The reality of informed consent: empirical studies on patient comprehension—systematic review
Abstract Background Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical...
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| Format: | Article |
| Language: | English |
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BMC
2021-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-020-04969-w |
| _version_ | 1818668438299607040 |
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| author | Tomasz Pietrzykowski Katarzyna Smilowska |
| author_facet | Tomasz Pietrzykowski Katarzyna Smilowska |
| author_sort | Tomasz Pietrzykowski |
| collection | DOAJ |
| description | Abstract Background Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients’ comprehension of an informed consent’s basic components shows that their level of understanding is limited. Methods Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients’ comprehension of specific informed consent components. Results In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators’ blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects. Conclusions We found that participants’ comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients’ full and genuine involvement in a shared medical decision-making process. |
| first_indexed | 2024-12-17T06:36:19Z |
| format | Article |
| id | doaj.art-aa77f2fffaf5469aa1c854a6e2743499 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-17T06:36:19Z |
| publishDate | 2021-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-aa77f2fffaf5469aa1c854a6e27434992022-12-21T22:00:00ZengBMCTrials1745-62152021-01-012211810.1186/s13063-020-04969-wThe reality of informed consent: empirical studies on patient comprehension—systematic reviewTomasz Pietrzykowski0Katarzyna Smilowska1Research Centre for Public Policy and Regulatory Governance, Faculty of Law and Administration, University of Silesia in KatowiceDepartment of Neurology; Centre of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center, Donders Institute for Brain, Cognition and BehaviourAbstract Background Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients’ comprehension of an informed consent’s basic components shows that their level of understanding is limited. Methods Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients’ comprehension of specific informed consent components. Results In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators’ blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects. Conclusions We found that participants’ comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients’ full and genuine involvement in a shared medical decision-making process.https://doi.org/10.1186/s13063-020-04969-wInformed consentClinical trialsMedical practiceLawEthicsComprehension |
| spellingShingle | Tomasz Pietrzykowski Katarzyna Smilowska The reality of informed consent: empirical studies on patient comprehension—systematic review Trials Informed consent Clinical trials Medical practice Law Ethics Comprehension |
| title | The reality of informed consent: empirical studies on patient comprehension—systematic review |
| title_full | The reality of informed consent: empirical studies on patient comprehension—systematic review |
| title_fullStr | The reality of informed consent: empirical studies on patient comprehension—systematic review |
| title_full_unstemmed | The reality of informed consent: empirical studies on patient comprehension—systematic review |
| title_short | The reality of informed consent: empirical studies on patient comprehension—systematic review |
| title_sort | reality of informed consent empirical studies on patient comprehension systematic review |
| topic | Informed consent Clinical trials Medical practice Law Ethics Comprehension |
| url | https://doi.org/10.1186/s13063-020-04969-w |
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