Research misconduct. Rory Jaffe

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1 Research misconduct Rory Jaffe

2 Kent State

3 Responsible conduct of research Research subject protection Conflicts of interest Data management Mentor trainee relationship Collaboration Authorship and publication Peer review

4 The deadly sins Falsification making up data or results and recording or reporting them Fabrication 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 Plagiarism the appropriation of another person s ideas, processes, results, or words without giving appropriate credit Ghost-writing

5 Why? Career pressure Grants, tenure Career ambitions Save the world Financial motives Inadequate supervision, education, training Easy to get away with it

6 Percent of institutions affected ( ) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% NIH funding rank Cases Inquiries Investigations

7 Incidence ( ) NIH funding rank Cases Inquiries Investigations

8 Examples

9 Quality control in publications? Sokal, A. Transgressing the boundaries: Towards a transformative hermeneutics of quantum gravity, Social Text #46/47, pp Sokal, A. A physicist experiments with cultural studies, Lingua Franca May/June 1996 Nowhere in all of this is there anything resembling a logical sequence of thought; one finds only citations of authority, plays on words, strained analogies, and bald assertions. ml

10 Excerpt from Transgressing We can see hints of it in the multidimensional and nonlinear logic of fuzzy systems theory106; but this approach is still heavily marked by its origins in the crisis of late-capitalist production relations.107 Catastrophe theory108, with its dialectical emphases on smoothness/discontinuity and metamorphosis/unfolding, will indubitably play a major role in the future mathematics; but much theoretical work remains to be done before this approach can become a concrete tool of progressive political praxis.109 Finally, chaos theory which provides our deepest insights into the ubiquitous yet mysterious phenomenon of nonlinearity will be central to all future mathematics. And yet, these images of the future mathematics must remain but the haziest glimmer: for, alongside these three young branches in the tree of science, there will arise new trunks and branches entire new theoretical frameworks of which we, with our present ideological blinders, cannot yet even conceive.

11 Examples of rules for images No specific feature within an image may be enhanced, obscured, moved, removed, or introduced. Adjustments of brightness, contrast, or color balance are acceptable if they are applied to the whole image and as long as they do not obscure, eliminate, or misrepresent any information present in the original. The grouping of images from different parts of the same gel, or from different gels, fields, or exposures must be made explicit by the arrangement of the figure (eg, dividing lines) and in the text of the figure legend. If the original data cannot be produced by an author when asked to provide it, the acceptance of the manuscript may be revoked.

12 Does this pass?

13 Lincoln

14 Lincoln, Calhoun 1860

15 Matthew Brady photograph, 1865

16 USA Today

17 Kent State

18 Story behind the photo John Paul Filo s Pulitzer prize-winning picture of Mary Ann Vecchio At some point in the early 1970s, a copy of the famous Kent State photo in the Time-Life library had been airbrushed to remove the pole behind Vecchio. This altered image appeared in print many times from 1972 through 1995 when it was finally noticed. Wikipedia

19 4/7/2007: Staff photographer suspended, later fired

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23 Trends in image problems

24 Sophisticated methods to detect false data Krueger, John, Forensic Examination of Questioned Scientific Images, Accountability in Research, 9:2, Mosimann, James, Dahlberg, John, Davidian, Nancy, and Krueger, John, Terminal Digits and the Examination of Questioned Date, Accountability in Research, 9:2, 75-92

25 Journal of Epidemiology and Community Health 2004;58: International Committee of Medical Journal Editors Among the several ethical issues discussed by the ICJME, authorship is probably one of the major fields for misconduct in biomedical publication, and in which more discrepancies are to be found among researchers, and also among authors and editors. Also it should be said that most of the time misconducts regarding authorship will have no important consequences for the public s health, but they have an effect on the public perception on the reliability on biomedical science.

26 Authorship Authorship credit based on substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; drafting the article or revising it critically for important intellectual content; and final approval of the version to be published. All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section.

