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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Scott, Anna Mae Kolstoe, Simon Ploem, M. C. ( Corrette) Hammatt, Zoë Glasziou, Paul |
| Abstract | 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. |
| Related Links | https://health-policy-systems.biomedcentral.com/counter/pdf/10.1186/s12961-019-0520-4.pdf |
| Ending Page | 8 |
| Page Count | 8 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 14784505 |
| DOI | 10.1186/s12961-019-0520-4 |
| Journal | Health Research Policy and Systems |
| Issue Number | 1 |
| Volume Number | 18 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2020-01-28 |
| Access Restriction | Open |
| Subject Keyword | Health Administration R & D Technology Policy Medicine Public Health Health Services Research Health Policy Research ethics research committees waste in research low-risk research exemption international variation human health research medical research R & D/Technology Policy Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Health Policy |
| Journal Impact Factor | 3.6/2023 |
| 5-Year Journal Impact Factor | 4.3/2023 |
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