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Ethics of Nursing ResearchFoundations of Nursing Research

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What are the most infamous examples of unethical research behavior? (3)
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Nuremberg experiments in Germany Japanese experiments during WWII Tuskeegee Experiment
What is the book The Truth about Unit 731 about?
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The atrocities performed in the name of science by the Japanese biological warfare unit
What are six ethical standards that are part of the Nuremberg code of 1947?
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1-The researcher must inform the subjects about the study 2-Research must be for the good of society 3-Research must be based on animal experiments if possible 4-The researcher must attempt to avoid harm to the subjects 5-The researcher must be qualified to conduct research 6-The subject or the researcher can stop the study if problems occur.
The United Nations adopted the __________ to guide ethical research practices.
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The Universal Declaration of Human Rights
The World Medical Association adopted the ________ to guide ethical research.
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Declaration of Helsinki (last updated 2000).
What is the Belmont Report? Who created it?
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A document published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It outlines three basic principles related to research subjects.
What are the three guiding principles of the Belmont Report?
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Respect for persons: research subjects should have autonomy and self determination Beneficence: research subjects should be protected from harm Justice: Research subjects should receive fair treatment
For which specific groups did the Department of Health and Human Services establish special guidelines for research involving them as participants?
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Children, mentally retarded individuals, and prisoners.
What is an IRB and what is its purpose?
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An IRB is an institutional review board. Every agency or committee that receives federal funding for research must have an IRB to review proposals.
What organization oversees IRBs?
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The Office of Protection from Research Risk (OPRR), a division of the federal government.
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How does HIPAA impact information gathered for research?
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Authorization for use and disclosure of the subject's information must be obtained in writing. Researchers may need to get the signature on a different document or integrate it into the informed consent document.
What organization published a set of guidelines specifically for nursing research?
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The American Nurses Association Research and Studies Commission
What document has the guidelines for nursing research as outlined by the ANA's Research and Studies Commission?
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Human Rights Guidelines for Nurses in Clinical and Other Research (1965, 1975, and 1985) and the Ethical Guidelines in the Conduct, Dissemination and Implementation of Nursing Research (1995)
What do the guidelines for nursing research address?
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The rights of research subjects and nurses involved in the research. Subjects must be protected from harm, be ensured privacy and dignity. Nurses should be fully informed about the purpose of the research and should be included on IRBs that review research proposals.
What is the major difference between the Human Rights Guidelines for Nurses in Clinical and Other Research document and the Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research document?
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There is more emphasis in the Ethical Guidelines document on research integrity and the reporting of suspected, alleged or known incidents of scientific misconduct.
What organization investigates suspected misconduct by researchers?
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The Office of Research Integrity (ORI), which is part of Department of Health and Human Services.
The principles means of ensuring the rights of research subjects are protected is through __________.
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Informed consent
_____________ concerns the subjects' participation in research in which they have a full understanding of the study before the study begins.
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Informed consent
The 12 major elements of informed consent are:
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-The researcher is identified and credentials presented -Subject selection process is identified -Purpose of the study is described -Study procedures are discussed -Potential risks are described -Potential benefits are described -Compensation, if any, is discussed -Alternative procedures, if any, are disclosed -Anonymity or confidentiality is assured -Right to refuse to participate or to withdraw from the study without penalty is assured -Offers to answer all questions is made -Means
I am a student at the University of Louisville and I am conducting a study as part of requirements for Kaiser Permanente's drug efficacy research... is an example of what part of informed consent?
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Identification of the researcher and presentation of credentials
  
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