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

Misconduct and Promoting Misconduct and Promoting Responsible Research Responsible Research

Chris B. Pascal, J.D., DirectorChris B. Pascal, J.D., Director

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The ORI Mission and AuthoritiesThe ORI Mission and Authorities

ORI has statutory and regulatory authority ORI has statutory and regulatory authority to respond to allegations of research to respond to allegations of research misconduct when supported by misconduct when supported by Public Public Health Service funds, Health Service funds,

42 USC 289b42 USC 289b Research misconduct is defined as Research misconduct is defined as

fabrication, falsification, or plagiarism in fabrication, falsification, or plagiarism in proposing, performing, or reviewing proposing, performing, or reviewing research, or in reporting research results, research, or in reporting research results, 42 CFR Part 9342 CFR Part 93

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ORI Mission and AuthorityORI Mission and Authority

Fabrication is making up data or Fabrication is making up data or results and recording or reporting results and recording or reporting themthem

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

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ORI Mission and Authority (cont)ORI Mission and Authority (cont)

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 Research misconduct does not include honest error or differences of include honest error or differences of opinion, 42 CFR Part 93opinion, 42 CFR Part 93

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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, andrelevant research community, and

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, 42 preponderance of the evidence, 42 CFR Part 93CFR Part 93

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ORI Statistics ORI Statistics

Statistics are based on the period Statistics are based on the period 1992 to July 20071992 to July 2007

Total misconduct findings: 189Total misconduct findings: 189 Percentage of misconduct findings Percentage of misconduct findings

that involve clinical research: 27%that involve clinical research: 27% Total debarments from federal Total debarments from federal

funding: 119funding: 119 Total cases opened from 1992: 501Total cases opened from 1992: 501 Total cases closed from 1992: 531Total cases closed from 1992: 531

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Statistics (cont)Statistics (cont) Total cases pending: 43Total cases pending: 43 Total number of allegations from Total number of allegations from

1992: 3,0841992: 3,084 Average number of allegations per Average number of allegations per

year: 200year: 200 Correction, retraction, and withdrawn Correction, retraction, and withdrawn

journal articles due to misconduct or journal articles due to misconduct or error: 149 error: 149

Retractions: 114; corrections: 31; Retractions: 114; corrections: 31; withdrawn: 4withdrawn: 4

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Additional authorities delegated to Additional authorities delegated to ORI ORI

ORI has been delegated broad ORI has been delegated broad additional authorities to promote additional authorities to promote research integrity and prevent research research integrity and prevent research misconduct, including education and misconduct, including education and training in the responsible conduct of training in the responsible conduct of research, activities designed to promote research, activities designed to promote research integrity and prevent research integrity and prevent misconduct, and research and misconduct, and research and evaluation programs, 65 Fed. Reg. evaluation programs, 65 Fed. Reg. 30601, May 12, 200030601, May 12, 2000

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Additional ORI ActivitiesAdditional ORI Activities Correct or retract scientific papers to Correct or retract scientific papers to

protect the integrity of the published protect the integrity of the published literature and the publicliterature and the public

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

Protect the complainant from Protect the complainant from retaliation through regulatory retaliation through regulatory obligations imposed on the research obligations imposed on the research institutions, 42 CFR 93.300 (d) institutions, 42 CFR 93.300 (d)

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ORI Activities (cont)ORI Activities (cont)

Provide education in the responsible Provide education in the responsible conduct of researchconduct of research

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

University of VermontUniversity of Vermont

Chris B. Pascal, J.D., Director, Chris B. Pascal, J.D., Director, Office of Research Integrity Office of Research Integrity

(ORI) (ORI)

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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.

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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..

