Columbia University Columbia University Institutional Policy on Institutional Policy on Research MisconductResearch Misconduct

Naomi J. Schrag, J.D.Naomi J. Schrag, J.D.Director of Research Compliance & TrainingDirector of Research Compliance & Training

Office of the Executive VP for ResearchOffice of the Executive VP for ResearchJune 21, 2006June 21, 2006

Copyright by the Trustees of Columbia University in the City of New York. All rights reserved. 2006.Copyright by the Trustees of Columbia University in the City of New York. All rights reserved. 2006.

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Why a new policy?Why a new policy?

Needed to comply with new HHS Needed to comply with new HHS regulations regulations Regulations required all institutions to develop Regulations required all institutions to develop

and implement new policies and proceduresand implement new policies and procedures Regulations provided new, clearer definitions Regulations provided new, clearer definitions

of key termsof key terms Wanted a uniform policy, applicable to all Wanted a uniform policy, applicable to all

Columbia campusesColumbia campuses

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What is the role of the Standing Committee What is the role of the Standing Committee on the Conduct of Research?on the Conduct of Research?

““Setting and communicating standards Setting and communicating standards with respect to Research Misconduct” with respect to Research Misconduct”

““Oversee[ing] the administrative Oversee[ing] the administrative procedures relating to the review of any procedures relating to the review of any allegation of Research Misconduct”allegation of Research Misconduct”

(Policy at 2, (Policy at 2, ¶ D.1¶ D.1))

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What Does the Standing What Does the Standing Committee Actually Do?Committee Actually Do?

ConsultConsult with individuals who have questions with individuals who have questions concerning possible Research Misconductconcerning possible Research Misconduct

Oversee administrative procedures and Oversee administrative procedures and safeguardssafeguards relating to misconduct review relating to misconduct review

Appoint Appoint Inquiry and Investigational committeesInquiry and Investigational committees

DecideDecide whether to accept, reject or, for whether to accept, reject or, for Investigations, modify the recommendations of Investigations, modify the recommendations of Inquiry and/or Investigation committees.Inquiry and/or Investigation committees.

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If you are advising If you are advising someone about possible someone about possible

Research Misconduct, you Research Misconduct, you need to know….need to know….

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What is research misconduct?What is research misconduct?

FabricationFabrication

Falsification Falsification

PlagiarismPlagiarism

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FabricationFabrication

““The making up of data or results and the The making up of data or results and the recording or reporting thereof.”recording or reporting thereof.”

(Policy at 1)(Policy at 1)

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FalsificationFalsification

“ “ the manipulation of Research materials, the manipulation of Research materials, equipment or processes, or the change or equipment or processes, or the change or omission of data or results such that the omission of data or results such that the Research is not accurately represented in Research is not accurately represented in the Research Record.”the Research Record.”

(Policy at 1)(Policy at 1)

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PlagiarismPlagiarism

““the appropriation of another person’s the appropriation of another person’s ideas, processes, results or words without ideas, processes, results or words without giving appropriate credit.”giving appropriate credit.”

(Policy at 2)(Policy at 2)

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What is NOT research misconductWhat is NOT research misconduct

““Research Misconduct does not include Research Misconduct does not include honest error or differences of opinion.”honest error or differences of opinion.”

““In addition, this Policy does not cover In addition, this Policy does not cover authorship disputes unless they involveauthorship disputes unless they involve

Plagiarism.”Plagiarism.”

(Policy at 1)(Policy at 1)

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What is NOT research misconduct?What is NOT research misconduct?

Violations of other University policies, such Violations of other University policies, such as:as: Rules of University ConductRules of University Conduct Policy on Protection Against Sexual Policy on Protection Against Sexual

HarassmentHarassment IP policiesIP policies Etc.Etc.

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

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Is this Research Misconduct?Is this Research Misconduct?

[Example from Bob Lewy][Example from Bob Lewy]

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Is this Research Misconduct?Is this Research Misconduct?

[Example from Bob Lewy][Example from Bob Lewy]

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What can someone What can someone concerned about potential concerned about potential Research Misconduct do?Research Misconduct do?

