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2 Responsible Conduct of Research Responsible Conduct of Research updated: 11/13/2012 ORA/Research Protections and Compliancewww.umbc.edu/research

Outline What are Research Ethics What is Responsible Conduct of Research FFP Examples Summary ORA/Research Protections and Compliancewww.umbc.edu/research

Responsible Conduct of Research The aim of discussing research ethics is to encourage integrity in the pursuit of scientific investigation and practice among of scientists, scholars, and professionals. Office of Research Integrity, Department of Health and Human Services In other words, be aware of: – –what it means to be a responsible researcher and how to conduct research “responsibly”   recognize ethical choices, make appropriate decisions and take appropriate actions based on those choices   encourage best practices in the conduct of research and scientific investigations   know that consequences will result from not complying with policies and procedures – –Doing the “right thing” “Do the right thing. It will gratify some people and astonish the rest.” – Mark Twain Peter Parker’s Uncle Ben: “Remember, with great power comes great responsibility. “ 4 ORA/Research Protections and Compliancewww.umbc.edu/research

Classic cases Hwang Woo-Suk South Korea Stem cell research Indicted on fraud, embezzlement, and bioethics violations Andrew Wakefield British gastroenterologist No Ethics Review Board approval Guilty of failure to disclose CoI, medical and scientific misconduct The Lancet and British Medical Journal retracted papers Eric Poehlman Obesity scientist First scientist to be imprisoned for falsifying information on a grant application Plead guilty to falsifying 17 NIH grant applications and fabricating data in 10 of his papers ( ) Diederik Stapel Dutch Psychologist Admitted that he had falsified data in some of his publications Many/most of his experiments never happened 150 publications he co-authored are under review 14 of 21 PhD theses that he supervised are in question

Research ethics fall within RCR Data Acquisition, Management, Sharing and Ownership Accurate collection of data and managed properly for confidentiality and privacy purposes Conflict of Interest & CommitmentManagement of real or perceived interference to assure that the interests do not adversely influence the research Research MisconductAvoid and deal with issues of egregious behavior (i.e. fabrication, falsification, or plagiarism – FFP) Publication Practices & Responsible AuthorshipAccurate report of the results and an honest and open assessment of the finding Mentor / Trainee ResponsibilitiesClear understanding of mutual responsibilities/proper supervision and a commitment for a productive environment Peer ReviewEvaluation by colleagues with similar knowledge and experience for self-regulation of the discipline CollaborationCollaborative research roles should be clarified early discussing and reaching agreement on the details Human SubjectsProtection of subjects and compliance with relevant Federal regulations as well as institutional guidelines and policies Research Involving AnimalsHumane care and use and compliance with relevant Federal regulations as well as institutional guidelines and policies Safe Laboratory Practices Safety of all project personnel and proper use of material – biosafety, hazardous materials, etc. ORA/Research Protections and Compliancewww.umbc.edu/research

Fig. 1. The nine circles of scientific hell (with apologies to Dante and xkcd). Neuroskeptic Perspectives on Psychological Science 2012;7: Copyright © by Association for Psychological Science ORA/Research Protections and Compliancewww.umbc.edu/research

Research misconduct Research misconduct means fabrication, falsification or plagiarism in proposing, performing or reviewing research, or in reporting research results. Research misconduct does not include honest error differences of opinion. ORA/Research Protections and Compliancewww.umbc.edu/research

FFP Fabrication (making up data or results and recording or reporting them) Falsification (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) Plagiarism (taking another person's ideas, processes, results, or words without giving appropriate credit) ORA/Research Protections and Compliancewww.umbc.edu/research

Examples Dr. Happy published an article in the Journal of Social Sciences. She was very excited about her findings that people really like anatomy class. Her study enrolled18 subjects. Her paper, however, indicated that 50 subjects had enrolled in the study, giving her theory more weight Is this research misconduct? 2. If so, is it falsification, fabrication, or plagiarism? Extracted from Powerpoint presentation - Tonya K. Edvalson, Research Compliance Manager, University of Utah - SRA Western/Northeast Section Meeting March 19, 2012

Examples Dr. Seuss studied children and their ability to rhyme after reading his books. He tested 47 children who all seemed to retain 50% of his stories after hearing them five times. He published this in the Journal of Great Children’s Books. He was employed by a University and received federal funding for his study. He believed his study to be exempt from IRB review Is this research misconduct? 2. If so, is it falsification, fabrication, or plagiarism? Extracted from Powerpoint presentation - Tonya K. Edvalson, Research Compliance Manager, University of Utah - SRA Western/Northeast Section Meeting March 19, 2012

Examples Melissa Jones is a graduate student in Dr. Really Smart’s laboratory. They are in the process of submitting a grant application and reviewing it for the tenth time for errors. Melissa notices a paragraph that is very familiar. She remembers it was one she thought she used in her recently published article. The grant application does not credit her for her contribution to the text Is this research misconduct? 2. If so, is it falsification, fabrication, or plagiarism? Extracted from Powerpoint presentation - Tonya K. Edvalson, Research Compliance Manager, University of Utah - SRA Western/Northeast Section Meeting March 19, 2012 ORA/Research Protections and Compliancewww.umbc.edu/research

Examples Dr. Incredibly Brave and Dr. Incredibly Strong recently collaborated on a research project at the University of Super Heroes (USH). They planned to publish their work before Dr. Brave left the University. Dr. Strong published the article without recognition to Dr. Brave. Dr. Brave complained to the Research Integrity Officer at USH that the article was plagiarized because it was their collective work Is this research misconduct? 2. If so, is it falsification, fabrication, or plagiarism? Extracted from Powerpoint presentation - Tonya K. Edvalson, Research Compliance Manager, University of Utah - SRA Western/Northeast Section Meeting March 19, 2012 ORA/Research Protections and Compliancewww.umbc.edu/research

Remember Uncle Ben’s advice Ask questions to gain knowledge and support… this impacts decision making and ultimately affects the action we take Be honest and transparent, not deceptive (e.g., falsifying, fabricating, or plagiarizing data or deceitful attribution of authorship) Be fair by not introducing unwanted bias into research results, conclusions, or inferences (e.g., conflicts of interest and commitment, sloppiness) Be benevolent, not be malicious (e.g., thievery of ideas, unfair criticism during peer review for personal gain; exploitive of others) Protect participants, research personnel, and the environment Be open to creativity and innovation Protect the public trust John Galland, Office of Research Integrity, 2009, Steps That Should Be Taken ( ORA/Research Protections and Compliancewww.umbc.edu/research

Interactive Movie on Research Misconduct "The Lab: Avoiding Research Misconduct" Choose a character in an interactive movie and make decisions about integrity in research that can have long- term consequences. The simulation addresses topics of RCR. ORA/Research Protections and Compliancewww.umbc.edu/research

16 Questions ORA/Research Protections and Compliancewww.umbc.edu/research