Bioethics
Online ISSN : 2189-695X
Print ISSN : 1343-4063
ISSN-L : 1343-4063
Requirements for general consent and their ethical underpinnings : considering the ideal form of general consent
Masanori OIKAWAMisao FUJITAAkira AKABAYASHI
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2014 Volume 24 Issue 1 Pages 235-243

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Abstract
The concept of general consent has received widespread attention in recent years. General consent enables researchers to reuse biological samples and personal data for new studies without obtaining another round of consent from participants. This presents ethical issues and requires careful consideration. A literature review was conducted to determine the requirements for general consent, and the nature of such consent. Firstly, the requirements of general consent were considered from two perspectives: (1) forms of general consent and (2) compensating for the short-comings of general consent via research systems (e.g., the right to withdraw consent, disclosure and transparency of research, prior review for new studies by an institutional review board, or the presence of supervisory systems). Secondly, this topic was analyzed from an ethical standpoint and considered in the context of a biobank adopting general consent. Results of the analysis suggest that "trust" in research systems is essential for the successful implementation of general consent. This type of consent may present a new ethical principle in the relationship between participants and researchers/research organizations, in addition to conventional ethical principles such as "respect for autonomy," "beneficence," or "non-maleficence."
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2014 Japan Association for Bioethics
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