1. Research Misconduct Ayodele S. Jegede, PhD, MHSc. West African Bioethics Training Program

2. Outline  Objective  Learning outcome  Research misconduct  Authorship  Case study

3. Objective  To orientate participant to unethical practices in publication of research findings

4. Learning outcomes  Participant know the criteria for recognizing research misconduct  Participants able to determine the roles and responsibilities of authors

5. Research Misconduct  What is it?:  Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research results.  Fabrication: making up results and recording or reporting them  Falsification: manipulation of research materials, equipment, or processes, or changing or omitting results such that the research is not accurately represented in the record.  Plagiarism: the appropriation of another’s ideas, processes, results, or words without giving proper credit.  Department of Health and Human Services

6. How often does scientific misconduct occur? There seems to be no consensus on the answer, although a range of estimates were presented at a conference called last month by a key federal watchdog agency to announce a $1 million grants program to investigate the prevalence of fraud, data fabrication, plagiarism, and other questionable practices in science. The 8-year-old Office of Research Integrity hopes to support studies gauging the frequency of misconduct and assessing efforts to raise ethical standards. Science 1 December 2000: Vol. 290. no. 5497, pp. 1662 - 1663

7. Department of Health & Human Services receivedDepartment of Health & Human Services received 267 reports of research misconduct (2004) 267 reports of research misconduct (2004) 50% increase from 200350% increase from 2003 35% of closed cases involve research misconduct35% of closed cases involve research misconduct  What is it not:  Honest error or differences of opinion

8. Criteria  Represent a significant departure from accepted practices  Have been committed intentionally, or knowingly, or recklessly; and  Be proven by a preponderance of evidence  What is NOT MISCONDUCT: honest, unintentional error

9. Top ten “POOR” behaviors [1]  1. Falsifying or ‘cooking’ research data  2. Ignoring major aspects of human-subject requirements  3. Not properly disclosing involvement in firms whose products are based on one‘s own research products are based on one‘s own research  4. Relationships with students, research subjects or clients that may be interpreted as questionable  5. Using another’s ideas without obtaining permission or giving due credit (plagiarism)

10. Top ten behaviors [2]  6. Unauthorized use of confidential information in connection with one’s own research connection with one’s own research  7. Failing to present data that contradict one’s own previous research ???? previous research ????  8. Circumventing certain minor aspects of human-subject requirements requirements  9. Overlooking others' use of flawed data or questionable interpretation of data interpretation of data  10. Changing the design, methodology or results of a study in response to pressure from a funding source (falsification)

11. Other Behaviours  11. Publishing the same data or results in two or more publications publications  12. Inappropriately assigning authorship credit  13. Withholding details of methodology or results in papers or proposals  14. Using inadequate or inappropriate research designs  15. Dropping observations or data points from analyses based on a gut feeling that they were inaccurate  16. Inadequate record keeping related to research projects

12. Why does misconduct happen?  Publish or Perish Pressure  Desire to “get ahead”  Personal problems  Character issues  Cultural Differences

13. SCIENTIFIC MISCONDUCT: Scandals Shake Chinese Science  “Too many incentives have blurred the reasons for doing science in some people's minds”  Lu Yongxiang, president of the Chinese Academy of Sciences  “Though it is difficult to ascertain the number of misconduct cases, the negative impact of these cases should not be underestimated”  Ministry of Education spokesperson Wang Xuming

14. How is misconduct identified  Suspected and reported by a colleague  Failure to confirm research results by own lab or others

15. Consequences (if misconduct is substantiated)  Withdrawal or correction of all pending and published papers and abstracts affected by the misconduct  Removal from project, rank and salary reduction, dismissal  Restitution of funds to the granting agency  Ineligibility to apply for grants for years  End of research career!

16. Researcher Faces Prison for Fraud in NIH Grant Applications and Papers Science 25 March 2005: Vol. 307. no. 5717, p. 1851 A researcher formerly at the University of Vermont College of Medicine has admitted in court documents to falsifying data in 15 federal grant applications and numerous published articles. Eric Poehlman, an expert on menopause, aging, and metabolism, faces up to 5 years in jail and a $250,000 fine and has been barred for life from receiving any U.S. research funding. The number and scope of falsifications discovered, along with the stature of the investigator, are quite remarkable. "This is probably one of the biggest misconduct cases ever," Poehlman, 49, first came under suspicion in 2000 when Walter DeNino, then a 24-year-old research assistant, found inconsistencies in spreadsheets used in a longitudinal study on aging. In an effort to portray worsening health in the subjects, DeNino tells Science, "Dr. Poehlman would just switch the data points."

17. Who is investigated and who is held accountable?  Investigated  All authors that are involved in the specific data in question  Held accountable  Primary author  Other authors whose results are found culpable  The PI

18. Mentor Responsibilities  Mentors have the responsibility to ensure that all trainees (post-docs, grad students, undergrads) are aware of the responsible conduct of research  Define the Relationship  Role of Trainee  Publication/Authorship  Serving as PI or Co-PI  Obligation to report  Good faith report

19. Scientists behaving badly “To protect the integrity of science, we must look beyond falsification, fabrication and plagiarism, to a wider range of questionable research practices” plagiarism, to a wider range of questionable research practices” SCIENCE: Vol 435|9, p.737 June 2005 COMMENTARY

20. Responsible Research Conduct The Office of Research Integrity (ORI) defines research integrity as “adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms.”The Office of Research Integrity (ORI) defines research integrity as “adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms.” Research integrity is essential to ensure the reliability of research results and to preserve public support for research.Research integrity is essential to ensure the reliability of research results and to preserve public support for research.

