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TheDeclarationofHelsinki(2013,Article 20)byWMAdeclaresthat,"Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should not stand to benefit from the knowledge, practices or interventions that result from the research".
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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".
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.
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