"Andrija Štampar" School of Public Health, University of Zagreb School of Medicine, Zagreb, Croatia.
Research Integrity Editor, Biochemia Medica.
Biochem Med (Zagreb). 2018 Oct 15;28(3):030201. doi: 10.11613/BM.2018.030201.
Informed consent is a process in which a human subject who is to participate in research needs to give his or her consent after being properly informed of the expected benefits as well as the potential harm of the research that will be performed. The function and purpose of the research ethics committee is to ensure that the research that will take place is in accordance with the relevant ethical standards. This means that the committee must assess the appropriateness of the design of the study reviewed. Research in the field of laboratory medicine has specific features, the use of samples that remain after routine analysis, data collection from databases containing patient information, data mining, collection of laboratory management data, method/instrument comparisons and validation, As most of such research is either retrospective or not directly associated with patients, the question arises as to whether all types of research require informed consent and ethics committee approval. This article aims to clarify what is specific about obtaining informed consent and ethical approval in laboratory medicine, to provide general guidance on informed consent and ethical approval requirements based on the type of study, and what information should be included in applications for ethical approval and informed consent. This could also provide some guidance for future contributors to the
知情同意是指在进行研究之前，人类受试者需要在充分了解预期收益以及将要进行的研究的潜在风险后，自愿表示同意。研究伦理委员会的作用和目的是确保将要进行的研究符合相关的伦理标准。这意味着委员会必须评估所审查的研究设计的适当性。实验室医学领域的研究具有特定的特征，包括使用常规分析后剩余的样本、从包含患者信息的数据库中收集数据、数据挖掘、收集实验室管理数据、方法/仪器比较和验证等。由于此类研究大多数是回顾性的，或者与患者没有直接关系，因此出现了一个问题，即是否所有类型的研究都需要知情同意和伦理委员会批准。本文旨在阐明实验室医学中获得知情同意和伦理批准的具体要求，根据研究类型提供关于知情同意和伦理批准要求的一般指导，并说明伦理批准和知情同意申请中应包含的信息。这也可为未来的实验室医学领域的研究人员提供一些指导。