27 Gøtzsche et al Ghost Authorship in Industry-Initiated Randomised Trials 75% incidence In most cases, the missing person performed the statistical analysis of the data

28 Why is ghost authorship a problem? Conflicts of interest hidden Editors should ask authors to disclose whether they had writing assistance and to identify the entity that paid for this assistance. Credit inappropriately taken

29 Vaccine warning as measles cases triple The triple vaccine has proved highly controversial in recent years over unfounded concerns that it may be linked to autism. The study that first sparked fears about its safety is currently being scrutinised in a hearing by the General Medical Council, the medical watchdog. Andrew Wakefield and two coauthors of his research are currently appearing before the GMC on charges of serious professional misconduct. The Times, August 31,2007

30 Presented by Angelique Dorsey

31 42 CFR Part 93 HHS Public Health Service Policies on Research Misconduct Completely replaced previous regulation (42 CFR Part 50) Became effective June 16, 2005

32 Research or research training supported by PHS Plagiarism of research records produced under PHS funding Applications for PHS support for research activities Applies to research proposals for PHS support, even if the research does not receive funding

33 Fabrication: making up data or results and recording or reporting them Falsification: 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 Plagiarism: taking another s ideas, processes, results, or words without giving appropriate credit 42 CFR

34 All allegations must be proved by a preponderance of the evidence ( ) Destruction, absence of research records, or the failure to provide these records is evidence of research misconduct when the accused: a) Intentionally, knowingly, or recklessly destroys the records, or b) Had the opportunity to maintain the records but did not, or c) Fails to produce records in his/her possession in a timely manner, and d) This is a significant departure for accepted practices

35 Must have an active assurance filed with PHS stating compliance with PHS requirements Must have written policies and procedures that implement the provisions of 42 CFR Part 93 must provide these to the PHS Office of Research Integrity (ORI) upon request Must give written notice to ORI that it will proceed with an investigation Must maintain written documentation explaining why an allegation does not warrant an investigation

36 Complainants have 6 years to make an allegation ( ) Time period can be modified for health and welfare reasons The inquiry into an allegation must be completed within 60 days and involves: notifying the respondent of the allegation obtaining custody of the research records and evidence Evaluating the evidence to determine whether an investigation is warranted Time period can be enlarged if the inquiry record includes documentation of reasons for the delay 42 CFR

37 Entire investigation must be completed within 120 days which includes: Completion of the inquiry process Issuing a charge letter which describes the allegations to the respondent Interviewing the respondent, complainant, and witnesses (which must be recorded and transcribed) Drafting the investigation report with findings on each allegation of research misconduct Submitting the report for review by the respondent Receiving and incorporating the respondent s comments into the final report If the institution provides an appeals process for the investigation findings, it also must be completed within the 120-day period o Other appeals, such as from personnel actions, are excluded from this time period

38 ORI has issued sample policies and procedures to assist institutions in complying with the research misconduct policies This policy is very detailed It does not take into consideration unique institutional compositions ORI has made a general request that policies implementing the new regulation be submitted to ORI for review and approval prior to implementing them at the institutional level

39 ORI expects each institution to have a Research Integrity Officer (RIO) and a Deciding Official (DO) The RIO is expected to be a person who has sufficient standing within the organization to ensure research is conducted appropriately ORI assumes the RIO will be in charge of research misconduct investigations conducted pursuant to these regulations The Deciding Official should be someone who is not actively involved in the investigation, but who can speak on behalf of the institution

40 ORI must be informed of the outcome and provided with the written report ORI can: accept the report and approve closure of the case ask for clarification of the findings initiate its own investigation (this can happen at any point in the process) take compliance actions against a person found to have committed research misconduct If no research misconduct is found, institutions have a duty to take reasonable steps to restore the reputation of the accused (42 CFR (k)) The inquiry and investigation records must be securely maintained for at least 7 years (42 CFR )

41 Office of Research Integrity Sample Policies and Procedures and RIO Responsibilities ORI Positions on Inquiry Issues