Misconduct and Other SinsMisconduct and Other Sins

Stan KorenmanStan Korenman

With assistance fromWith assistance from

Richard Smith Editor, BMJRichard Smith Editor, BMJ

NORMSNORMS

Norms are general statements implying Norms are general statements implying obligations and/or evaluationsobligations and/or evaluations

Norms are shared by members of a certain Norms are shared by members of a certain groupgroup

A belief held by a single individual alone about A belief held by a single individual alone about the merits of a particular kind of action is not a the merits of a particular kind of action is not a normnorm

Norms Of ScientistsNorms Of Scientists

Intellectual integrity and objectivityIntellectual integrity and objectivity Tolerance for disputesTolerance for disputes Doubt of certitudeDoubt of certitude Recognition of errorRecognition of error Unselfish engagementUnselfish engagement Communal spiritCommunal spirit

» Cournand A. The code of the scientist and its Cournand A. The code of the scientist and its relationship to ethics. relationship to ethics. ScienceScience 1977;198:699-706. 1977;198:699-706.

Questionable Research Practices Questionable Research Practices SwazeySwazey

Conduct by faculty (number of exposures)

0 1-2 3-5 5+

Inappropriately assigning authorship credit

69%

28%

3%

1%

Overlooking other’s use of flawed research data or the questionable interpretation of data

78%

18%

2%

2%

Using university resources for outside consulting work or other inappropriate personal purposes

57%

33%

6%

4%

Failing to present data that contradict one’s previous research

85%

13%

1%

1%

Personal ExperiencesPersonal Experiences

Famous case of misconductFamous case of misconduct

Were shown an unpublished paperWere shown an unpublished paper

Suspect the work of othersSuspect the work of others

Know an unethical scientistKnow an unethical scientist

Personal ExperiencesPersonal Experiences

% % %%

FacultyFaculty traineestrainees

Famous case of misconductFamous case of misconduct 43.5 43.5 23.5 23.5

Was shown an unpublished paper 65.7Was shown an unpublished paper 65.7 66.0 66.0

Suspect work of othersSuspect work of others 66.0 66.0 29.7 29.7

Knows an unethical scientist 50.0Knows an unethical scientist 50.0 26.3 26.3

When Norms Beget RegulationsWhen Norms Beget Regulations

Your university is mandated by the Federal Your university is mandated by the Federal government to:government to:

Manage federal assurance to conduct research ethically. Manage federal assurance to conduct research ethically.

Ensure that research does not violate rules, (e.g. Ensure that research does not violate rules, (e.g. Unauthorized stem cell research or research using Unauthorized stem cell research or research using anthrax).anthrax).

Mandates disclosure and management of financial interests Mandates disclosure and management of financial interests and conflicts of interest. and conflicts of interest.

Handle allegations of misconduct properlyHandle allegations of misconduct properly

Why Research Misconduct Why Research Misconduct MattersMatters

It’s like child abuse: we didn’t recognise it, It’s like child abuse: we didn’t recognise it, now, sadly, we see a lot of it.now, sadly, we see a lot of it.

It undermines public trust.It undermines public trust. It corrupts the scientific record and leads to It corrupts the scientific record and leads to

false conclusions that are sometimes false conclusions that are sometimes perpetuated for quite a while.perpetuated for quite a while.

Sins Are Everywhere as are Sins Are Everywhere as are SinnersSinners

Research Malfeasance: Research Malfeasance: Unethical but not IllegalUnethical but not Illegal

Defective research practicesDefective research practices: supervision, record : supervision, record keeping, monitoring, adverse event reportingkeeping, monitoring, adverse event reporting

Biased analysisBiased analysis:: Unfair reportingUnfair reporting:: guest authors, failure to disclose guest authors, failure to disclose

conflicts of interest, conflicts of interest, Poor scientist interactionsPoor scientist interactions: : exploitative or exploitative or

negligent mentoring, violations of confidentiality, failure negligent mentoring, violations of confidentiality, failure to share, false accusations, unfair allocation of authorshipto share, false accusations, unfair allocation of authorship

Biased peer reviewBiased peer review

Malfeasance: Illegal but Not Malfeasance: Illegal but Not Research MisconductResearch Misconduct

