Participant information sheets in clinical research: Compromising the ethics of informed consent?
Authors: Negoescu, A.F., Gelling, L. and ÖstÖr, A.J.K.
Pages: 495-499
Abstract:Clinical research forms the foundation on which rest the advancement of medical knowledge and improvement in patient experience and outcomes. In order to obtain accurate information, as well as to protect research participants and ensure their safety, it is crucial that potential participants go through a meaningful informed consent process, and they understand what they are engaging to and what is expected of them. The progress recently achieved in the implementation of new biologic therapies across many rheumatic disorders depended on the information provided by clinical trials. The current way of delivering information about a biologic drug in a clinical trial is in the form of A4 sheets, with participant information sheet (PIS) sometimes exceeding thirty pages. We are concerned that in these circumstances participants feel overwhelmed, which can lead to poor quality and, in some cases, even unethical research. The unfriendliness of both the language and length of the PIS is a perfect recipe for failure to engage people in clinical research. Even more worryingly, individuals may be participating in research without truly understanding what their participation will involve. Here we discuss the ethical implications of informing patients about new therapies available through clinical trials.
Source: Scopus
Participant information sheets in clinical research: Compromising the ethics of informed consent?
Authors: Negoescu, A.F., Gelling, L. and ÖstÖr, A.J.K.
Editors: ciurtin, C. and Isenberg, D.
Pages: 495-499
Publisher: Nova Biomedical
Place of Publication: New York, USA
ISBN: 9781634852746
Abstract:© 2016 Nova Science Publishers, Inc. Clinical research forms the foundation on which rest the advancement of medical knowledge and improvement in patient experience and outcomes. In order to obtain accurate information, as well as to protect research participants and ensure their safety, it is crucial that potential participants go through a meaningful informed consent process, and they understand what they are engaging to and what is expected of them. The progress recently achieved in the implementation of new biologic therapies across many rheumatic disorders depended on the information provided by clinical trials. The current way of delivering information about a biologic drug in a clinical trial is in the form of A4 sheets, with participant information sheet (PIS) sometimes exceeding thirty pages. We are concerned that in these circumstances participants feel overwhelmed, which can lead to poor quality and, in some cases, even unethical research. The unfriendliness of both the language and length of the PIS is a perfect recipe for failure to engage people in clinical research. Even more worryingly, individuals may be participating in research without truly understanding what their participation will involve. Here we discuss the ethical implications of informing patients about new therapies available through clinical trials.
Source: Manual
Preferred by: Leslie Gelling