Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit
Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit...
Ausführliche Beschreibung
Autor*in: |
Cragg, William J [verfasserIn] Taylor, Chris [verfasserIn] Moreau, Lauren [verfasserIn] Collier, Howard [verfasserIn] Gilberts, Rachael [verfasserIn] McKigney, Niamh [verfasserIn] Dennett, Joanna [verfasserIn] Graca, Sandra [verfasserIn] Wheeler, Ian [verfasserIn] Bishop, Liam [verfasserIn] Barrett, Adam [verfasserIn] Hartley, Suzanne [verfasserIn] Greenwood, John P [verfasserIn] Swoboda, Peter P [verfasserIn] Farrin, Amanda J [verfasserIn] |
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E-Artikel |
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Englisch |
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2024 |
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Anmerkung: |
© The Author(s) 2024 |
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Übergeordnetes Werk: |
Enthalten in: Trials - BioMed Central, 2000, 25(2024), 1 vom: 08. Mai |
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Übergeordnetes Werk: |
volume:25 ; year:2024 ; number:1 ; day:08 ; month:05 |
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DOI / URN: |
10.1186/s13063-024-08149-y |
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SPR055785786 |
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520 | |a Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. | ||
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700 | 1 | |a Taylor, Chris |e verfasserin |4 aut | |
700 | 1 | |a Moreau, Lauren |e verfasserin |0 (orcid)0000-0002-0280-6345 |4 aut | |
700 | 1 | |a Collier, Howard |e verfasserin |0 (orcid)0000-0002-0107-0604 |4 aut | |
700 | 1 | |a Gilberts, Rachael |e verfasserin |0 (orcid)0000-0003-3326-7900 |4 aut | |
700 | 1 | |a McKigney, Niamh |e verfasserin |0 (orcid)0000-0003-1599-5701 |4 aut | |
700 | 1 | |a Dennett, Joanna |e verfasserin |4 aut | |
700 | 1 | |a Graca, Sandra |e verfasserin |0 (orcid)0009-0005-7299-7967 |4 aut | |
700 | 1 | |a Wheeler, Ian |e verfasserin |0 (orcid)0000-0003-0955-8556 |4 aut | |
700 | 1 | |a Bishop, Liam |e verfasserin |4 aut | |
700 | 1 | |a Barrett, Adam |e verfasserin |4 aut | |
700 | 1 | |a Hartley, Suzanne |e verfasserin |4 aut | |
700 | 1 | |a Greenwood, John P |e verfasserin |0 (orcid)0000-0002-2861-0914 |4 aut | |
700 | 1 | |a Swoboda, Peter P |e verfasserin |0 (orcid)0000-0001-7162-7079 |4 aut | |
700 | 1 | |a Farrin, Amanda J |e verfasserin |0 (orcid)0000-0002-2876-0584 |4 aut | |
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10.1186/s13063-024-08149-y doi (DE-627)SPR055785786 (SPR)s13063-024-08149-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Cragg, William J verfasserin (orcid)0000-0002-1274-8521 aut Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. Electronic consent (dpeaa)DE-He213 Remote consent (dpeaa)DE-He213 eConsent (dpeaa)DE-He213 Taylor, Chris verfasserin aut Moreau, Lauren verfasserin (orcid)0000-0002-0280-6345 aut Collier, Howard verfasserin (orcid)0000-0002-0107-0604 aut Gilberts, Rachael verfasserin (orcid)0000-0003-3326-7900 aut McKigney, Niamh verfasserin (orcid)0000-0003-1599-5701 aut Dennett, Joanna verfasserin aut Graca, Sandra verfasserin (orcid)0009-0005-7299-7967 aut Wheeler, Ian verfasserin (orcid)0000-0003-0955-8556 aut Bishop, Liam verfasserin aut Barrett, Adam verfasserin aut Hartley, Suzanne verfasserin aut Greenwood, John P verfasserin (orcid)0000-0002-2861-0914 aut Swoboda, Peter P verfasserin (orcid)0000-0001-7162-7079 aut Farrin, Amanda J verfasserin (orcid)0000-0002-2876-0584 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:05 https://dx.doi.org/10.1186/s13063-024-08149-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 05 |
spelling |
10.1186/s13063-024-08149-y doi (DE-627)SPR055785786 (SPR)s13063-024-08149-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Cragg, William J verfasserin (orcid)0000-0002-1274-8521 aut Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. Electronic consent (dpeaa)DE-He213 Remote consent (dpeaa)DE-He213 eConsent (dpeaa)DE-He213 Taylor, Chris verfasserin aut Moreau, Lauren verfasserin (orcid)0000-0002-0280-6345 aut Collier, Howard verfasserin (orcid)0000-0002-0107-0604 aut Gilberts, Rachael verfasserin (orcid)0000-0003-3326-7900 aut McKigney, Niamh verfasserin (orcid)0000-0003-1599-5701 aut Dennett, Joanna verfasserin aut Graca, Sandra verfasserin (orcid)0009-0005-7299-7967 aut Wheeler, Ian verfasserin (orcid)0000-0003-0955-8556 aut Bishop, Liam verfasserin aut Barrett, Adam verfasserin aut Hartley, Suzanne verfasserin aut Greenwood, John P verfasserin (orcid)0000-0002-2861-0914 aut Swoboda, Peter P verfasserin (orcid)0000-0001-7162-7079 aut Farrin, Amanda J verfasserin (orcid)0000-0002-2876-0584 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:05 https://dx.doi.org/10.1186/s13063-024-08149-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 05 |