Destruction or theft of research propertyDestruction or theft of research property Misuse or theft of research fundsMisuse or theft of research funds Harassment of personnelHarassment of personnel Violation of safety rules for; Violation of safety rules for;

human subjects, animal subjects, radiation, chemicals, gases, human subjects, animal subjects, radiation, chemicals, gases, biologicalsbiologicals

Interfering with an inquiry or investigationInterfering with an inquiry or investigation

Malfeasance in Human StudiesMalfeasance in Human Studies

Poor experimental designPoor experimental design

Not following protocol scrupulously:Not following protocol scrupulously:– inclusion or exclusion criteria inclusion or exclusion criteria – hidden amendments hidden amendments – not accounting for accidental protocol variancesnot accounting for accidental protocol variances– bias, delay or failure to report serious adverse bias, delay or failure to report serious adverse

eventsevents Calling a study “practice” or “QA”, not Calling a study “practice” or “QA”, not

consenting and then reporting as research.consenting and then reporting as research.

Institutional Requirements for Institutional Requirements for Reporting in Human ResearchReporting in Human Research

The Department of Health and Human Services (DHHS) and theFood 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

(i) unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance

with this policy, or the requirements or determinations of the IRB; and

(ii) any suspension or termination of IRB approval”

[45 CFR 46.103(b)(5)]. [21 CFR 56.108(b)].

UCLA IRB RequirementsUCLA 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 regulations or requirements, determinations, or policies of the IRB.

Investigators must report immediately upon discovery and no later than ten days from the occurrence.

Sec 93.103 Research MisconductSec 93.103 Research Misconduct  May 2005May 2005

Research misconduct means fabrication, Research misconduct means fabrication, falsification, or plagiarism in proposing, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting performing, or reviewing research, or in reporting research results.research results.

(a) Fabrication is making up data or results and (a) Fabrication is making up data or results and recording or reporting themrecording or reporting them. .

(b) Falsification is manipulating research (b) Falsification is manipulating research materials, equipment, or processes, or changing or materials, equipment, or processes, or changing or omitting data or results such that the research is omitting data or results such that the research is not accurately represented in the research recordnot accurately represented in the research record. .

Sec 93.103 Research MisconductSec 93.103 Research Misconduct  May 2005May 2005

(c) Plagiarism is the appropriation of (c) Plagiarism is the appropriation of another person's ideas, processes, results, or another person's ideas, processes, results, or words without giving appropriate credit.words without giving appropriate credit.

(d) Research misconduct does not include (d) Research misconduct does not include

honest error or differences of opinion.honest error or differences of opinion.

Sec 93.104 Requirements for Sec 93.104 Requirements for findings of research misconductfindings of research misconduct  

There be a significant departure from There be a significant departure from accepted practices of the relevant research accepted practices of the relevant research community; and community; and

The misconduct be committed intentionally, The misconduct be committed intentionally, knowingly, or recklessly; and knowingly, or recklessly; and

The allegation be proven by a The allegation be proven by a preponderance of the evidence.preponderance of the evidence.

Burden of proof. The Burden of proof. The institution or HHS has institution or HHS has the burden of proofthe burden of proof for making a finding of for making a finding of research misconduct.research misconduct.

Sec 93.106 Evidentiary StandardsSec 93.106 Evidentiary Standards

The destruction, absence of, or respondent's The destruction, absence of, or respondent's failure to provide research records failure to provide research records adequately documenting the questioned adequately documenting the questioned research is evidence of research research is evidence of research misconduct. misconduct.

Affirmative DefenseAffirmative Defense

(2) The (2) The respondentrespondent has the burden of going forward has the burden of going forward with and the burden of proving, by a preponderance with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses of the evidence, any and all affirmative defenses raised, as well as any mitigating factors that are raised, as well as any mitigating factors that are relevant to a decision to impose administrative relevant to a decision to impose administrative actions following a positive finding of research actions following a positive finding of research misconduct.misconduct.

