Research Misconduct Thomas J. Inzana, Ph.D. Associate Vice-President for Research Programs and Research Integrity Officer Federal Laws on Research Misconduct Public concern over research misconduct initially arose in the early 1980’s. At the time, research institutions sometimes ignored or covered up potential misconduct problems rather than investigate them. In December 2000 the Office of Science and Technology Policy adopted a federal policy on research misconduct. DHHS enacted regulation effective 6/15/05 “Public Health Service Policies on Research Misconduct” Implements legislative and policy changes applicable to research misconduct that occurred over last several years. Covers any entity that applies for a research, research-training or research-related grant or cooperative agreement with the Public Health Service (PHS) Purpose of Research Misconduct Policies ► Establish definitions for research misconduct ► Outline procedures for reporting and investigating misconduct ► Provide protection for whistleblowers and persons accused of misconduct Research Misconduct ► What is it?: The Department of Health and Human Services defines research misconduct as: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research results. ► Fabrication: making up results and recording or reporting them ► Falsification: manipulation of research materials, equipment, or processes, or changing or omitting results such that the research is not accurately represented in the record. ► Plagiarism: the appropriation of another’s ideas, processes, results, or words without giving proper credit. Criteria for Research Misconduct Represents a significant departure from accepted practices Has been committed intentionally, or knowingly, or recklessly; and Can be proven by a preponderance of evidence What is NOT MISCONDUCT: honest, unintentional error + = Research Misconduct SCIENTIFIC MISCONDUCT: How Prevalent Is Fraud? That's a million-Dollar Question Science 1 December 2000: Vol. 290. no. 5497, pp. 1662 - 1663 How often does scientific misconduct occur? There seems to be no consensus on the answer, although a range of estimates were presented at a conference called last month by a key federal watchdog agency to announce a $1 million grants program to investigate the prevalence of fraud, data fabrication, plagiarism, and other questionable practices in science. The 9-year-old Office of Research Integrity hopes to support studies gauging the frequency of misconduct and assessing efforts to raise ethical standards. Department of Health & Human Services received 267 reports of research misconduct (2004) • 50% increase from 2003 • 35% of closed cases involve research misconduct • ► What is it not: Honest error or differences of opinion ORI 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. Nature 453, 980-982 (19 June 2008) ► SURVEY of 2,212 Researchers Observed 201 instances of misconduct E.G. ► "A post doc changed the numbers in assays in order to 'improve' the data." ► "A colleague duplicated results between three different papers but differently labeled data in each paper." ► "A co-investigator on a large, interdisciplinary grant application reported that a postdoctoral fellow in his laboratory falsified data submitted as preliminary data in the grant. As principal investigator of the grant, I submitted supplementary data to correct the application." ► "A colleague used Photoshop to eliminate background bands on a western blot to make the data look more specific than they were." ORI Recommendations ► Adopt zero tolerance ► Protect whistleblowers ► Clarify how to report ► Train the mentors ► Model ethical behavior 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 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 Why does misconduct happen? Publish or Perish Pressure Desire to “get ahead” Personal problems Character issues Cultural Differences ??? SCIENTIFIC MISCONDUCT: Scandals Shake Chinese Science ► "Too many incentives have blurred the reasons for doing science in some people's minds“ Lu Yongxiang, president of the Chinese Academy of Sciences ► "Though it is difficult to ascertain the number of misconduct cases, the negative impact of these cases should not be underestimated“ Ministry of Education spokesperson Wang Xuming How is misconduct identified ► Suspected and reported by a colleague ► Failure to confirm research results by own lab or others Institutional Procedures Required to Qualify for PHS Funding ► ► ► ► ► The designation of an individual authorized to receive and investigate allegations of misconduct (RIO) Provisions for an initial inquiry to determine if allegations have merit Provisions for a formal investigation to determine the truth of the allegations The designation of an individual authorized to adjudicate the conclusions of the investigation and impose administrative actions to redress the misconduct or to vindicate the person charged (DO) Provisions for reporting findings to ORI Investigation Process ► Allegations reported to and assessed by RIO ► RIO reviews allegations, sequesters research records, and if credible forwards to inquiry committee ► Inquiry report is made and if investigation is substantiated records are forwarded to the investigation committee ► Initial draft reviewed by RIO and DO (Provost), and final report sent to all