Ethox Seminar - The Significance of Human Interaction in Consent to Research: ASCEND PLUS and Beyond

Abstract

The significance of human interaction in the consent process is being challenged in a number of ways with the advent of a range of digital technological approaches to the process. In Europe there is regulatory scepticism about the appropriateness of having no human interaction in the consent process for participation in clinical trials, whether remotely or in the clinic. Regulators in the US seem more reticent about the importance of this feature.
It may be that the need to preserve human interaction in consent is over-stated. In the context of modern technology, with automated chat facilities and the ability to clarify and answer questions electronically, the question remains as to what extra role and extra value is provided by human interaction.
This issue turns on demonstrating the ethical value of human interaction in the conventional consent setting and then reflecting this against the contexts of remote, electronic, and AI-enabled consent processes. This paper considers two particular possibilities in this regard. First, that the clinician-researcher has special responsibilities to those who would fall under their care and so should establish a direct, human connection with consenters. Second, that the value of human interaction depends on the consenter’s trust in the clinical-researcher and the subtle power dynamics involved in the relationship – which importantly work against the theoretical ethical justification of the process as capturing informed voluntary agreement.
In both cases, reliance on the human element poses important challenges to how we think about consent and its legitimacy.

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