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TheDeclarationofHelsinki(2013,Article27)byWMAdeclaresthat,"When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely dependent of this relationship".
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The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, China, & the US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question.
Infomed consent is a process by which a subject unvoluntarily confirms his or her willingness to participate in a particular study, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Clinical trials generate data on safety and efficacy. Clinical trials are closely supervised by appropriate regulatory authorities. All studies involving a medical or therapeutic intervention on patients may not be approved by a supervising ethics committee before permission is granted to run the trial.
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