Misconduct and Other Sins

1. Misconduct and Other Sins Stan Korenman With assistance from Richard Smith Editor, BMJ

2. NORMS • Norms are general statements implying obligations and/or evaluations • Norms are shared by members of a certain group • A belief held by a single individual alone about the merits of a particular kind of action is not a norm

3. Norms Of Scientists • Intellectual integrity and objectivity • Tolerance for disputes • Doubt of certitude • Recognition of error • Unselfish engagement • Communal spirit • Cournand A. The code of the scientist and its relationship to ethics. Science 1977;198:699-706.

4. Questionable Research Practices Swazey

5. Personal Experiences Famous case of misconduct Were shown an unpublished paper Suspect the work of others Know an unethical scientist

6. Personal Experiences % % Facultytrainees Famous case of misconduct 43.5 23.5 Was shown an unpublished paper 65.7 66.0 Suspect work of others 66.0 29.7 Knows an unethical scientist 50.0 26.3

7. When Norms Beget Regulations • Your university is mandated by the Federal government to: • Manage federal assurance to conduct research ethically. • Ensure that research does not violate rules, (e.g. Unauthorized stem cell research or research using anthrax). • Mandates disclosure and management of financial interests and conflicts of interest. • Handle allegations of misconduct properly

8. Why Research Misconduct Matters • It’s like child abuse: we didn’t recognise it, now, sadly, we see a lot of it. • It undermines public trust. • It corrupts the scientific record and leads to false conclusions that are sometimes perpetuated for quite a while.

9. Sins Are Everywhere as are Sinners

10. Research Malfeasance: Unethical but not Illegal • Defective research practices: supervision, record keeping, monitoring, adverse event reporting • Biased analysis: • Unfair reporting: guest authors, failure to disclose conflicts of interest, • Poor scientist interactions: exploitative or negligent mentoring, violations of confidentiality, failure to share, false accusations, unfair allocation of authorship • Biased peer review

11. Malfeasance: Illegal but Not Research Misconduct • Destruction or theft of research property • Misuse or theft of research funds • Harassment of personnel • Violation of safety rules for; human subjects, animal subjects, radiation, chemicals, gases, biologicals • Interfering with an inquiry or investigation

12. Malfeasance in Human Studies • Poor experimental design • Not following protocol scrupulously: • inclusion or exclusion criteria • hidden amendments • not accounting for accidental protocol variances • bias, delay or failure to report serious adverse events • Calling a study “practice” or “QA”, not consenting and then reporting as research.

13. Institutional Requirements for Reporting in Human Research The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) require that institutions have “written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of any • unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliancewith this policy, or the requirements or determinations of the IRB; and • any suspension or termination of IRB approval” [45 CFR 46.103(b)(5)]. [21 CFR 56.108(b)].

14. UCLA IRB Requirements UCLA personnel, including investigators, research team, faculty, staff, administration or students are responsible for the protection of the rights and welfare of human research subjects. To this end, all parties are responsible for reporting serious or continuing noncompliance with applicable human research regulationsor requirements, determinations, or policies of the IRB. Investigators must report immediately upon discovery and no later than ten days from the occurrence.

15. Sec 93.103 Research MisconductMay 2005 • 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.

16. Sec 93.103 Research MisconductMay 2005 • (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.

17. Sec 93.104 Requirements for findings of research misconduct • There be a significant departure from accepted practices of the relevant research community; and • The misconduct be committed intentionally, knowingly, or recklessly; and • The allegation be proven by a preponderance of the evidence. • Burden of proof. The institution or HHS has the burden of proof for making a finding of research misconduct.

18. Sec 93.106 Evidentiary Standards • The destruction, absence of, or respondent's failure to provide research records adequately documenting the questioned research is evidence of research misconduct.

19. Affirmative Defense • (2) The respondent has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised, as well as any mitigating factors that are relevant to a decision to impose administrative actions following a positive finding of research misconduct. • In determining whether HHS or the institution has carried its burden of proof, the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.

20. Sec. 93.210 Good faith • Good faith as applied to a complainant or witness, means having a belief in the truth of one's allegation or testimony that a reasonable person in the complainant's or witness's position could have, based on what they knew at the time. • Good faith of a committee member means carrying out the duties assigned impartially for the purpose of helping an institution meet its responsibilities. A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.

