ORI 1/07 1

The Office of Research The Office of Research Integrity: Responding to Integrity: Responding to

Misconduct and Promoting Misconduct and Promoting Responsible Research Responsible Research

John E. Dahlberg, Ph.D.John E. Dahlberg, Ph.D.

DirectorDirector

Division of Investigative Division of Investigative OversightOversight

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ORI’s MissionORI’s Mission

Mission: Mission: To promote the integrity of To promote the integrity of PHS-PHS-

supported extramural and supported extramural and intramural research programsintramural research programs

Respond effectively to allegations Respond effectively to allegations of research misconductof research misconduct

Promote research integrityPromote research integrity

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Definition of Research MisconductDefinition of Research Misconduct

Fabrication is making up data or results Fabrication is making up data or results and recording or reporting themand recording or reporting them

Falsification is manipulating research Falsification is manipulating research materials, equipment, or processes, or materials, equipment, or processes, or changing or omitting data or results changing or omitting data or results such that the research is not accurately such that the research is not accurately represented in the research recordrepresented in the research record

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Definition of Research MisconductDefinition of Research Misconduct

Plagiarism is the appropriation of Plagiarism is the appropriation of another person’s ideas, processes, another person’s ideas, processes, results, or words without giving results, or words without giving appropriate creditappropriate credit

Research misconduct does not include Research misconduct does not include honest error or differences of opinion honest error or differences of opinion

(42 CFR Part 93.103)(42 CFR Part 93.103)

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Proof of Research Misconduct Proof of Research Misconduct

Requires -Requires - That there be a significant departure That there be a significant departure

from accepted practices of the from accepted practices of the relevant research community, relevant research community, andand

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

The allegation be proven by a The allegation be proven by a preponderance of the evidence, preponderance of the evidence, (42 CFR Part 93.104) (42 CFR Part 93.104)

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Additional ORI ActivitiesAdditional ORI Activities Administer the Assurance program, a Administer the Assurance program, a

database of all institutions eligible to database of all institutions eligible to receive PHS fundsreceive PHS funds

Correct or retract research Correct or retract research publications to protect the integrity of publications to protect the integrity of the scientific literaturethe scientific literature

Protect the confidentiality of Protect the confidentiality of respondents, complainants, and respondents, complainants, and witnesseswitnesses

Protect witnesses from retaliation Protect witnesses from retaliation (42 CFR 93.300 (d) )(42 CFR 93.300 (d) )

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ORI Activities (cont)ORI Activities (cont)

Provide education in RCRProvide education in RCR Collaborate with the research Collaborate with the research

community to improve biomedical community to improve biomedical researchresearch

Exclude dishonest investigators from Exclude dishonest investigators from PHS and Federal agency funded research PHS and Federal agency funded research

Make public findings of misconduct so Make public findings of misconduct so that institutions and individuals will be that institutions and individuals will be aware of wrongdoingaware of wrongdoing

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ORI lacks jurisdictions for many ORI lacks jurisdictions for many types of inappropriate behavior: types of inappropriate behavior:

some are referred to other agenciessome are referred to other agencies

Misuse of human or animal subjectsMisuse of human or animal subjects Misconduct and other complaints Misconduct and other complaints

involving FDA-regulated research involving FDA-regulated research Financial mismanagementFinancial mismanagement Radiation or biosafety hazardsRadiation or biosafety hazards Conflict of interestConflict of interest

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Other issues not within ORI’s Other issues not within ORI’s jurisdiction:jurisdiction:

Honest error or honest differences in Honest error or honest differences in interpretations or judgments of datainterpretations or judgments of data

Authorship or credit disputesAuthorship or credit disputes Duplicate publicationDuplicate publication Collaboration agreements or Collaboration agreements or

research-related disputes among research-related disputes among collaboratorscollaborators

Intellectual propertyIntellectual property

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Issues not within ORI’s jurisdiction Issues not within ORI’s jurisdiction (Continued)(Continued)

Laboratory managementLaboratory management Quality control/quality assurance Quality control/quality assurance

(eg., surveillance data)(eg., surveillance data) Employment issues such as job Employment issues such as job

changes, promotion, termination, changes, promotion, termination, salary, etc.salary, etc.

