Improving the quality of informed consent in clinical trials

The project was an extension of the study 03SR in exploring the practices and perceptions of informed consent in clinical trials. In the Public Engagement (PE) component, we aimed to improve the quality of informed consent during recruitment into clinical trials by introducing different interventions to healthcare workers and patients.

Findings from 03SR suggested that informed consent is a complex issue that cannot be solved from the root within the scope of this project. Therefore, in the project, we had activities as follows:

  • Several meetings with different stakeholders including Public and Community Engagement (PCE), a clinical trial team, and the Clinical Trials Unit (CTU) to discuss the most possible way to tackle the problem.
  • After several discussions, we decided to have new versions of informed consent forms (ICF) and a support document that provides needed information about a certain disease and a clinical trial. The document is an attachment of the ICF delivered to research participants after the informed consent session. Those documents were tested with a small group of research participants and received good feedback.
  • A recommendation for improving the quality of the informed consent process was prepared and sent to the CTU as a reference for their future use.
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