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

• DOI: 10.1186/s12961-019-0520-4
• Publication Date: 2020-01-28T09:03:41Z
• Authors: Anna Mae Scott; Simon Kolstoe; M. C. ( Corrette)...; Zoë Hammatt; Paul Glasziou
• Keywords: Research Ethics; Health Services Research; Human research; Health administration

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