Disputes over space, equipment Disputes over space, equipment access, collaborative workaccess, collaborative work

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Research Misconduct in Research Misconduct in Clinical ResearchClinical Research

By policy, in clinical trails, certain types of falsifications By policy, in clinical trails, certain types of falsifications are not handled by ORI as allegations of research are not handled by ORI as allegations of research misconduct. These include:misconduct. These include: Falsified or forged consent formsFalsified or forged consent forms Failure to report an adverse event to the IRB or Failure to report an adverse event to the IRB or

sponsorsponsor Protocol deviations such as entering ineligible Protocol deviations such as entering ineligible

subjects, administering an off-protocol drug, forging subjects, administering an off-protocol drug, forging a physician’s signature on ordersa physician’s signature on orders

Failure to obtain informed consentFailure to obtain informed consent Breach of patient confidentialityBreach of patient confidentiality Failure to obtain IRB approval for changes to protocolFailure to obtain IRB approval for changes to protocol

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Research Misconduct in Clinical Research Misconduct in Clinical Research, Research, (Continued)(Continued)

Behaviors that Behaviors that areare considered research misconduct: considered research misconduct: Falsifications:Falsifications:

Substitutions of one subject’s record for another’sSubstitutions of one subject’s record for another’s Changing research record to favor the study’s Changing research record to favor the study’s

hypothesishypothesis Altering eligibility dates and eligibility test resultsAltering eligibility dates and eligibility test results Falsifying dates on patient screening logsFalsifying dates on patient screening logs

Fabrications:Fabrications: Not conducting interviews with subjects and creating Not conducting interviews with subjects and creating

records of the interviewrecords of the interview Making up patient visits and inserting that record into Making up patient visits and inserting that record into

the medical chartthe medical chart Recording the results of follow-up visits with deceased Recording the results of follow-up visits with deceased

subjectssubjects

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Types of data that have been falsified Types of data that have been falsified or fabricated in clinical studiesor fabricated in clinical studies

InterviewsInterviews Entry criteriaEntry criteria Screening logsScreening logs Approval formsApproval forms Follow-up Follow-up

exams/dataexams/data Consent formsConsent forms Test scoresTest scores

Laboratory resultsLaboratory results Patient dataPatient data Number of subjectsNumber of subjects Dates of proceduresDates of procedures ProtocolProtocol Study resultsStudy results

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ORI’s Handling of CasesORI’s Handling of Cases Allegation – at institution or at ORIAllegation – at institution or at ORI Allegation Assessment – if at ORI, referred to Allegation Assessment – if at ORI, referred to

institutioninstitution Institution InquiryInstitution Inquiry Institution Investigation – institutional actionsInstitution Investigation – institutional actions DIO Review of Institution’s InvestigationDIO Review of Institution’s Investigation ORI Director’s Decision on proposed administrative ORI Director’s Decision on proposed administrative

actionsactions If misconduct, seek settlement or send charge If misconduct, seek settlement or send charge

letter followed by hearingletter followed by hearing If misconduct found, possible appealIf misconduct found, possible appeal With final departmental finding, impose With final departmental finding, impose

administrative actionsadministrative actions

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Some ORI Statistics Some ORI Statistics

1992 to July 2007 statistics:1992 to July 2007 statistics: Total misconduct findings Total misconduct findings

189189 Misconduct findings that involve Misconduct findings that involve

clinical research clinical research 27%27%

Findings leading to debarment Findings leading to debarment 119119 Total cases opened from 1992 Total cases opened from 1992 501501 Total cases closed from 1992 Total cases closed from 1992 531531

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Statistics (cont)Statistics (cont) Total cases pending Total cases pending 43 43 Total allegations from 1992 Total allegations from 1992

3,0843,084 Allegations per year Allegations per year ~225~225 Retracted papersRetracted papers 114114 Corrected papers Corrected papers 31 31 Withdrawn papers Withdrawn papers 4 4 Total of correct, retracted, and Total of correct, retracted, and

withdrawn journal articles withdrawn journal articles 149 149

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Major misconduct case: Major misconduct case: Eric Poehlman, Ph.D. Eric Poehlman, Ph.D.

