Schaefer G Owen, Laurie Graeme, Menon Sumytra, Campbell Alastair V, Voo Teck Chuan
Centre for Biomedical Ethics, National University of Singapore, Yong Loo Lin School of Medicine, Block MD11, Clinical Research Centre, #02-03, 10 Medical Drive, Singapore, 117597, Singapore.
School of Law, University of Edinburgh, Old College, South Bridge, Edinburgh, EH8 9YL, UK.
BMC Med Ethics. 2020 Mar 20;21(1):23. doi: 10.1186/s12910-020-00467-5.
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.
包括新加坡、澳大利亚、新西兰以及最近的爱尔兰在内的几个司法管辖区，在使用二次健康数据或组织进行生物医学研究时，对于给予同意豁免有公共利益或公益标准。然而，在这种情况下，公共利益的概念并未得到明确界定，这给试图实施该标准的机构、机构审查委员会（IRB）和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。我们首先解释了要求仅向符合公共利益标准的研究给予豁免的伦理依据，然后探讨如何设定进一步的标准，以确定某项特定研究在多大程度上能够合理地声称符合公共利益。我们提出一种方法，该方法并不试图直接衡量利益的大小，而是考虑更易于应用的指标。为确保一致且合理的解释，研究机构和IRB在确定哪些研究符合公共利益要求时，还应纳入诸如透明度和公众参与等程序特征。
二次生物医学研究中同意豁免的公共利益要求应以明确界定的系统评估标准为指导。这样的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、审议及修订。
