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‘The ethics approval took 20 months on a trial which was meant to help terminally ill cancer patients. In the end we had to send the funding back’: a survey of views on human research ethics reviews
  1. Anna Mae Scott1,
  2. Iain Chalmers2,
  3. Adrian Barnett3,
  4. Alexandre Stephens4,
  5. Simon E Kolstoe5,
  6. Justin Clark6,
  7. Paul Glasziou1
  1. 1Institute for Evidence Based Healthcare, Bond University, Gold Coast, Queensland, Australia
  2. 2Retired, Oxford, UK
  3. 3School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia
  4. 4The University of Sydney, Sydney, New South Wales, Australia
  5. 5Institute of Biomedical and Bimolecular Science, University of Portsmouth, Portsmouth, Hampshire, UK
  6. 6Centre for Research in Evidence-Based Practice (CREBP), Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia
  1. Correspondence to Dr Anna Mae Scott, Institute for Evidence Based Healthcare, Bond University, Gold Coast, QLD 4226, Australia; ascott{at}bond.edu.au

Abstract

Background We conducted a survey to identify what types of health/medical research could be exempt from research ethics reviews in Australia.

Methods We surveyed Australian health/medical researchers and Human Research Ethics Committee (HREC) members. The survey asked whether respondents had previously changed or abandoned a project anticipating difficulties obtaining ethics approval, and presented eight research scenarios, asking whether these scenarios should or should not be exempt from ethics review, and to provide (optional) comments. Qualitative data were analysed thematically; quantitative data in R.

Results We received 514 responses. Forty-three per cent of respondents to whom the question applied, reported changing projects in anticipation of obstacles from the ethics review process; 25% reported abandoning projects for this reason. Research scenarios asking professional staff to provide views in their area of expertise were most commonly exempted from ethics review (to prioritise systematic review topics 84%, on software strengths/weaknesses 85%); scenarios involving surplus samples (82%) and N-of-1 (single case) studies (76%) were most commonly required to undergo ethics review. HREC members were 26% more likely than researchers to require ethics review. Need for independent oversight, and low risk, were most frequently cited in support of decisions to require or exempt from ethics review, respectively.

Conclusions Considerable differences exist between researchers and HREC members, about when to exempt from review the research that ultimately serves the interests of patients and the public. It is widely accepted that evaluative research should be used to reduce clinical uncertainties—the same principle should apply to ethics reviews.

  • research ethics
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Footnotes

  • Contributors The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. AMS is the guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests AB declares: support by an NHMRC fellowship (APP1117784). SK declares: he chairs research ethics committees for Public Health England, the UK NHS and Ministry of Defence. He is the UK adapting author for the Oxford University Press online Research Integrity course.

  • Patient consent for publication Not required.

  • Ethics approval Human Research Ethics Committee provided approval for the project (32214912). The first page of the survey provided information about the survey content and its aims, privacy, data protection and consent. Participation and completion were voluntary. No incentives for completion were offered.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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