Informed consent : communication and miscommunication in clinical trials

[摘要] ENGLISH ABSTRACT: BackgroundInformed Consent (IC) has been proposed as the optimal method for ensuring theethical entry of patients into clinical trials. IC is a vital part of the research processand as such entails more than obtaining a signature on a form. The IC must begiven freely, without coercion, and must be based on a clear understanding of whatparticipation involves.AimThe overall aim of this study was to attain an understanding of participants'knowledge regarding informed consent when participating in a research project.MethodsThe study was conducted at two public hospitals in a city in the Eastern CapeProvince of South Africa. The quantitative study used descriptive survey design. Aself administered questionnaire was used as a tool for data collection.ResultsThe sample size consisted of 170 women with an average of 25.9 years. Themajority had completed secondary level education. More than half of the participantsdid not have knowledge of the purpose of the original study. The majority ofparticipants did not have knowledge of their responsibilities. Forty-two percent gaveuninformative responses and 26% indicated they did not know their responsibilities.None of the participants understood the concept of randomization. The majority(85.9%) of participants indicated that information provided on the IC forms wassufficient for them to decide to participate.ConclusionDespite extensive efforts to ensure that participants understood their participation inthe original studies, this study found poor recall of vital information for IC. A signedinformed consent does not guarantee that participants understand information given.RecommendationsThe existing methods of communicating and obtaining of an informed consent seemto be insufficient for participants to make an informed decision. A new approach withmore interactive features such as combination of audio-visual techniques mightincrease the possibilities of the understanding.

[发布机构] Stellenbosch University