21. Sec 93.300 Institutional Responsibilities for Compliance  A) written policies; B) respond competently and objectively. Avoid COIs. C) foster a high integrity research environment. D) protect the reputations of complainants, witnesses and committee members and protect against retaliation. E) provide confidentiality F) ensure the cooperation of respondents and other institutional members with research misconduct proceedings G) cooperate with HHS H) assist in administering and enforcing any HHS administrative actions; And I) have an active assurance of compliance.

22. Process • Suspicion of wrongdoing • Informal communication • Formal communication • Inquiry • Investigation • Adjudication • Sanctions

23. Suspicion of Wrongdoing Informal Communication Lab Chief Department Chair Ombudsman Nature of Complaint Possible Scientific Misconduct Misunderstanding Disagreement Breach of Manners, Larceny YES NO Scientific Integrity Officer Mediation YES Sequester Data Initiate Formal Inquiry

24. Formal Inquiry Possible Misconduct Not Misconduct Formal Investigation Expert Committee Determine nature & extent of misconduct Quasi-legal procedure Legal representation Data sequestered ORI notified Mediation Restore Reputation NO Committee Report YES Adjudication Office of Research Integrity Institute Sanctions: Institutional, Governmental

25. Our Response to Whistleblowers

26. Whistleblowing • Practical issues: Consider it an inquiry rather than an accusation Talk it over with friends Is there another side to the story? Write it down. Focus on the science and exact details Try to develop support You shouldn’t illegally examine someone’s data Derived in part from Chris Gunsalus, 1998 Sci. and Eng. Ethics; 4:51-64

27. Whistleblowing 2 • You may not have a right to know what’s going on. Is that okay for you? • What kind of satisfaction do you want from the inquiry? • If it’s your boss, you may have to move. Is that okay for you? • Is there a way to achieve your goals without going to the “authorities”? • Are you prepared for the long haul and for a bad outcome?

28. ORI : Ten Years of Reporting • 3662 Institutions, many sm. businesses • 1375 Inst higher learning, res. orgs., Res. Inst, labs, and foundations. • # reporting misconduct 53/ year • 55% a single instance, 20% > 5 • 703 individual cases filed

29. ORI : Ten Years of Reporting • 703 Individual cases filed • 602 inquiries • 221 investigations • 110 findings of misconduct (from 76 institutions)

30. New Misconduct Rules • http://www.ori.dhhs.gov/documents/FR_Doc_05-9643.shtml

31. Litigation, the New Approach to Research Management • Historical - informed consent claims for medical treatment back to 1914. • New - Three developments • New legal claims • Increased number and types of defendants • Use of class action technique • Fraud cases can result in punitive damages and really big awards • This section derived from Mello, Studdert and Brennan: 2003 Ann Int Med; 139:40-45.

32. New Defendants • Now suing everyone including • The university • The teaching hospital • The PI • The sponsor • Top university officials • Individual IRB members • The hospital’s patient advocate (Abiomed)

33. New Defendants • Grimes v. Kennedy-Krieger Institute of Johns Hopkins - lead exposure study. Controls were allowed to continue to be exposed to lead. • Maryland’s highest court faulted the judgement of the IRB and determined that its ruling constituted negligence • With many individuals subject to the same conditions - ripe setting for class action suits. Much more lucrative for the attorneys

34. Impacts of Litigation • More suits inevitable • May tighten up research on humans - a good thing • May make IRBs super-conservative a bad thing • May make monitoring of research mandatory • May create a spate of rule-making.

35. Why does misconduct happen? • Why not? It happens in all other human activities. • Pressure to publish, survivalist mentality. • Defective ethical sensitivity (sociopath). • Inadequate training. Not taught good practices. Indeed, sometimes encouraged in the opposite. • Does sloppy behaviour spill over to fraud? • You can often get away with it. The system works on trust.

36. Trust • Research on humans is based on trust: • That the truth is told about the study • That COIs are revealed • That the institution is fulfilling its responsibilities to the participants. • That those conducting the study have the best interests of the participants at the top of their agenda.