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Research Research Misconduct Misconduct Thomas J. Inzana, Ph.D. Thomas J. Inzana, Ph.D. Associate Vice-President Associate Vice-President for Research Programs for Research Programs and and Research Integrity Research Integrity Officer Officer

Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

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Page 1: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Research MisconductResearch MisconductThomas J. Inzana, Ph.D.Thomas J. Inzana, Ph.D.

Associate Vice-President for Associate Vice-President for Research ProgramsResearch Programs

and and

Research Integrity OfficerResearch Integrity Officer

Page 2: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Federal Laws on Research Federal Laws on Research MisconductMisconduct

Public concern over research misconduct Public concern over research misconduct initially arose in the early 1980’s.initially arose in the early 1980’s.

At the time, research institutions sometimes At the time, research institutions sometimes ignored or covered up potential misconduct ignored or covered up potential misconduct problems rather than investigate them.problems rather than investigate them.

In December 2000 the Office of Science and In December 2000 the Office of Science and Technology Policy adopted a federal policy on Technology Policy adopted a federal policy on research misconduct.research misconduct.

Page 3: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

DHHS enacted regulation effective DHHS enacted regulation effective 6/15/056/15/05 ““Public Health Service Policies on Research Public Health Service Policies on Research

Misconduct”Misconduct” Implements legislative and policy changes Implements legislative and policy changes

applicable to research misconduct that applicable to research misconduct that occurred over last several years.occurred over last several years.

Covers any entity that applies for a research, Covers any entity that applies for a research, research-training or research-related grant or research-training or research-related grant or cooperative agreement with the Public cooperative agreement with the Public Health Service (PHS)Health Service (PHS)

Page 4: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Purpose of Research Misconduct Purpose of Research Misconduct PoliciesPolicies

►Establish definitions for research Establish definitions for research misconductmisconduct

►Outline procedures for reporting and Outline procedures for reporting and investigating misconductinvestigating misconduct

►Provide protection for whistleblowers Provide protection for whistleblowers and persons accused of misconductand persons accused of misconduct

Page 5: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Research MisconductResearch Misconduct► What is it?:What is it?:

The Department of Health and Human Services The Department of Health and Human Services defines research misconduct as:defines research misconduct as:

Fabrication, falsification, or plagiarismFabrication, falsification, or plagiarism in in proposingproposing, performing, or , performing, or reviewingreviewing research research results.results.

► FabricationFabrication:: making up resultsmaking up results and recording or and recording or reporting themreporting them

► FalsificationFalsification:: manipulationmanipulation of research materials, of research materials, equipment, or processes, or changing or omitting results equipment, or processes, or changing or omitting results such that the research is such that the research is not accurately represented in not accurately represented in the record.the record.

► PlagiarismPlagiarism:: the the appropriation of another’sappropriation of another’s ideas, ideas, processes, results, or words without processes, results, or words without giving proper creditgiving proper credit..

Page 6: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Criteria for Research Criteria for Research MisconductMisconduct

Represents a Represents a significant departuresignificant departure from from accepted practicesaccepted practices

Has been committed Has been committed intentionallyintentionally, or , or knowinglyknowingly, or , or recklesslyrecklessly; and ; and

Can be proven by a preponderance of Can be proven by a preponderance of evidenceevidence

What is What is NOT MISCONDUCTNOT MISCONDUCT: : honest, honest, unintentional errorunintentional error

+ = Research Misconduct

Page 7: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

SCIENTIFIC MISCONDUCT: How Prevalent Is Fraud? SCIENTIFIC MISCONDUCT: How Prevalent Is Fraud? That's a million-Dollar QuestionThat's a million-Dollar Question

ScienceScience 1 December 2000: Vol. 290. no. 5497, pp. 1662 - 1663 1 December 2000: Vol. 290. no. 5497, pp. 1662 - 1663 How often does scientific misconduct occur? How often does scientific misconduct occur?

There seems to be no consensus on the There seems to be no consensus on the answer, although a range of estimates were answer, although a range of estimates were presented at a conference called last month presented at a conference called last month by a key federal watchdog agency to by a key federal watchdog agency to announce announce a $1 million grants program to a $1 million grants program to investigate the prevalence of fraud, data investigate the prevalence of fraud, data fabrication, plagiarism, and other questionable fabrication, plagiarism, and other questionable practices in sciencepractices in science. The 9-year-old Office of . The 9-year-old Office of Research Integrity hopes to support studies Research Integrity hopes to support studies gauging the frequency of misconduct and gauging the frequency of misconduct and assessing efforts to raise ethical standards. assessing efforts to raise ethical standards.