parties (respondent, complainent, RIO, DO) ► Institutional decision and administrative action Consequences (if misconduct is substantiated) ► Withdrawal or correction of all pending and published papers and abstracts affected by the misconduct ► Reprimand, removal from project, rank and salary reduction, dismissal ► Restitution of funds to the granting agency ► Ineligibility to apply for Federal grants for years ► I.E. the end of your research career! Case Example - Pat J. Palmer Fabricated 6 interview records Fabricated claim of Ph.D. (B.S. and M.S. also) Falsified that she was co-author on 10 articles Did I say I have a Ph.D. in Epidemiology? Example SCIENTIFIC MISCONDUCT: Truth and Consequences Science 1 September 2006: Vol. 313. no. 5791, pp. 1222 - 1226 MADISON, WISCONSIN--After making the difficult decision to turn in their adviser for scientific misconduct, a group of graduate students is trying to recover from the resulting damage to their careers. One afternoon, in the conference room down the hall from the lab, Ly told Goodwin she was concerned about her progress: The project she'd been working on, Ly felt, wasn't yielding usable results. Despite months of effort, Ly was unable to replicate earlier observations from the lab. Misconduct as an Excuse? Chronicle of Higher Education ► Colorado Regents Vote to fire Ward Churchill (Prof. of ethic studies at Univ. Col. Boulder) Research misconduct cited, but Professor says decision was political and sues ► Six years ago Ward Churchill compared the American victims of 9/11 to Nazi bureaucrats ► The BOR says that the firing was due to “repeated and deliberate research misconduct that fell below the minimum standard of professional integrity, involving fabrication, improper citation, and plagiarism”. Nursing Professor at Tennessee State University ► ► ► James Linn – admitted research misconduct by "knowingly and intentionally falsifying and/or fabricating the data and results of a study in which he purportedly tested the effects of an intervention to reduce sexual risk behaviors in high risk, impaired populations of homeless men with mental illness by reporting false values for variables" Published in Cellular and Molecular Biology Funded by National Institute of General Medical Sciences Debarred for 3 years from contracting/subcontracting with any agency of the U.S. Government Serving in an advisory capacity to the PHS Researcher Faces Prison for Fraud in NIH Grant Applications and Papers Science 25 March 2005: Vol. 307. no. 5717, p. 1851 A researcher formerly at the University of Vermont College of Medicine has admitted in court documents to falsifying data in 15 federal grant applications and numerous published articles. Eric Poehlman, an expert on menopause, aging, and metabolism, faces up to 5 years in jail and a $250,000 fine and has been barred for life from receiving any U.S. research funding. The number and scope of falsifications discovered, along with the stature of the investigator, are quite remarkable. "This is probably one of the biggest misconduct cases ever," Poehlman, 49, first came under suspicion in 2000 when Walter DeNino, then a 24-year-old research assistant, found inconsistencies in spreadsheets used in a longitudinal study on aging. In an effort to portray worsening health in the subjects, DeNino tells Science, "Dr. Poehlman would just switch the data points." Who is investigated and who is held accountable? ► Investigated All authors that are involved in the specific data in question ► Held accountable Primary author Other authors whose results are found culpable The PI Mentor Responsibilities Mentors have the responsibility to ensure that all trainees (post-docs, grad students, undergrads) are aware of the responsible conduct of research Define the Relationship Role of Trainee Publication/Authorship Serving as PI or Co-PI Obligation to report Good faith report VT Requirements Establish policies and procedures for investigating and reporting instances of alleged research misconduct Respond to allegations Promote responsible conduct of research Provide assurances necessary to permit VT to participate in Federally supported research Provide annual report Procedures for Responding to Allegations of Misconduct in Research Undergraduate Honor System Complainant Anonymous Referrals of Research Misconduct Graduate Honor System HHS or Other Sponsor VT Official Committee on Faculty Ethics Submit Allegations to RIO (Falsification, Fabrication, Plagiarism in Research) Within 7 days Refer to appropriate University unit No RIO performs assessment of allegation Is allegation within definition of Misconduct in Research? Yes Non-sponsored research and Respondent is either: Classified staff Graduate students Undergraduate students No Does allegation warrant inquiry Yes Potential Evidence of Misconduct Identified No Yes Not sufficiently credible and specific Review with standing members of Inquiry Committee No Dismiss Allegation Procedures for Responding to Allegations of Misconduct in Research (continued) Research Records Obtain Custody RIO Initiates Inquiry Process Provide written notification Respondent Within 10 days RIO Convenes Inquiry Committee · 1 standing member · 1 CFE member · Members and experts as appointed by RIO for the case · RIO charge to committee · · Brief on Allegation