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Tuskegee Syphilis Study (1932-1972) |
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Conducted by the US Public Health Service Studied the natural progression of untreated syphilis Ethical Objections: researchers knowingly failed to treat patients Led to: major changes in US Law & informed consent |
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Nazi Medical War Crimes (1939-1945) |
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Medical experiments on prisoners Prisoners did not give consent Nuremberg Code |
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Basis for international ethics codes on voluntary consent 1. Importance for gaining voluntary consent 2. Avoidance of unnecessary physical/psychological suffering 3. Avoidance of research where death/disabling injury is likely 4. End any experiment if its continuation is dangerous 5. Research conducted only by highly qualified researchers 6. Research is conducted only for the good of society |
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Jewish Chronic Disease Hospital Study (1963) |
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US Public Health Study Experiments on the chronically ill - inject patients with cancerous cells Deception |
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Milgram Experiment (1961) |
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Tortured people in other room Psychological damage Did not tell subjects |
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Attempts to summarize basic ethical principles 1. Respect for persons 2. Beneficence 3. Justice |
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Individuals should be treated as autonomous agents Must be given the information they need to decide There should be no pressure to participate People with diminished autonomy may need additional protection - can still decide if able - guardian may decide |
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Participants enter into the research voluntarily and with adequate information. Participants can change their mind or withdraw at any time. |
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Making efforts to secure well being by maximizing possible benefits and minimizing possible harm. Balance risks and benefits |
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Participants are to be treated fairly |
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a living individual about whom a researcher obtains either data throughout intervention or interaction with the person or identifiable private information. |
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Researcher Responsibilities |
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1. The study is properly designed, scientifically sound, yields valid results. 2. Participation meets selection/eligibility requirements 3. The study is approved by IRB and conducted according to protocol 4. Informed consent is appropriately obtained 5. Protocol changes/adverse events are reported to the IRB 6. The rights and welfare of the participants are monitored throughout the study 7. All members of the research team are qualified and trained |
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Research participant must be competent to consent. |
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Comprehend Agree Be voluntary and free from coercion |
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Researcher must disclose all relevant information to potential participants. |
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Study purpose Nature of the research procedure Reasonable alternatives to the proposed intervention Risks, benefits, uncertainties of intervention |
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IRB (Institutional Review Board) |
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Comprised of researchers and community members Meet to review research proposals, ensuring that researchers are meeting responsibilities and protecting research participants Ensure respect for persons, beneficence, and justice |
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Describes what something means by relating it to other abstract concepts Use other words - not the root word. |
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3 Types of Conceptual Definitions |
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1. Daily: generally accepted by society (slang) 2. Poetic: figurative interpretations (lyrics) 3. Scholarly: specific, technical meanings (identify what is included and excluded) |
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Describes what is to be observed by specifying what researchers must do to make observations Provides specific steps The "recipe" |
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Moving from the conceptual definition to operational definition |
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a strong linkage between a conceptual definition an its operational definition The better the conceptual fit, the more likely it is that the researchers are observing the phenomenon they intend to study. Influenced by choice of measurement. |
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1. Nominal 2. Ordinal 3. Interval 4. Ratio |
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Numbers are used simply to identify or "name" a category The numbers are not important but represent a category |
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Uses rank order to determine differences but no info about differences. |
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Establishes equal distances between points on the measurement scale, but zero is arbitrary. |
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Extends interval to include an absolute zero |
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Researcher develops many statements about the variables being researched Multiple people rate the statements from 1 (most unfavorable) to 11 (most favorable) Statements that are rated consistently by most people are selected and assigned a value based on average scores Final statements then used to measure variables (questionnaire) |
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"Method of summated agreement" Create statements that clearly are positive or negative toward a topic Ask people to indicate the degree to which they agree or disagree Sum responses to all items Infer overall attitude from summed ratings |
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Create a series of bipolar adjectives with 5/7 point scales Ask people to select one point that expresses their attitude for each item Sum the scores for all items measuring each variable. |
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A cumulative scale. If you agree with the last item on the list, you should agree with all the others that came before it. |
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1. External 2. Internal 3. Measurement |
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Generalizability The results can be applied to a larger set of situations or people. |
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Accuracy of the conclusions The study should be designed and conducted so that it leads to accurate findings) |
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accuracy of the measures how well researchers measure what they intend to measure Technically a type of internal validity Consistency and reliability is a key aspect. |
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measures reliability in quantitative research. Can range from -1 (perfect neg.) 0 (no relationship) and 1 (perfect positive) .70 or greater indicates a reliable measure |
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To obtain reliability statistics... |
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1. Test-retest method. Make measurements more than once, if answers vary they might be wrong. 2. Split-half method. Split variables in half and the two groups should measure similarly. 3. Intercoder reliability. Independent coders or observers agree in their judgements. |
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Means that researchers measure their variables in a consistent and stable manner across time, questions, and individuals. |
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2 Types of Measurement Validity |
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1. Content Validity: the measure should appear to assess the variable being investigated. Face & Expert validity. 2. Construct Validity: the measure should relate appropriately to other theoretically consistent variables. |
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Threats to Internal Validity |
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1. History: changes in the external environment affect people in the study 2. Sensitization (or testing effect): initial measurement influences later measurement 3. Instrumentation: changes in the methods used to collect data 4. Maturation: physical or psychological changes within the participants over time 5. Mortality: loss of research participants in the course of the research 6. Selection: methods use to obtain participants. A threat to internal validity but also affects external validity. Use of appropriate sampling methods is key. |
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1. Random: probability 2. Non-Random: non-probability |
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1. Convenience Sampling 2. Purposive or Judgmental Sampling 3. Snowball Sampling 4. Quota Sampling |
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The Logic of Probability Sampling |
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1. A sample must reflect the same degree of variation as the actual population. 2. Non-probability samples are riddled with potential bias 3. To ensure representativeness all members of the population must have an equal chance of being selected 4. Uses probability theory to assess the degree of representativeness of the sample. |
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Types of Probability Sampling Designs |
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1. Simple Random Sampling 2. Systematic Sampling 3. Stratified Sampling 4. Multistage Cluster Sampling |
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Random selection is key. It guards against conscious or unconscious bias and enables the prediction of population parameters and estimates of error. Sample size matters. |
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