Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception
Background:Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim:To document the extent and to identify factors associated with therapeutic misconception...
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| Veröffentlicht in: | Journal of medical ethics 2008-09, Vol.34 (9), p.e16-e16 |
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| container_title | Journal of medical ethics |
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| creator | Durand-Zaleski, I S Alberti, C Durieux, P Duval, X Gottot, S Ravaud, Ph Gainotti, S Vincent-Genod, C Moreau, D Amiel, P |
| description | Background:Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim:To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies).Patients and methods:The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire.Results:A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69–97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion:The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators. |
| doi_str_mv | 10.1136/jme.2007.023473 |
| format | Article |
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Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim:To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies).Patients and methods:The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire.Results:A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69–97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion:The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.</description><identifier>ISSN: 0306-6800</identifier><identifier>EISSN: 1473-4257</identifier><identifier>DOI: 10.1136/jme.2007.023473</identifier><identifier>PMID: 18757616</identifier><identifier>CODEN: JMETDR</identifier><language>eng</language><publisher>England: BMJ Publishing Group Ltd and Institute of Medical Ethics</publisher><subject>Adult ; Bioethics ; Clinical Trials as Topic ; Clinical Trials as Topic - ethics ; Clinical Trials as Topic - psychology ; Communication ; Consent Forms ; Consent Forms - ethics ; Female ; France ; Humanities and Social Sciences ; Humans ; Informed Consent ; Informed Consent - ethics ; Informed Consent - psychology ; Life Sciences ; Male ; Middle Aged ; Parental Consent ; Parental Consent - ethics ; Parental Consent - psychology ; Patient Satisfaction ; Patients ; Population ; Questionnaires ; Recall ; Santé publique et épidémiologie ; Sociology ; Statistics as Topic ; Surveys and Questionnaires</subject><ispartof>Journal of medical ethics, 2008-09, Vol.34 (9), p.e16-e16</ispartof><rights>2008 BMJ Publishing Group Ltd and the Institute of Medical Ethics</rights><rights>Copyright: 2008 2008 BMJ Publishing Group Ltd and the Institute of Medical Ethics</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b430t-7ba2847cbf01bd36af3aa6cae4aba2f1592dc2c6f0380bc54692a719f71d85093</citedby><cites>FETCH-LOGICAL-b430t-7ba2847cbf01bd36af3aa6cae4aba2f1592dc2c6f0380bc54692a719f71d85093</cites><orcidid>0000-0002-9336-1395 ; 0000-0003-4557-9266 ; 0000-0002-4078-1476</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jme.bmj.com/content/34/9/e16.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttps://jme.bmj.com/content/34/9/e16.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,230,314,780,784,885,3196,23571,27924,27925,77600,77631</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18757616$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-00850486$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Durand-Zaleski, I S</creatorcontrib><creatorcontrib>Alberti, C</creatorcontrib><creatorcontrib>Durieux, P</creatorcontrib><creatorcontrib>Duval, X</creatorcontrib><creatorcontrib>Gottot, S</creatorcontrib><creatorcontrib>Ravaud, Ph</creatorcontrib><creatorcontrib>Gainotti, S</creatorcontrib><creatorcontrib>Vincent-Genod, C</creatorcontrib><creatorcontrib>Moreau, D</creatorcontrib><creatorcontrib>Amiel, P</creatorcontrib><title>Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception</title><title>Journal of medical ethics</title><addtitle>J Med Ethics</addtitle><description>Background:Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim:To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies).Patients and methods:The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire.Results:A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69–97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion:The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.