Plan on Inquiry Provide written notification objection to members (within 10 days) Resolve conflicts of interest within committee Inquiry Committee Initiates Inquiry Process · · · 60 calendar days for completion Interviews Examine research records Evaluate evidence Prepare Initial Inquiry Report · · Review by RIO for compliance with policy Modification as appropriate in consultation with RIO Respondent Procedures for Responding to Allegations of Misconduct in Research (continued) Revise Initial Inquiry Report (if required) Respondent Review 10 days for comments 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 Complainant Review 10 days for comments Discuss comments on report (Inquiry Committee, the RIO, and DO) No Investigation · · · No Retain records for 7 years Provide notices Provide guidance to Respondent if needed Prepare Final Inquiry Report Is Investigation Warranted? (Majority vote of Inquiry Committee) (Within 60 days of start of Inquiry Process unless documented extension.) Procedures for Responding to Allegations of Misconduct in Research (continued) Yes Provide Written Notification Secure Additional Records & Evidence ORI · · · Decision to begin Copy of report Other information as requested Begin Investigation Within 30 calendar days Respondent · · Allegations to be investigated as a result of inquiry New allegations to be investigated within scope of initial allegations RIO charge to committee · · RIO Convenes Investigation Committee · 2 standing member · 1 CFE member · Members and experts as appointed by RIO for the case · Provide written notification Respondent objection to members (within 10 days) Resolve conflicts of interest within committee Investigation Committee Initiates Investigation Process Brief on Allegation Discuss procedures and requirements Pursue Investigation · · · Interviews Examination of research records and evidence Pursue new issues and leads discovered that are relevant Procedures for Responding to Allegations of Misconduct in Research (continued) Draft Investigation Report + copy of (or supervised access to) evidence + copy of (or supervised access to) evidence · · · · Respondent Review · · 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 Provide comments within 30 days Discuss Comments on Report (Investigation Committee, RIO and DO) Prepare Final Investigation Report Is there Misconduct in Research? Committee findings (Positive or Negative) (majority vote) Complainant Review Provide comments within 30 days Procedures for Responding to Allegations of Misconduct in Research (continued) DO Final Determination (Findings and administrative actions) Notice to Respondent and Complainant Within 10 days File Appeal Process Findings No Appeal Deciding Official review Within 120 days start of Investigation Within 120 days of start of appeal Procedural Noncompliance RIO Review Recommendations to Investigation Committee and DO DO Determination Final Decision Appeal Faculty Review Committee or Appropriate Grievance Procedure Procedures for Responding to Allegations of Misconduct in Research (continued) Final Decision (continued) RIO Provides Written Notifications Institutional Administrative Action Notice to other sponsors DO Determination Respondent No Misconduct Notice to ORI (Within 120 days start of investigation or appeal process) Appropriate administrative actions Restoration of Respondent Reputation Complainant Misconduct Protections of Complainants, witnesses, and committee members · · · · · · · Withdrawal or correction of publications Removal of person from project Restitution to sponsor Other internal institutional actions · Others as appropriate (paper, magazine) 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 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. Responsible Research Conduct The Office of Research Integrity (ORI) defines research integrity as “adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms.” • Research integrity is essential to ensure the reliability of research results and to preserve public support for research. • Information Sources DHHS 42 CFR Parts 50 and 93; Federal Register/Vol 70, No. 94, 2005. “Fraud and the Role of Intensions” On Being A Scientist, Committee on the Conduct of Science, National Academy of Sciences. National Academy Press, Washington, D.C., 1989, page 15, ISBN 0-309-04091-4 Martinson, B., Anderson, M.,& de Vries, R., “Scientists behaving badly”. Journal of Nature 435, 737-738, June 2005. Office of Research Integrity http://ori.dhhs.gov/ Office of Research Integrity: Case Summary-Pat J. Palmer. Federal Register: February 17, 2004, 69:31, 7488-7489. Steneck, Nicholas H. (2004) ORI: Introduction to the Responsible Conduct of Research. WEBSITE FOR THIS POWER POINT FILE: http://www.research.vt.edu/reports/Research_Misconduct.ppt Contact Us Dr. Thomas Inzana, Associate Vice President for Research Programs, Office of the Vice President for Research [email protected] http://www.research.vt.edu/announcement/misconduct.html https://www.fdi.vt.edu/public/modules/selfenroll/_viewevent.php?eventPk1=5885 231-5188 Linda Bucy, Interim Assistant Vice President Office of Sponsored Programs [email protected] 231-9477 Carol Roberson, Special Assistant for Research Contract Affairs Office of the Vice President for Research [email protected] 231-5520 Questions?