Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands

Simon Kolstoe,M. C. ( Corrette) Ploem,Paul Glasziou,Zoë Hammatt,Anna Mae Scott

doi:10.1186/s12961-019-0520-4

Abstract

BackgroundDisproportionate 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.MethodsWe 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.ResultsNine 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.ConclusionsExamples 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.

Highlights

In 2009, it was estimated that 85% of research funding for biomedical science research is avoidably wasted, at an annual cost of approximately $170 billion [1,2,3]
Most health and medical research involving humans is generally required to undergo a review for adherence to ethical standards and guidelines in terms of the balance of benefits and harms, rights and well-being of participants
In the United Kingdom, this included research projects that were exempted from a requirement to undergo review by a National Health Service (NHS) research ethics committee; in the United States, ‘exempt’ projects were those that fell outside the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46). (In practice, these two approaches would be considered ‘bypassing ethics review altogether’ and ‘informing the committee but not applying for ethics review’ end of the spectrum)

Summary

Introduction

In 2009, it was estimated that 85% of research funding for biomedical science (including clinical, health services and basic science) research is avoidably wasted, at an annual cost of approximately $170 billion [1,2,3]. This waste is due to the failure to ask questions relevant to users of research, appropriately design, conduct and analyse research, efficiently regulate and manage research, produce accessible and full research reports, and produce unbiased and useable research reports [2]. 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

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Discussion

Conclusion