Ethical Considersa0ons for Conduc0ng Clinical Research (SCSHA Session 15) February 26, 2015 Disclosures ¨  R. Jordan Hazelwood, M.Ed., CCC-SLP, BCS-S, CBIS, CCRE South Carolina Speech Language Hearing Association February 26, 2015 | Myrtle Beach, SC | Session 15 Relevant Financial Relationships ¤  ETHICAL CONSIDERATIONS FOR CONDUCTING CLINICAL RESEARCH ¤  ¤  MUSC, Student Tuition/Scholarships MUSC, Employment Salary MUSC, Graduate Assistant, Grant Support n  n  n  n  ¨  Relevant Non-Financial Relationships ¤  ¤  ¤  MUSC, Clinical & Translational Research Ethics Certificate, Fellow SCSHA, Member ASHA, Member n  n  ¤  Ethics ¨  ¨  ¨  Dysphagia Research Society, Member medicine, politics, law, philosophy Respect for persons (Autonomy) ¤  Informed consent vulnerable subjects ¤  Confidentiality ¤  Protect “right” answer Bioethics reviews ethical concepts within biology and medicine ¤  Technology, SIG 13, General Member SIG 13, Education Committee Member Ethical Principles Seeks to resolve questions of morality Systematically defends the concepts of right or wrong ¤  No ¨  NIH/NIDCD 1K24DC12801, Research and Mentoring on Swallowing Impairment and Respiratory-Swallow Coordination, 2013-2018 VA RR&D I21RX001364-01, Small Projects in Rehabilitation Research (SPiRE), 2013-2015 VA RR&D C7135R, Respiratory Phase Training in Dysphagic Veterans with Oropharyngeal Cancer, 2010-2013 NIH/NICDC 1R21DC010480-A1, Respiratory Phase Training in Head and Neck Cancer, 2009-2012 ¨  Beneficence ¤  Valid scientific methodology risks not greater than likely benefits ¤  Acceptable ¨  Justice ¤  Fair distribution of benefits/burdens vulnerable populations ¤  Includes Statistics Study involving the art and science of data analysis ¨  Framed around probability, or the chance of something occurring ¨  Purpose ¨  reduce large amounts of data to manageable format ¤  To assist in making inferences ¤  To organize and summarize data ASHA Guidelines for the Responsible Conduct of Research ¨  ¤  To ¨  “The discipline of communication sciences and disorders (CSD) is committed to advancing knowledge through basic, translational, and applied research regarding (a) normal speech, language, hearing, and swallowing; (b) the nature, prevention, and amelioration of communication and swallowing disorders; and (c) intervention strategies and the effectiveness, efficiency, and outcomes of clinical treatment. The American Speech-LanguageHearing Association (ASHA) believes that advancements in basic knowledge and clinical practice emerge from the diligent application of sound research methodologies and the peer-reviewed, published dissemination of findings.” “The responsible conduct of research—from the earliest stages of a project and onward—has a direct bearing not only on the quality of any resulting article but also on ethical issues that arise during the publication process. These guidelines are intended to help researchers avoid ethical pitfalls through all phases of the research and publication process.” http://www.asha.org/policy/GL2009-00308.htm#sthash.a9lirsHV.dpuf R. Jordan Hazelwood, M.Ed., CCC-‐SLP, BCS-‐S, CBIS, CCRE 1 Ethical Considersa0ons for Conduc0ng Clinical Research (SCSHA Session 15) Research Stages February 26, 2015 Planning Planning Research question Hypothesis ¨  Population ¨  Inclusion/Exclusion ¨  Location ¨  Outcome variables ¨  End points ¨  Literature review ¨  ¨  Publication Interpretation Data Analysis Design Execution Data Processing Design Safety Time ¨  Blinding ¨  Randomization ¨  Sample Size ¨  Reliability/Validity Execution Data Collection Fabrication ¨  Falsification ¨  Intent-to-treat ¨  Interim statistical analysis plans ¨  Data Safety Monitoring Board ¨  ¨  ¨  ¨  ¨  Why are some clinical trials impossible to conduct? Data Processing Data cleaning Data entry ¨  Data dictionary coding Data Analysis Missing data Statistical testing ¨  Transformation ¨  Outliers ¨  Theoretical “drive” ¨  ¨  ¨  ¨  R. Jordan Hazelwood, M.Ed., CCC-‐SLP, BCS-‐S, CBIS, CCRE 2 Ethical Considersa0ons for Conduc0ng Clinical Research (SCSHA Session 15) Interpretation Graphical representation Drawing conclusions ¨  Information out of context ¨  Statistical vs. Clinical significance February 26, 2015 Publication Reporting survey results Knowing your audience ¨  REPLICATION! ¨  ¨  ¨  ¨  Implications References ¨  An unethical study: ¤  Misuse of people or resources ¤  Publication of incorrect or misleading results ¨  Beware of conflicts of interest! ¨  Who is responsible? ¨  ¨  ¨  Altman DG (1980, Nov). Statistics and ethics in medical research: misuse of statistics is unethical. British Medical Journal, 281, 1182-1184. Lang T, Altman D (2013). Basic statistical reporting for articles published in clinical medical journals: the SAMPL Guidelines. In: Smart P, Maisonneuve H, Polderman A (eds). Science Editor’s Handbook, European Association of Science Editors. Failure to guard against these occurrences is certainly unethical! MUSC’s Fellowship in CTRE Program Questions? The Fellowship in Clinical and Translational Research Ethics program was created as part of the Clinical Research Ethics Core of the South Carolina Clinical and Translational Research Institute. The program is designed to provide health professionals who are interested in clinical research ethics with sufficient background in that discipline to warrant special recognition in the form of a Certificate in Clinical Research Ethics. R. Jordan Hazelwood, M.Ed., CCC-SLP, BCS-S, CBIS, CCRE Medical University of South Carolina Charleston, SC [email protected] http://academicdepartments.musc.edu/humanvalues/cre %20fellowship%20program/CTRE%20home%20page R. Jordan Hazelwood, M.Ed., CCC-‐SLP, BCS-‐S, CBIS, CCRE 3