Ethics

Front 1

conflict of interest

Back 1

is when a researchers primary interest in the integrity of the study is compromised by a secondary interest such as personal gain

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nuremberg code

Back 2

was developed after the nazi war. it is a list of 10 principles to guide research involving human subjects

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thailidomided tragedy

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children with serious birth defects after given the drug thailidomide as a dedative, the drug wasnt properly tested but the big farmasudical companies wanted it on the shelf asap

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kefauver harris amendments

Back 4

manufacturers are now required to present evidence on the safety and effectiveness of their product to the FDA before marketing. people have to volunteer to be in clinical trials

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declaration of Helsinki

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guide to how to deal with human subjects

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tuskegee syphilis study

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40 year observational study to see untreated syphilis men they were told they were given treatment when they were infact not

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national research act

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act passed by us congress to try and have ethics in research

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belmont report

Back 8

respect for person

beneficence

and justice

report done to show basic standards and underlie that should be conducted with human subjects

Front 9

respect for persons

Back 9

people are to be treated as independent and autonomous individuals

Front 10

vulnerable populations

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those who may not be in full control of their decision making

Front 11

assent

Back 11

that a child has agreed to participate in a study. depends on a childs developmental levels

Front 12

informed concent

Back 12

the study tells the participants about the risks involved in participation, all participants must give their concent

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voluntary participation

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the right of the voluntary participant to terminate the study without any consequences

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beneficences

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the expected impact of a persons well being that may result from participating in the study the benefits should out number the risks

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justice

Back 15

participations in research should be based on fairness and not circumstances that give researchers access to or control of a population based on status

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anonymity

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that no one not even the researcher should be able to identify the individual based on the data

Front 17

de identifications

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the process of removing identifying information from data sets in order to assure the anonymity

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institutional review boards (IRBS)

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a panel of people who review research proposals with respect to ethical implications and decide whether additional actions need to be taken to assure the safety of and rights of participants.

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protocol

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a detailed summary of the purposes and procedures of the study

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phase i study

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giving drugs to a small group of people to test side effects and dosage

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phase II

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to see if it is effective and it evaluates its safety

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phase III

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give it to a large group of people to test is effectivness, and will allow the drug or treatment to be used safely

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research misconduct

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fabrication

falsification

plagirism

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plecemeal and duplicate publication

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possibilty that you could maximize reward if you were to re package data into different artcles using the same data study

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fairness in publication credit

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should be based on quantity and quality of researchers contribution to the study