21. PUBLICATION PRACTICES & AUTHORSHIP  Publication of results fulfills our responsibility to communicate research findings to the scientific community.  Publication of clinical studies also fulfills our responsibility to have a scientific benefit in return for putting human subjects at risk.

22. Why is publication so important for scientists?  Publications share findings that benefit society and promote human health  Credit for a discovery belongs to the first to publish  Reputations and research funding are based on the number and impact of publications  Prestigious positions are gained through reputation and publications

23. Other than presentations at scientific meetings, publication in a scientific journal should normally be the mechanism for the first public disclosure of new findings. Why? [An exception may be appropriate when serious public health or safety issues are involved.]

24. Authorship is: the primary mechanism for determining the allocation of credit for scientific advances and thus the primary basis for assessing a scientist's contributions to developing new knowledge. the primary mechanism for determining the allocation of credit for scientific advances and thus the primary basis for assessing a scientist's contributions to developing new knowledge.   As such, it potentially conveys great benefit, as well as responsibility.

25. Authorship involves: Authorship involves:  the listing of the names of participants in all communications to scientific colleagues (oral or written)  decisions about who will be the first author, the senior author, and the corresponding author

26. Other ways of establishing credit besides authorship ? Acknowledgments - for individuals who have provided encouragement and advice about the study, editorial assistance, technical support, or space, financial support, reagents, or specimens. Acknowledgments - for individuals who have provided encouragement and advice about the study, editorial assistance, technical support, or space, financial support, reagents, or specimens. The use of anyone else’s discoveries, words, ideas, data, or analyses must be cited in a way that others can find the reference and see the contribution. The use of anyone else’s discoveries, words, ideas, data, or analyses must be cited in a way that others can find the reference and see the contribution.

27. When should authorship issues be discussed?  before and during the course of a study.  when material is to be presented in a public forum or submitted (originally or in revision) for publication.  Each author should indicate willingness to support the general conclusions of the study before its presentation or submission.

28. Irresponsible Authorship Honorary authorship - an author who does not meet the criteria - an author who does not meet the criteria Ghost authorship - failure to include as an author someone who - failure to include as an author someone who made substantial contributions to the article made substantial contributions to the article Refusal to accept responsibility for an article despite ready acceptance of credit despite ready acceptance of credit Duplicate and redundant publications Rennie et al, JAMA 280:222, 1998 Rennie et al, JAMA 280:222, 1998

29. Rennie et al’s Hypothesis Research articles in large-circulation prestigious medical journals would be more likely to have honorary authors. Review articles in smaller-circulation journals that publish symposia proceedings would be more likely to have ghost authors. Rennie et al, JAMA 280:222, 1998 Rennie et al, JAMA 280:222, 1998

30. Research articlesReviews Honorary 79 (16%)61 (26%) Ghost 65 (13%)23 (10%) The corresponding authors of 492 research articles and 240 reviews in: Amer J Cardiology, Amer J Medicine, Amer J ObGyn, Annals Internal Medicine, JAMA, and NEJM were surveyed. Rennie et al, JAMA 280:222, 1998 Rennie et al, JAMA 280:222, 1998 Authorship Analysis

31. Annals of Internal Medicine Authorship Criteria Authors should meet all of these criteria: Conceived and planned the work, Conceived and planned the work, or interpreted the evidence it presents, or both or interpreted the evidence it presents, or both Wrote the paper, or reviewed successive Wrote the paper, or reviewed successive versions and took part in the revision process versions and took part in the revision process Approved the final version Approved the final version What is missing from this list? What is missing from this list?

32. Annals of Internal Medicine Authorship Criteria The following, by themselves, are not criteria for authorship: o holding position of administrative leadership o contributing patients or reagents o collecting and assembling data

33. Case Study Dr. Colleen May is a participating neurologist in a clinical trial to assess the efficacy and toxicity of a new anticonvulsant medication. For the duration of the 2-year study, each neurologist is to meet with each of his/her patients for an average of 30 minutes per month. In Dr. May’s case, this amounts to an average of 20 hours per month..

34. During each visit, the physicians administer a variety of specialized tests, requiring judgments dependent on their experience and training in neurology. At the completion of the study,the results are to be unblinded and analyzed by the project leaders. It is anticipated that at least two publications will be prepared for the New England Journal of Medicine.

35. Dr. May has just learned that she will be listed in the Acknowledgements, but not as a coauthor of the manuscript. Dr. May argues that she has provided nearly 500 hours of her expert time, far more than needed to complete a publishable study in her experimental lab. Does Dr. May have a case for authorship?

36. acknowledgement  Dr. Thomas Inzana, Associate Vice President for Research Programs, Office of the Vice President for Research tinzana@vt.edu  Guidelines for the Conduct of Research in the Intramural Research Program at NIH http://www.nih.gov/campus/irnews/guidelines.htm

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