1. Columbia University Institutional Policy on Research Misconduct Naomi J. Schrag, J.D. Director of Research Compliance & Training Office of the Executive VP for Research June 21, 2006 Copyright by the Trustees of Columbia University in the City of New York. All rights reserved. 2006.

2. 2 Why a new policy?  Needed to comply with new HHS regulations Regulations required all institutions to develop and implement new policies and procedures Regulations required all institutions to develop and implement new policies and procedures Regulations provided new, clearer definitions of key terms Regulations provided new, clearer definitions of key terms  Wanted a uniform policy, applicable to all Columbia campuses

3. 3 What is the role of the Standing Committee on the Conduct of Research?  “Setting and communicating standards with respect to Research Misconduct”  “Oversee[ing] the administrative procedures relating to the review of any allegation of Research Misconduct” (Policy at 2, ¶ D.1)

4. 4 What Does the Standing Committee Actually Do?  Consult with individuals who have questions concerning possible Research Misconduct  Oversee administrative procedures and safeguards relating to misconduct review  Appoint Inquiry and Investigational committees  Decide whether to accept, reject or, for Investigations, modify the recommendations of Inquiry and/or Investigation committees.

5. 5 If you are advising someone about possible Research Misconduct, you need to know….

6. 6 What is research misconduct?  Fabrication  Falsification  Plagiarism

7. 7 Fabrication “The making up of data or results and the recording or reporting thereof.” (Policy at 1)

8. 8 Falsification “ the manipulation of Research materials, equipment or processes, or the change or omission of data or results such that the Research is not accurately represented in the Research Record.” (Policy at 1)

9. 9 Plagiarism  “the appropriation of another person’s ideas, processes, results or words without giving appropriate credit.” (Policy at 2)

10. 10 What is NOT research misconduct  “Research Misconduct does not include honest error or differences of opinion.”  “In addition, this Policy does not cover authorship disputes unless they involve Plagiarism.” Plagiarism.” (Policy at 1)

11. 11 What is NOT research misconduct?  Violations of other University policies, such as: Rules of University Conduct Rules of University Conduct Policy on Protection Against Sexual Harassment Policy on Protection Against Sexual Harassment IP policies IP policies Etc. Etc.

12. 12 Sometimes Research Misconduct is easy to spot...

13. 13

14. 14 Is this Research Misconduct?  [Example from Bob Lewy]

15. 15 Is this Research Misconduct?  [Example from Bob Lewy]

16. 16 What can someone concerned about potential Research Misconduct do?  Talk to someone else Officer of Instruction or Officer of Research Officer of Instruction or Officer of Research Responsible Academic Officer Responsible Academic Officer The Chair, Dean or Director of the Department, School, Institute or Center where the Respondent is a memberThe Chair, Dean or Director of the Department, School, Institute or Center where the Respondent is a member Member of Standing Committee Member of Standing Committee Director of Research Compliance & Training Director of Research Compliance & Training Office of General Counsel Office of General Counsel  Try to resolve the concern informally (Policy, p. 3 ¶ E)

17. 17 Informal Resolution  Resolve the concern informally, through the Responsible Academic Officer (e.g., Chair, Dean, etc.) (Policy, p. 3 ¶ E)

18. 18 If informal resolution fails, what is the next step?  File a formal, written allegation with either the Chair of the Standing Committee or the EVPR. (Policy, p. 3, ¶ E(3))

19. 19 A formal allegation is serious:  “An allegation of Research Misconduct may have profound implications for the Complainant, the Respondent and any Witness in a Research Misconduct proceeding.”  “Any individual making an allegation of Research Misconduct should take great care in documenting the basis of any charge.” (Policy, p. 3, ¶ E.4)

20. 20 Safeguards for the Complainant  The University must ensure that: The Complainant is treated fairly and reasonably The Complainant is treated fairly and reasonably All reasonable and practical efforts are made to protect the Complainant from potential or actual retaliation All reasonable and practical efforts are made to protect the Complainant from potential or actual retaliation Diligent efforts are made to protect or restore the position and reputation of the Complainant Diligent efforts are made to protect or restore the position and reputation of the Complainant (Policy at 7, ¶ K(3)(a))

21. 21 Safeguards for Respondent  Presumption of innocence  Should be protected from penalty and public knowledge of accusation until judged culpable  University shall not impede work while case is pending unless EVPR determines compelling reasons to suspend work (Policy, p. 8, ¶ K(4)(a) - (b))

22. 22 University Guarantees  If, as a result of a finding of Research Misconduct, a Respondent with whom a Complainant or Witness works loses funding for research  Then, the University will guarantee the salary, stipend or tuition of such person  The substance of the guarantee depends on the person’s position (Policy, p. 9, ¶ K(7))

