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. 2012 Nov 16:13:30.
doi: 10.1186/1472-6939-13-30.

Pharmaceutical information systems and possible implementations of informed consent -- developing an heuristic

Thomas Ploug  1 , Søren Holm
Affiliations

Pharmaceutical information systems and possible implementations of informed consent -- developing an heuristic

Thomas Ploug et al. BMC Med Ethics. .

Abstract

Background: Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use.

Analysis: The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context.

Results and conclusion: Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system.The danger of routinisation of consent is identified.The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent.

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Figures

Figure 1
Figure 1
The three-dimensional space of informed consent.
Figure 2
Figure 2
Models of informed consent, Figure2consists of the three-dimensional space of Figure1with the addition of well-defined points on the ’registration-axis’ (horisontal), the ’use-axis’ (vertical), and the ’information-axis’. The numbers give the ranking of the specific point (i.e. triangle) in the three-dimensional space in which it is positioned such that the higher the number the weaker the protection of personal autonomy. The colours mark three basic clusters of points according to their protection of personal autonomy. The circles mark the ’positions’ taken by members of the Danish Council of Ethics.
See this image and copyright information in PMC

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