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How many regulations impact the conduct of research?

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Presentation on theme: "How many regulations impact the conduct of research?"— Presentation transcript:

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3 How many regulations impact the conduct of research?

4 Why do we care about conducting ethical research? First and foremost, it is the right thing to do! As an institution of higher learning, we strive daily to nurture and strengthen our relationship with the community. A headline or news item on TV or radio can shatter that trust in a matter of seconds As funded researchers, we must be accountable stewards of those funds and conduct ourselves in an integrity driven manner

5  Institution Driven ◦ Position ◦ Role ◦ Employment Location  Facility Driven ◦ Hospitals ◦ Center for Predictive Medicine ◦ Private Practice

6  Activity Driven ◦ Animals ◦ Humans ◦ Chemicals / Hazardous Materials / Equipment  Data Driven ◦ Protected Health Information ◦ Confidential / Sensitive Data  Sponsor Driven ◦ Training ◦ Reporting ◦ Purchasing / Spending

7 Responsible Conduct of Research Human Subjects HIPAA Animal Subjects Biological and Environmental Safety Conflicts of Interest Fiscal Responsibility Professional Standards Social Responsibility in Science Research Misconduct

8 Responsible Conduct of Research Human Subjects HIPAA Animal Subjects Biological and Environmental Safety Conflicts of Interest Fiscal Responsibility Professional Standards Social Responsibility in Science Research Misconduct

9 Conflict of Interest is not a “four letter word”… but even in the best of times it can be confusing to navigate

10  Why do we care???? ◦ It helps to assure the public that the research community is acting in conformity with the spirit and guidelines of the University of Louisville Policy and with the public good in mind ◦ Newspaper Headlines ◦ Governmental Agency Reports ◦ Scientific Journals ◦ Funding Agencies

11  University of Louisville supports technology transfer  to patent and license,  to participate in the establishment of industry partnerships,  to accept company-sponsored research funding, and  to consult.  Federal government has mandated that universities seek to commercialize the results of federally supported research for the public good

12  Conflict of Financial Interest ◦ A researcher has a responsibility to respect the well being of the University  Conflict of Research Integrity ◦ Researchers should maintain the highest level of scientific integrity in the conduct of research. The complete, objective, and timely distribution of new findings through publications and presentations, is essential for research integrity.  Conflict of Educational Mission ◦ Students and post-doctoral fellows must be assured of an educationally appropriate training program  Conflict of Commitment ◦ The workforce owes its primary commitment and allegiance to the University

13  The University has established policies that define potential conflicts and provide guidelines and procedures for limiting and managing them.  Annual disclosure requirement remains in effect  Thresholds for disclosure have been lowered  Training is required  External Interests must be reviewed across the aggregate relationship  Relationships with non-profits are no longer exempt from disclosure  Directly sponsored or directly reimbursed travel must be disclosed

14 Responsible Conduct of Research Human Subjects HIPAA Animal Subjects Biological and Environmental Safety Conflicts of Interest Fiscal Responsibility Professional Standards Social Responsibility in Science Research Misconduct

15  Financial Stewardship  Institutional and Sponsor Requirements  Training required

16 Responsible Conduct of Research Human Subjects HIPAA Animal Subjects Biological and Environmental Safety Conflicts of Interest Fiscal Responsibility Professional Standards Social Responsibility in Science Research Misconduct

17  Authorship and Publication  Collaboration  Data Management and Stewardship  Mentor / Mentee Relationships  Peer Review

18  Original work in which the author has made a new and significant intellectual contribution to others  Be Careful! ◦ Taking Credit=Responsibility for Accuracy  Avoid Dilution ◦ Only include those who significantly contributed ◦ Laboratory, financial or technical assistance (i.e.) may be acknowledged with consent  Author Order ◦ Responsibility of Principals and determined early! ◦ Become familiar with order of authorship in your discipline  Nativio, D.G. (Sep2000 ) Authorship. Journal of the American Academy of Nurse Practitioners. (V12, I 9, p351). Retrieved August 3, 2009 from

19  All authors should review final before submission  Be prepared to produce original data  Be prepared to produce breakdown of contributions  Nativio, D.G. (Sep2000 ) Authorship. Journal of the American Academy of Nurse Practitioners. (V12, I 9, p351). Retrieved August 3, 2009 from

20  Basis of collaborative arrangement is “contractual”  Look ahead, plan ahead, anticipate  Be direct and honest about possible problems, misunderstandings

21  In shared research all must adhere to ethical standards.  Confidentiality when promised or appropriate should be maintained.  Design and conduct research with honesty and integrity.  Original data must be recorded, preserved, made accessible to University.

