Fabrication and Falsification of Data and Plagiarism A

Fabrication and Falsification of Data, and Plagiarism: A Lesson in Avoiding Research Misconduct Lauren Solberg, JD, MTS Assistant VP, Human Subjects Protection and Research Integrity Meharry Medical College Vanderbilt CRC Research Skills Workshop August 3, 2012

Goals of this Session Introduce Office of Research Integrity/RCR n Define Research Misconduct n Define Fabrication of Data, with examples n Define Falsification of Data, with examples n Define Plagiarism, with examples n Learn to Avoid Research Misconduct n Learn About Reporting/Investigating Research Misconduct n

Office of Research Integrity (ORI) n http: //ori. dhhs. gov n Oversees PHS research integrity activities on behalf of Secretary for HHS n n Evaluate research misconduct investigations Advise individuals and institutions on research misconduct Analyze research integrity policies and procedures Provide education on RCR

ORI Emphasis on RCR n n n n n Data Acquisition, Management, Sharing and Ownership Conflict of Interest and Commitment Human Subjects Animal Welfare Research Misconduct Publication Practices and Responsible Authorship Mentor / Trainee Responsibilities Peer Review Collaborative Science

Research Misconduct Defined 42 C. F. R. § 93. 103 n Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

How Prevalent Is It? n 2010: ORI received 155 allegations n n n 9 findings of misconduct made All findings of fabrication/falsification C. f. 2011: 4 findings of plagiarism ORI Annual Report 2010, http: //ori. hhs. gov/images/ddblock/ori_annual_report_2010. pdf n October 2011, Nature n Journal of Neuroscience EIC reported 76 ethics investigations in over 3 years Published online 5 October 2011, Nature 478, 26 -28 (2011)

Costs of Research Misconduct n n n Roswell Park Cancer Institute in Buffalo, NY Allegation: “enhancing and fabricating images and data in federal grant application” Estimated direct costs: $525, 000 n n Salaries, administrative costs Estimated indirect costs: $1. 3 million n Lost or withdrawn grants, and more Michalek AM, Hutson AD, Wicher CP, Trump DL (2010) The Costs and Underappreciated Consequences of Research Misconduct: A Case Study. PLo. S Med 7(8): e 1000318.

Fabrication of Data 42 C. F. R. § 93. 103(a) n Making up data or results and recording or reporting them

Examples of Fabrication of Data – from ORI n n Creating records of interviews of subjects that were never performed Preparing records for calls and follow-up contacts to subjects who had already died or were otherwise lost to follow-up

Eric Poehlman, Ph. D (2005/2006) n n Former UVM College of Medicine faculty member Fabricated information in 17 federal grant applications as well as in journal articles Admitted to 54 different findings of research misconduct See Jeneen Interlandi, An Unwelcome Discovery, N. Y. TIMES MAGAZINE, October 22, 2006

Penalty for Dr. Poehlman n n Sentenced to prison for 1 year and a day for making material false statements in grant applications Settlement agreement provided for him to pay $180, 000 (plus interest) to the U. S. Also agreed to pay $16, 000 in attorney fees to whistleblower (his laboratory technician) 10 letters of retraction published in various journals

Additional Consequences n Permanent debarment n n n Cannot contract/subcontract with any U. S. government agency Cannot participate in any programs with U. S. government funds Prohibition on serving in any advisory capacity to PHS n n No service on any advisory committees, boards, or peer review committees No consulting or contracting with PHS

Meleik Goodwill, Ph. D (2011) n n n Former post-doctoral fellow at N. Y. S. Dept. of Health Fabricated data published in journal figures Entered into voluntary settlement agreement – for 3 years: n Any institution where she works must submit supervisory plan to ORI for any PHS-funded research she conducts/plans to conduct n Institution must certify that data provided in PHS-funded applications, manuscripts, reports were obtained and reported with integrity n Precluded from serving in advisory capacity to PHS

Falsification of Data 42 C. F. R. § 93. 103(b) Manipulating research materials, equipment, or processes n Changing or omitting data or results such that the research is not accurately represented in the research record n

Examples of Falsification of Data – from ORI Changing the times/dates that blood samples were drawn from human subjects n Falsely reporting that certain clinical trial staff, who were certified to perform the procedures on the subjects, had done so, when they had not n

Research Staff – Held to the Same Standard n n n 2012 – Calleen Zach, former Research Assistant & Database Manager at Creighton University Falsified subject enrollment numbers on NIH grant applications and Creighton IRB forms For 5 years: n n Debarment Prohibited from serving in advisory capacity to PHS

Sinae Kim, Ph. D. (2012) n n n Emory University, former postdoctoral fellow Falsified data in manuscripts (not published), poster, meeting presentations, funded grants, grant applications 2 year voluntary exclusion agreement n n Debarment Will not serve in advisory capacity to PHS

Plagiarism 42 C. F. R. § 93. 103(c) Appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. n In other words – using someone else’s work as though it were your own n

Mahesh Visvanathan, Ph. D. (2011) n n n University of Kansas – Research Assistant Professor, Bioinformatics Core ORI found he intentionally and knowingly plagiarized text in 3 articles, 1 abstract Voluntary settlement agreement – for 2 years: n Supervision of PHS-funded research by KU n Institution must certify that data provided in PHS-funded applications, manuscripts, reports were obtained and reported with integrity, citations included appropriately/as necessary Precluded from serving in advisory capacity to PHS n