Page 8: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

• Department of Health & Human Services Department of Health & Human Services received received

267 reports of research misconduct (2004) 267 reports of research misconduct (2004) • 50% increase from 200350% increase from 2003• 35% of closed cases involve research 35% of closed cases involve research

misconductmisconduct

►What is it notWhat is it not:: Honest error or differences of opinionHonest error or differences of opinion

Page 9: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

ORI 2007 Annual ReportORI 2007 Annual Report► In 2007, ORI opened 14 new cases and closed 28

cases.► Of the 28 cases closed by ORI, 10 cases resulted in

sustained findings of research misconduct and/or PHS administrative actions against the respondents.

► Debarments were imposed in 7 of the 10 cases that resulted in research misconduct findings: 1 for life, 2 for 5 years, and 4 for 3 years. PHS administrative actions imposed in the remaining cases were one 4-year supervisory period, two 3-year supervisory periods, and a 3-year certification period.

► Thirty-five percent of ORI’s closed cases in 2007 resulted in PHS misconduct. There is an historical average of about 33 percent of cases are found to be misconduct.

Page 10: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

NatureNature 453453, 980-982 (19 June , 980-982 (19 June 2008) 2008)

► SURVEY of 2,212 ResearchersSURVEY of 2,212 Researchers Observed 201 instances of misconductObserved 201 instances of misconduct E.G.E.G.

► "A post doc changed the numbers in assays in order to "A post doc changed the numbers in assays in order to 'improve' the data."'improve' the data."

► "A colleague duplicated results between three different "A colleague duplicated results between three different papers but differently labeled data in each paper."papers but differently labeled data in each paper."

► "A co-investigator on a large, interdisciplinary grant "A co-investigator on a large, interdisciplinary grant application reported that a postdoctoral fellow in his application reported that a postdoctoral fellow in his laboratory falsified data submitted as preliminary data laboratory falsified data submitted as preliminary data in the grant. As principal investigator of the grant, I in the grant. As principal investigator of the grant, I submitted supplementary data to correct the submitted supplementary data to correct the application."application."

► "A colleague used Photoshop to eliminate background "A colleague used Photoshop to eliminate background bands on a western blot to make the data look more bands on a western blot to make the data look more specific than they were."specific than they were."

Page 11: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

ORI RecommendationsORI Recommendations

►Adopt zero toleranceAdopt zero tolerance►Protect whistleblowersProtect whistleblowers►Clarify how to reportClarify how to report►Train the mentorsTrain the mentors►Model ethical behaviorModel ethical behavior

Page 12: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Top ten “POOR” behaviors► 1. Falsifying or ‘cooking’ research data► 2. Ignoring major aspects of human-subject

requirements► 3. Not properly disclosing involvement in firms whose products are based on one‘s own research► 4. Relationships with students, research subjects or

clients that may be interpreted as questionable► 5. Using another’s ideas without obtaining permission or giving due credit (plagiarism)► 6. Unauthorized use of confidential information in connection with one’s own research► 7. Failing to present data that contradict one’s own previous research ????► 8. Circumventing certain minor aspects of human-

subject requirements

Page 13: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Top ten behaviors(continued)

► 9. Overlooking others' use of flawed data or questionable interpretation of data► 10. Changing the design, methodology or results of a study in response to pressure from a funding source (falsification)► Other behaviors► 11. Publishing the same data or results in two or more publications► 12. Inappropriately assigning authorship credit► 13. Withholding details of methodology or results in papers or proposals► 14. Using inadequate or inappropriate research designs► 15. Dropping observations or data points from analyses based

on a gut feeling that they were inaccurate► 16. Inadequate record keeping related to research projects

Page 14: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Why does misconduct Why does misconduct happen?happen?

Publish or Perish Publish or Perish PressurePressure

Desire to “get ahead”Desire to “get ahead” Personal problemsPersonal problems Character issuesCharacter issues Cultural DifferencesCultural Differences ??????

