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| Basic principles of Belmont Report |
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Definition
Respect for persons
Beneficence
Justice |
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Definition
| Proclaims individuals capable of self-determination |
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Definition
| Obligates researchers to maximize potential benefits and minimize possible harm |
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Definition
| Requires the benefits and burdens of research be fairly distributed |
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Term
| The two most overriding rules of ethics are |
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Definition
| that participants should not be harmed in any way and that the participants' privacy rights are maintained |
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Definition
| telling research participants about all aspects of the research that might reasonably influence their decision to participate |
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Term
| Four important elements of informed consent |
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Definition
1. Subjects are fully aware of nature and purpose of research project
2. consent is voluntarily given
3. Person has legal capacity to give consent
4. Responsibility for obtaining consent rests with researcher |
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Term
| Types of vulnerable subjects |
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Definition
children
handicapped
hospital patients
welfare recipients
prisoners
pregnant women |
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Term
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Definition
| assure compliance with governmental regulations |
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Definition
| exempt from review expedited review full review |
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Term
| Criteria for IRB approval |
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Definition
Risks to subjects are minimized
Risks to subjects are reasonable in relation to anticipated benefits
Informed consent will be appropriately documented
Selection of subjects is equitable in relation to the purpose of the research and its setting |
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Term
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Definition
Copies of all surveys
Identify the sources of potential subjects
Describe the procedures used in the study
Describe the informed consent procedures to be used
Describe risks and benefits |
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Term
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Definition
| falsification, fabrication, plagarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research |
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Term
| Ethical obligations in research |
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Definition
Responsible for htier subjects
Responsible for their own actions and those of any research aides
Must provide informed consent
Protects subject from harm, danger, and discomfort
Maintain anonymity and confidentiality |
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Definition
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