Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial
The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosth...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-06-01
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| Series: | Healthcare |
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| Online Access: | https://www.mdpi.com/2227-9032/10/6/1036 |
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| author | Maria López-Parra Francesc Zamora-Carmona Mònica Sianes-Gallén Esmeralda López-González Dolors Gil-Rey Helena Costa-Ventura Miriam Borrás-Sánchez Gemma Rayo-Posadas Marta Arizu-Puigvert Roser Vives-Vilagut |
| author_facet | Maria López-Parra Francesc Zamora-Carmona Mònica Sianes-Gallén Esmeralda López-González Dolors Gil-Rey Helena Costa-Ventura Miriam Borrás-Sánchez Gemma Rayo-Posadas Marta Arizu-Puigvert Roser Vives-Vilagut |
| author_sort | Maria López-Parra |
| collection | DOAJ |
| description | The informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. Methods: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. Results: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. Conclusions: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects. |
| first_indexed | 2024-03-09T23:40:57Z |
| format | Article |
| id | doaj.art-74efc821bd724587abd6b2c1e05a3e5c |
| institution | Directory Open Access Journal |
| issn | 2227-9032 |
| language | English |
| last_indexed | 2024-03-09T23:40:57Z |
| publishDate | 2022-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Healthcare |
| spelling | doaj.art-74efc821bd724587abd6b2c1e05a3e5c2023-11-23T16:51:55ZengMDPI AGHealthcare2227-90322022-06-01106103610.3390/healthcare10061036Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled TrialMaria López-Parra0Francesc Zamora-Carmona1Mònica Sianes-Gallén2Esmeralda López-González3Dolors Gil-Rey4Helena Costa-Ventura5Miriam Borrás-Sánchez6Gemma Rayo-Posadas7Marta Arizu-Puigvert8Roser Vives-Vilagut9Parc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, Sabadell, 08206 Barcelona, SpainParc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, Sabadell, 08206 Barcelona, SpainParc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, Sabadell, 08206 Barcelona, SpainParc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, Sabadell, 08206 Barcelona, SpainParc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, Sabadell, 08206 Barcelona, SpainParc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, Sabadell, 08206 Barcelona, SpainInstitut Català de la Salut, North Metropolitan, 08924 Barcelona, SpainParc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, Sabadell, 08206 Barcelona, SpainParc Taulí Hospital Universitari, Institut d’Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Parc Taulí 1, Sabadell, 08206 Barcelona, SpainDepartament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, 08193 Barcelona, SpainThe informed consent (IC) of subjects participating in experimental studies is the mainstay to comply with the ethical principle of autonomy to ensure that the participation is voluntary. This experience was performed within the context of a single-center randomized clinical trial in elective prosthetic surgery. Obtaining IC in clinical trials is not without difficulties, and especially in the case of vulnerable populations it can be very challenging. This work aimed to identify the difficulties during the IC process for a clinical trial in subjects older than 65 years old and quantify and describe the use of IC in front of a witness. Methods: This is a mixed methodology study with a qualitative part (focus group with 4 nurses involved in the inclusion of subjects) and a quantitative part describing the characteristics of patients who signed IC forms. Results: The main difficulties identified are related to comprehension, sensory impairments, education level, and time. IC in front of witnesses was used in 20 patients out of 508. Conclusions: The participation of subjects older than 65 years old in clinical trials requires an adaptation of the process. The use of IC in front of a witness should always be considered in studies including elderly subjects.https://www.mdpi.com/2227-9032/10/6/1036agedinformed consent formnursesrandomized controlled trial |
| spellingShingle | Maria López-Parra Francesc Zamora-Carmona Mònica Sianes-Gallén Esmeralda López-González Dolors Gil-Rey Helena Costa-Ventura Miriam Borrás-Sánchez Gemma Rayo-Posadas Marta Arizu-Puigvert Roser Vives-Vilagut Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial Healthcare aged informed consent form nurses randomized controlled trial |
| title | Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial |
| title_full | Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial |
| title_fullStr | Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial |
| title_full_unstemmed | Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial |
| title_short | Patient Information and Informed Consent for Research in the Elderly: Lessons Learned from a Randomized Controlled Trial |
| title_sort | patient information and informed consent for research in the elderly lessons learned from a randomized controlled trial |
| topic | aged informed consent form nurses randomized controlled trial |
| url | https://www.mdpi.com/2227-9032/10/6/1036 |
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