Department of Emergency Medicine, Western Health, Melbourne, Victoria, Australia.
Joseph Epstein Centre for Emergency Medicine Research, Western Health, Melbourne, Victoria, Australia.
Emerg Med Australas. 2021 Apr;33(2):379-384. doi: 10.1111/1742-6723.13728. Epub 2021 Jan 27.
Some emergency medicine research, especially retrospective studies using medical records review, rely on waiver of consent for use of personal health information (PHI) contained in clinical records. This is a secondary use of PHI and waiver of consent raises ethical, legal and practical issues. Granting of a waiver of consent is often (but not always) approved by a human research ethics committee and requires separate but inter-related consideration of the legal and ethical issues. In part, this involves a balancing of the public interest versus the risk to privacy and an evaluation of whether subjects would, mostly likely, have agreed to the use of their PHI had they been asked. To date, there are no robust data about whether use of PHI without consent for research would be acceptable to people who attend Australasian EDs for care.
一些急救医学研究，特别是使用病历回顾的回顾性研究，依赖于放弃使用临床记录中包含的个人健康信息 (PHI) 的同意。这是对 PHI 的二次使用，放弃同意会引发伦理、法律和实际问题。同意的放弃通常（但不总是）由人类研究伦理委员会批准，并需要对法律和伦理问题进行单独但相互关联的考虑。在某种程度上，这涉及到在公共利益与隐私风险之间进行权衡，以及评估如果事先询问，受试者是否很可能会同意使用他们的 PHI。迄今为止，关于未经同意使用 PHI 进行研究是否会被参加澳大利亚和亚洲急诊室护理的人接受，尚无可靠数据。
