Improvement of informed consent and the quality of consent documents

Abstract

Guidelines on informed consent intend to protect patients and promote ethical research conduct. To give informed consent, individuals should understand the purpose, process, risks, benefits, and alternatives to research (or a proposed clinical intervention) and make a free, voluntary decision about whether to participate. Many participants have incomplete understanding of various features of clinical trials. Issues associated with the length, format, and language of documents for written informed consent are common. Here, we analyse the written consent form, particularly in the context of clinical research, and the discussions that take place between clinician or investigator and patient. We review strategies to improve consent forms, particularly the use of plain language. Recommendations are made on discussions between investigator and patient to improve participant comprehension and satisfaction with the informed-consent process.