In determining whether HHS or the institution has In determining whether HHS or the institution has carried its burden of proof, the finder of fact shall carried its burden of proof, the finder of fact shall give due consideration to admissible, credible give due consideration to admissible, credible evidence of honest error or difference of opinion evidence of honest error or difference of opinion presented by the respondent. presented by the respondent.

Sec. 93.210 Good faithSec. 93.210 Good faith

Good faithGood faith as applied to a complainant or witness, means as applied to a complainant or witness, means having a having a belief in the truth of one's allegation or testimonybelief in the truth of one's allegation or testimony that a reasonable person in the complainant's or witness's that a reasonable person in the complainant's or witness's position could have, based on what they knew at the time. position could have, based on what they knew at the time.

Good faith of a committee memberGood faith of a committee member means means carrying out the carrying out the duties assigned impartiallyduties assigned impartially for the purpose of helping an for the purpose of helping an institution meet its responsibilities. A committee member institution meet its responsibilities. A committee member does not act in good faith if his/her acts or omissions on does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those professional, or financial conflicts of interest with those involved in the research misconduct proceeding.involved in the research misconduct proceeding.

Sec 93.300 Institutional Sec 93.300 Institutional Responsibilities for Compliance Responsibilities for Compliance 

A) written policies; A) written policies; B) respond competently and objectively. Avoid COIs.B) respond competently and objectively. Avoid COIs.C) foster a high integrity research environment. C) foster a high integrity research environment. D) protect the reputations of complainants, witnesses and D) protect the reputations of complainants, witnesses and

committee members and protect against retaliation. committee members and protect against retaliation. E) provide confidentiality E) provide confidentiality F) ensure the cooperation of respondents and other institutional F) ensure the cooperation of respondents and other institutional

members with research misconduct proceedings members with research misconduct proceedings G) cooperate with HHS G) cooperate with HHS H) assist in administering and enforcing any HHS H) assist in administering and enforcing any HHS

administrative actions; And administrative actions; And I) have an active assurance of compliance.I) have an active assurance of compliance.

ProcessProcess

Suspicion of wrongdoingSuspicion of wrongdoing Informal communicationInformal communication Formal communicationFormal communication InquiryInquiry InvestigationInvestigation AdjudicationAdjudication SanctionsSanctions

Suspicion of Wrongdoing

Informal CommunicationLab Chief

Department ChairOmbudsman

Nature of Complaint

Possible Scientific Misconduct

MisunderstandingDisagreement

Breach of Manners, Larceny

Scientific Integrity Officer

Sequester Data

Initiate Formal Inquiry

YES

YES

NO

Mediation

Formal Inquiry

Possible Misconduct Not Misconduct

Formal InvestigationExpert Committee

Determine nature & extent of misconduct

Quasi-legal procedure

Legal representation

Data sequestered

ORI notified

Mediation

Restore Reputation

Committee Report

NO

Adjudication

Sanctions:

Institutional, Governmental

Office of Research Integrity

Institute

YES

Our Response to WhistleblowersOur Response to Whistleblowers

WhistleblowingWhistleblowing

Practical issues:Practical issues:

Consider it an inquiry rather than an Consider it an inquiry rather than an accusationaccusation

Talk it over with friendsTalk it over with friends

Is there another side to the story?Is there another side to the story?

Write it down. Focus on the science and exact Write it down. Focus on the science and exact detailsdetails

Try to develop supportTry to develop support

You shouldn’t illegally examine someone’s dataYou shouldn’t illegally examine someone’s dataDerived in part from Chris Gunsalus, 1998 Sci. and Eng. Ethics; 4:51-64Derived in part from Chris Gunsalus, 1998 Sci. and Eng. Ethics; 4:51-64

Whistleblowing 2Whistleblowing 2

You may You may notnot have a right to know what’s going have a right to know what’s going on. Is that okay for you?on. Is that okay for you?

What kind of satisfaction do you want from the What kind of satisfaction do you want from the inquiry?inquiry?

If it’s your boss, you may have to move. Is that If it’s your boss, you may have to move. Is that okay for you?okay for you?

Is there a way to achieve your goals without Is there a way to achieve your goals without going to the “authorities”?going to the “authorities”?

Are you prepared for the long haul and for a Are you prepared for the long haul and for a bad outcome?bad outcome?

