Background Before enrolling in a clinical trial, subjects have to be informed about the nature of the study and every possible benefit and risk, in order to consciously decide whether to participate. For this reason, during the evaluation phase of a protocol, the Ethics Committee (EC) of the Verona University Hospital, among other tasks, expresses its opinion about ‘the adequacy and completeness of the written information to the subject’, possibly requiring changes to the document.
Purpose To describe, in the cohort of studies evaluated by the EC in the year 2012, the problems related to the inadequacy of informed consent, analysing the reasons for suspending studies.
Materials and methods The Scientific Secretariat of the EC is located at the Pharmacy Service and is composed of two pharmacists. Protocols evaluated by the EC in the year 2012 were selected from the EC database. From this sample, protocols with informed consent forms for which the EC required changes were identified.
Results In 2012, the EC evaluated 185 clinical trials. Of these, 101 were with non-commercial sponsors and 84 with commercial sponsors. 85 were observational studies and 100 were interventional clinical trials. For 34.1% of the studies the EC required changes to the informed consent sheet for the patient. Of the 63 studies for which changes were requested, 20 were observational studies and 43 interventional clinical trials; moreover 30 had a non-commercial sponsor and 33 came from a commercial sponsor.
Overall, the EC required 101 changes to the informed consent: 27 requests (26.7%) to add information in the text, 22 requests (21.8%) to change the language (e.g. explanation of acronyms, simplification of medical terms), 20 requests (19.8%) to correct inaccuracies, 14 requests (13.9%) to clarify the nature of the study (e.g., study design, receiving placebo), 14 requests (13.9%) to comply with the requirements of the forms, 2 requests (1.99%) to simplify information for children and adolescents and 2 requests (1.99%) about specifications of contraception methods.
Conclusions The survey shows that the informed consent remains a critical issue involving both commercial and non-commercial studies.
In light of this issue, the EC of the Verona University Hospital wrote a document on ‘Good Practice for Informed Consent’, to help sponsors and investigators to finalise in advance an appropriate information document for the patient.
In particular, there is now a proposal to give sponsors a checklist with all essential elements, structured with answers and questions.
No conflict of interest.
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