SI chpt 3
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self-determination and the capacity of individuals to make decisions affecting their lives and to act on those decisions
the obligation to attend to the well-being of individuals
fairness in the research process, or the equitable distribution of the benefits and burdens
placebo group, used for experimental comparison
Institutional Review Board (IRB)
- -reviews research proposals prior to implementation to ensure that the reights of research subjects are protected
- -composed of at least 5 members
the evidence that the risks and discomforts to the subject have been minimized and are sufficiently outweighed by the potential benefits of the proposed study
accelerated review of a proposal by an IRB, based on minimal risk
An ethical principle that requires obtaining the consent of the individual to participate in a study based on full prior disclosure of risks and benefits
include disclosure of information and the subject's comprehension of that information, consent elements, ensuring the voluntary nature of participation and the subject's competence to consent and authorization to use data in a manner specified in the protocol
physical, psychological or social harm that goes beyond expected experience in daily life.
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