of nature and the physical world • Integrity is expected because science is built upon a foundation of trust and honesty; the utmost integrity must be woven into experimentation and its interpretations • Changes in the last two decades • Headlines, news shows, books, etc. speak of stolen viruses, falsified results, whistleblowers, scientific hoaxes and misconduct investigations • Misconduct is not new • Louis Pasteur- Used a anthrax vaccine developed by his competitor, Toussaint • Watson and Crick- Used Rosalind Franklin’s data in their publication on the double helix • There are numerous accounts of this kind of activity

3. Perceptions of scientists and science • Scientists are humans • Humans are fallible, impressionable, impulsive, and subjective • Humans fall prey to self-deception, rationalizing their actions in ways that mislead themselves and others • The term “Sloppy Science” is frequently used to describe some behaviors • Note that the distinction between sloppy science and misconduct can be nebulous • Scientists change their previous interpretations and conclusions • Headlines about Oat Brain (Several other examples exist) • “Next miracle food” in 1986 • “Oat bran claims weakened” in 1990s • “Lots of Oat Bran found to cut cholesterol” current opinion

5. Scientific method • A gap in knowledge is identified and questions posed • Existing information studied and a hypothesis/educated guess is formed • Information is gathered, analyzed and interpreted to test the hypothesis • Results may support or refute a hypothesis, but the hypothesis cannot be proved; it can only be disproved

6. Myth of the Scientific Method • Bauer, H. 1992. Scientific Literacy and the Myth of the Scientific Method. University of Illinois Press, Chicago • He contends that this method rarely proceeds by the organized, systematic approach. • Approaches to solving problems and answering questions involve various blends of empiricism and theorizing • Depending on the scientific discipline and on the intellect and personality of the scientist, research is conducted with considerable variations of the scientific method

7. Reporting science • Central dogma: Introduction, Methods, Results, and Discussion • Sir Peter Medawar in 1963 stated that scientific papers misrepresent the thought processes that lead to the work reported. His take was that scientific discovery does not proceed by an inductive process by which unbiased observations are made and facts are collected. From these experimental raw materials, generalizations emerge. • David Goodstein 1991 wrote that “every scientific paper is written as if that particular investigation were a triumphant precession from one truth to another. All scientists who perform research know that every scientific experiment is chaotic-like war. You never know what is going on; you cannot usually understand what the data mean. But in the end, you figure out what it was all about and then, with hindsight, you write it up describing it as one clear and certain step after the other. This is a kind of hypocrisy, but it is deeply embedded in the way we do science.”

8. Scientific Misconduct • Office of Research Integrity, PHS, DHHS • Misconduct or Misconduct of Science 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. It does not include honest error or honest differences in interpretations or judgments of data. (Federal register 54:32446-32451, August 8, 1989) • Office of the Inspector General NSF • Misconduct means fabrication, falsification, plagiarism or other serious deviation from accepted practices in preparing, carrying out, or reporting results from activities funded by NSF, or retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith. (Federal register 56:22286-22290, May 14, 1991)

9. Fabrication, Falsification, and Plagiarism • Fabrication - making up results • Falsification – tampering with results • Plagiarism – passing off another’s ideas as your own

10. Purpose of RIC • To ensure research at TSU is conducted effectively, objectively and without improper influence or the appearance of improper influence, the Research Integrity Committee was established. • This committee is not required by the Office of Research Integrity, but it serves the purpose in meeting several PHS requirements on allegations involving scientific misconduct in research and other requirements by the Alcohol, Firearms and Tobacco (AFT) Organization.

11. Sites for National and Local Policies • Office of Research Integrity/DHHS www.ori.hhs.gov Introduction • Division of Research and Sponsored Programs www.tnstate.edu/research/RSP.htm

12. RIC Con’t. • The Committee has oversight of all inquiries and investigations associated with allegations of scientific misconduct. • Many queries involve questions of "honest differences” in interpretation or judgments of data which are specifically excluded under the PHS definition (45 CFR 50,102). These inquiries and investigations on scientific misconduct include the following: • Research Fraud • Falsification • Plagiarism • Fabrication • Other Serious Deviations • The latest is a new standard of Recklessness in Research Misconduct Under the new misconduct regulation adopted in 2005 (42 CFR Part 93), acting recklessly in conducting research can result in a finding of misconduct. Section 93.104 states that: a finding of research misconduct made under this part requires that- (a) there be a significant departure from accepted practices of the relevant research community: and (b) the misconduct be committed intentionally, knowingly, or recklessly; and (c) the allegation be proven by the preponderance of the evidence.