University of VermontUniversity of Vermont

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The initial allegations arose when Dr. The initial allegations arose when Dr. Poehlman provided a colleague, about a Poehlman provided a colleague, about a week apart, two versions of a spreadsheet week apart, two versions of a spreadsheet containing physical, dietary, energetic, and containing physical, dietary, energetic, and metabolic data on elderly men and women metabolic data on elderly men and women seen twice, on average, about six years seen twice, on average, about six years apart. apart.

In the complainant’s own words:In the complainant’s own words:

Initial AllegationsInitial Allegations

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The incident that triggered my suspicions The incident that triggered my suspicions occurred in late September, 2000 - I was occurred in late September, 2000 - I was asked by Dr. Poehlman to write a paper asked by Dr. Poehlman to write a paper from a longitudinal database (Protocol from a longitudinal database (Protocol #678). The paper was to examine the #678). The paper was to examine the effects of age on lipids in men and effects of age on lipids in men and women… When I presented him with the women… When I presented him with the data, he was not satisfied with the results data, he was not satisfied with the results and asked for the database in order to and asked for the database in order to verify data entries and check for what he verify data entries and check for what he described as "reversed" datapoints, … It described as "reversed" datapoints, … It was my belief that I was mistakenly given was my belief that I was mistakenly given a “true” version of the dataset originally a “true” version of the dataset originally and then given the manipulated version and then given the manipulated version the second time…the second time…

Initial allegations (cont)Initial allegations (cont)

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The Scope of the MisconductThe Scope of the Misconduct

The following two slides provide a The following two slides provide a glimpse of the massive scope of Dr. glimpse of the massive scope of Dr. Poehlman’s alterations in the data Poehlman’s alterations in the data base for the longitudinal study of base for the longitudinal study of aging, protocol #678.aging, protocol #678.

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Dr. Poehlman’s changes to total energy expenditure values included many fabrications (blue) and reversals of visit one and visit two values (red)

The net effects were to greatly inflate the number of subjects and to reverse the apparent effect of aging.

Correct TEE values

Dr. Poehlman’s TEE values

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Dr. Poehlman’s changes to glucose involved near complete reversal of T1 and T2 values, allowing him to claim that glucose levels rose with age when the real data showed the opposite.

Tip of the iceberg

The total number of reversals, falsifications and fabrications made by Dr. Poehlman to the 467 database was greater than 4000, all in a small fraction of the hundreds of fields of data.

Although he had reported data from this study in three unfunded grant applications, almost nothing was published, and the “harm done,” by itself, was not extensive.

However, much more was subsequently revealed….

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Additional IssuesAdditional Issues

Dr. Poehlman claimed to have conducted a Dr. Poehlman claimed to have conducted a longitudinal study of the menopause longitudinal study of the menopause transition involving 35 women seen twice six transition involving 35 women seen twice six years apart.years apart.

This study was reported in a 1995 paper in This study was reported in a 1995 paper in the the Annals of Internal MedicineAnnals of Internal Medicine and five and five follow-up papers as well as in many grant follow-up papers as well as in many grant applications.applications.

The study was not conducted: Dr. Poehlman The study was not conducted: Dr. Poehlman falsified the number of subjects at T1 and falsified the number of subjects at T1 and never saw the women a second timenever saw the women a second time..

The data from the Annals paper claimed to show that the menopause transition quickly leads to undesirable changes in weight, fat mass, resting metabolic rate, leisure time activity, and waist-to-hip ratio.

None of these conclusions were legitimate (although cross-sectional studies have suggested that changes do occur eventually).

Additional fabricated results from this study were reported in later papers and grant applications.

