Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers
Objective Low-risk pragmatic clinical research such as learning health system research, quality assurance activities and comparative effectiveness studies are approaches to embedding clinical research within routine practice to generate generalisable evidence. Individual written informed consent may...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2025-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/3/e091896.full |
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| author | Christoph Wanner Brendan Smyth Carmel Hawley Vlado Perkovic Michael Walsh Patrick Rossignol Sunita Bavanandan David Wheeler Vivekanand Jha Meg Jardine Rathika Krishnasamy Grace Balicki Abhinav Bassi Amanda Siriwardana Erika Dempsey James Kauffman Behram Khan Zuo Li Jule Pinter |
| author_facet | Christoph Wanner Brendan Smyth Carmel Hawley Vlado Perkovic Michael Walsh Patrick Rossignol Sunita Bavanandan David Wheeler Vivekanand Jha Meg Jardine Rathika Krishnasamy Grace Balicki Abhinav Bassi Amanda Siriwardana Erika Dempsey James Kauffman Behram Khan Zuo Li Jule Pinter |
| author_sort | Christoph Wanner |
| collection | DOAJ |
| description | Objective Low-risk pragmatic clinical research such as learning health system research, quality assurance activities and comparative effectiveness studies are approaches to embedding clinical research within routine practice to generate generalisable evidence. Individual written informed consent may present a barrier to the feasibility and inclusiveness of such low-risk clinical research. Within an overarching moral and ethical framework, the form and requirements of consent vary in both clinical practice and research settings according to the context and level of risk. Within some low-risk research settings, waiver of consent may be appropriate.Analysis We sought to describe contemporary national and international English-language guidelines pertaining to the use and oversight of waiver of consent in clinical research. We identify 14 guidelines including 1 international, 1 regional and 12 national statements, and summarise the principles in each for circumstances in which a waiver of consent is appropriate.Conclusion While complete international harmonisation of policy may be neither realistic nor necessary, there are numerous unifying concordances suggesting a broad consensus on the approach to waiver of consent research. |
| format | Article |
| id | doaj-art-53219e9074de45fca3beaccb75deae27 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-53219e9074de45fca3beaccb75deae272025-08-20T03:40:41ZengBMJ Publishing GroupBMJ Open2044-60552025-03-0115310.1136/bmjopen-2024-091896Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchersChristoph Wanner0Brendan Smyth1Carmel Hawley2Vlado Perkovic3Michael Walsh4Patrick Rossignol5Sunita Bavanandan6David Wheeler7Vivekanand Jha8Meg Jardine9Rathika Krishnasamy10Grace Balicki11Abhinav Bassi12Amanda Siriwardana13Erika DempseyJames KauffmanBehram KhanZuo LiJule PinterDepartment of Internal Medicine I, Universitätsklinikum Würzburg, Würzburg, BY, Germany3 Department of Renal Medicine, St George Hospital, Sydney, New South Wales, AustraliaThe University of Queensland School of Medicine, Herston, Queensland, Australiaexecutive director, George clinicalDepartment of Clinical Epidemiology and Biostatistics, McMaster University Hamilton, CanadaInstitut Lorrain Du Coeur Et Des Vaisseaux Louis Mathieu, Université de Lorraine, Inserm, Centre d’Investigations Cliniques- Plurithématique 14-33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Vandoeuvre-les-nancy, France3 Department of Nephrology, Hospital Kuala Lumpur, Kuala Lumpur, MalaysiaDepartment of Renal Medicine, University College London, London, UKnephrologistDepartment of Renal Medicine, Concord Repatriation General Hospital, Sydney, New South Wales, AustraliaFaculty of Medicine, The University of Queensland, Brisbane, Queensland, AustraliaThe George Institute for Global Health, Newtown, New South Wales, AustraliaThe George Institute for Global Health India, New Delhi, Delhi, IndiaSydney Medical School, The University of Sydney, Sydney, New South Wales, AustraliaObjective Low-risk pragmatic clinical research such as learning health system research, quality assurance activities and comparative effectiveness studies are approaches to embedding clinical research within routine practice to generate generalisable evidence. Individual written informed consent may present a barrier to the feasibility and inclusiveness of such low-risk clinical research. Within an overarching moral and ethical framework, the form and requirements of consent vary in both clinical practice and research settings according to the context and level of risk. Within some low-risk research settings, waiver of consent may be appropriate.Analysis We sought to describe contemporary national and international English-language guidelines pertaining to the use and oversight of waiver of consent in clinical research. We identify 14 guidelines including 1 international, 1 regional and 12 national statements, and summarise the principles in each for circumstances in which a waiver of consent is appropriate.Conclusion While complete international harmonisation of policy may be neither realistic nor necessary, there are numerous unifying concordances suggesting a broad consensus on the approach to waiver of consent research.https://bmjopen.bmj.com/content/15/3/e091896.full |
| spellingShingle | Christoph Wanner Brendan Smyth Carmel Hawley Vlado Perkovic Michael Walsh Patrick Rossignol Sunita Bavanandan David Wheeler Vivekanand Jha Meg Jardine Rathika Krishnasamy Grace Balicki Abhinav Bassi Amanda Siriwardana Erika Dempsey James Kauffman Behram Khan Zuo Li Jule Pinter Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers BMJ Open |
| title | Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers |
| title_full | Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers |
| title_fullStr | Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers |
| title_full_unstemmed | Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers |
| title_short | Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers |
| title_sort | waiver of informed consent in clinical research a summary of contemporary guidelines and a resource for researchers |
| url | https://bmjopen.bmj.com/content/15/3/e091896.full |
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