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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 Poehlman falsified data in additional papers and grant applications in areas as papers and grant applications in areas as wide ranging as Alzheimer’s disease, the wide ranging as Alzheimer’s disease, the effect of endurance training on RMR, and effect of endurance training on RMR, and the effects of hormone replacement the effects of hormone replacement therapy on post-menopausal women.therapy on post-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 findings which were documented, allowing findings of scientific misconduct to be made.of scientific misconduct to be 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 and The reality is that an established and renowned principal investigator with renowned principal investigator with this volume of complex data could this volume of complex data could easily generate and propagate false easily generate and propagate false values for months, even years, 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 The misconduct affected studies related to disease prevention, related to disease prevention, including research on the health of including research on the health of older men and women, the effect of older men and women, the effect of diet, exercise, menopause status, diet, exercise, menopause status, hormone replacement, and disease hormone replacement, and disease statusstatus

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Summary Summary

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

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

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Publications Identified for Publications Identified for Retraction/CorrectionRetraction/Correction

1. Poehlman E., Goran, M., Gardner, A., Ades, P., Arciero, P., 1. Poehlman E., Goran, M., Gardner, A., Ades, P., Arciero, P., Katzman-Rooks, S., Montgomery, S.M., Toth, M., and Sutherland, Katzman-Rooks, S., Montgomery, S.M., Toth, M., and Sutherland, P., Determinants of decline in resting metabolic rate in aging P., Determinants of decline in resting metabolic rate in aging females, females, American Journal of PhysiologyAmerican Journal of Physiology, 264:E450-E455, 1993., 264:E450-E455, 1993.

2. Poehlman, E., Toth, M., and Gardner, A., Changes in Energy 2. Poehlman, E., Toth, M., and Gardner, A., Changes in Energy Balance and body composition at menopause: a controlled Balance and body composition at menopause: a controlled longitudinal study, longitudinal study, Annals of Internal MedicineAnnals of Internal Medicine vol. 123, No. 9 (1 vol. 123, No. 9 (1 November): 673-675, 1995. November): 673-675, 1995.

3. Poehlman, E., Toth, M., Ades, P., and Rosen, C., Menopause-3. Poehlman, E., Toth, M., Ades, P., and Rosen, C., Menopause-associated changes in plasma lipids, insulin-like growth factor I associated changes in plasma lipids, insulin-like growth factor I and blood pressure: a longitudinal study. and blood pressure: a longitudinal study. European Journal of European Journal of Clinical InvestigationClinical Investigation 27:322-326, 1997. All pages. 27:322-326, 1997. All pages.

4. Poehlman, E. and Tchernof, A., Traversing the menopause: 4. Poehlman, E. and Tchernof, A., Traversing the menopause: changes in energy expenditure and body composition, changes in energy expenditure and body composition, Coronary Coronary Artery DiseaseArtery Disease 9:799-803, 1998. 9:799-803, 1998.

5. Tchernof, A. and Poehlman E., Effects of the menopause 5. Tchernof, A. and Poehlman E., Effects of the menopause transition on body fatness and body fat distribution, transition on body fatness and body fat distribution, Obesity Obesity ResearchResearch vol. 6, No. 3 (May):246-254 1998. 249, 250, 251, 252. vol. 6, No. 3 (May):246-254 1998. 249, 250, 251, 252.

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Published PapersPublished Papers 6. Tchernof, A., Poehlman, E., and Despres, J., Body fat 6. Tchernof, A., Poehlman, E., and Despres, J., Body fat

distribution, the menopause transition, and hormone replacement distribution, the menopause transition, and hormone replacement therapy. therapy. Diabetes and MetabolismDiabetes and Metabolism 26:12-20 2000. 17. 26:12-20 2000. 17.

7. Rawson, E. and Poehlman, E., Resting metabolic rate and aging, 7. Rawson, E. and Poehlman, E., Resting metabolic rate and aging, In: Recent Research Developments in Aging, Research Signpost In: Recent Research Developments in Aging, Research Signpost Group, India, 2000 (pp. R 1791, R 1792 and R 1804, reference 34). Group, India, 2000 (pp. R 1791, R 1792 and R 1804, reference 34).

8. Poehlman, E. "Menopause, energy expenditure, and body 8. Poehlman, E. "Menopause, energy expenditure, and body composition," composition," Acta Obstet Gynecol ScandActa Obstet Gynecol Scand 81:603-611, 2002 81:603-611, 2002 (pages 605, 606 and 607, 608) (falsified RMR, LTPA, FM, W/H, RQ (pages 605, 606 and 607, 608) (falsified RMR, LTPA, FM, W/H, RQ from the "longitudinal menopause study").from the "longitudinal menopause study").