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Additional Issues (cont)Additional Issues (cont)

The UVM investigation, ORI, and the U.S. The UVM investigation, ORI, and the U.S. Attorney’s office determined that Dr. Attorney’s office determined that Dr. Poehlman falsified data in additional papers Poehlman falsified data in additional papers and grant applications in areas as wide and grant applications in areas as wide ranging as Alzheimer’s disease, the effect of ranging as Alzheimer’s disease, the effect of endurance training on RMR, and the effects endurance training on RMR, and the effects of hormone replacement therapy on post-of hormone replacement therapy on post-menopausal women.menopausal women.

Many of these false claims were also made Many of these false claims were also made in talks given by Dr. Poehlman, some of in talks given by Dr. Poehlman, some of which were documented, allowing additional which were documented, allowing additional findings of scientific misconduct to be findings of scientific misconduct to be made.made.

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Dr. Poehlman’s obstruction effortsDr. Poehlman’s obstruction efforts

Starting immediately after being accused Starting immediately after being accused of misconduct, Dr. Poehlman aggressively of misconduct, Dr. Poehlman aggressively attempted to obstruct the University attempted to obstruct the University investigation, and subsequently the investigation, and subsequently the Government’s review.Government’s review.

He accused his young colleagues of having He accused his young colleagues of having falsified the 678 database.falsified the 678 database.

He went to Federal court to attempt to He went to Federal court to attempt to block UVM from notifying ORI of the block UVM from notifying ORI of the pending investigation.pending investigation.

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Obstruction (cont)Obstruction (cont)

During the investigation, he solicited letters During the investigation, he solicited letters of support from collaborators and former of support from collaborators and former technicians who claimed that they had helped technicians who claimed that they had helped with the longitudinal menopause study; with the longitudinal menopause study; these claims resulted from Dr. Poehlman’s these claims resulted from Dr. Poehlman’s false assurances and edits of the letters, and false assurances and edits of the letters, and they placed these witnesses in legal jeopardy.they placed these witnesses in legal jeopardy.

Dr. Poehlman submitted falsified and Dr. Poehlman submitted falsified and fabricated documents to the UVM committee fabricated documents to the UVM committee in an effort to show that the 35 women in the in an effort to show that the 35 women in the menopause study had visited the GCRC a menopause study had visited the GCRC a second time.second time.

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Why did it take so long to discover? Why did it take so long to discover?

““The reality is that an established The reality is that an established and renowned principal investigator and renowned principal investigator with this volume of complex data with this volume of complex data could easily generate and propagate could easily generate and propagate false values for months, even years, false values for months, even years, without anyone catching on” (UVM without anyone catching on” (UVM Report, p. 19)Report, p. 19)

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Summary Summary Dr. Poehlman falsified and fabricated data Dr. Poehlman falsified and fabricated data

in NIH grant applications and in published in NIH grant applications and in published articles over a 10 year period with NIH articles over a 10 year period with NIH funding of almost $3 millionfunding of almost $3 million

Counting two USDA applications, he Counting two USDA applications, he provided falsified and fabricated provided falsified and fabricated preliminary data to government agencies preliminary data to government agencies in 17 different competitive and non-in 17 different competitive and non-competitive applications.competitive applications.

Falsifications and fabrications were made Falsifications and fabrications were made in applications worth over $11,000,000 if in applications worth over $11,000,000 if funding would have been approved. funding would have been approved.

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SummarySummary The misconduct affected studies related to The misconduct affected studies related to

disease prevention, including research on disease prevention, including research on the health of older men and women, the the health of older men and women, the effect of diet, exercise, menopause status, effect of diet, exercise, menopause status, hormone replacement, and disease status.hormone replacement, and disease status.

The University of Vermont made 22 The University of Vermont made 22 findings of scientific misconduct in areas findings of scientific misconduct in areas represented by 3 GCRC protocols.represented by 3 GCRC protocols.