allfields_unstemmed |
10.1186/s13063-024-08149-y doi (DE-627)SPR055785786 (SPR)s13063-024-08149-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Cragg, William J verfasserin (orcid)0000-0002-1274-8521 aut Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. Electronic consent (dpeaa)DE-He213 Remote consent (dpeaa)DE-He213 eConsent (dpeaa)DE-He213 Taylor, Chris verfasserin aut Moreau, Lauren verfasserin (orcid)0000-0002-0280-6345 aut Collier, Howard verfasserin (orcid)0000-0002-0107-0604 aut Gilberts, Rachael verfasserin (orcid)0000-0003-3326-7900 aut McKigney, Niamh verfasserin (orcid)0000-0003-1599-5701 aut Dennett, Joanna verfasserin aut Graca, Sandra verfasserin (orcid)0009-0005-7299-7967 aut Wheeler, Ian verfasserin (orcid)0000-0003-0955-8556 aut Bishop, Liam verfasserin aut Barrett, Adam verfasserin aut Hartley, Suzanne verfasserin aut Greenwood, John P verfasserin (orcid)0000-0002-2861-0914 aut Swoboda, Peter P verfasserin (orcid)0000-0001-7162-7079 aut Farrin, Amanda J verfasserin (orcid)0000-0002-2876-0584 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:05 https://dx.doi.org/10.1186/s13063-024-08149-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 05 |
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10.1186/s13063-024-08149-y doi (DE-627)SPR055785786 (SPR)s13063-024-08149-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Cragg, William J verfasserin (orcid)0000-0002-1274-8521 aut Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. Electronic consent (dpeaa)DE-He213 Remote consent (dpeaa)DE-He213 eConsent (dpeaa)DE-He213 Taylor, Chris verfasserin aut Moreau, Lauren verfasserin (orcid)0000-0002-0280-6345 aut Collier, Howard verfasserin (orcid)0000-0002-0107-0604 aut Gilberts, Rachael verfasserin (orcid)0000-0003-3326-7900 aut McKigney, Niamh verfasserin (orcid)0000-0003-1599-5701 aut Dennett, Joanna verfasserin aut Graca, Sandra verfasserin (orcid)0009-0005-7299-7967 aut Wheeler, Ian verfasserin (orcid)0000-0003-0955-8556 aut Bishop, Liam verfasserin aut Barrett, Adam verfasserin aut Hartley, Suzanne verfasserin aut Greenwood, John P verfasserin (orcid)0000-0002-2861-0914 aut Swoboda, Peter P verfasserin (orcid)0000-0001-7162-7079 aut Farrin, Amanda J verfasserin (orcid)0000-0002-2876-0584 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:05 https://dx.doi.org/10.1186/s13063-024-08149-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 05 |
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10.1186/s13063-024-08149-y doi (DE-627)SPR055785786 (SPR)s13063-024-08149-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Cragg, William J verfasserin (orcid)0000-0002-1274-8521 aut Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. Electronic consent (dpeaa)DE-He213 Remote consent (dpeaa)DE-He213 eConsent (dpeaa)DE-He213 Taylor, Chris verfasserin aut Moreau, Lauren verfasserin (orcid)0000-0002-0280-6345 aut Collier, Howard verfasserin (orcid)0000-0002-0107-0604 aut Gilberts, Rachael verfasserin (orcid)0000-0003-3326-7900 aut McKigney, Niamh verfasserin (orcid)0000-0003-1599-5701 aut Dennett, Joanna verfasserin aut Graca, Sandra verfasserin (orcid)0009-0005-7299-7967 aut Wheeler, Ian verfasserin (orcid)0000-0003-0955-8556 aut Bishop, Liam verfasserin aut Barrett, Adam verfasserin aut Hartley, Suzanne verfasserin aut Greenwood, John P verfasserin (orcid)0000-0002-2861-0914 aut Swoboda, Peter P verfasserin (orcid)0000-0001-7162-7079 aut Farrin, Amanda J verfasserin (orcid)0000-0002-2876-0584 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:05 https://dx.doi.org/10.1186/s13063-024-08149-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 05 |
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approaches and experiences implementing remote, electronic consent at the leeds clinical trials research unit |
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Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit |
abstract |
Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. © The Author(s) 2024 |
abstractGer |
Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. © The Author(s) 2024 |
abstract_unstemmed |
Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach. © The Author(s) 2024 |
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score |
7.399659 |