ORI : Ten Years of ReportingORI : Ten Years of Reporting

3662 Institutions, many sm. businesses3662 Institutions, many sm. businesses 1375 Inst higher learning, res. orgs., Res. 1375 Inst higher learning, res. orgs., Res.

Inst, labs, and foundations.Inst, labs, and foundations. # reporting misconduct 53/ year# reporting misconduct 53/ year 55% a single instance, 20% > 555% a single instance, 20% > 5 703 individual cases filed703 individual cases filed

ORI : Ten Years of ReportingORI : Ten Years of Reporting

703 Individual cases filed703 Individual cases filed 602 inquiries602 inquiries 221 investigations221 investigations 110 findings of misconduct (from 76 110 findings of misconduct (from 76

institutions)institutions)

New Misconduct RulesNew Misconduct Rules

http://www.ori.dhhs.gov/documents/http://www.ori.dhhs.gov/documents/FR_Doc_05-9643.shtmlFR_Doc_05-9643.shtml

Litigation, the New Approach to Litigation, the New Approach to Research ManagementResearch Management

Historical - informed consent claims for medical Historical - informed consent claims for medical treatment back to 1914.treatment back to 1914.

New - Three developmentsNew - Three developments– New legal claimsNew legal claims– Increased number and types of defendantsIncreased number and types of defendants– Use of class action techniqueUse of class action technique

Fraud cases can result in punitive damages and Fraud cases can result in punitive damages and really big awardsreally big awards

This section derived from Mello, Studdert and Brennan: 2003 Ann Int Med; 139:40-45.This section derived from Mello, Studdert and Brennan: 2003 Ann Int Med; 139:40-45.

New DefendantsNew Defendants

Now suing everyone including Now suing everyone including – The universityThe university– The teaching hospitalThe teaching hospital– The PIThe PI– The sponsorThe sponsor– Top university officialsTop university officials– Individual IRB membersIndividual IRB members– The hospital’s patient advocate (Abiomed)The hospital’s patient advocate (Abiomed)

New DefendantsNew Defendants

Grimes v. Kennedy-Krieger Institute of Grimes v. Kennedy-Krieger Institute of Johns Hopkins - lead exposure study. Johns Hopkins - lead exposure study. Controls were allowed to continue to be Controls were allowed to continue to be exposed to lead.exposed to lead.

» Maryland’s highest court faulted the judgement of the Maryland’s highest court faulted the judgement of the IRB and determined that its ruling constituted IRB and determined that its ruling constituted negligencenegligence

With many individuals subject to the same With many individuals subject to the same conditions - ripe setting for class action suits.conditions - ripe setting for class action suits.Much more lucrative for the attorneysMuch more lucrative for the attorneys

Impacts of LitigationImpacts of Litigation

More suits inevitableMore suits inevitable May tighten up research on humans - a good May tighten up research on humans - a good

thingthing May make IRBs super-conservative a bad May make IRBs super-conservative a bad

thingthing May make monitoring of research May make monitoring of research

mandatorymandatory May create a spate of rule-making.May create a spate of rule-making.

Why does misconduct happen?Why does misconduct happen?

Why not? It happens in all other human activities.Why not? It happens in all other human activities. Pressure to publish, survivalist mentality.Pressure to publish, survivalist mentality. Defective ethical sensitivity (sociopath).Defective ethical sensitivity (sociopath). Inadequate training. Not taught good practices. Inadequate training. Not taught good practices.

Indeed, sometimes encouraged in the opposite.Indeed, sometimes encouraged in the opposite. Does sloppy behaviour spill over to fraud?Does sloppy behaviour spill over to fraud? You can often get away with it. The system works on You can often get away with it. The system works on

trust.trust.

TrustTrust

Research on humans is based on trust:Research on humans is based on trust: That the truth is told about the studyThat the truth is told about the study That COIs are revealedThat COIs are revealed That the institution is fulfilling its That the institution is fulfilling its

responsibilities to the participants.responsibilities to the participants. That those conducting the study have the That those conducting the study have the

best interests of the participants at the top of best interests of the participants at the top of their agenda.their agenda.