Passive consent for passive participation?

The justification for consent

Today, there is widespread consensus that the requirement for active, informed consent in medical and health research is ethically correct and important. This consensus is so strong that we may sometimes forget the justification. We share the views of the ethicists James Wilson and David Hunter, who argue that the best justification for strict regulation of research is primarily associated with risk (2). Medical and health research can expose the participants to risk and inconvenience, even though it may not have as its primary objective to achieve therapeutic gain for the individuals concerned. It is essential to inform potential participants about this, so that they can make an informed and active choice of whether or not to expose themselves to this eventuality.

Risk is mainly associated with physical harm, but mental strain may also be relevant. In turn, physical and psychological risk associated with participation in research is linked to projects that imply an intervention or interaction, so-called primary research.

Secondary research refers to studies of previously collected data that may include anything from health information in patient records to central health registries. In this article we will not discuss registry-based research which must comply with other types of regulations. Secondary research is characterised by an absence of physical risk, and in this respect, a fundamental distinction can be drawn between primary and secondary research. Reference to risk may indeed be relevant also when it comes to secondary research, for example in the form of violations of privacy or integrity. We therefore do not claim that secondary research is invariably risk-free or ethically unproblematic, nor that primary research always implies risk. We nevertheless believe that the fundamental position that active consent has held in medical research ethics since the Nuremberg Code and the Declaration of Helsinki must be understood on the basis of primary research. Interaction – and the risk associated with it – represents the paradigmatic justification for strict research regulations and the requirement for active and informed consent.

If active and informed consent is considered to be of crucial importance also in secondary research, a justification other than risk is needed. Such a justification could be respect for autonomy as such. An autonomy-based justification for consent does not require that the research involves risk or inconvenience; the belief that each individual has the right to decide over his or her own data is sufficient. Hence one may believe it is important to be asked, even though there may be little to ask for. In addition, we associate consent with such basic principles as respect, good manners and courtesy – we ask before borrowing something (3).