Page 15: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

SCIENTIFIC MISCONDUCT:SCIENTIFIC MISCONDUCT:Scandals Shake Chinese ScienceScandals Shake Chinese Science

►"Too many "Too many incentivesincentives have blurred the have blurred the reasons for doing science in some reasons for doing science in some people's minds“people's minds“ Lu Yongxiang, president of the Chinese Lu Yongxiang, president of the Chinese

Academy of Sciences Academy of Sciences ►"Though it is difficult to ascertain the "Though it is difficult to ascertain the

number of misconduct cases, the number of misconduct cases, the negative impact of these cases should negative impact of these cases should not be underestimated“not be underestimated“ Ministry of Education spokesperson Wang Ministry of Education spokesperson Wang

Xuming Xuming

Page 16: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

How is misconduct identifiedHow is misconduct identified

►Suspected and reported by a colleagueSuspected and reported by a colleague►Failure to confirm research results Failure to confirm research results

by own lab or othersby own lab or others

Page 17: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Institutional Procedures Required to Institutional Procedures Required to Qualify for PHS FundingQualify for PHS Funding

► The designation of an individual authorized to receive The designation of an individual authorized to receive and investigate allegations of misconduct (RIO)and investigate allegations of misconduct (RIO)

► Provisions for an initial inquiry to determine if Provisions for an initial inquiry to determine if allegations have meritallegations have merit

► Provisions for a formal investigation to determine the Provisions for a formal investigation to determine the truth of the allegationstruth of the allegations

► The designation of an individual authorized to The designation of an individual authorized to adjudicate the conclusions of the investigation and adjudicate the conclusions of the investigation and impose administrative actions to redress the impose administrative actions to redress the misconduct or to vindicate the person charged (DO)misconduct or to vindicate the person charged (DO)

► Provisions for reporting findings to ORIProvisions for reporting findings to ORI

Page 18: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Investigation ProcessInvestigation Process

► Allegations reported to and assessed by RIOAllegations reported to and assessed by RIO► RIO reviews allegations, sequesters research RIO reviews allegations, sequesters research

records, and if credible forwards to inquiry records, and if credible forwards to inquiry committeecommittee

► Inquiry report is made and if investigation is Inquiry report is made and if investigation is substantiated records are forwarded to the substantiated records are forwarded to the investigation committeeinvestigation committee

► Initial draft reviewed by RIO and DO Initial draft reviewed by RIO and DO (Provost), and final report sent to all parties (Provost), and final report sent to all parties (respondent, complainent, RIO, DO)(respondent, complainent, RIO, DO)

► Institutional decision and administrative Institutional decision and administrative actionaction

Page 19: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Consequences (if misconduct is Consequences (if misconduct is substantiated)substantiated)

►Withdrawal or correction of all pending Withdrawal or correction of all pending and published papers and abstracts and published papers and abstracts affected by the misconductaffected by the misconduct

►Reprimand, removal from project, rank Reprimand, removal from project, rank and salary reduction, dismissaland salary reduction, dismissal

►Restitution of funds to the granting Restitution of funds to the granting agencyagency

► Ineligibility to apply for Federal grants for Ineligibility to apply for Federal grants for yearsyears

►I.E. the end of your research career!I.E. the end of your research career!

Page 20: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Case Example - Pat J. Case Example - Pat J. PalmerPalmer

Fabricated 6 interview Fabricated 6 interview recordsrecords

Fabricated claim of Fabricated claim of Ph.D.Ph.D.

(B.S. and M.S. also)(B.S. and M.S. also)

Falsified that she was Falsified that she was

co-author on 10 articlesco-author on 10 articles

Did I say I have a Ph.D. in

Epidemiology?

Page 21: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

ExampleExample

Page 22: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer
Page 23: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

SCIENTIFIC MISCONDUCT: Truth and SCIENTIFIC MISCONDUCT: Truth and ConsequencesConsequences

ScienceScience 1 September 2006: Vol. 313. no. 5791, pp. 1222 - 1226 1 September 2006: Vol. 313. no. 5791, pp. 1222 - 1226 MADISON, WISCONSIN--MADISON, WISCONSIN--After making the After making the

difficult decision to turn in their adviser for difficult decision to turn in their adviser for scientific misconduct, a group of graduate scientific misconduct, a group of graduate students is trying to recover from the students is trying to recover from the resulting damage to their careers. resulting damage to their careers.

One afternoon, in the conference room down One afternoon, in the conference room down the hall from the lab, Ly told Goodwin she was the hall from the lab, Ly told Goodwin she was concerned about her progress: The project concerned about her progress: The project she'd been working on, Ly felt, wasn't yielding she'd been working on, Ly felt, wasn't yielding usable results. Despite months of effort, Ly usable results. Despite months of effort, Ly was unable to replicate earlier observations was unable to replicate earlier observations from the lab. from the lab.