9. Poehlman, E., Gardner, A., and Goran, M., Influence of 9. Poehlman, E., Gardner, A., and Goran, M., Influence of Endurance training on energy intake, nor epinephrine kinetics, and Endurance training on energy intake, nor epinephrine kinetics, and metabolic rate in older individuals, metabolic rate in older individuals, MetabolismMetabolism 41(September):941-948, 199241(September):941-948, 1992

10. Poehlman, E., Gardner, A., Arciero, P., Goran, M., and Calles, 10. Poehlman, E., Gardner, A., Arciero, P., Goran, M., and Calles, J., Effects of endurance training on total fat oxidation in elderly J., Effects of endurance training on total fat oxidation in elderly persons persons J. Appl. Physiol.J. Appl. Physiol. 76(6):2281-2287, 1994. 76(6):2281-2287, 1994.

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

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

Serious and detailed efforts are Serious and detailed efforts 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 heavily on honest scientists in the lab to come forward with evidence of to come forward with evidence of misconductmisconduct

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

As a senior official you can set the tone for As a senior official you can set the tone for the institution and make integrity a high the 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, reporting, and publishing on recording, reporting, and publishing datadata

As a staff scientist in the lab, you can As a staff 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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Introduction to the Introduction to the Responsible Conduct of Responsible Conduct of

ResearchResearch

Chris B. Pascal, J.D.Chris B. Pascal, J.D.

Director, Office of Research Director, Office of Research IntegrityIntegrity

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The RCR Road MapThe RCR Road Map

Defining RCRDefining RCR Basic building blocks for RCRBasic building blocks for RCR Examples of institutional policies and Examples of institutional policies and

guidelinesguidelines Elements of RCR educationElements of RCR education Connection between RCR and qualityConnection between RCR and quality Develop/implement an RCR programDevelop/implement an RCR program

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What is RCR-The ORI View?What is RCR-The ORI View?

Doing the right thingDoing the right thing Conducting research with the Conducting research with the

knowledge and skills needed to knowledge and skills needed to conform to responsible practices conform to responsible practices

Understanding and applying relevant Understanding and applying relevant regulatory requirements and regulatory requirements and scientific normsscientific norms

Much more than avoiding misconductMuch more than avoiding misconduct

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What is RCR-The IOM View?What is RCR-The IOM View?

The Institute of Medicine (2002) The Institute of Medicine (2002) states that “the responsible conduct states that “the responsible conduct of research is not distinct from of research is not distinct from research; on the contrary, research; on the contrary, competency in research competency in research encompasses encompasses the responsible the responsible conduct of that research and the conduct of that research and the capacity for ethical decision making.” capacity for ethical decision making.” (Italics in original.)(Italics in original.)

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IOM-What is RCR at the IOM-What is RCR at the Individual Level? Individual Level?

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

Accuracy in representing Accuracy in representing contributions 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 (cont)RCR at the Individual Level (cont)

ORI recommends that investigators ORI recommends that investigators and administrators assume personal and administrators assume personal responsibility for avoiding or responsibility for avoiding or managing conflictsmanaging conflicts

Protection of human subjects; Protection of human subjects; humane care of animalshumane care of animals

Adherence to mutual responsibilities Adherence to mutual responsibilities between investigators and research between investigators and research teamsteams

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IOM-What is RCR at the IOM-What is RCR at the institutional level?institutional level?

Provide leadership in RCRProvide leadership in RCR Encourage respect for everyone Encourage respect for everyone

involvedinvolved 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 Thorough inquiries and investigations Thorough inquiries and investigations

into alleged misconductinto alleged misconduct

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IOM-Institutional level (cont.)IOM-Institutional level (cont.)

