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Research Misconduct: Are You Ready To Respond?

Research Misconduct: Are You Ready To Respond?. Ranjini Ambalavanar, Ph.D. Division of Investigative Oversight (DIO) Office of Research Integrity (ORI) November 2019. Applying for a Grant?.

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Research Misconduct: Are You Ready To Respond?

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  1. Research Misconduct:Are You Ready To Respond? Ranjini Ambalavanar, Ph.D. Division of Investigative Oversight (DIO) Office of Research Integrity (ORI) November 2019

  2. Applying for a Grant? You submit an NIH grant application which was written by you with the help of the laboratory members. You were not aware of the falsified/fabricated data and/or plagiarized text. Are you liable for research misconduct? Decisions by an ALJ on two of the recent ORI cases established that a PI and/or corresponding author, can be liable for research misconduct even if he/she was completely unaware of any falsification or plagiarism.

  3. Research misconduct - 42 CFR § 93.103 PHS Policies on Research Misconduct Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.  (c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

  4. ORI Divisions MISSION To promote the integrity of PHS-supported extramural and intramural research programs by responding effectively to allegations of research misconduct and promoting research integrity GOAL Oversight Review of research misconduct Investigations Education in Responsible Conduct of Research Functions Division of Education and Integrity Division of Investigative Oversight

  5. Jurisdiction, Supporting Coordination & Collaboration International Universities American Association for the Advancement of Science Association of American Medical Colleges NIST/DOC DOD DOE CDC Medical Centers FDA OIG USDA Council of Graduate Schools AHRQ OGC NSF Biotech Companies DOI SAMHSA OHRP Public Health Service National Academy of Science HRSA IHS Association of American University Professors VA NIH DOJ NASA US Colleges & Universities Clinical sites

  6. Who Do You Contact? • Authorship or credit disputes • Institution, Journal • Misuse of human subjects • (OHRP – Office of Human Research Protections) • Misuse of animals in research • (OLAW - Office of Laboratory Animal Welfare) • Conflict of interest issues • (NIH grants policy office) • Financial mismanagement • (OMA - Office of Management Assessment) • Radiation or biosafety hazards • (ORS - Office of Research Services) • Other regulatory violations (FDA) • No PHS funding 2019 data is until September 30th

  7. Research Misconduct vs Questionable Research Practices Most of the scientists conduct research with a high degree of integrity contributing to advancement in science Misconduct Questionable Research Practices/ Sloppy Science No Misconduct Most research on research integrity suggests a 1-10% rate of misconduct or questionable research practices

  8. What leads to Research Misconduct Rationalization Perceived Pressure Opportunity Adopted from Cressey’s Fraud Triangle

  9. Additional evidence: • Interviews • Expert opinion • Forensic analysis • Additional Issues Steps in Research Misconduct Proceedings ORI oversight Inquiry Allegation Assessment Investigation 120 days 60 days • Agree, or • Insufficient evidence for ORI finding • From: • Within institution • Colleagues • Peer reviewers • Coauthors • Journal editors • Research Integrity Officer (RIO) • Initial assessment • Organizes the remaining institutional processes • Recommend Administrative Actions based on: • Scope of the misconduct • Aggravating /mitigating factors • Actions Include: • Fix research record • Require special certification(s) • Suspend/terminate PHS-funding • Supervise offender(s) • Prohibit PHS-advisory role • Debar from future funding • To: • Institution: • Supervisor, Chair • RIO • Funding agency • Journal • ORI All ORI Findings are published in The Federal Register, the ORI website and newsletter, and the NIH website

  10. Respondents’ statements……

  11. Inadequate supervision, guidance or training • PI not present in the laboratory • Excessive work-load • Demanding desired results to meet a deadline • Use of threats and intimidation as tactics to obtain desired results • No review of raw data • Sloppy research records • No guidance or standards for keeping data • Not protected over time (conveniently lost) • Accessible to multiple staff • Not backed up and stored securely • Researchers take data from the institution Some Red Flags

  12. PHS Administrative Actions

  13. Case Summaries and NIH eRA Links to PHS Administrative Action Bulletin Board

  14. Photoshop Gradient Map

  15. Reveals that formulas were used to generate selected data Use “Show Formulas”Tools>Options>View>Window Options; check formulas

  16. Data Reuse - Ch3 and Ch 5

  17. Reused DNA sequencing files in Electronic Records • Many of the sequence files Respondent provided as his own contain data taken from sequencing runs performed 2 years before he/she joined the lab. Examples of 2 files shown below • Both files represent the same sequence run (here lane 53) in 2007 and dated October 11, 2010.

  18. Clinical Research Data Interviews Entry criteria Screening logs Approval forms Follow-up exams/data Consent forms Test scores Laboratory results Patient data Number of subjects Dates of procedures Protocol Study results Respondents in 68 cases with finding Research Asst./Assoc. Students Research Coordinator/Nurse Practitioner Fellows Technician All Professors Other

  19. Post Mastectomy treatment (tamoxifen vs. placebo) Falsified NSABP enrollment form Physical exam record from Pt. Chart Enrolled patient despite skin findings that would have made patient ineligible

  20. Follow up Visits For Patient 10: dated “01-18-88”

  21. Follow up Visits For - Patient 10: dated “08-31-88”

  22. Follow up Visits For - Patient 10: dated “11-29-88”

  23. Follow up Visits For - Patient 10: dated “03-21-89”

  24. Follow up Visits For - Patient 10: dated “02-02-90”

  25. Patient 10: Death Certificate “September 29, 1987” 28 months prior to last reported follow-up (2-2-90) 4 months prior to first shown (1-18-88) follow up

  26. Pressures are Perpetuated at Every Level. What can You Do?

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