Page 24: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Misconduct as an Excuse?Misconduct as an Excuse?Chronicle of Higher EducationChronicle of Higher Education

► Colorado Regents Vote to fire Ward Churchill (Prof. Colorado Regents Vote to fire Ward Churchill (Prof. of ethic studies at Univ. Col. Boulder)of ethic studies at Univ. Col. Boulder) Research misconduct cited, but Professor says decision Research misconduct cited, but Professor says decision

was political and sueswas political and sues

► Six years ago Ward Churchill compared the Six years ago Ward Churchill compared the American victims of 9/11 to Nazi bureaucratsAmerican victims of 9/11 to Nazi bureaucrats

► The BOR says that the firing was due to “repeated The BOR says that the firing was due to “repeated and deliberate research misconduct that fell below and deliberate research misconduct that fell below the minimum standard of professional integrity, the minimum standard of professional integrity, involving fabrication, improper citation, and involving fabrication, improper citation, and plagiarism”.plagiarism”.

Page 25: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Nursing Professor at Tennessee State Nursing Professor at Tennessee State UniversityUniversity

► James Linn – admitted research misconduct by James Linn – admitted research misconduct by "knowingly and intentionally falsifying and/or "knowingly and intentionally falsifying and/or fabricating the data and results of a study in which fabricating the data and results of a study in which he purportedly tested the effects of an intervention he purportedly tested the effects of an intervention to reduce sexual risk behaviors in high risk, to reduce sexual risk behaviors in high risk, impaired populations of homeless men with mental impaired populations of homeless men with mental illness by reporting false values for variables" illness by reporting false values for variables"

► Published in Published in Cellular and Molecular BiologyCellular and Molecular Biology► Funded by National Institute of General Medical Funded by National Institute of General Medical

SciencesSciences Debarred for 3 years from contracting/subcontracting with Debarred for 3 years from contracting/subcontracting with

any agency of the U.S. Governmentany agency of the U.S. Government Serving in an advisory capacity to the PHSServing in an advisory capacity to the PHS

Page 26: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Researcher Faces Prison for Fraud in NIH Grant Researcher Faces Prison for Fraud in NIH Grant Applications and PapersApplications and Papers

ScienceScience 25 March 2005: Vol. 307. no. 5717, p. 1851 25 March 2005: Vol. 307. no. 5717, p. 1851 A researcher formerly at the University of Vermont College of A researcher formerly at the University of Vermont College of

Medicine has Medicine has admitted in court documents to falsifying data admitted in court documents to falsifying data in 15 federal grant applications and numerous published in 15 federal grant applications and numerous published articlesarticles. .

Eric Poehlman, an expert on menopause, aging, and Eric Poehlman, an expert on menopause, aging, and metabolism, faces up to 5 years in jail and a $250,000 fine metabolism, faces up to 5 years in jail and a $250,000 fine and has been and has been barred for life from receiving any U.S. research barred for life from receiving any U.S. research fundingfunding. .

The number and scope of falsifications discovered, along with The number and scope of falsifications discovered, along with the stature of the investigator, are quite remarkable. "the stature of the investigator, are quite remarkable. "This is This is probably one of the biggest misconduct cases everprobably one of the biggest misconduct cases ever," ,"

Poehlman, 49, first Poehlman, 49, first came under suspicioncame under suspicion in 2000 when in 2000 when Walter Walter DeNino, then a 24-year-old research assistant, found DeNino, then a 24-year-old research assistant, found inconsistencies in spreadsheetsinconsistencies in spreadsheets used in a longitudinal study used in a longitudinal study on aging. on aging.

In an effort to portray worsening health in the subjects, DeNino In an effort to portray worsening health in the subjects, DeNino tells tells ScienceScience, ", "Dr. Poehlman would just switch the data Dr. Poehlman would just switch the data pointspoints." ."

Page 27: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Who is investigated and who is Who is investigated and who is held accountable?held accountable?

