Individual consent in cluster randomised trials for non-pharmaceutical interventions: going beyond the Ottawa statement
This paper discusses the issue of overriding the right of individual consent to participation in cluster randomised trials (CRTs). We focus on CRTs testing the efficacy of non-pharmaceutical interventions. As an example, we consider school closures during the COVID-19 pandemic. In Norway, a CRT was...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Critical Public Health |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/09581596.2024.2338074 |
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| author | Marissa LeBlanc Jon Williamson Francesco De Pretis Jürgen Landes Elena Rocca |
| author_facet | Marissa LeBlanc Jon Williamson Francesco De Pretis Jürgen Landes Elena Rocca |
| author_sort | Marissa LeBlanc |
| collection | DOAJ |
| description | This paper discusses the issue of overriding the right of individual consent to participation in cluster randomised trials (CRTs). We focus on CRTs testing the efficacy of non-pharmaceutical interventions. As an example, we consider school closures during the COVID-19 pandemic. In Norway, a CRT was promoted as necessary for providing the best evidence to inform pandemic management policy. However, the proposal was rejected by the Norwegian Research Ethics Committee since it would violate the requirement for individual informed consent. This sparked debate about whether ethics stand in the way of evidence-based health policy, since the Norwegian Research Ethics law’s strict requirements for individual consent make it practically impossible to carry out CRTs of public health interventions. We argue that, in the case of the school closure trial, the suggested CRT would not have eliminated an epistemic gap and thus would not have justified the violation of consent rights. First, we focus on the methodological challenges to estimating quantifiable effects of school closures in the specific case of an airborne infectious disease. Second, in line with Evidential Pluralism, we highlight the value of alternative lines of evidence for informing school closure policy in a pandemic. In general, we propose that a trial requiring the waiver of participants’ consent rights must be highly likely to eliminate an epistemic gap. We elaborate on the practical aspects of this criterion and discuss the potential advantages of adding it to the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. |
| format | Article |
| id | doaj-art-d5a8ff1afc414b54b9e6bad28cd2adb3 |
| institution | Kabale University |
| issn | 0958-1596 1469-3682 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Critical Public Health |
| spelling | doaj-art-d5a8ff1afc414b54b9e6bad28cd2adb32024-12-17T07:39:38ZengTaylor & Francis GroupCritical Public Health0958-15961469-36822024-12-013411910.1080/09581596.2024.2338074Individual consent in cluster randomised trials for non-pharmaceutical interventions: going beyond the Ottawa statementMarissa LeBlanc0Jon Williamson1Francesco De Pretis2Jürgen Landes3Elena Rocca4Department for Method Development and Analytics, Norwegian Institute of Public Health, Oslo, NorwayDepartment of Philosophy & Centre for Reasoning, Cornwallis NW, University of Kent, Canterbury, UKDepartment of Communication and Economics, University of Modena and Reggio Emilia, Reggio Emilia RE, ItalyDepartment of Philosophy ``Piero Martinetti’’, University of Milan, Milan, ItalyDepartment of Life Sciences and Health, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, NorwayThis paper discusses the issue of overriding the right of individual consent to participation in cluster randomised trials (CRTs). We focus on CRTs testing the efficacy of non-pharmaceutical interventions. As an example, we consider school closures during the COVID-19 pandemic. In Norway, a CRT was promoted as necessary for providing the best evidence to inform pandemic management policy. However, the proposal was rejected by the Norwegian Research Ethics Committee since it would violate the requirement for individual informed consent. This sparked debate about whether ethics stand in the way of evidence-based health policy, since the Norwegian Research Ethics law’s strict requirements for individual consent make it practically impossible to carry out CRTs of public health interventions. We argue that, in the case of the school closure trial, the suggested CRT would not have eliminated an epistemic gap and thus would not have justified the violation of consent rights. First, we focus on the methodological challenges to estimating quantifiable effects of school closures in the specific case of an airborne infectious disease. Second, in line with Evidential Pluralism, we highlight the value of alternative lines of evidence for informing school closure policy in a pandemic. In general, we propose that a trial requiring the waiver of participants’ consent rights must be highly likely to eliminate an epistemic gap. We elaborate on the practical aspects of this criterion and discuss the potential advantages of adding it to the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials.https://www.tandfonline.com/doi/10.1080/09581596.2024.2338074COVID-19evidence-based policyinfectious disease managementOttawa statement on the ethical design and conduct of cluster randomized trialsEvidential pluralism |
| spellingShingle | Marissa LeBlanc Jon Williamson Francesco De Pretis Jürgen Landes Elena Rocca Individual consent in cluster randomised trials for non-pharmaceutical interventions: going beyond the Ottawa statement Critical Public Health COVID-19 evidence-based policy infectious disease management Ottawa statement on the ethical design and conduct of cluster randomized trials Evidential pluralism |
| title | Individual consent in cluster randomised trials for non-pharmaceutical interventions: going beyond the Ottawa statement |
| title_full | Individual consent in cluster randomised trials for non-pharmaceutical interventions: going beyond the Ottawa statement |
| title_fullStr | Individual consent in cluster randomised trials for non-pharmaceutical interventions: going beyond the Ottawa statement |
| title_full_unstemmed | Individual consent in cluster randomised trials for non-pharmaceutical interventions: going beyond the Ottawa statement |
| title_short | Individual consent in cluster randomised trials for non-pharmaceutical interventions: going beyond the Ottawa statement |
| title_sort | individual consent in cluster randomised trials for non pharmaceutical interventions going beyond the ottawa statement |
| topic | COVID-19 evidence-based policy infectious disease management Ottawa statement on the ethical design and conduct of cluster randomized trials Evidential pluralism |
| url | https://www.tandfonline.com/doi/10.1080/09581596.2024.2338074 |
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