Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks

Research output: Contribution to journalComment/debatepeer-review

Authors

Colleges, School and Institutes

External organisations

  • THIS Institute, University of Cambridge, Cambridge, UK.
  • Warwick University

Abstract

In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to 'unethical research' and a 'government experimenting on its own people'. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.

Bibliographic note

© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

Details

Original languageEnglish
Pages (from-to)34-35
Number of pages2
JournalJournal of Medical Ethics
Volume46
Issue number1
Early online date18 Dec 2019
Publication statusPublished - 14 Jan 2020

Keywords

  • clinical trials, policy guidelines/Inst review boards/review cttes, research ethics