Department of Law, University of Manchester, Manchester, UK.
Health Care Anal. 2021 Sep;29(3):213-230. doi: 10.1007/s10728-021-00435-z. Epub 2021 Jul 14.
There is significant research value in the secondary use of surplus human tissue which has been removed during clinical care and is stored in diagnostic archives. However, this value is limited without access to information about the person from whom the tissue was removed. As the research value of surplus tissue is often not realised until after the patient's episode of care, it is often the case that no consent has been given for any surplus tissue to be used for research purposes. The Human Tissue Act 2004 does permit research use of surplus tissue without consent, but the researcher must not be in possession of information which could identify the person from whom the tissue was removed. Due to the commonly applied 'consent or anonymise' approach, linking tissue and data is challenging and full anonymisation would likely render much research on surplus tissue ineffectual. This article suggests that in recognising the value in surplus tissue linked with information about the person, a 'share and protect' approach which considers safeguards other than anonymisation, where obtaining consent for research use would not be feasible, would better balance the public benefit of health research with the protection of individual rights and interests than a requirement for either consent or anonymisation.
对在临床护理过程中切除并存储在诊断档案中的多余人体组织进行二次利用具有重要的研究价值。然而，如果无法获取组织捐献者的信息，这种价值将受到限制。由于剩余组织的研究价值通常要在患者接受治疗后才能体现出来，因此往往没有同意将任何多余的组织用于研究目的。2004 年《人体组织法案》允许在未经同意的情况下将剩余组织用于研究，但研究人员不得掌握可识别组织捐献者身份的信息。由于通常采用“同意或匿名化”的方法，因此将组织和数据联系起来具有挑战性，而完全匿名化可能会使对剩余组织的大部分研究变得无效。本文认为，在认识到与组织捐献者身份相关的剩余组织的价值时，采用一种“共享和保护”的方法，考虑除匿名化之外的保障措施，在无法获得研究使用同意的情况下，这种方法比要求同意或匿名化更能平衡健康研究的公共利益与对个人权利和利益的保护。
