Exceptions to the rule of informed consent for research with an intervention.
作者： Susanne Rebers , Neil K. Aaronson , Flora E. van Leeuwen , Marjanka K. Schmidt
DOI: 10.1186/S12910-016-0092-6
关键词: Law 、 Data mining 、 Research ethics 、 Philosophy of medicine 、 Informed consent 、 PsycINFO 、 Intervention (law) 、 Quality (business) 、 MEDLINE 、 Consent Waiver 、 Medicine
摘要: In specific situations it may be necessary to make an exception the general rule of informed consent for scientific research with intervention. Earlier reviews only described subsets arguments exceptions waive consent. Here, we provide a more extensive literature review possible and accompanying based on from 1997 onwards, using both Pubmed PsycINFO in our search strategy. We identified three main categories acceptability waiver: data validity quality, major practical problems, distress or confusion participants. Approval by medical ethical board always needs obtained. Further, examples conditions under which waiving might allowed, such as additional privacy protection measures. The reasons legitimized authors papers this overview can used researchers form their own opinion about requesting study. Importantly, rules guidelines applicable country, institute field should followed. Moreover, also take they feel is consideration. After discussions relevant stakeholders, formal request sent IRB.
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