Passive consent for passive participation?



    Passive consent meets important ethical concerns and ought to be more applied in certain types of medical and health-related research.

    The purpose of the Health Research Act is to promote good and ethically sound research (1). A key approach to this effect is to instruct the researchers to obtain consent from the participants. One challenge, however, is that the Act stipulates only two categories – either active consent or exemption from consent. We believe that there are good ethical reasons to commend passive consent and give it a clearer role to play.

    The road ahead

    The road ahead

    To promote high-quality and ethically defensible research, a balance must be struck between various concerns. We argue that some nuances should be introduced into the requirements for consent stipulated by the Health Research Act. Active consent should remain the norm in primary research. Passive consent ought to be regarded as the norm for passive research or secondary research in which there is little at stake for the participants. This is not a matter of sacrificing the interests of the individual at the altar of the common good. It is about finding an optimal ethical solution for both concerns.

    The current legal framework does not completely preclude a more prominent role for passive consent, but nor does it promote it, given the formulations about the main rule and an exemption clause. We suspect that the rules for consent are out of step with the opinions of participants, researchers and ethics committees regarding what should be an appropriate balance between concerns for the participants' integrity and welfare on the one hand and for promotion of socially useful research on the other. Passive consent for passive participation in research could be good research ethics.

    The authors wish it to be noted that this article is not written on behalf of the system of national and regional research ethics committees. The viewpoints reflected herein must be read as the authors' own and are intended as an invitation to a debate on the regulation of Norwegian health research.


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