</description><subject>Adult</subject><subject>Bioethics</subject><subject>Clinical Trials as Topic</subject><subject>Clinical Trials as Topic - ethics</subject><subject>Clinical Trials as Topic - psychology</subject><subject>Communication</subject><subject>Consent Forms</subject><subject>Consent Forms - ethics</subject><subject>Female</subject><subject>France</subject><subject>Humanities and Social Sciences</subject><subject>Humans</subject><subject>Informed Consent</subject><subject>Informed Consent - ethics</subject><subject>Informed Consent - psychology</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Parental Consent</subject><subject>Parental Consent - ethics</subject><subject>Parental Consent - psychology</subject><subject>Patient Satisfaction</subject><subject>Patients</subject><subject>Population</subject><subject>Questionnaires</subject><subject>Recall</subject><subject>Santé publique et épidémiologie</subject><subject>Sociology</subject><subject>Statistics as Topic</subject><subject>Surveys and Questionnaires</subject><issn>0306-6800</issn><issn>1473-4257</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AVQMV</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>K50</sourceid><sourceid>M1D</sourceid><sourceid>M2O</sourceid><recordid>eNqFkc-L1DAUx4Mo7rh69iYFQVDobH41Sb0tg-ssFEVQD17Ca5oyGdtkNmn98d-b0mEFL-by4L1Pvi_hg9BzgreEMHF1HO2WYiy3mDIu2QO0IbmUnFbyIdpghkUpFMYX6ElKR5wPVfVjdEGUrKQgYoPubn0f4mi7wgSfrJ8K5wszOO8MDEW0yUI0h6V5E8Eb-7aAlGxK44KC74oezBRiWtrBOJhy0k83HYrpYCOc7Dw5U4wu5XRjT5ML_il61MOQ7LNzvURfbt593u3L5uP72911U7ac4amULVDFpWl7TNqOCegZgDBgOeRJT6qadoYa0WOmcGsqLmoKktS9JJ2qcM0u0es19wCDPkU3QvytAzi9v2700sM4c1yJHySzr1b2FMPdbNOklyfbYQBvw5y0qLkivJYZfPkPeAxz9PkfmkhFiFBU8kxdrZSJIaVo-_v9BOvFm87e9OJNr97yjRfn3LnNMv7yZ1EZKFfApcn-up9D_K6FZLLSH77u9Lc9_dTsKqGbzL9Z-XY8_nf7HxVssGg</recordid><startdate>200809</startdate><enddate>200809</enddate><creator>Durand-Zaleski, I S</creator><creator>Alberti, C</creator><creator>Durieux, P</creator><creator>Duval, X</creator><creator>Gottot, S</creator><creator>Ravaud, Ph</creator><creator>Gainotti, S</creator><creator>Vincent-Genod, C</creator><creator>Moreau, D</creator><creator>Amiel, P</creator><general>BMJ Publishing Group Ltd and Institute of Medical Ethics</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0-V</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>88J</scope><scope>8AF</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>AABKS</scope><scope>ABSDQ</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AVQMV</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K50</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1D</scope><scope>M1P</scope><scope>M2O</scope><scope>M2P</scope><scope>M2R</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>1XC</scope><scope>BXJBU</scope><orcidid>https://orcid.org/0000-0002-9336-1395</orcidid><orcidid>https://orcid.org/0000-0003-4557-9266</orcidid><orcidid>https://orcid.org/0000-0002-4078-1476</orcidid></search><sort><creationdate>200809</creationdate><title>Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception</title><author>Durand-Zaleski, I S ; Alberti, C ; Durieux, P ; Duval, X ; Gottot, S ; Ravaud, Ph ; Gainotti, S ; Vincent-Genod, C ; Moreau, D ; Amiel, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b430t-7ba2847cbf01bd36af3aa6cae4aba2f1592dc2c6f0380bc54692a719f71d85093</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Bioethics</topic><topic>Clinical Trials as Topic</topic><topic>Clinical Trials as Topic - 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Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>HAL-SHS: Archive ouverte en Sciences de l'Homme et de la Société</collection><jtitle>Journal of medical ethics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Durand-Zaleski, I S</au><au>Alberti, C</au><au>Durieux, P</au><au>Duval, X</au><au>Gottot, S</au><au>Ravaud, Ph</au><au>Gainotti, S</au><au>Vincent-Genod, C</au><au>Moreau, D</au><au>Amiel, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception</atitle><jtitle>Journal of medical ethics</jtitle><addtitle>J Med Ethics</addtitle><date>2008-09</date><risdate>2008</risdate><volume>34</volume><issue>9</issue><spage>e16</spage><epage>e16</epage><pages>e16-e16</pages><issn>0306-6800</issn><eissn>1473-4257</eissn><coden>JMETDR</coden><abstract>Background:Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.Aim:To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies).Patients and methods:The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire.Results:A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69–97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.Conclusion:The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.</abstract><cop>England</cop><pub>BMJ Publishing Group Ltd and Institute of Medical Ethics</pub><pmid>18757616</pmid><doi>10.1136/jme.2007.023473</doi><orcidid>https://orcid.org/0000-0002-9336-1395</orcidid><orcidid>https://orcid.org/0000-0003-4557-9266</orcidid><orcidid>https://orcid.org/0000-0002-4078-1476</orcidid></addata></record> |
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| ispartof | Journal of medical ethics, 2008-09, Vol.34 (9), p.e16-e16 |
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| subjects | Adult Bioethics Clinical Trials as Topic Clinical Trials as Topic - ethics Clinical Trials as Topic - psychology Communication Consent Forms Consent Forms - ethics Female France Humanities and Social Sciences Humans Informed Consent Informed Consent - ethics Informed Consent - psychology Life Sciences Male Middle Aged Parental Consent Parental Consent - ethics Parental Consent - psychology Patient Satisfaction Patients Population Questionnaires Recall Santé publique et épidémiologie Sociology Statistics as Topic Surveys and Questionnaires |
| title | Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception |
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