Handouts - SC Speech Language Hearing Association

Ethical Considersa0ons for Conduc0ng Clinical Research (SCSHA Session 15) February 26, 2015 Disclosures
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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
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MUSC, Student Tuition/Scholarships
MUSC, Employment Salary
MUSC, Graduate Assistant, Grant Support
n 
n 
n 
n 
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Relevant Non-Financial Relationships
¤ 
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MUSC, Clinical & Translational Research Ethics Certificate, Fellow
SCSHA, Member
ASHA, Member
n 
n 
¤ 
Ethics
¨ 
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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
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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
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¤  To
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“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
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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
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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”
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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!
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Implications
References
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An unethical study:
¤  Misuse
of people or resources
¤  Publication of incorrect or misleading results
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Beware of conflicts of interest!
¨ 
Who is responsible?
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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