a Department of Philosophy , Johns Hopkins University , Baltimore , USA.
b Center for Biomedical Ethics and Law, Department of Public Health and Primary Care , University of Leuven , Leuven , Belgium.
Account Res. 2017;24(8):483-496. doi: 10.1080/08989621.2017.1396896.
While the anonymization of biological samples and data may help protect participant privacy, there is still debate over whether this alone is a sufficient safeguard to ensure the ethical conduct of research. The purpose of this systematic review is to examine whether the review of an ethics committee is necessary in the context of anonymized research, and what the considerations in said ethics review would be. The review of normative documents issued by both national and international level organizations reveals a growing concern over the ability of anonymization procedures to prevent against reidentification. This is particularly true in the context of genomic research where genetic material's uniquely identifying nature along with advances in technology have complicated previous standards of identifiability. Even where individual identities may not be identifiable, there is the risk of group harm that may not be protected by anonymization alone. We conclude that the majority of normative documents support that the review of an ethics committee is necessary to address the concerns associated with the use of anonymized samples and data for research.
虽然生物样本和数据的匿名化可能有助于保护参与者的隐私，但对于仅通过这种方式是否足以确保研究的伦理行为，仍存在争议。本系统评价的目的是检验在匿名研究的背景下，伦理委员会的审查是否有必要，以及在这种伦理审查中应考虑哪些因素。对国家和国际组织发布的规范性文件的审查显示，人们越来越关注匿名化程序防止重新识别的能力。在基因组研究的背景下，这种情况尤其如此，因为遗传物质的独特识别性质以及技术的进步使得以前的可识别性标准变得复杂。即使个人身份可能无法识别，也存在群体伤害的风险，而匿名化本身可能无法保护这种风险。我们得出结论，大多数规范性文件都支持伦理委员会的审查是必要的，以解决与使用匿名样本和数据进行研究相关的问题。
