Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service.
checklist
consent form
drugs
neurosciences
patient information sheet
quality
research ethics committee
Journal
European journal of neurology
ISSN: 1468-1331
Titre abrégé: Eur J Neurol
Pays: England
ID NLM: 9506311
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
30
03
2020
revised:
08
06
2020
accepted:
22
06
2020
pubmed:
1
7
2020
medline:
24
6
2021
entrez:
29
6
2020
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND AND PURPOSE
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1825-1831Informations de copyright
© 2020 European Academy of Neurology.
Références
European Medicines Agency. Guideline for good clinical practice E6 (R2). 2016. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf (accessed 12/11/2019)
World Medical Association (WMA) 1964. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Last amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (accessed 12/11/2019)
Council for International Organizations of Medical Sciences (CIOMS) 2002. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS; 2002. https://www.fhi360.org/sites/all/libraries/webpages/fhi-retc2/Resources/CIOMS02.pdf (accessed 12/11/2019).
Bracken- Roche D, Bell E, Macdonald ME, Racine E. The concept of vulnerability in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Sys 2017; 15: 1-18.
Labuzetta JN, Burnstein R, Pickard J. Ethical issues in consenting vulnerable patients for neuroscience research. J Psychopharmacol 2011; 25: 205-210.
Bozzaro C, Boldt J, Schweda M. Are older people a vulnerable group? Philosophical and bioethical perspectives on ageing and vulnerability. Bioethics 2018; 32: 233-239.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials in medicinal products for human use and repealing Directive 2001/20/EC. Off J Eur Union 2014; L158/1: 1-76.
Abdoler E, Wendler D. Using data to improve surrogate consent for clinical research with incapacitated adults. J Empir Res Hum Res 2012; 7: 37-50.
Lühnen J, Mühlhauser I, Steckelberg A. The quality of informed consent forms - a systematic review and critical analysis. Dtsch Arztebl Int 2018; 115: 377-383.
Calle-Urra JE, Parra-Hidalgo P, Saturno-Hernández PJ, Martínez-Martínez MJ, Navarro-Moya FJ. Assessment of the formal quality of informed consent documents in 9 hospitals. Rev Calid Asist 2013; 28: 234-243.
Marrero-Álvarez P, Ruiz-Ramos J, Megías-Vericat JE, Tordera-Baviera M, Poveda-Andrés JL. Evaluation of the patient information sheet and informed consent in clinical trials. Rev Calid Asist 2013; 28: 139-144.
Tam NT, Huy T, Bich T, Long P, Huyen T. Participants understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ 2015; 93: 186-98H.
Guarino PD, Vertrees JE, Asthana S, et al. Measuring informed consent capacity in an Alzheimer’s disease clinical trial. Alzheimers Dement 2016; 2: 258-266.
Howe E. Informed consent, participation in research, and the Alzheimer’s patient. Innov Clin Neurosci 2012; 9: 47-51.
Paris A, Deygas B, Cornu C, et al. Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings. Br J Clin Pharmacol 2015; 80: 1010-1020.