ORI confirmed 21 of the findings made by ORI confirmed 21 of the findings made by UVM and made 35 additional findings in the UVM and made 35 additional findings in the same plus 2 additional areas ( 5 protocols).same plus 2 additional areas ( 5 protocols).

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The role of the Justice The role of the Justice Department: ORI AssuranceDepartment: ORI Assurance

Assurance on application form PHS 398, #15Assurance on application form PHS 398, #15 Principal Investigator/Program Director Principal Investigator/Program Director

Assurance: I certify that the statements Assurance: I certify that the statements herein are true, complete and accurate to herein are true, complete and accurate to the best of my knowledge. I am aware that the best of my knowledge. I am aware that any false, fictitious, or fraudulent any false, fictitious, or fraudulent statements or claims may subject me to statements or claims may subject me to criminal, civil, or administrative penalties. I criminal, civil, or administrative penalties. I agree to accept responsibility for the agree to accept responsibility for the scientific conduct of the project and to scientific conduct of the project and to provide the required progress reports if a provide the required progress reports if a grant is awarded as a result of this grant is awarded as a result of this application.application.

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This is what led to Dr. Poehlman pleading guilty to a felony

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What Was the involvement of the What Was the involvement of the Vermont U.S. AttorneyVermont U.S. Attorney

Defended civil litigation brought by Dr. Defended civil litigation brought by Dr. Poehlman to prevent mandatory reporting Poehlman to prevent mandatory reporting of misconduct investigation to ORI of misconduct investigation to ORI

Opened civil and criminal fraud Opened civil and criminal fraud investigations into Dr. Poehlman’s research investigations into Dr. Poehlman’s research activities, assisted by ORI and HHS OIGactivities, assisted by ORI and HHS OIG

Decided that false claims of Dr. Poehlman Decided that false claims of Dr. Poehlman warranted a criminal charge and personal warranted a criminal charge and personal monetary settlement of $180,000monetary settlement of $180,000

Dr. Poehlman sentenced to jail term of one Dr. Poehlman sentenced to jail term of one year and a day based on admission to one year and a day based on admission to one felony count and ordered to a federal prison felony count and ordered to a federal prison work camp in Marylandwork camp in Maryland

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ORI actions and the ORI actions and the Whistleblower’s role Whistleblower’s role

ORI/ASH actions against Dr. ORI/ASH actions against Dr. Poehlman include lifetime debarment Poehlman include lifetime debarment from Federal research funding and from Federal research funding and retraction/correction of ten published retraction/correction of ten published paperspapers

The whistleblower in this case later The whistleblower in this case later filed a qui tam suit under Federal filed a qui tam suit under Federal fraud laws and received a relator’s fraud laws and received a relator’s share of 12% ($22,000) of the share of 12% ($22,000) of the Federal recovery of $180,000Federal recovery of $180,000

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Impact of Dr. Poehlman’s Actions in Impact of Dr. Poehlman’s Actions in the Scientific Communitythe Scientific Community

Millions of dollars in Federal grant Millions of dollars in Federal grant money have been mis-spent.money have been mis-spent.

The careers of Dr. Poehlman’s The careers of Dr. Poehlman’s students and collaborators have students and collaborators have been damaged or impaired.been damaged or impaired.

Other researchers have wasted their Other researchers have wasted their time and laboratory resources trying time and laboratory resources trying to reproduce and extend the false to reproduce and extend the false claims made by Dr. Poehlman. claims made by Dr. Poehlman.

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Impact of Dr. Poehlman’s Actions Impact of Dr. Poehlman’s Actions on the General Publicon the General Public

Dr. Poehlman’s research attempted to Dr. Poehlman’s research attempted to identify ways to modify life style to identify ways to modify life style to lengthen life and improve its quality. lengthen life and improve its quality.

The loyal and dedicated volunteers in the The loyal and dedicated volunteers in the Vermont community felt betrayed and Vermont community felt betrayed and may be reluctant to continue volunteering may be reluctant to continue volunteering for studies at UVM.for studies at UVM.

