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  1. Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better.Mila Petrova & Stephen Barclay - 2019 - BMC Medical Ethics 20 (1):7.
    The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service procedures and the electronic Integrated Research Application System. We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive (...)
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  • Measuring inconsistency in research ethics committee review.Samantha Trace & Simon Erik Kolstoe - 2017 - BMC Medical Ethics 18 (1):1-10.
    Background The review of human participant research by Research Ethics Committees or Institutional Review Boards is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” where multiple committees review the same project. Committee reviews (...)
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