An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent

Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical resea...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Sabine Bossert [verfasserIn] Daniel Strech [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2017

Schlagwörter:	Informed consent Participatory consent improvement Understanding in informed consent

Übergeordnetes Werk:	In: Trials - BMC, 2006, 18(2017), 1, Seite 8
Übergeordnetes Werk:	volume:18 ; year:2017 ; number:1 ; pages:8

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/s13063-017-2204-0

Katalog-ID:	DOAJ044965796

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520			\|a Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.
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allfields	10.1186/s13063-017-2204-0 doi (DE-627)DOAJ044965796 (DE-599)DOAJd1a7471f6cd14cee972e9142c062b673 DE-627 ger DE-627 rakwb eng R5-920 Sabine Bossert verfasserin aut An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges. Informed consent Participatory consent improvement Understanding in informed consent Medicine (General) Daniel Strech verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:8 https://doi.org/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/article/d1a7471f6cd14cee972e9142c062b673 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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 AR 18 2017 1 8
spelling	10.1186/s13063-017-2204-0 doi (DE-627)DOAJ044965796 (DE-599)DOAJd1a7471f6cd14cee972e9142c062b673 DE-627 ger DE-627 rakwb eng R5-920 Sabine Bossert verfasserin aut An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges. Informed consent Participatory consent improvement Understanding in informed consent Medicine (General) Daniel Strech verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:8 https://doi.org/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/article/d1a7471f6cd14cee972e9142c062b673 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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 AR 18 2017 1 8
allfields_unstemmed	10.1186/s13063-017-2204-0 doi (DE-627)DOAJ044965796 (DE-599)DOAJd1a7471f6cd14cee972e9142c062b673 DE-627 ger DE-627 rakwb eng R5-920 Sabine Bossert verfasserin aut An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges. Informed consent Participatory consent improvement Understanding in informed consent Medicine (General) Daniel Strech verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:8 https://doi.org/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/article/d1a7471f6cd14cee972e9142c062b673 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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 AR 18 2017 1 8
allfieldsGer	10.1186/s13063-017-2204-0 doi (DE-627)DOAJ044965796 (DE-599)DOAJd1a7471f6cd14cee972e9142c062b673 DE-627 ger DE-627 rakwb eng R5-920 Sabine Bossert verfasserin aut An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges. Informed consent Participatory consent improvement Understanding in informed consent Medicine (General) Daniel Strech verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:8 https://doi.org/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/article/d1a7471f6cd14cee972e9142c062b673 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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 AR 18 2017 1 8
allfieldsSound	10.1186/s13063-017-2204-0 doi (DE-627)DOAJ044965796 (DE-599)DOAJd1a7471f6cd14cee972e9142c062b673 DE-627 ger DE-627 rakwb eng R5-920 Sabine Bossert verfasserin aut An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges. Informed consent Participatory consent improvement Understanding in informed consent Medicine (General) Daniel Strech verfasserin aut In Trials BMC, 2006 18(2017), 1, Seite 8 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:18 year:2017 number:1 pages:8 https://doi.org/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/article/d1a7471f6cd14cee972e9142c062b673 kostenfrei http://link.springer.com/article/10.1186/s13063-017-2204-0 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ 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 AR 18 2017 1 8
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Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. 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callnumber-first	R - Medicine
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topic_title	R5-920 An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent Informed consent Participatory consent improvement Understanding in informed consent
topic	misc R5-920 misc Informed consent misc Participatory consent improvement misc Understanding in informed consent misc Medicine (General)
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title	An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent
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title_full	An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent
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title_sort	integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent
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title_auth	An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent
abstract	Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.
abstractGer	Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.
abstract_unstemmed	Abstract Background The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. Methods In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. Results The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. Conclusions In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.
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title_short	An integrated conceptual framework for evaluating and improving ‘understanding’ in informed consent
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