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Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of information

¹ Centre for Bioethics, LIME, Karolinska Institutet, Stockholm, Sweden
² Department of Health Services Research, Institute of Public Health, University of Copenhagen, Denmark

Correspondence to:
Professor N Lynöe
Centre for Bioethics, LIME, Karolinska Institutet, Stockholm, Sweden; niels.lynoe{at}lime.ki.se Information is usually supposed to be a prerequisite for people making decisions on whether or not to participate in a clinical trial. Previously conducted studies and research ethics scandals indicate that participants have sometimes lacked important pieces of information. Over the past few decades the quantity of information believed to be adequate has increased significantly, and in some instances a new maxim seems to be in place: the more information, the better the ethics in terms of respecting a participant’s autonomy. The authors hypothesise that the dose-response curve from pharmacology or toxicology serves as a model to illustrate that a large amount of written information does not equal optimality. Using the curve as a pedagogical analogy when teaching ethics to students in clinical sciences, and also in engaging in dialogue with research institutions, may promote reflection on how to adjust information in relation to the preferences of individual participants, thereby transgressing the maxim that more information means better ethics.

Keywords: clinical research; informed consent; participants’ perceptions; pedagogical model; information

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