BACKGROUND Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. METHODS We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. RESULTS Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories - evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation - were exempted by one country each. The remaining categories were exempted by two or three countries. CONCLUSIONS Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

中文翻译：

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将低风险的健康和医学研究从伦理审查中免除：比较澳大利亚，英国，美国和荷兰。

背景技术健康和医学研究的不适当的调节导致研究浪费。更好地了解不同司法管辖区的伦理审查对研究的豁免，可能有助于指导审查程序的修改并减少研究浪费。我们的目的是找出在澳大利亚，英国，美国和荷兰免于伦理审查的低风险人类健康和医学研究实例。方法我们审查了为每个国家的研究伦理提供国家指导的文件，包括由国家卫生和医学研究委员会（澳大利亚），国家卫生服务局（英国），人类研究保护办公室（美国）和中央情报局撰写的文件。人类研究委员会（荷兰）。确定了免于道德审查的研究项目的示例和类型，并将相似的示例和类型组合在一起。结果在这四个国家中，有九类研究被排除在道德审查之外。这些是现有的数据或标本，问卷或调查，访谈，上市后研究，对公益或服务计划的评估，随机对照试验，在专业人员中进行的研究，审计和服务评估以及其他豁免。在所有国家/地区，现有的无法识别的数据和样本均获豁免。四个国家/地区豁免四类-公共利益或服务计划的评估，随机对照试验，以工作人员为专业角色的研究以及审计和服务评估。其余类别被两个或三个国家豁免。结论不受研究伦理审查的研究实例和类型差异很大。考虑到研究人员和伦理委员会的巨大成本和负担，有必要针对豁免制定并提供更清晰的指导，并以透明的基本原理为例进行举例说明。