23. 23 University Guarantees  Officers of Instruction: salary in accordance with University policy.  Officers of Research, staff, other officers: salary or stipend for at least six months after last day person is paid from terminated funding.  Students: in accordance with commitment made by School, subject to remaining in good standing. (Policy, p. 9, ¶ K(7))

24. 24 Safeguards for Witnesses, Preliminary Reviewers and Committee Members  Reasonable and practical efforts to protect from potential or actual retaliation  Diligent efforts to protect or restore position and reputation (Policy, p. 9, ¶ K(7))

25. 25 Confidentiality Obligations  NOT absolute  “To the extent possible consistent with a fair and thorough investigation and as allowed by law...” (Policy, p. 7, ¶ K(1))

26. 26 Confidentiality Obligations  Knowledge about the identity of: a Complainant, a Complainant, a Respondent a Respondent any Witnesses any Witnesses “shall be limited to those persons identified in this Policy and others who need to know.”  “All written materials and information with respect to any proceedings shall be kept confidential.” (Policy, p. 7 ¶ K(1))

27. 27 After a formal Allegation is filed, what happens next?  Standing Committee sequesters the Research Record and evidence  Three-Phased Misconduct Proceeding begins: Inquiry Inquiry Investigation Investigation Adjudication Adjudication (Policy, p. 3, ¶ F.1)

28. 28 Sequestering the Evidence  What must be sequestered? The “Research Record”: The “Research Record”: the record of data or results that embody the facts resulting from the research inquiry, including, without limitation, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports and journal articles.the record of data or results that embody the facts resulting from the research inquiry, including, without limitation, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports and journal articles. Except: for scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.Except: for scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. Other evidence. Other evidence. (Policy, p. 4, ¶ 2)

29. 29 Inquiry  “The gathering of preliminary information and fact-finding to assess whether such Allegation has substance and if so, whether an Investigation is warranted.” (Policy, p. 3, ¶ F.1(a)) (Policy, p. 3, ¶ F.1(a))

30. 30 Who conducts the Inquiry?  3 or more Preliminary Reviewers  Appointed by the Chair, in consultation with the Standing Committee  Officers of Instruction, Officers of Research, Officer of the Libraries, or students, who may or may not be members of the Standing Committee (Policy, p. 4, ¶ G.1)

31. 31 How comprehensive is the Inquiry?  NOT all-inclusive  “The Preliminary Reviewers shall review such evidence and interview such persons as may be necessary to make an assessment of whether the Allegation has substance and whether an Investigation is warranted.” (Policy, p. 4, ¶ G.3)

32. 32 Steps for an Inquiry:

33. 33 Safeguards  Complainant: Right to meet with Preliminary Reviewers Right to meet with Preliminary Reviewers  Respondent: Right to meet with Preliminary Reviewers Right to meet with Preliminary Reviewers Right to have reasonable access to evidence supporting the Allegation Right to have reasonable access to evidence supporting the Allegation Right to respond to the Allegation orally and in writing Right to respond to the Allegation orally and in writing (Policy, pp. 7-8, ¶ K(3) and (4))

34. 34 Time Frame  In general, an Inquiry must be completed within 60 days of its initiation.  The Standing Committee may approve one or more reasonable extensions to the extent deemed necessary or appropriate. (Policy, p. 5, ¶ G(8))

35. 35 What is the role of the Standing Committee?  Chair consults with members of Standing Committee in appointing Inquiry Committee  Standing Committee sequesters evidence  The Standing Committee may accept or reject the recommendation of the Preliminary Reviewers. (Policy, p. 4, ¶ G(1)-(2), (7))

36. 36 What if the Standing Committee decides an Investigation is warranted?

37. 37 What is an Investigation?  the formal development of a factual record with respect to such Allegation  the examination and evaluation of such record leading to: dismissal of the case or dismissal of the case or a recommendation of a finding of Research Misconduct and/or other appropriate corrective actions a recommendation of a finding of Research Misconduct and/or other appropriate corrective actions (Policy, p. 3, ¶ F(1)(b))

38. 38 What does the Standing Committee do?  Appoint the Ad Hoc Committee to conduct the Investigation  Accept, reject, or modify the recommendations of the Ad Hoc Committee

39. 39 What does the Ad Hoc Committee do?  Examine all relevant Research records and evidence  Interview the Complainant, Respondent, and Witnesses  Draft a report

40. 40 Safeguards for the Complainant  Complainant may: Identify witnesses to be interviewed Identify witnesses to be interviewed Be accompanied by counsel for advisory purposes only when appearing before the Ad hoc Committee Be accompanied by counsel for advisory purposes only when appearing before the Ad hoc Committee Obtain a copy of a transcript of his/her own testimony, if any, and to correct such transcript, if necessary Obtain a copy of a transcript of his/her own testimony, if any, and to correct such transcript, if necessary (Policy, p. 7, ¶ K(3)(c))