13. TSU Procedures Handling Allegations • Action Step I: File allegations with VP RSP and/or RIO and an inquiry is initiated • The RIC gathers information concerning the allegations and notifies the respondent of the charges. • The respondent provides written response to the allegations to the RIC along with documentation of evidence supporting the response • The RIC reviews the response and evidence and submits a Inquiry Report to the VP RSP indicating whether an investigation is warranted. • Action Step II: Investigation of Research Misconduct • The purpose is to explore further the allegations and determine whether fraud has been committed • Individuals involved in the research in question are notified, requested to respond to the allegations, data are analyzed for accuracy, and the primary respondent is interviewed.

14. Report of Findings • a finding of fraud, • a finding of serious scientific misconduct short of fraud, • a finding that no culpable conduct was committed, but serious errors were discovered • finding that no fraud, misconduct, or serious scientific error was committed.

15. The Nature and Severity ofDisciplinary Action • Removal from the project • Letter of reprimand and special monitoring of future work • Probation • Salary reduction • Suspension • Rank reduction • Barred from University sponsored leaves • Termination of Employment • Ineligible for University Awards • Termination of Research/ Training Incentive Pay • Travel Restrictions • Barred from Conducting Future Research Projects at TSU

16. APPEAL/FINAL REVIEW • The decision of the Committee can be appealed through a written appeal of the Committee’s decision • The appeal must be restricted to the body of evidence already presented • Appeals involving new evidence may warrant a new investigation • The decision of the review made by the President of the University is final

17. TSUCompliance Committees • IRB/Human Subjects Committee • Institutional Animal Care and Use Committee • Biosafety Committee • Radiation Safety Subcommittee • Research Integrity Committee • Resources for Research Compliance

18. Human subjects

19. Use of Animals in Research • Office of Laboratory Animal welfare • Why animal research matters

20. Mentoring • Characteristics of the Mentor-Trainee Relationship • Mentors demonstrate and teach style and methodology in doing scientific research • Mentors evaluate and critique scientific research • Mentors foster the socialization of trainees • Mentors promote career development • Mentors perform different duties at different times • Trainees depend on mentors • The mentor-trainee relationship is an exclusive one • The mentor-trainee relationship requires trust

21. Selection of a Mentor • Active publication record in high-quality, peer-reviewed journals • Extramural financial support base: competitiveness and continuity of support • National recognition: meeting and seminar invitations, invited presentations, consultant ships • Rank, tenure status, and proximity to retirement age • Prior training record: time it takes trainees to complete a degree, number of trainees, and enthusiasm for previous trainees’ accomplishments • Current positions of recent graduates • Recognition for student accomplishments (co-authorship practices) • Organizational structure of the laboratory and direct observation of the laboratory in operation

23. International Committee of Medical Journal Editors

24. Ownership of Data and Intellectual Property • Funding Agencies • Research Institutions • TSU Policy

26. Scientific Record Keeping • I. Reasons for data collection and proper record keeping: • Authenticity • Accountability • Application • II.Keeping useful scientific recrods • Useful databooks explain: • Why you did it • How you did it • Where materials are • What happened (and what didn’t happen) • Your interpretation • What’s next • Good databooks: • Are legible • Are well organized • Allow repetition of your experiments • Are the ultimate record of your scientific contributions

27. Shared Values

30. Terry’s Final Word A half true, twisted true, exaggerated true, a true told in any form or fashion other than the truth, whole truth, and nothing but the truth is a whole lie.

31. Sources of Information Presented • Scientific Integrity: an Introductory Text with Cases. 2nd Edition by Francis L. Macrina • ORI Introduction to the Responsible Conduct of Research by Nicholas H. Steneck