Dr. Poehlman’s actions had a negative Dr. Poehlman’s actions had a negative impact on the level of trust in science for impact on the level of trust in science for health care consumers who rely on honest health care consumers who rely on honest research results for improved health care.research results for improved health care.

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Lessons LearnedLessons Learned

Research misconduct can go undetected Research misconduct can go undetected for years, even when the misconduct is for years, even when the misconduct is massive massive

A determined cheater can mislead A determined cheater can mislead collaborators indefinitelycollaborators indefinitely

Institutional commitment and careful Institutional commitment and careful adherence to policies and procedures are adherence to policies and procedures are needed for successful investigationsneeded for successful investigations

ORI and the research community rely ORI and the research community rely heavily on honest scientists in the lab to heavily on honest scientists in the lab to come forward with evidence of misconductcome forward with evidence of misconduct

DIO Oversight: Forensics

During the 20 years that OSI/ORI have existed, investigators have developed a number of computer-assisted tools and approaches to help strengthen institutional findings.

The following slides will provide a few examples of this.

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Detection of Fabricated Detection of Fabricated NumbersNumbers

If sets of transcribed If sets of transcribed numbers are provided as “raw are provided as “raw data” rather than instrument printouts, consider data” rather than instrument printouts, consider whether the numbers might have been fabricatedwhether the numbers might have been fabricated..

Research by ORI and others shows that insignificant (right-most) digits in numbers, if real, e.g. from instruments, are uniformly distributed while numbers made up by people often are non-uniform.

ORI 4/05 41

Here is a DIO scan of a spreadsheet submitted by a

respondent that was unaccompanied by

an instrument printout.

Under pressure, he subsequently

provided similar data that was

accompanied by printouts from a

scintillation counter.

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The tool used by DIOThe tool used by DIO

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The DigiProbe ScreenThe DigiProbe ScreenStart with the numbers copied into a text file

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Data Sets 4-11

Digit

0 1 2 3 4 5 6 7 8 9

Fre

quen

cy

0

10

20

30

40

50

60

Right-most digit; p = 0.778Second right-most (10s), p = 0.787

Data Sets 1-3 (no counter tapes)

Digit

0 1 2 3 4 5 6 7 8 9

Fre

quen

cy

0

10

20

30

40

50

60

70 Right-most digit; p = < 0.00001Second right-most (10s), p = <0.00001

Bar graphs effectively illustrate the distribution of digits for the two right most positions for the data sets without counter tapes (left) and those with counter tapes (right).

DIO analysis of the distribution of the two right most digits in data sets 1-11(group V)

Data set Total Digits p value

1 100, 100 <0.00001, <0.00001

2 156, 156 <.00001, 0.00002

3 156, 156 0.02519, 0.00451

4 56, 56 0.57784, 0.47087

5 42, 42 0.22426, 0.22426

6 78, 78 0.46860, 0.57069

7 93, 93 0.27719, 0.97832

8 74, 74 0.07906, 0.51789

9 77, 77 0.33904,0.40441

10 42, 39 0.19768, 0.24219

11 50, 50 0.81654, 0.77919

1-3 412, 412 <0.00001, <0.00001

4-11 512, 509 0.77754, 0.78696

Probabilities obtained with DigiProbe for the 11 assays and for the assays with and without counter tapes grouped together.

0.010.020.030.040.050.060.070.080.0

1 2 3 4 5 6 7 8 9 102 Year Reporting Period ('89-90 to '07-08)

ORI Cases With Questioned Images

Examples of analyzing images

Several examples follow which illustrate how ORI can examine images provided by institutions during their investigation.

Many of ORI’s cases involve images that are duplicated from paper to paper or paper to grant application. This may be duplicate publication, but when such images are said to be the result of different experiments, one of the images, at minimum, has been potentially falsified.

The first example, however, is a little different.

ORI 4/05 48

ORI 4/05 49

Screen shot from Photoshop showing analysis under way – the small circle in the Color Picker is the brush size moved to a color approximately matching the image’s background.

