Training for Investigators and Research Personnel Research Misconduct Training for Investigators and Research Personnel

POP QUIZ POP QUIZ POP QUIZ POP QUIZ

What is research misconduct? Fabrication, falsification, or appropriation in proposing, performing, or reviewing research, or in reporting research results Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results Forgery, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results Forgery, distortion, or appropriation in proposing, performing, or reviewing research, or in reporting research results B http://ori.hhs.gov/definition-misconduct

Defining Research Misconduct It is important to note that ‘Research misconduct does not include honest error or differences of opinion’ (OSTP 2000, 76260-4). To be considered research misconduct, the behavior must have been performed ‘intentionally, knowingly, or recklessly.’ “In December 2000, the U.S. Office of Science and Technology Policy (OSTP) proposed a research misconduct policy, which was subsequently adopted by ten federal agencies. The Policy defines research misconduct as fabrication, falsification, and plagiarism, which are often collectively referred to as FFP. According to OSTP, ‘research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.’ It is important to note that ‘Research misconduct does not include honest error or differences of opinion’ (OSTP 2000, 76260-4). To be considered research misconduct, the behavior must have been performed ‘intentionally, knowingly, or recklessly.’ ” https://www.citiprogram.org/

Ok, but what do you mean by fabrication, falsification, and plagiarism?

making up data or results and recording or reporting them What is Fabrication? 10 years of fabrication In 2012, University of Kentucky biomedical researcher Eric Smart was discovered to have falsified or fabricated 45 figures over the course of 10 years. His research on the molecular mechanisms behind cardiovascular disease and diabetes was well regarded, despite his having used data from knockout mouse models that never existed. “Dr. Smart’s papers were highly cited in the specific caveolae/cardiovascular research field,” Philippe Frank of Thomas Jefferson University in Philadelphia told The Scientist. Smart resigned from his university post in 2011, when the investigation in his misconduct started, and agreed to exclude himself from federal grant applications for the next 7 years. He now teaches chemistry at a local school. By Edyta Zielinska http://www.the-scientist.com/?articles.view/articleNo/33695/title/Top-Science-Scandals-of-2012/ making up data or results and recording or reporting them http://ori.hhs.gov/definition-misconduct

What is Falsification? Record-setting retractions Setting the record for the most publications up for retraction by a single author, Japanese anesthesiologist Yoshitaka Fujii fabricated data in a whopping 172 papers. Beginning his career in falsification in 1993 while at the Tokyo Medical and Dental University, he continued it at the University of Tsukuba, and at Toho University in Tokyo, where he was finally dismissed in February 2012. According to investigations, Fujii never actually saw the patients he reported in his clinical studies, failed to get ethical review board approval for his research, and misled co-authors, sometimes including their names without their permission or knowledge. Although the retractions are not expected to have a large impact on the field—many of them had low citation rates—Fujii used the publications to further his career, publishing a total of 249 papers. By Edyta Zielinska http://www.the-scientist.com/?articles.view/articleNo/33695/title/Top-Science-Scandals-of-2012/ 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 http://ori.hhs.gov/definition-misconduct

What is Plagiarism? Plagiary Farooqui - He was a research associate professor of dermatology at the University of Cincinnati, who plagiarized material on hormone expression in human skin from the significance section of a National Science Foundation (NSF) grant application, as alleged by a reviewer for NSF, which the respondent had obtained from another confidential reviewer and used in his NIH grant application. After ORI imposed on him in 1996 a 3-year certification and non-service period, NSF OIG expanded the case, finding more of the same plagiarism in NSF applications, so NSF debarred him for an additional period. By Alan R. Price http://quod.lib.umich.edu/p/plag/5240451.0001.001/--cases-of-plagiarism-handled?rgn=main;view=fulltext the appropriation of another person's ideas, processes, results, or words without giving appropriate credit http://ori.hhs.gov/definition-misconduct

Why does this matter?

Research Misconduct affects Research Integrity Research integrity includes: the use of honest and verifiable methods in proposing, performing, and evaluating research reporting research results with particular attention to adherence to rules, regulations, guidelines, and following commonly accepted professional codes or norms. https://grants.nih.gov/grants/research_integrity/whatis.htm

605 Research Integrity https://www.youtube.com/watch?v=x_MsPvgetxw

Can research misconduct affect anything else?