► InvestigatedInvestigated All authors that are involved in the All authors that are involved in the

specific data in questionspecific data in question

►Held accountableHeld accountable Primary authorPrimary author Other authors whose results are found Other authors whose results are found

culpableculpable The PIThe PI

Page 28: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Mentor ResponsibilitiesMentor Responsibilities

MentorsMentors have the have the responsibilityresponsibility to to ensure that all trainees (post-docs, grad ensure that all trainees (post-docs, grad students, undergrads) are students, undergrads) are awareaware of the of the responsible conduct of researchresponsible conduct of research Define the RelationshipDefine the Relationship

Role of TraineeRole of Trainee Publication/Authorship Publication/Authorship Serving as PI or Co-PIServing as PI or Co-PI

Obligation to reportObligation to report Good faith reportGood faith report

Page 29: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

VT RequirementsVT Requirements Establish policies and proceduresEstablish policies and procedures

for for investigating and reportinginvestigating and reporting instances of alleged instances of alleged research research misconductmisconduct

Respond to allegationsRespond to allegations Promote responsible conduct of Promote responsible conduct of

researchresearch Provide assurances necessary to Provide assurances necessary to

permit VT to participate in permit VT to participate in Federally supported researchFederally supported research

Provide annual reportProvide annual report

Page 30: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Procedures for Responding to Allegations of Misconduct in Research

Submit Allegations to RIO(Falsification, Fabrication, Plagiarism in Research)

Is allegation within definition of

Misconduct in Research?

Not sufficiently credible and specific

Potential Evidence of Misconduct Identified

Review with standing members of Inquiry

Committee

Complainant

VT Official

Anonymous

HHS or Other Sponsor

Referrals of Research Misconduct

Non-sponsored research and Respondent is either:Classified staffGraduate studentsUndergraduate students

Dismiss Allegation

Refer to appropriate University

unit

Undergraduate Honor System

Graduate Honor System

Committee on Faculty Ethics

Within 7 days RIO performs assessment of allegation

No

Does allegation warrant inquiry

Yes

No No

YesNo

Yes

Page 31: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Procedures for Responding to Allegations of Misconduct in Research (continued)

RIO Convenes Inquiry Committee· 1 standing member· 1 CFE member· Members and experts as

appointed by RIO for the case

Inquiry CommitteeInitiates Inquiry Process

60 calendar days for completion

· Resolve conflicts of interest within committee

Within 10 days

Prepare Initial Inquiry Report

· Interviews· Examine research records· Evaluate evidence

· Review by RIO for compliance with policy

· Modification as appropriate in consultation with RIO

RIOInitiates Inquiry

Process

RespondentResearch Records Obtain Custody Provide written notification

RespondentProvide written notification

objection to members (within 10 days)

RIO charge to committee

· Brief on Allegation· Plan on Inquiry

Page 32: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Procedures for Responding to Allegations of Misconduct in Research (continued)

Revise Initial Inquiry Report(if required)

Respondent Review

Prepare Final Inquiry ReportIs Investigation Warranted?

(Majority vote of Inquiry Committee)· Retain records for 7 years· Provide notices· Provide guidance to

Respondent if needed

No

Complainant Review

10 days for comments10 days for comments

Discuss comments on report(Inquiry Committee, the RIO, and DO)

Report to Include· Name and position of Respondent· Description of allegations· Contract/ funding source information· Basis for recommendation including list

of research records reviewed· Attach Respondent’s and

Complainant’s comments· Name and titles of committee members · Whether any action should be taken if

investigation not recommended

(Within 60 days of start of Inquiry Process unless

documented extension.)

No Investigation

Page 33: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Procedures for Responding to Allegations of Misconduct in Research (continued)

Secure Additional Records & EvidenceORI

Respondent

· Decision to begin· Copy of report· Other information as

requested

· Allegations to be investigated as a result of inquiry

· New allegations to be investigated within scope of initial allegations

RIO Convenes Investigation Committee· 2 standing member· 1 CFE member· Members and experts as appointed

by RIO for the case

Investigation Committee Initiates Investigation Process

Pursue Investigation

· Interviews· Examination of research records and evidence· Pursue new issues and leads discovered that are relevant

Provide Written Notification

Begin InvestigationWithin 30 calendar days

Respondent

Provide written notification

objection to members (within 10 days)

· Resolve conflicts of interest within committee

RIO charge to committee

· Brief on Allegation· Discuss procedures

and requirements

Yes

Page 34: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Procedures for Responding to Allegations of Misconduct in Research (continued)

Draft Investigation Report

Respondent ReviewComplainant Review

Discuss Comments on Report(Investigation Committee, RIO

and DO)

· Describes allegations· Identifies respondent· Identifies & summarize

research records & evidence

· Describe and document any federal support

· Describe policy and procedures used

· Statement of findings for each allegation

+ copy of (or supervised access to) evidence

Provide comments within 30 daysProvide comments within 30 days

+ copy of (or supervised access to) evidence

Prepare Final Investigation Report

Is there Misconduct in Research?