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The result of removing most of the “scribbling.”

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ObservationsObservations

The most compelling evidence for misconduct in The most compelling evidence for misconduct in this case was obtained from the fabricated data this case was obtained from the fabricated data sets not examined by the university.sets not examined by the university.

This conclusion is made significantly stronger by the presence of “control data” from companion assays for which counter tapes were available.

In no instance was the distribution of non-leading digits non-uniform when tapes were available, and in each of the three assays without tapes, digits were non-uniform at both positions.

Moving to the digital age The next examples illustrate the importance

of the eye to detect evidence of inappropriate image manipulation.

In addition, many ORI cases rely on prompt sequestration of evidence, including hard drives and portable storage media, to ensure that manipulated images can be shown to have originated with a particular individual.

Time-date stamps are often probative with respect to how and when the manipulations occurred.

Moving to the digital age The next examples illustrate the importance of

the eye to detect evidence of inappropriate image manipulation.

In addition, many ORI cases rely on prompt sequestration of evidence, including hard drives and portable storage media, to ensure that manipulated images can be shown to have originated with a particular individual.

Time-date stamps are often probative with respect to how and when the manipulations occurred.

A Slippery Slope

The next few slides show how difficult it can be to determine if a manipulation is appropriate, possibly inappropriate, or obviously fraudulent.

Generally, ORI is reluctant to make findings of misconduct when an image has been “beautified” by altering background, or by reuse of loading controls, when the actual data verifies the factual findings claimed in the grant or paper.

However, adding or removing important elements of a figure can often be considered evidence for intentional falsification.

An example of unique images that alerted the institution to apparent falsification. The original images were of all positive or all negative cells positive for a gene different from HIV DNA or RNA.

How to detect non-obvious changes

Some of the following slides will illustrate how Photoshop can be used to help our eyes visualize alterations to images, and verify suspected duplications, through the use of specific tools such as the gradient map, contours, and various enhancements such as contrast and intensity.

DETECTIONDETECTIONIncrease Visibility of “Hidden” Increase Visibility of “Hidden”

DetailsDetails

Principles/Methods

Scope of Falsified Images

Portion of On-Line Journal Image

Bulk of Falsified Images are ‘Blots’Bulk of Falsified Images are ‘Blots’

Note Multiple Inconsistencies

rotatedrotated

duplicated

Author “tells” us where

to look

Note: * denotes key metabolic gene

But It’s Not Just BlotsExamples

On-Line Journal Image:On-Line Journal Image:

Increase contrast

Remap Intensities

Visualize with Gradient Map:Visualize with Gradient Map:

Add False-Color

Methods

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What can you do at your What can you do at your institution?institution?

You can help set the tone for the You can help set the tone for the institution and make integrity a high institution and make integrity a high prioritypriority

As an administrator, you can develop and As an administrator, you can develop and implement policies that support integrity implement policies that support integrity

As a principal investigator, you can As a principal investigator, you can establish specific standards for your staff establish specific standards for your staff on recording, retaining, reporting, and on recording, retaining, reporting, and publishing datapublishing data

As a junior scientist in the lab, you can As a junior scientist in the lab, you can make a personal commitment to integrity make a personal commitment to integrity and practice it on a daily basisand practice it on a daily basis

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Responsible Conduct of Responsible Conduct of Research (RCR)Research (RCR)

What can ORI and institutions What can ORI and institutions do to help prevent research do to help prevent research

misconduct?misconduct?