Effects of Research Misconduct on Society Identifying and determining the impact of a research misconduct case can sometimes take years. Since society contributes to the advancement of knowledge through public funding, public trust can be betrayed. Funds, valuable resources and time are wasted when other researchers attempt to build on or replicate erroneous research. The public can be put at risk if false claims are made. https://www.citiprogram.org/

Effects of Research Misconduct on Researchers and their Organizations Direct costs from a full scale research misconduct investigation can cost well over $500,000. Funds from sponsors may need to be re-paid if an allegation is verified. Allegations of research misconduct can severely damage an organization’s reputation. It may be very difficult for a tarnished organization to attract potential sponsors and to recruit potential faculty and students. An individual researcher’s credibility will also be negatively affected. https://www.citiprogram.org/

Other Problematic Research Behaviors Questionable Research Practices – Behaviors that closely border on research misconduct but do not fall under its strict definition. Noncompliance – Conducting research in a manner that disregards or violates federal regulations or organizational policies. Sexual Harassment – This is sometimes a dimension of a research misconduct allegation if someone is pressured to engage in research misconduct. Authorship Disputes – Disagreements about authorship. These are ethically problematic but they are not included as part of the definition of research misconduct. https://www.citiprogram.org/

What can we do to prevent research misconduct?

Strategies for Preventing or Mitigating Research Misconduct “Setting the right tone and good mentoring go a long way towards enhancing research integrity. Encouraging mentoring throughout an organization is an effective strategy for preventing misconduct. Other prevention strategies, such as periodically verifying data collection methods, and discussing roles and responsibilities before and during a research project, are also essential. Seeking clarification and advice from trusted colleagues or an ombudsperson when something seems awry can also help avert misconduct. As Steinberg (2002) notes, ‘The smart move is to incorporate preventive strategies into your everyday business practices so staff and colleagues know what is expected of them and of you.’ ” https://www.citiprogram.org/

Quality Assurance and Quality Control “Quality assurance (QA): the systematic and independent examination of all trial-related activities and documents. These audits determine whether the evaluated activities were appropriately conducted and that the data were generated, recorded, analyzed, and accurately reported according to protocol, standard operating procedures (SOPs), and good clinical practices (GCPs). Quality control (QC): periodic operational checks within each functional department to verify that clinical data are generated, collected, handled, analyzed, and reported according to protocol, SOPs, and GCPs.” http://www.appliedclinicaltrialsonline.com/quality-control-and-assurance

What can we do if we witness research misconduct?

Responsibility to Report Misconduct “All institutional members will report observed, suspected, or apparent research misconduct to the RIO or, to the Compliance Hotline at 1-866-294-9352 (toll free). If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may meet with or contact the RIO or designee, to discuss the suspected research misconduct informally, which may include discussing it anonymously and/or hypothetically. If the circumstances described by the individual do not meet the definition of research misconduct, the RIO will refer the individual or allegation to other offices or officials with responsibility for resolving the problem. At any time, an institutional member may have confidential discussions and consultations about concerns of possible misconduct with the RIO or with the Institutional Compliance Office and will be counseled about appropriate procedures for reporting allegations.” http://elpaso.ttuhsc.edu/opp/_documents/73/op7307a.pdf https://secure.ethicspoint.com/domain/media/en/gui/44534/index.html

Summary Research misconduct is defined by fabrication, falsification, or plagiarism. Research misconduct does not include honest error or differences of opinion. Research misconduct affects research integrity. There exist other problematic behaviors that can also be seen as unethical but are not defined by research misconduct. Research misconduct not only affects society but researchers and organizations as well. There are several ways in which research misconduct can be mitigated or prevented As a member of the TTUHSC EP team, it is your responsibility to report observed, suspected or apparent research misconduct.

The Research Clinic http://ori.hhs.gov/TheResearchClinic

Resources TTUHSC El Paso HRPP Manual: http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf CITI Program https://www.citiprogram.org/ Quality Assurance and Quality Control http://www.appliedclinicaltrialsonline.com/quality-control-and-assurance The Office of Research Integrity http://ori.hhs.gov/definition-misconduct What is research integrity? https://grants.nih.gov/grants/research_integrity/whatis.htm The Office of Research Integrity Interactive Game “The Lab” http://ori.hhs.gov/thelab The Office of Research Integrity Interactive Game “The Research Clinic” http://ori.hhs.gov/TheResearchClinic YouTube https://www.youtube.com/watch?v=x_MsPvgetxw TTUHSC EP OP 73.07 http://elpaso.ttuhsc.edu/opp/default.aspx

Questions?