Talk to someone elseTalk 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, The Chair, Dean or Director of the Department, School, Institute or Center where the Respondent is a memberInstitute or Center where the Respondent is a member

Member of Standing CommitteeMember of Standing Committee Director of Research Compliance & Training Director of Research Compliance & Training Office of General CounselOffice of General Counsel

Try to resolve the concern informallyTry to resolve the concern informally

(Policy, p. 3 (Policy, p. 3 ¶ E)¶ E)

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Informal ResolutionInformal Resolution

Resolve the concern informally, through Resolve the concern informally, through the Responsible Academic Officer (e.g., the Responsible Academic Officer (e.g., Chair, Dean, etc.)Chair, Dean, etc.)

(Policy, p. 3 (Policy, p. 3 ¶ E)¶ E)

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If informal resolution fails, what is If informal resolution fails, what is the next step?the next step?

File a formal, written allegation with either File a formal, written allegation with either the Chair of the Standing Committee or the Chair of the Standing Committee or the EVPR.the EVPR.

(Policy, p. 3, (Policy, p. 3, ¶ E(3))¶ E(3))

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A formal allegation is serious:A formal allegation is serious:

““An allegation of Research Misconduct An allegation of Research Misconduct may have profound implications for the may have profound implications for the Complainant, the Respondent and any Complainant, the Respondent and any Witness in a Research Misconduct Witness in a Research Misconduct proceeding.”proceeding.”

““Any individual making an allegation of Any individual making an allegation of Research Misconduct should take great Research Misconduct should take great care in documenting the basis of any care in documenting the basis of any charge.”charge.”

(Policy, p. 3, (Policy, p. 3, ¶ E.4¶ E.4))

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Safeguards for the ComplainantSafeguards for the Complainant

The University must ensure that:The University must ensure that: The Complainant is treated fairly and The Complainant is treated fairly and

reasonablyreasonably All reasonable and practical efforts are made All reasonable and practical efforts are made

to protect the Complainant from to protect the Complainant from potential or potential or actual retaliationactual retaliation

Diligent efforts are made to protect or restore Diligent efforts are made to protect or restore the position and reputation of the Complainantthe position and reputation of the Complainant

(Policy at 7, (Policy at 7, ¶ K(3)(a)¶ K(3)(a)))

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Safeguards for ReSafeguards for Respondentspondent

Presumption of innocencePresumption of innocence Should be protected from penalty and Should be protected from penalty and

public knowledge of accusation until public knowledge of accusation until judged culpablejudged culpable

University shall not impede work while University shall not impede work while case is pending unless EVPR determines case is pending unless EVPR determines compelling reasons to suspend workcompelling reasons to suspend work

(Policy, p. 8, (Policy, p. 8, ¶ K(4)(a) - (b))¶ K(4)(a) - (b))

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University GuaranteesUniversity Guarantees

If, as a result of a finding of Research If, as a result of a finding of Research Misconduct, a Respondent with whom a Misconduct, a Respondent with whom a Complainant or Witness works loses funding for Complainant or Witness works loses funding for researchresearch

Then, the University will guarantee the salary, Then, the University will guarantee the salary, stipend or tuition of such personstipend or tuition of such person

The substance of the guarantee depends on the The substance of the guarantee depends on the person’s positionperson’s position

(Policy, p. 9, (Policy, p. 9, ¶ K(7))¶ K(7))

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University GuaranteesUniversity Guarantees

Officers of Instruction: Officers of Instruction: salary in accordance with University policy.salary in accordance with University policy.

Officers of Research, staff, other officers: Officers of Research, staff, other officers: salary or stipend for at least six months after last salary or stipend for at least six months after last day person is paid from terminated funding.day person is paid from terminated funding.

Students: Students: in accordance with commitment made by in accordance with commitment made by School, subject to remaining in good standing.School, subject to remaining in good standing.

(Policy, p. 9, (Policy, p. 9, ¶ K(7))¶ K(7))

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Safeguards for Witnesses, Preliminary Safeguards for Witnesses, Preliminary Reviewers and Committee MembersReviewers and Committee Members

Reasonable and practical efforts to protect Reasonable and practical efforts to protect from potential or actual retaliationfrom potential or actual retaliation

Diligent efforts to protect or restore Diligent efforts to protect or restore position and reputationposition and reputation

(Policy, p. 9, (Policy, p. 9, ¶ K(7))¶ K(7))

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Confidentiality ObligationsConfidentiality Obligations

NOT absoluteNOT absolute

““To the extent possible consistent with a To the extent possible consistent with a fair and thorough investigation and as fair and thorough investigation and as allowed by law. . .”allowed by law. . .”