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The Nine Elements of RCRThe Nine Elements of RCR1. Acquisition, management, sharing and ownership of data2. Conflict of interest and commitment3. Research misconduct (plagiarism, falsification & fabrication)4. Publication practices and responsible authorship5. Mentor/mentee responsibilities6. Peer review7. Collaborative scholarship8. Human subjects9. Animal subjects

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RCR at the Individual Level RCR at the Individual Level encompasses: encompasses:

Intellectual honesty in proposing, Intellectual honesty in proposing, performing, and reporting researchperforming, and reporting research

Accuracy in representing contributions Accuracy in representing contributions Fairness in peer reviewFairness in peer review Transparency in conflicts of interestTransparency in conflicts of interest

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RCR at the Individual Level also RCR at the Individual Level also entails: entails:

Assuming personal responsibility for Assuming personal responsibility for avoiding or managing conflictsavoiding or managing conflicts

Taking responsibility for protecting Taking responsibility for protecting human subjects and for the humane human subjects and for the humane care of animalscare of animals

Appropriately recording research Appropriately recording research results and retaining research recordsresults and retaining research records

Careful and thoughtful mentoring of Careful and thoughtful mentoring of students and junior scientistsstudents and junior scientists

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How can RCR be implemented How can RCR be implemented at the institutional level?at the institutional level?

Provide leadership in RCRProvide leadership in RCR Facilitate productive interactions Facilitate productive interactions

between trainees and mentorsbetween trainees and mentors Advocate adherence to rules Advocate adherence to rules

regarding the conduct of researchregarding the conduct of research Provide training to both mentors, Provide training to both mentors,

junior scientists, and students junior scientists, and students tailored to their respective needstailored to their respective needs

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RCR at the Institutional level RCR at the Institutional level (cont.)(cont.)

Conduct inquiries and investigations Conduct inquiries and investigations into alleged misconductinto alleged misconduct

RCR training should include discussions RCR training should include discussions of misconduct cases and their adverse of misconduct cases and their adverse consequences to respondentsconsequences to respondents

Consider publicizing your cases Consider publicizing your cases (suitably redacted) to ensure that staff (suitably redacted) to ensure that staff realize that you take misconduct realize that you take misconduct seriously and act on allegationsseriously and act on allegations

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A few key issues that DIO has found A few key issues that DIO has found contribute most significantly to allowing contribute most significantly to allowing

misconductmisconduct1. Inadequate record keeping and lack of 1. Inadequate record keeping and lack of

guidance from mentors on how to guidance from mentors on how to record and retain research data;record and retain research data;

2. Failure of mentors to regularly review 2. Failure of mentors to regularly review raw data; overreliance on derivative raw data; overreliance on derivative data (PowerPoint presentations) at lab data (PowerPoint presentations) at lab meetingsmeetings

3. Unquestioning acceptance of data that 3. Unquestioning acceptance of data that others consider “too good to be true”others consider “too good to be true”

More issues that facilitate misconductMore issues that facilitate misconduct

4. Lack of transparency within the laboratory 4. Lack of transparency within the laboratory and among the staffand among the staff

5. Labs so large that authority becomes 5. Labs so large that authority becomes diffuse diffuse

6. P.I.s are spread too thin, and do not provide 6. P.I.s are spread too thin, and do not provide adequate training and guidance to studentsadequate training and guidance to students

The bottom line – good mentorship and the The bottom line – good mentorship and the constant review of raw data can profoundly constant review of raw data can profoundly reduce the likelihood of a mentee committing reduce the likelihood of a mentee committing research misconduct.research misconduct.

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ORI can provide assistanceORI can provide assistance240 453 8800; 240 453 8800; AskORI@hhs.gov

Telephone or on site assistance availableTelephone or on site assistance available Allegation assessment Allegation assessment Advice on policies and procedures, for example :Advice on policies and procedures, for example :

Sequestration of evidenceSequestration of evidence Acquisition of digital information (forensic Acquisition of digital information (forensic

imaging of hard drives)imaging of hard drives) Properly getting an inquiry or investigation under Properly getting an inquiry or investigation under

wayway Analysis of the evidence, such as assisting with Analysis of the evidence, such as assisting with

analysis of questioned images analysis of questioned images Investigative strategy and legal problemsInvestigative strategy and legal problems

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ConclusionConclusion

DEVELOP AN RCR PROGRAM THAT DEVELOP AN RCR PROGRAM THAT WORKS FOR YOU! WORKS FOR YOU!

http://ori.hhs.gov