Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs)
Abstract Background Randomised trials often struggle with recruitment, retention, and delays, impacting both finances and patient care. To improve trial processes, trialists can do Studies Within A Trial (SWATs) that compare trial process alternatives. A SWAT is a self-contained research study that...
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2025-08-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-025-08958-9 |
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| author | Hanne Bruhn Shaun Treweek Charles Weijer Matthias Briel Mike Clarke Rachel Crowley Katie Gillies Heidi Green Ellen Murphy Adwoa Parker Geneviève Shiely Hayes Peter Hart Frances Shiely |
| author_facet | Hanne Bruhn Shaun Treweek Charles Weijer Matthias Briel Mike Clarke Rachel Crowley Katie Gillies Heidi Green Ellen Murphy Adwoa Parker Geneviève Shiely Hayes Peter Hart Frances Shiely |
| author_sort | Hanne Bruhn |
| collection | DOAJ |
| description | Abstract Background Randomised trials often struggle with recruitment, retention, and delays, impacting both finances and patient care. To improve trial processes, trialists can do Studies Within A Trial (SWATs) that compare trial process alternatives. A SWAT is a self-contained research study that is embedded within a host trial, or several host trials, with the aim of evaluating or exploring alternative ways of delivering or organising a particular trial process. Although SWATs are recognised by funders, there are differences in how they are implemented, such as different consent requirements in the UK and Ireland. This complicates SWAT conduct, raises ethical considerations, and highlights the need for standardised, ethical approaches to SWATs. The purpose of the current study was to devise guidance to address this. Methods We used existing systematic reviews, searched PubMed and the SWAT register, and contacted SWAT teams known to the authors to identify relevant randomised SWATs to include in our literature review. We extracted information on SWAT descriptives and 19 outcomes of interest pre-identified by the authors as being potential ethical considerations. We themed our findings. We held three consensus building fora, all including representatives from eight key stakeholder groups representing a broad range of roles in trials. We presented participants with two SWATs to start conversation on perceived ethical issues. We also incorporated the findings of our literature review. Consensus building fora were recorded, transcribed, and analysed using NVivo, focusing on ethical principles, challenges, and solutions. Results We developed guidance on ethical considerations applicable to randomised SWATs. There are 14 ethical considerations covering all stages of a SWAT, from development and SWAT team selection to communication of results. The considerations are posed as questions, so trial teams can easily answer these when designing their SWAT. Conclusions Studies Within A Trial are generally perceived to be low risk and low burden to participants. However, there are still varying ethical standards applied to these studies by researchers, sponsors, and ethics committees. These guidelines will be helpful to anyone planning or reviewing SWATs in understanding these differences and their ethical implications, and provide a practical guide for the ethical conduct of SWATs. |
| format | Article |
| id | doaj-art-ec9fd5db34c5436ab5284a1875c96ccf |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-ec9fd5db34c5436ab5284a1875c96ccf2025-08-20T03:46:12ZengBMCTrials1745-62152025-08-0126111510.1186/s13063-025-08958-9Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs)Hanne Bruhn0Shaun Treweek1Charles Weijer2Matthias Briel3Mike Clarke4Rachel Crowley5Katie Gillies6Heidi Green7Ellen Murphy8Adwoa Parker9Geneviève Shiely Hayes10Peter Hart11Frances Shiely12Trials Research and Methodologies Unit, HRB Clinical Research Facility, University College CorkAberdeen Centre for Evaluation, University of AberdeenDepartments of Medicine and Philosophy, Western UniversityCLEAR Methods Center, Department of Clinical Research, University Hospital Basel, University of BaselNorthern Ireland Methodology Hub, Centre for Public Health, Queen’s University BelfastRare Disease Clinical Trial Network, University College Dublin & St Vincent’s University HospitalAberdeen Centre for Evaluation, University of AberdeenFreelance Health Equity and Patient Involvement SpecialistTrials Research and Methodologies Unit, HRB Clinical Research Facility, University College CorkYork Trials Unit, Department of Health Sciences, University of YorkTrials Research and Methodologies Unit, HRB Clinical Research Facility, University College CorkSchool of Public Health, University College CorkTrials Research and Methodologies Unit, HRB Clinical Research Facility, University College CorkAbstract Background Randomised trials often struggle with recruitment, retention, and delays, impacting both finances and patient care. To improve trial processes, trialists can do Studies Within A Trial (SWATs) that compare trial process alternatives. A SWAT is a self-contained research study that is embedded within a host trial, or several host trials, with the aim of evaluating or exploring alternative ways of delivering or organising a particular trial process. Although SWATs are recognised by funders, there are differences in how they are implemented, such as different consent requirements in the UK and Ireland. This complicates SWAT conduct, raises ethical considerations, and highlights the need for standardised, ethical approaches to SWATs. The purpose of the current study was to devise guidance to address this. Methods We used existing systematic reviews, searched PubMed and the SWAT register, and contacted SWAT teams known to the authors to identify relevant randomised SWATs to include in our literature review. We extracted information on SWAT descriptives and 19 outcomes of interest pre-identified by the authors as being potential ethical considerations. We themed our findings. We held three consensus building fora, all including representatives from eight key stakeholder groups representing a broad range of roles in trials. We presented participants with two SWATs to start conversation on perceived ethical issues. We also incorporated the findings of our literature review. Consensus building fora were recorded, transcribed, and analysed using NVivo, focusing on ethical principles, challenges, and solutions. Results We developed guidance on ethical considerations applicable to randomised SWATs. There are 14 ethical considerations covering all stages of a SWAT, from development and SWAT team selection to communication of results. The considerations are posed as questions, so trial teams can easily answer these when designing their SWAT. Conclusions Studies Within A Trial are generally perceived to be low risk and low burden to participants. However, there are still varying ethical standards applied to these studies by researchers, sponsors, and ethics committees. These guidelines will be helpful to anyone planning or reviewing SWATs in understanding these differences and their ethical implications, and provide a practical guide for the ethical conduct of SWATs.https://doi.org/10.1186/s13063-025-08958-9Trial methodologySWATStudy within a trialMethodology guidanceResearch ethicsTrial Forge |
| spellingShingle | Hanne Bruhn Shaun Treweek Charles Weijer Matthias Briel Mike Clarke Rachel Crowley Katie Gillies Heidi Green Ellen Murphy Adwoa Parker Geneviève Shiely Hayes Peter Hart Frances Shiely Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs) Trials Trial methodology SWAT Study within a trial Methodology guidance Research ethics Trial Forge |
| title | Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs) |
| title_full | Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs) |
| title_fullStr | Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs) |
| title_full_unstemmed | Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs) |
| title_short | Trial Forge Guidance 5: ethical considerations in randomised Studies Within A Trial (SWATs) |
| title_sort | trial forge guidance 5 ethical considerations in randomised studies within a trial swats |
| topic | Trial methodology SWAT Study within a trial Methodology guidance Research ethics Trial Forge |
| url | https://doi.org/10.1186/s13063-025-08958-9 |
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