(Policy, p. 7, (Policy, p. 7, ¶ K(1)¶ K(1)))

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Confidentiality ObligationsConfidentiality Obligations

Knowledge about the identity of: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 shall be limited to those persons identified in this Policy and others who need to know.”and others who need to know.”

““All written materials and information with respect to any All written materials and information with respect to any proceedings shall be kept confidential.”proceedings shall be kept confidential.”

(Policy, p. 7 (Policy, p. 7 ¶ K(1))¶ K(1))

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After a formal Allegation is filed, After a formal Allegation is filed, what happens next?what happens next?

Standing Committee sequesters the Research Standing Committee sequesters the Research Record and evidenceRecord and evidence

Three-Phased Misconduct Proceeding begins:Three-Phased Misconduct Proceeding begins: InquiryInquiry InvestigationInvestigation AdjudicationAdjudication

(Policy, p. 3, (Policy, p. 3, ¶ ¶ F.1)F.1)

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Sequestering the EvidenceSequestering the Evidence What must be sequestered?What must be sequestered?

The “Research Record”: The “Research Record”: • the record of data or results that embody the facts resulting from the the record of data or results that embody the facts resulting from the

research inquiry, including, without limitation, research proposals, research inquiry, including, without limitation, research proposals, laboratory records, both physical and electronic, progress reports, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports and journal abstracts, theses, oral presentations, internal reports and journal articles.articles.

• ExceptExcept: for scientific instruments shared by a number of users, : for scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.the evidentiary value of the instruments.

Other evidence.Other evidence.

(Policy, p. 4, (Policy, p. 4, ¶ 2)¶ 2)

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InquiryInquiry

““The gathering of preliminary information The gathering of preliminary information and fact-finding to assess whether such and fact-finding to assess whether such Allegation has substance and if so, Allegation has substance and if so, whether an Investigation is warranted.”whether an Investigation is warranted.”

(Policy, p. 3, (Policy, p. 3, ¶ F.1(a))¶ F.1(a))

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Who conducts the Inquiry?Who conducts the Inquiry?

3 or more Preliminary Reviewers3 or more Preliminary Reviewers

Appointed by the Chair, in consultation with the Appointed by the Chair, in consultation with the Standing CommitteeStanding Committee

Officers of Instruction, Officers of Research, Officers of Instruction, Officers of Research, Officer of the Libraries, or students, Officer of the Libraries, or students, who may or who may or may not be members of the Standing Committeemay not be members of the Standing Committee

(Policy, p. 4, (Policy, p. 4, ¶ G.1)¶ G.1)

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How comprehensive is the Inquiry? How comprehensive is the Inquiry?

NOT all-inclusiveNOT all-inclusive

““The Preliminary Reviewers shall review such The Preliminary Reviewers shall review such evidence and interview such persons as may be evidence and interview such persons as may be necessary to make an assessment of whether necessary to make an assessment of whether the Allegation has substance and whether an the Allegation has substance and whether an Investigation is warranted.”Investigation is warranted.”

(Policy, p. 4, (Policy, p. 4, ¶ G.3)¶ G.3)

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| Preliminary Reviewers review evidence and conduct interviews as

necessary |

Preliminary Reviewers draft Inquiry Report

| Comments from Complainant and

Respondent |

Final Inquiry Report to Standing Committee

Chair, in consultation with Standing Committee, appoints Preliminary

Reviewers

Steps for an Inquiry:Steps for an Inquiry:

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SafeguardsSafeguards

Complainant: Complainant: Right to meet with Preliminary ReviewersRight to meet with Preliminary Reviewers

Respondent:Respondent: Right to meet with Preliminary ReviewersRight to meet with Preliminary Reviewers Right to have reasonable access to evidence Right to have reasonable access to evidence

supporting the Allegationsupporting the Allegation Right to respond to the Allegation orally and in Right to respond to the Allegation orally and in

writingwriting

(Policy, pp. 7-8, (Policy, pp. 7-8, ¶ K(3) and (4))¶ K(3) and (4))

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Time FrameTime Frame

In general, an Inquiry must be completed In general, an Inquiry must be completed within 60 days of its initiation.within 60 days of its initiation.