Offer educational opportunities in Offer educational opportunities in RCRRCR

Monitor and evaluate the institutional Monitor and evaluate the institutional environment supporting integrity and environment supporting integrity and RCR and use this knowledge for RCR and use this knowledge for continuous quality improvementcontinuous quality improvement

ORI recommends that institutions ORI recommends that institutions provide adequate resources to provide adequate resources to implement and manage the above implement and manage the above objectives and principlesobjectives and principles

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Basic Building Blocks for RCRBasic Building Blocks for RCR

Understand Questionable Research Understand Questionable Research Practices and Other MisconductPractices and Other Misconduct

Adopt institutional policies Adopt institutional policies Adopt research guidelinesAdopt research guidelines Demonstrate leadership at the Demonstrate leadership at the

individual and institutional levelindividual and institutional level

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Basic Building Blocks (cont)Basic Building Blocks (cont)

ORI/PHS nine core areas for RCR ORI/PHS nine core areas for RCR educationeducation

Data management; mentor/trainee Data management; mentor/trainee relationships; collaborative research; relationships; collaborative research; publication and responsible publication and responsible authorship; peer review; human authorship; peer review; human subject protections; animal welfare; subject protections; animal welfare; conflict of interest; research conflict of interest; research misconduct-integritymisconduct-integrity

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Questionable Research Questionable Research Practices: How Related to Practices: How Related to

RCR?RCR?1.Failure to retain research data;1.Failure to retain research data;

2.Maintaining inadequate research 2.Maintaining inadequate research records;records;

3.Authorship without a significant 3.Authorship without a significant research contribution;research contribution;

4.Refusing reasonable access to unique 4.Refusing reasonable access to unique research materials or data;research materials or data;

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QRP (cont.)QRP (cont.)

5.Misrepresenting speculations as fact or 5.Misrepresenting speculations as fact or releasing preliminary research results, releasing preliminary research results, without sufficient data to allow critical without sufficient data to allow critical review.review.

6.Inadequate supervision or exploitation of 6.Inadequate supervision or exploitation of subordinates; andsubordinates; and

7.Using inappropriate statistics to enhance 7.Using inappropriate statistics to enhance significance of research findingssignificance of research findings

Source: “Responsible Science: Ensuring the Source: “Responsible Science: Ensuring the Integrity of the Research Process” (NAS, Integrity of the Research Process” (NAS, 1992).1992).

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Nature, Vol. 435, June 9, 2005Nature, Vol. 435, June 9, 2005

““Scientists Behaving Badly”Scientists Behaving Badly”

Authors: Brian C. Martinson, Melissa S. Authors: Brian C. Martinson, Melissa S. Anderson, and Raymond de VriesAnderson, and Raymond de Vries

Funding: ORI/NIH Research Program on Funding: ORI/NIH Research Program on Research IntegrityResearch Integrity

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Elements of RCR EducationElements of RCR Education

Education on scientific norms, Education on scientific norms, including norms within the disciplineincluding norms within the discipline

Teaching practical skills in research, Teaching practical skills in research, such as how to responsibly peer such as how to responsibly peer review a paper or proposal and what review a paper or proposal and what type of contribution is needed for type of contribution is needed for authorshipauthorship

Teaching regulatory requirements Teaching regulatory requirements related to related to

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RCR Education (cont)RCR Education (cont)

(cont) human subjects, animal (cont) human subjects, animal welfare, misconduct, and conflict of welfare, misconduct, and conflict of interestinterest

Teaching on institutional specific Teaching on institutional specific standards, such as research standards, such as research guidelines and institutional policies guidelines and institutional policies on academic misconduct and on academic misconduct and questionable research practicesquestionable research practices

Teaching/development of specific Teaching/development of specific skills, abilities, and skills, abilities, and

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RCR Education (cont)RCR Education (cont)

(cont) competencies related to RCR (cont) competencies related to RCR and good research practices, such as and good research practices, such as how to select and interpret data for how to select and interpret data for publication or submission in a grant publication or submission in a grant application and when it is application and when it is appropriate to exclude data appropriate to exclude data

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Potential benefits of RCR?Potential benefits of RCR?

For the scientistFor the scientist In the lab In the lab For the institutionFor the institution For the public interestFor the public interest

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ORI Rapid Response Technical ORI Rapid Response Technical Assistance 240 453 8800Assistance 240 453 8800

Telephone or on site assistance availableTelephone or on site assistance available Allegation assessment Allegation assessment Advice on policies and proceduresAdvice on policies and procedures Sequestration of evidenceSequestration of evidence Starting the inquiry or investigationStarting the inquiry or investigation Analysis of the evidence Analysis of the evidence Investigative strategy and legal Investigative strategy and legal

problemsproblems

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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