Slide 1Chapter 7 – Data EthicsEthics Violations and ProtectionsAlso,Clinical TrialsClinical TrialsBehavioral and Social Science ExperimentsChapter 8 – Measuring Chapter 9 – Do Numbers Make Sense?Percent ChangeSlide 10MeasurementExample:Example:Further…Example:Measurements, valid and invalidSlide 17Your scale has two kinds of errors: BIAS and RANDOM ERRORYour scale has two kinds of errors: BIAS and RANDOM ERRORWe can think about errors in measurement this way:Chapters 7, 8, 91Chapter 7 – Data Ethics•American Statistical Association (ASA) – Largest and most well-know organization of statisticians (www.amstat.org )•Emphasis on ethics well known. See their “Ethical Guidelines for Statistical Practice” (http://www.amstat.org/about/ethicalguidelines.cfm ) address eight general topic areas and specify important ethical considerations:•A. Professionalism: need for competence, judgment, diligence, self-respect, and worthiness of respect of other people •B. Responsibilities: practitioner's responsibility for assuring that statistical work is suitable to the needs and resources of those who are paying for it, that funders understand the capabilities and limitations of statistics in addressing their problem, and that the funder's confidential information is protected •C. Responsibilities in Publications and Testimony: report sufficient information to give readers, including other practitioners, a clear understanding of intent of work, how and by whom it was performed, and any validity limitations•D. Responsibilities to Research Subjects: protecting the interests of human and animal subjects of research – not only during data collection but also in the analysis, interpretation, and publication of the resulting findings•E. Responsibilities to Research Team Colleagues addresses the mutual responsibilities of professionals participating in multidisciplinary research teams•F. Responsibilities to Other Statisticians or Statistical Practitioners: interdependence of professionals doing similar work, whether same or different organizations (i.e., contribute to the strength of their professions overall by sharing nonproprietary data and methods, participating in peer review, and respecting differing professional opinions)•G. Responsibilities Regarding Allegations of Misconduct: investigating potential ethical violations and treating those involved with both justice and respect. •H. Responsibilities of Employers: recognize the highly interdependent nature of statistical ethics and statistical validity•Must not pressure practitioners to produce a particular "result," regardless of its statistical validity•Avoid the potential social harm that can result from the dissemination of false or misleading statistical work2Ethics Violations and Protections•Obvious ethics violations which are hopefully obvious to the general public•Using deception in order to obtain responses•Publishing fake data•Leaving subjects out of the analysis because their results don’t say what you want them to say, etc… •Other ethics violations are not so obvious•Subject of debate•Need systems in place to define ethical violations and help avoid them•Federal Guidelines to Protect Human Subjects in Research requires research (directly or indirectly) supported by the Dept of Health and Human Services to have an Institutional Review Board (IRB) which:•Reviews studies in advance to protect the subjects from possible harm•Does not decide whether the study will produce valuable information•Must have at least five members•At least one scientist, one non-scientist, at least one unaffiliated with the org•Members should be diverse (race, gender, and culture)•Check out our university’s IRB http://orc.research.sc.edu/irb.shtml 3Also,•If research involves human subjects, Informed Consent must be obtained before data are collected•Informed in advance about any risk of harm•Consent is usually in writing•All individual data must be kept confidential•Only statistical summaries for groups of subjects may be made public•Anonymity – subjects’ names are not known, even to the director of the study •difficult to follow-up with the patient later•Anonymity is not common is statistical studies4Clinical Trials•Experiments that study the effectiveness of medical treatments on actual patients•Use randomized comparative experiments to study the effectiveness of newly proposed treatments / drugs•Can be risky•World Medical Association, formed in 1947, with mission is to “to serve humanity by endeavoring to achieve the highest international standards in Medical Education, Medical Science, Medical Art and Medical Ethics, and Health Care for all people in the world”•Developed Declaration of Helsinki – a statement of ethical principles:•Provide guidance to physicians and other participants in medical research involving human subjects•“In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.”•Medical treatments in clinical trials ONLY when there is reason to hope that they will help the patients in the trials•Well-being of subjects must come first•Future benefits alone cannot justify any experiment with human subjects5Clinical Trials•Are Placebo Controls Ethical? •Long been debated in terms of ethics•Arguments for and against them•Recent controlled experiment and ethical debates•http://www.nytimes.com/2010/09/19/health/research/19trial.html•National Institute of Health (clinicaltrials.gov) - Phases of Clinical Trials•Phase I trials: researchers test experimental drug or treatment in small group of people (20-80) for first time to evaluate safety, determine safe dosage range, and identify side effects•Phase II trials: experimental study drug or treatment given to larger group of people (100-300) to see if effective and to further evaluate safety•Phase III trials: experimental study drug or treatment given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare commonly used treatments, and collect information that to allow experimental drug or treatment to be used safely•Phase IV trials: post marketing studies delineate additional information including the drug's risks, benefits, and optimal use•More stringent Phase IV testing needed?•Vioxx – drug approved for treatment of arthritis with8,076