22  What the Mentor can do! ◦ Serve as a Positive Role Model ◦ Be Available ◦ Continually Evaluate Progress and Performance ◦ Serve as Career Coach ◦ Engage Beyond Current Projects ◦ Encourage Relationships ◦ University of Louisville Graduate School Graduate Council. ( ) Mentor and Graduate Student Strategies for Success. Retrieved August 3, 2009 from https://graduate.louisville.edu/pubs/mentor-and-graduate-student-strategies-for-success.html

23  What the Mentee can do! ◦ Keep in Touch  Problems ◦ Contribute Knowledge  Good mentors know mentees will surpass them ◦ Seek Advice from Others  From best prepared ◦ Change the relationship if necessary  Not all are successful ◦ University of Louisville Graduate School Graduate Council. ( ) Mentor and Graduate Student Strategies for Success. Retrieved August 3, 2009 from https://graduate.louisville.edu/pubs/mentor-and-graduate-student-strategies-for-success.html

24  Reviewers shall provide reviews that are thorough  Reviewers shall provide reviews that are unbiased  Reviews should be done in a timely fashion  Expert reviews and the materials being evaluated shall remain confidential

25 Responsible Conduct of Research Human Subjects HIPAA Animal Subjects Biological and Environmental Safety Conflicts of Interest Fiscal Responsibility Professional Standards Social Responsibility in Science Research Misconduct

26 Why do we care about conducting socially responsible (ethical) research? Ethical questions arise because of social responsibilities to others in the community and because behavior is capable of influencing the welfare of others

27  Research with Vulnerable Populations  International Research  Research on Controversial Issues  Dual Use Technologies  Genetic manipulation of plants, organisms, people

28  Valid research design  Competent research personnel  Consequences / Impacts have been identified and addressed as needed  Design, Performance and reporting of the research is free from bias

29 Responsible Conduct of Research Human Subjects HIPAA Animal Subjects Biological and Environmental Safety Conflicts of Interest Fiscal Responsibility Professional Standards Social Responsibility in Science Research Misconduct

30  Research Misconduct means fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting research results

31  Making up data or results and recording or reporting them It would have taken me forever to actually perform all of those tests.

32  Altering raw data for reporting purposes 22% 98% 12% 100% Sample size: 16 Sample size: 900

33  Reporting others’ data, ideas, processes, results, or words without giving credit by acknowledging the source Copier

34  Allegations of Research Misconduct ◦ Consult with Research Integrity Ombudsperson  Barbara Speck (Nursing)  Richard Stremel (Physiology)  Eleanor Lederer (Renal Medicine)  Douglas Darling (Dentistry) ◦ Consult with Research Integrity  Allison Ratterman –

35  While not meeting the federal definition of research misconduct, the following behaviors are examples of unethical research practices: ◦ Forging a practitioner's signature on medical orders; ◦ Breaching human subject confidentiality; ◦ Failing to obtain IRB and/or FDA approval for changes implemented in an approved protocol. ◦ Serious deviation from accepted practices in proposing or carrying out research, improper manipulation of experiments to obtain biased results, deceptive statistical or analytical manipulations, or improper reporting of results. ◦ Improper use of information gained by privileged access, such as information obtained through service on peer review panels and editorial boards. ◦ Deliberately sabotaging or physically damaging the laboratory research set up, equipment, or records.

36  Allegations of Research Misconduct Process ◦ Allegation Referral Form  Dr. Ratterman will work with you to complete the form ◦ Research Integrity Ombudsperson performs Preliminary Assessment ◦ Depending on outcome of assessment, inquiry may be opened

37  Allegations of Research Misconduct Process ◦ Inquiry determines whether alleged actions meet regulatory criteria of research misconduct or unacceptable research practices  If yes, investigation opened  If no, recommendation made for resolution of any identified issues ◦ Investigation determines if misconduct occurred, by whom and to what extent ◦ Deciding Official determines institutional action required

38  Plan, then act  When in doubt, ask  Make use of available resources both inside your unit, your institution and beyond…

39  Faculty and Administrators  Research Integrity Program  Professional Societies  Colleagues

40 Questions???? If you have questions about anything included in this presentation, please feel free to contact: Allison Griffin Ratterman, Ph.D. Research Integrity Program Office of the Executive Vice President for Research research.louisville.edu/researchintegrity

41 Sources used for this presentation include: “Culture and Global Business Research” road.uww.edu/.../Marketing%20Research%20Spring “Responsible Conduct of Research” presentation by Allison Griffin Ratterman PhD “The Research Integrity Program” presentation by Laura Engel Screen Beans Art : © A Bit Better Corporation, used under licensed permission Clip art provided by Microsoft “Clip art on Office Online” at : us/clipart/download.aspx “Ethical Concerns in Research: What is all the fuss about?” The Research Integrity Program, University of Louisville, Presentation by Allison Griffin Ratterman Ph. D.


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