Gerald Lushington, Ph. D. (2011) n n n University of Kansas - Director, Bioinformatics Core, Molecular Graphics & Modeling Laboratory ORI found he approved publication of 3 articles, 1 abstract that he knew included significant amount of plagiarized text Voluntary settlement agreement – for 2 years: n Supervision of PHS-funded research by KU n Institution must certify that data provided in PHS-funded applications, manuscripts, reports were obtained and reported with integrity, citations included appropriately/as necessary Precluded from serving in advisory capacity to PHS n

Plagiarism Detection Web Sites n Turnitin - http: //www. turnitin. com/static/index. php n n i. Thenticate - http: //www. ithenticate. com/ n n n Evaluates student papers and academic works From creators of Turnitin Compares document submitted into system to documents on web, academic publications Cross. Check - http: //www. crossref. org/ n n For publishers (scholarly, professional) Uses i. Thenticate software

Self-Plagiarism Sometimes referred to as dual publication n May include publishing your own previously published text, figures, charts, etc. without attribution and/or permission n Publishing word-for-word translation of author’s own article previously published in another language without acknowledgement n

What’s the Problem? Regulatory definition contemplates only copying of works of others n BUT copying your own work without appropriate citation is unacceptable n WHY?

Ethics, Copyright, Terms and Conditions n n n Goal of publication is to contribute to a body of knowledge – redundancy resulting from dual publication thought to not accomplish this goal Many journals require authors to transfer the copyright to the journal n Example – JAMA (copyright ownership is transferred to AMA) Many journals specify in instructions to authors that they expect submissions to not have been previously published or be under consideration elsewhere

Accidents Happen Research misconduct does not include honest error or differences in opinion (42 C. F. R. § 93. 103(d)) n BUT it need not be committed intentionally to be satisfy regulatory definition n Could be committed intentionally, knowingly, or recklessly (42 C. F. R. § 93. 104) n

What Does This Mean? n You engage in research misconduct if you: n n n INTEND or SET OUT TO falsify or fabricate data, or plagiarize, Are AWARE that you are falsifying or fabricating data, or plagiarizing, even though you did not set out to do so, OR WILLFULLY IGNORE that misconduct is/may be going on

To Make A Finding… Must be a significant departure from accepted practices of relevant research community; n Misconduct must be committed intentionally, knowingly, or recklessly; and n Allegation must be proven by preponderance of evidence n 42 C. F. R. § 93. 104

Avoiding Research Misconduct n Treat grants and publications the same way n n From an NIH RFA: NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. From JAMA: Manuscripts are considered with the understanding that they have not been published previously in print or electronic format and are not under consideration by another publication or electronic medium. Copies of related or possibly duplicative materials (ie, those containing substantially similar content or using the same or similar data) that have been previously published or are under consideration elsewhere must be provided at the time of manuscript submission.

Avoiding Research Misconduct (cont’d) Be aware of journal requirements re: copyright, permission to reprint, citations n Be scrupulous about citations n If you copy exact wording, use quotes, and cite appropriately n

Avoiding Research Misconduct (cont’d) If you see something, say something n Seek advice from a colleague or mentor when a situation seems questionable n

Misconduct Policies Meharry Medical College: http: //www. mmc. edu/gen_counsel/docs/polici es/Research%20 Misconduct. pdf n Vanderbilt University: http: //vanderbilt. edu/facultymanual/manage/wp-content/files/VU-Policyfor-Responding-to-Allegations-of-Research. Misconduct. pdf n

Making an Allegaion – Initial Steps n At Meharry – report to AVP, Human Subjects Protection & Research Integrity n Anonymous reports will be forwarded to Office of Corporate Compliance At Vanderbilt – report to applicable Dean n Decision will be made whether to open an inquiry, conduct further investigation n

Reporting Research Misconduct Identity of those who report misconduct of others will be kept confidential to extent possible n Identity of accused will be kept confidential to extent possible n BUT – do not report misconduct unless there is good faith basis for doing so n No retaliation as result of making report n

Investigating Research Misconduct Allegation will be reviewed to determine if further investigation is needed n By federal regulation, if further investigation is warranted, ORI must be notified n Research may be suspended during investigation and if there is finding of research misconduct n

Consequences of Finding of Misconduct n If there is a determination of misconduct, results could include reprimand, retraction or correction of publications, special monitoring of future work, repayment of grant funds, probation or suspension, termination of employment

Reminder n n n Researchers must conduct research responsibly Not limited to avoiding fabrication and falsification of data, and plagiarism All misconduct will be dealt with by Meharry/Vanderbilt internally, and where necessary, forwarded to appropriate federal agency n n Failure to obtain appropriate IRB approval for human subjects research before beginning any part of research Forgery of physician’s signature on medical order Failure to obtain or properly document informed consent Failure to report adverse event to sponsor or IRB

Summary Defined research misconduct n Defined fabrication and falsification of data, and plagiarism n Learned how to avoid engaging in research misconduct n Learned about reporting/investigating research misconduct n

Contact Information Email: lsolberg@mmc. edu n Campus Phone: 327 -6237 n Office Location: Meharry Medical College, West Basic Sciences Building, Room 2203 n