The Standing Committee may approve The Standing Committee may approve one or more reasonable extensions to the one or more reasonable extensions to the extent deemed necessary or appropriate.extent deemed necessary or appropriate.

(Policy, p. 5, (Policy, p. 5, ¶ G(8))¶ G(8))

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What is the role of the Standing What is the role of the Standing Committee?Committee?

Chair consults with members of Standing Chair consults with members of Standing Committee in appointing Inquiry Committee in appointing Inquiry CommitteeCommittee

Standing Committee sequesters evidenceStanding Committee sequesters evidence The Standing Committee may accept or The Standing Committee may accept or

reject the recommendation of the reject the recommendation of the Preliminary Reviewers.Preliminary Reviewers.

(Policy, p. 4, (Policy, p. 4, ¶ G(1)-(2), (7))¶ G(1)-(2), (7))

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

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What is an Investigation?What is an Investigation?

the formal development of a factual record the formal development of a factual record with respect to such Allegationwith respect to such Allegation

the examination and evaluation of such the examination and evaluation of such record leading to: record leading to: dismissal of the case or dismissal of the case or a recommendation of a finding of Research a recommendation of a finding of Research

Misconduct and/or other appropriate Misconduct and/or other appropriate corrective actionscorrective actions

(Policy, p. 3, (Policy, p. 3, ¶ F(1)(b))¶ F(1)(b))

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What does the Standing Committee What does the Standing Committee do?do?

Appoint the Ad Hoc Committee to conduct Appoint the Ad Hoc Committee to conduct the Investigationthe Investigation

Accept, reject, or modify the Accept, reject, or modify the recommendations of the Ad Hoc recommendations of the Ad Hoc CommitteeCommittee

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What does the Ad Hoc Committee What does the Ad Hoc Committee do?do?

Examine all relevant Research records Examine all relevant Research records and evidenceand evidence

Interview the Complainant, Respondent, Interview the Complainant, Respondent, and Witnessesand Witnesses

Draft a reportDraft a report

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Safeguards for the ComplainantSafeguards for the Complainant

Complainant may:Complainant may: Identify witnesses to be interviewedIdentify witnesses to be interviewed

Be accompanied by counsel for advisory purposes Be accompanied by counsel for advisory purposes only when appearing before the Ad hoc Committeeonly when appearing before the Ad hoc Committee

Obtain a copy of a transcript of his/her own testimony, Obtain a copy of a transcript of his/her own testimony, if any, and to correct such transcript, if necessaryif any, and to correct such transcript, if necessary

(Policy, p. 7, (Policy, p. 7, ¶ K(3)(c))¶ K(3)(c))

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Safeguards for the RespondentSafeguards for the Respondent Respondent may:Respondent may:

Appear before the Ad Hoc Committee to present testimony on Appear before the Ad Hoc Committee to present testimony on her/her behalfher/her behalf

Identify witnesses to be interviewedIdentify witnesses to be interviewed

Be accompanied by counsel for advisory purposes only when Be accompanied by counsel for advisory purposes only when appearing before the Ad hoc Committeeappearing before the Ad hoc Committee

Obtain a copy of a transcript of his/her own testimony, if any, Obtain a copy of a transcript of his/her own testimony, if any, and to correct such transcript, if necessaryand to correct such transcript, if necessary

(Policy, p. 7, (Policy, p. 7, ¶ K(3)(c))¶ K(3)(c))

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Steps for an InvestigationSteps for an Investigation

Comments from ComplainantComments from Complainantand Respondentand Respondent

Standing Committee appoints Ad Hoc Committee to Standing Committee appoints Ad Hoc Committee to conduct Investigation conduct Investigation

Ad Hoc Committee examines Research records and Ad Hoc Committee examines Research records and evidence; interviews Complainant, Respondent, and evidence; interviews Complainant, Respondent, and

witnesses.witnesses.

Ad Hoc Committee prepares draft Investigation Ad Hoc Committee prepares draft Investigation Report, including whether finding of Research Report, including whether finding of Research Misconduct should be made, and, if so, what Misconduct should be made, and, if so, what

corrective action is recommendedcorrective action is recommended

Final Ad Hoc Committee Investigation Report to Final Ad Hoc Committee Investigation Report to Standing CommitteeStanding Committee

4343

A Finding of Research Misconduct A Finding of Research Misconduct Must Meet Three Requirements:Must Meet Three Requirements:

Significant departureSignificant departure from accepted practices in from accepted practices in the relevant research community;the relevant research community;

The Research Misconduct has been committed The Research Misconduct has been committed intentionally, knowingly or recklesslyintentionally, knowingly or recklessly;;

The Allegation is proved by a The Allegation is proved by a Preponderance of Preponderance of the Evidencethe Evidence..