Committee findings (Positive or Negative)

(majority vote)

Page 35: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Procedures for Responding to Allegations of Misconduct in Research (continued)

DO Final Determination(Findings and administrative actions)

Notice to Respondent and Complainant

File Appeal Process

Final Decision

No Appeal

RIO ReviewDeciding Official

review

Procedural NoncomplianceFindings

Within 120 days start of Investigation

Within 10 days

Within 120 days of start of appeal

Recommendations to Investigation Committee and DO

DO Determination

Faculty Review Committee or Appropriate Grievance

Procedure

Appeal

Page 36: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Procedures for Responding to Allegations of Misconduct in Research (continued)

Final Decision (continued)

Institutional Administrative Action

Appropriate administrative

actions

· Final Investigation Report with attachments

· Statement of whether institution accepts findings (or outcomes of appeal)

· Statement of Whether institution found misconduct

· Description of any pending or completed administrative action

RIO ProvidesWritten Notifications

RespondentComplainant

Others as appropriate

(paper, magazine)

DO Determination

Protections of Complainants, witnesses, and committee members

Restoration of Respondent Reputation

Notice to ORI(Within 120 days start of

investigation or appeal process)

No Misconduct

· Withdrawal or correction of publications

· Removal of person from project

· Restitution to sponsor· Other internal institutional

actions

Misconduct

Notice to other sponsors

Page 37: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

SCIENCE: Vol 435|9, p.737 June 2005 COMMENTARY

Scientists behaving badly “To protect the integrity of science, we

must look beyond falsification, fabrication and

plagiarism, to a wider range of questionable research practices”

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

Page 38: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Responsible Research Responsible Research ConductConduct

• The Office of Research The Office of Research Integrity (ORI) defines Integrity (ORI) defines research integrityresearch integrity as as “adherence to rules, “adherence to rules, regulations, guidelines, and regulations, guidelines, and commonly accepted commonly accepted professional codes or professional codes or norms.”norms.”

• Research integrity is Research integrity is essential to ensure the essential to ensure the reliability of research reliability of research results and to preserve results and to preserve public support for research.public support for research.

Page 39: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Information SourcesInformation Sources DHHS 42 CFR Parts 50 and 93; Federal Register/Vol 70, No. DHHS 42 CFR Parts 50 and 93; Federal Register/Vol 70, No.

94, 2005.94, 2005. ““Fraud and the Role of Intensions” On Being A Scientist, Fraud and the Role of Intensions” On Being A Scientist,

Committee on the Conduct of Science, National Academy of Committee on the Conduct of Science, National Academy of Sciences. National Academy Press, Washington, D.C., 1989, Sciences. National Academy Press, Washington, D.C., 1989, page 15, ISBN 0-309-04091-4 page 15, ISBN 0-309-04091-4

Martinson, B., Anderson, M.,& de Vries, R., “Scientists Martinson, B., Anderson, M.,& de Vries, R., “Scientists behaving badly”. Journal of Nature 435, 737-738, June 2005.behaving badly”. Journal of Nature 435, 737-738, June 2005.

Office of Research Integrity Office of Research Integrity http://ori.dhhs.gov/ Office of Research Integrity: Case Summary-Pat J. Palmer. Office of Research Integrity: Case Summary-Pat J. Palmer.

Federal Register: February 17, 2004, 69:31, 7488-7489.Federal Register: February 17, 2004, 69:31, 7488-7489. Steneck, Nicholas H. (2004) ORI: Introduction to the Steneck, Nicholas H. (2004) ORI: Introduction to the

Responsible Conduct of Research.Responsible Conduct of Research. WEBSITE FOR THIS POWER POINT FILE:WEBSITE FOR THIS POWER POINT FILE:

http://www.research.vt.edu/reports/Research_Misconduct.ppt

Page 40: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Contact UsContact Us Dr. Thomas Inzana, Associate Vice President for Research Programs, Office of Dr. Thomas Inzana, Associate Vice President for Research Programs, Office of

the Vice President for Researchthe Vice President for [email protected]

http://www.research.vt.edu/announcement/misconduct.html   

https://www.fdi.vt.edu/public/modules/selfenroll/_viewevent.php?eventPk1=5885

231-5188231-5188 Linda Bucy, Interim Assistant Vice PresidentLinda Bucy, Interim Assistant Vice President

Office of Sponsored ProgramsOffice of Sponsored [email protected]

Carol Roberson, Special Assistant for Research Contract Affairs Carol Roberson, Special Assistant for Research Contract Affairs Office of the Vice President for ResearchOffice of the Vice President for [email protected]

Page 41: Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer

Questions?Questions?