Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service
Background and purpose: </strong>Clinical trials (CTs) aimed at vulnerable groups, such as patients with mental disorders, create ethical complexity. The patient information sheet (PIS) should provide all of the information about the CT that is relevant to the subject's decision to partic...
| Autores: | , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión aceptada para publicación |
| Fecha de publicación: | 2020 |
| País: | España |
| Institución: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:2445/226212 |
| Acceso en línea: | https://hdl.handle.net/2445/226212 |
| Access Level: | acceso abierto |
| Palabra clave: | Neurologia Assaigs clínics Medicaments Neurociències Neurology Clinical trials Drugs Neurosciences |
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Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology serviceJaramillo Velez, A. G.Aguas Compaired, M. (Margarita)Granados Plaza, M.Mariño Hernández, Eduardo L.Modamio Charles, PilarNeurologiaAssaigs clínicsMedicamentsNeurociènciesNeurologyClinical trialsDrugsNeurosciencesBackground and purpose: </strong>Clinical trials (CTs) aimed at vulnerable groups, such as patients with mental disorders, create ethical complexity. The patient information sheet (PIS) should provide all of the information about the CT that is relevant to the subject's decision to participate. After being informed, the subject will decide freely whether to take part in the CT and will read and sign the informed consent form (ICF). The objective was to assess the quality of PISs/ICFs from a hospital neurology service. The assessment was made using validated and reliable checklists of the information included in the PISs/ICFs of CTs with medicinal products.</p><p><strong>Methods: </strong>The study comprised analyses of compliance with the checklists of 21 PISs and ICFs reviewed/approved during 2016-2017 by a medicinal research ethics committee.</p><p><strong>Results: </strong>All PISs/ICFs were from multicenter CTs sponsored by pharmaceutical companies in different therapeutic areas, mainly Parkinson's (52.4%) and Alzheimer's (38.1%) diseases. The PISs from the neurology service demonstrated good compliance (≥80%) with the checklist, whereas ICFs should be improved. Sponsors omitted some relevant information, such as the study title or that the participant be informed of any information arising from the research that may be relevant to the subject's health, although this information may be in the PIS.</p><p><strong>Conclusions: </strong>The PISs/ICFs of CTs of medicinal products that are currently used need improvement. PISs and ICFs should be separate documents for each CT. In particular, the PISs/ICFs should consider the criteria related to the decision of participants, protect their rights and ensure that the information received is complete.Wiley2026202620202026info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersion19 p.application/pdfhttps://hdl.handle.net/2445/226212Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésVersió postprint del document publicat a: https://doi.org/10.1111/ene.14420European Journal of Neurology, 2020, vol. 27, num.10, p. 1825-1831https://doi.org/10.1111/ene.14420(c) European Academy of Neurology, 2020info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2262122026-05-29T05:05:01Z |
| dc.title.none.fl_str_mv |
Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service |
| title |
Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service |
| spellingShingle |
Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service Jaramillo Velez, A. G. Neurologia Assaigs clínics Medicaments Neurociències Neurology Clinical trials Drugs Neurosciences |
| title_short |
Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service |
| title_full |
Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service |
| title_fullStr |
Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service |
| title_full_unstemmed |
Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service |
| title_sort |
Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service |
| dc.creator.none.fl_str_mv |
Jaramillo Velez, A. G. Aguas Compaired, M. (Margarita) Granados Plaza, M. Mariño Hernández, Eduardo L. Modamio Charles, Pilar |
| author |
Jaramillo Velez, A. G. |
| author_facet |
Jaramillo Velez, A. G. Aguas Compaired, M. (Margarita) Granados Plaza, M. Mariño Hernández, Eduardo L. Modamio Charles, Pilar |
| author_role |
author |
| author2 |
Aguas Compaired, M. (Margarita) Granados Plaza, M. Mariño Hernández, Eduardo L. Modamio Charles, Pilar |
| author2_role |
author author author author |
| dc.subject.none.fl_str_mv |
Neurologia Assaigs clínics Medicaments Neurociències Neurology Clinical trials Drugs Neurosciences |
| topic |
Neurologia Assaigs clínics Medicaments Neurociències Neurology Clinical trials Drugs Neurosciences |
| description |
Background and purpose: </strong>Clinical trials (CTs) aimed at vulnerable groups, such as patients with mental disorders, create ethical complexity. The patient information sheet (PIS) should provide all of the information about the CT that is relevant to the subject's decision to participate. After being informed, the subject will decide freely whether to take part in the CT and will read and sign the informed consent form (ICF). The objective was to assess the quality of PISs/ICFs from a hospital neurology service. The assessment was made using validated and reliable checklists of the information included in the PISs/ICFs of CTs with medicinal products.</p><p><strong>Methods: </strong>The study comprised analyses of compliance with the checklists of 21 PISs and ICFs reviewed/approved during 2016-2017 by a medicinal research ethics committee.</p><p><strong>Results: </strong>All PISs/ICFs were from multicenter CTs sponsored by pharmaceutical companies in different therapeutic areas, mainly Parkinson's (52.4%) and Alzheimer's (38.1%) diseases. The PISs from the neurology service demonstrated good compliance (≥80%) with the checklist, whereas ICFs should be improved. Sponsors omitted some relevant information, such as the study title or that the participant be informed of any information arising from the research that may be relevant to the subject's health, although this information may be in the PIS.</p><p><strong>Conclusions: </strong>The PISs/ICFs of CTs of medicinal products that are currently used need improvement. PISs and ICFs should be separate documents for each CT. In particular, the PISs/ICFs should consider the criteria related to the decision of participants, protect their rights and ensure that the information received is complete. |
| publishDate |
2020 |
| dc.date.none.fl_str_mv |
2020 2026 2026 2026 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/acceptedVersion |
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article |
| status_str |
acceptedVersion |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/2445/226212 |
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https://hdl.handle.net/2445/226212 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
Versió postprint del document publicat a: https://doi.org/10.1111/ene.14420 European Journal of Neurology, 2020, vol. 27, num.10, p. 1825-1831 https://doi.org/10.1111/ene.14420 |
| dc.rights.none.fl_str_mv |
(c) European Academy of Neurology, 2020 info:eu-repo/semantics/openAccess |
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(c) European Academy of Neurology, 2020 |
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openAccess |
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19 p. application/pdf |
| dc.publisher.none.fl_str_mv |
Wiley |
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Wiley |
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Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica) reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Recercat. Dipósit de la Recerca de Catalunya |
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Recercat. Dipósit de la Recerca de Catalunya |
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