Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards (IRBs) and regulators trying to implement the criterion. This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment.

中文翻译：

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阐明如何在卫生数据和组织研究的同意豁免中部署公共利益标准。

包括新加坡，澳大利亚，新西兰和最近的爱尔兰在内的多个司法管辖区都具有公共利益或公共利益标准，可以使用二级健康数据或组织在生物医学研究中给予同意豁免。但是，在这种情况下，公共利益的概念定义不明确，这给机构，机构审查委员会（IRB）和试图实施该标准的监管机构带来了困难。本文阐明了如何合理地运用公共利益标准。我们首先解释要求仅对符合公共利益标准的研究授予豁免的伦理基础，然后探讨如何进一步确定标准，以确定给定研究可以合法声称符合公共利益的程度。我们提出一种方法，该方法不尝试直接测量收益的大小，而是考虑更直接应用的指标。为了确保一致和合理的解释，研究机构和IRB还应在确定哪些研究满足公共利益要求时纳入透明度和公众参与等程序特征。二级生物医学研究中放弃同意书的公共利益要求应以明确的系统评价标准为指导。此类标准及其应用需要定期接受委员会内部和机构内部的审查，反思，审议和修正。为了确保一致和合理的解释，研究机构和IRB还应在确定哪些研究满足公共利益要求时纳入透明度和公众参与等程序特征。二级生物医学研究中放弃同意书的公共利益要求应以明确的系统评价标准为指导。此类标准及其应用需要定期接受委员会内部和机构内部的审查，反思，审议和修正。为了确保一致和合理的解释，研究机构和IRB还应在确定哪些研究满足公共利益要求时纳入透明度和公众参与等程序特征。二级生物医学研究中放弃同意书的公共利益要求应以明确的系统评价标准为指导。此类标准及其应用需要定期接受委员会内部和机构内部的审查，反思，审议和修正。二级生物医学研究中放弃同意书的公共利益要求应以明确的系统评价标准为指导。此类标准及其应用需要定期接受委员会内部和机构内部的审查，反思，审议和修正。二级生物医学研究中放弃同意书的公共利益要求应以明确的系统评价标准为指导。此类标准及其应用需要定期接受委员会内部和机构内部的审查，反思，审议和修正。