41. 41 Safeguards for the Respondent  Respondent may: Appear before the Ad Hoc Committee to present testimony on her/her behalf Appear before the Ad Hoc Committee to present testimony on her/her behalf Identify witnesses to be interviewed Identify witnesses to be interviewed Be accompanied by counsel for advisory purposes only when appearing before the Ad hoc Committee Be accompanied by counsel for advisory purposes only when appearing before the Ad hoc Committee Obtain a copy of a transcript of his/her own testimony, if any, and to correct such transcript, if necessary Obtain a copy of a transcript of his/her own testimony, if any, and to correct such transcript, if necessary (Policy, p. 7, ¶ K(3)(c))

42. 42 Steps for an Investigation Comments from Complainant and Respondent Standing Committee appoints Ad Hoc Committee to conduct Investigation Ad Hoc Committee examines Research records and evidence; interviews Complainant, Respondent, and witnesses. Ad Hoc Committee prepares draft Investigation Report, including whether finding of Research Misconduct should be made, and, if so, what corrective action is recommended Final Ad Hoc Committee Investigation Report to Standing Committee

43. 43 A Finding of Research Misconduct Must Meet Three Requirements:  Significant departure from accepted practices in the relevant research community;  The Research Misconduct has been committed intentionally, knowingly or recklessly;  The Allegation is proved by a Preponderance of the Evidence. (Policy, p. 4, ¶ F(2))

44. 44 Corrective Actions and Penalties  Commensurate with seriousness of Research Misconduct, including, without limitation, whether it: Was knowing, intentional or reckless; Was knowing, intentional or reckless; Was an isolated event or part of a pattern; or Was an isolated event or part of a pattern; or Had significant impact on the Research Record, Research subjects, other researchers, the University, other institutions or the public. Had significant impact on the Research Record, Research subjects, other researchers, the University, other institutions or the public. (Policy, p. 8, ¶ K(8)(a))

45. 45 What is the time frame for an Investigation?  In general, the Investigation should be completed within 120 days from initiation  The Standing Committee may approve one or more reasonable extensions to the extent deemed necessary or appropriate. (Policy, p. 6, ¶ J(8))

46. 46 What happens after the Standing Committee votes on the Ad Hoc Committee’s Recommendations ?  Adjudication: “the formal procedure for reviewing and evaluating the evidentiary record and report of an Investigation and “the formal procedure for reviewing and evaluating the evidentiary record and report of an Investigation and for determining whether to agree with the recommended findings and to impose appropriate corrective actions.” for determining whether to agree with the recommended findings and to impose appropriate corrective actions.” (Policy, p. 3, ¶ F(1)(c))

47. 47 Steps for Adjudication EVPR reviews report of Ad Hoc Committee and Standing Committee and consults with Responsible Academic Officer and, if the Respondent is a CUMC Respondent, the EVPHS | EVPR accepts, rejects or modifies recommendations

48. 48 Appeal  Respondent has the right to appeal  To the Provost  As to either: the finding of Research Misconduct; or the finding of Research Misconduct; or the corrective actions imposed the corrective actions imposed (Policy, p. 6, ¶ J)

49. 49 Is this misconduct? Rogue Scientist Has Own Scientific Method June 5, 2006 | Issue 4223 Issue 4223Issue 4223 TALLAHASSEE, FL—Only months after abandoning a tenured position at Lehigh University, maverick chemist Theodore Hapner managed to disprove two of the three laws of thermodynamics and show that gold is a noxious gas, turning the world of science— defined for centuries by exhaustive research, painstaking observation, and hard-won theories—completely on its head. The brash chemist, who conducts independent research from his houseboat, has infuriated peers by refusing to "play by the rules of Socrates, Bacon, and Galileo," calling test results as he sees them, despite overwhelming evidence to the contrary. The brash chemist, who conducts independent research from his houseboat, has infuriated peers by refusing to "play by the rules of Socrates, Bacon, and Galileo," calling test results as he sees them, despite overwhelming evidence to the contrary. "If you're looking for some button-down traditionalist who relies on so-called induction, conventional logic, and verification to arrive at what the scientific community calls 'proof,' then I'm afraid you've got the wrong guy," said the intrepid 44-year-old rebel, who last month unveiled a revolutionary new model of atomic structure that contradicted 300 years of precedent. "But if you want your results fast and with some flair, then come with me and I'll prove that the boiling point of water is actually 547 degrees Fahrenheit."

50. 50 Questions?  Naomi J. Schrag Director of Research Compliance & Training 212-854-8123 ns2333@columbia.edu ns2333@columbia.edu  Jane E. Booth, Esq. Office of General Counsel 212-854-0286 jeb@gc.columbia.edu jeb@gc.columbia.edu