Assessment of the quality of Patient Information Sheets and Informed Consent Forms for clinical trials at a Hospital Neurology Service.

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 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 PIS/ICFs from a Hospital Neurology Service (NS). The assessment was made using validated and reliable checklists of the information included in the PIS/ICFs of CTs with medicinal products.

METHODS: Analyses of the compliance with the checklists of 21 PIS and ICFs reviewed/approved during 2016-2017 by a medicinal Research Ethics Committee.

RESULTS: All PIS/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 NS demonstrated good compliance (≥ 80%) with the checklist, while ICFs should be improved. Sponsors omitted some relevant information such as 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 PIS/ICFs of CTs of medicinal products currently used need improvement. PISs and ICFs should be separate documents for each CT. The PIS/ICFs should consider, in particular, those criteria related to the decision of participants, protect their rights and ensure that the information received is complete.