(Policy, p. 4, (Policy, p. 4, ¶ F(2))¶ F(2))

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Corrective Actions and PenaltiesCorrective Actions and Penalties

Commensurate with seriousness of Research Commensurate with seriousness of Research Misconduct, including, without limitation, whether Misconduct, including, without limitation, whether it:it: Was knowing, intentional or reckless;Was knowing, intentional or reckless; Was an isolated event or part of a pattern; orWas an isolated event or part of a pattern; or Had significant impact on the Research Record, Had significant impact on the Research Record,

Research subjects, other researchers, the University, Research subjects, other researchers, the University, other institutions or the public.other institutions or the public.

(Policy, p. 8, (Policy, p. 8, ¶ K(8)(a))¶ K(8)(a))

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What is the time frame for an What is the time frame for an Investigation?Investigation?

In general, the Investigation should be In general, the Investigation should be completed within 120 days from initiationcompleted within 120 days from initiation

The Standing Committee may approve The Standing Committee may approve one or more reasonable extensions to the one or more reasonable extensions to the extent deemed necessary or appropriate.extent deemed necessary or appropriate.

(Policy, p. 6, (Policy, p. 6, ¶ J(8))¶ J(8))

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What happens after the Standing What happens after the Standing Committee votes on the Ad Hoc Committee votes on the Ad Hoc

Committee’s RecommendationsCommittee’s Recommendations??

Adjudication: Adjudication: ““the formal procedure for reviewing and evaluating the the formal procedure for reviewing and evaluating the

evidentiary record and report of an Investigation and evidentiary record and report of an Investigation and for determining whether to agree with the for determining whether to agree with the

recommended findings and to impose appropriate recommended findings and to impose appropriate corrective actions.”corrective actions.”

(Policy, p. 3, (Policy, p. 3, ¶ F(1)(c))¶ F(1)(c))

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Steps for AdjudicationSteps for Adjudication

EVPR reviews report of Ad Hoc EVPR reviews report of Ad Hoc Committee and Standing Committee and Committee and Standing Committee and

consults with Responsible Academic consults with Responsible Academic Officer and, if the Respondent is a Officer and, if the Respondent is a CUMC Respondent, the EVPHS CUMC Respondent, the EVPHS

|

EVPR accepts, rejects or modifies EVPR accepts, rejects or modifies recommendationsrecommendations

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AppealAppeal

Respondent has the right to appealRespondent has the right to appeal To the ProvostTo the Provost As to either:As to either:

the finding of Research Misconduct; or the finding of Research Misconduct; or the corrective actions imposedthe corrective actions imposed

(Policy, p. 6, (Policy, p. 6, ¶ J)¶ J)

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Is this misconduct?Is this misconduct?

Rogue Scientist Has Own Scientific MethodRogue Scientist Has Own Scientific MethodJune 5, 2006 | June 5, 2006 | Issue 42•23Issue 42•23TALLAHASSEE, FL—Only months after abandoning a tenured position at Lehigh TALLAHASSEE, FL—Only months after abandoning a tenured position at Lehigh University, maverick chemist Theodore Hapner managed to disprove two of the three laws 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—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 defined for centuries by exhaustive research, painstaking observation, and hard-won theories—completely on its head. theories—completely on its head.

The brash chemist, who conducts independent research from his houseboat, has 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 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.  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, "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,' 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 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 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 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."and I'll prove that the boiling point of water is actually 547 degrees Fahrenheit."

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Questions?Questions?

Naomi J. SchragNaomi J. SchragDirector of Research Compliance & Director of Research Compliance & TrainingTraining212-854-8123212-854-8123ns2333@columbia.eduns2333@columbia.edu

Jane E. Booth, Esq.Jane E. Booth, Esq.Office of General CounselOffice of General Counsel212-854-0286212-854-0286jeb@gc.columbia.edujeb@gc.columbia.edu