Responsible Conduct of Research 101 Allison Griffin Ratterman

Responsible Conduct of Research 101 Allison Griffin Ratterman, Ph. D. Director, Research Integrity Program Office of the Executive Vice President for Research and Innovation University of Louisville

The Average Researcher

Research Compliance How many regulations impact the conduct of research?

Why do we care about conducting ethical research? l First and foremost, it is the right thing to do! l 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 l As funded researchers, we must be accountable stewards of those funds and conduct ourselves in an integrity driven manner

Compliance and Training Milestones Institution Driven ◦ Position ◦ Role ◦ Employment Location Facility Driven ◦ Hospitals ◦ Center for Predictive Medicine ◦ Private Practice

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

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

Key Contacts Human Subjects -852 -5188 Privacy - 852 -3803 Animal Use - 852 -7307 Environmental Health and Safety – 852 -6670

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

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

Conflicts of Interest 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

Conflicts of Interest: University Research Enterprise � 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

Conflicts of Interest: Types of Conflicts in Research 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

Conflicts of Interest: University Process The University has established policies that define potential conflicts and provide guidelines and procedures for limiting and managing them. Annual disclosure requirement (at least annually or within 30 days of change Thresholds for disclosure have been lowered External Interests must be reviewed across the aggregate relationship Training is required Relationships with non-profits are no longer exempt from disclosure Directly sponsored or directly reimbursed travel must be disclosed

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

Fiscal Responsibility Financial Stewardship Institutional and Sponsor Requirements Training required

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

Professional Standards Authorship and Publication Collaboration Data Management and Stewardship Mentor / Mentee Relationships Peer Review

Authorship and Publication 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. (Sep 2000 ) Authorship. Journal of the American Academy of Nurse Practitioners. (V 12, I 9, p 351). Retrieved August 3, 2009 from http: //web. ebscohost. com/ehost/pdf? vid=6&hid=9&sid=80 c 85 c 3 f-550 d-4411 -af 19 -666 faaec 0 dd 1%40 sessionmgr 11

Authorship and Publication All authors should review final before submission Be prepared to produce original data Be prepared to produce breakdown of contributions Nativio, D. G. (Sep 2000 ) Authorship. Journal of the American Academy of Nurse Practitioners. (V 12, I 9, p 351). Retrieved August 3, 2009 from http: //web. ebscohost. com/ehost/pdf? vid=6&hid=9&sid=80 c 85 c 3 f-550 d-4411 -af 19 -666 faaec 0 dd 1%40 sessionmgr 11

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

Data Acquisition, Management, Sharing and Ownership 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.

Mentor / Mentee Relationships 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. (1998 -1999) 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

Mentor / Mentee Relationships 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. (1998 -1999) 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

Peer 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

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

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

Social Responsibility in Research with Vulnerable Populations International Research on Controversial Issues Dual Use Technologies Genetic manipulation of plants, organisms, people

Keys to Socially Responsible Research 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

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

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

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

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

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

Research Misconduct Proceedings Allegations of Research Misconduct ◦ Consult with Research Integrity Ombudsperson Barbara Speck (Nursing) Richard Stremel (Physiology) Eleanor Lederer (Renal Medicine) Douglas Darling (Dentistry) Michael Perlin (Biology) Cathy bays (Delphi/Nursing) ◦ Consult with Research Integrity Allison Ratterman – 852 -2453

Unacceptable Research Practices 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.

Research Misconduct Proceedings 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

Research Misconduct Proceedings 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

Getting all the pieces… Plan, then act When in doubt, ask Make use of available resources both inside your unit, your institution and beyond…

Available Resources Faculty and Administrators Research Integrity Program Professional Societies Colleagues

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 akgrif 01@louisville. edu ori@louisville. edu 502 -852 -2454 research. louisville. edu/researchintegrity

Sources used for this presentation include: http: //louisville. edu/research/humansubjects/investigator-research-team-information www. asiaplanet. net http: //web. missouri. edu/~bondesonw/Laud. html www. kwintessential. co. uk/resources/global-etiquette “Culture and Global Business Research” road. uww. edu/. . . /Marketing%20 Research%20 Spring “Responsible Conduct of Research” presentation by Allison Griffin Ratterman Ph. D “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 : http: //office. microsoft. com/enus/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. http: //louisville. edu/research/humansubjects/investigator-research-team-information