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What are the Ethics of Electronic Consent Forms?

While bioethics has generally understood technologies to be a source of ethical problems, there is relatively little reflection about issues associated with technology’s role in bioethics itself. The move towards electronic consent is one area in technology. While there is substantial research on consent and the consent process the gradual shift towards digital consent forms appears to have arrived without necessary bioethical reflection. What are the ethical implications of this shift?

Yet, there are other more compelling questions that this brings about: Could the digitization of consent forms support even more robust kinds of consent on the part of patients and research subjects? Given what we know about the gaps between the ideals of consent and the reality of consent in clinical and research settings, could electronic supports be used precisely in areas where consent “breaks down?” How might ethical aims be sustained or emboldened via systems?

Understanding Consent

Before delving more comprehensively into the issue of digital consent forms, it is necessary to think about the aims of consent. For bioethics, consent requires that several critical functions be performed. This is to say that consent obliges the presence of several components simultaneously. Often, these include disclosure, understanding, and voluntariness, among others.

In comparing written and digital consent forms concerning the issue of consent, one must assess each format in relation to these underlying components. Below, I have included a table from an article where researchers compared paper-based consent forms against electronic processes concerning the elements of informed consent:

Table 1. Reproducing a table outlining components and Challenges of Informed Consent with Traditional Paper Forms and Electronic Methods. See Grady, C., Cummings, S. R., Rowbotham, M. C., McConnell, M. V., Ashley, E. A., & Kang, G. (2017). Informed Consent. New England Journal of Medicine, 376(9), 856–867. https://doi.org/10.1056/NEJMra1603773

 

Benefits of Electronic Informed Consent

Indeed, written consent forms often fail. With hand-written consent forms one finds, illegibility, unclear patient and procedure details, and patient’s signature. Digitalization would clear solve these issues. However, there are other issues related to the underlying ethical aims behind the intention of the consent process where digital forms could enable new approaches.

Consent is Not Static: Dynamic Consent

The development of something called, “dynamic consent” undoes one of the problems not only of written-based consent forms but also of the consent process itself. An individuals consent occurs at one moment in time, in a given context and may reflect a specific kind of understanding. Yet, people’s consent changes. How does this change in consent, part of the reality of ethics as it’s lived in “real life,” become honored in a newer mode of consent? Dynamic consent enables consenters to alter, change and withdraw consent long after the initial signing of a given document. By enabling an electronic site where consent is stored and accessible, consenters can change consent.

Disclosure is Not Static: Dynamic Disclosure

For the same reasons that a flexible and dynamic consent form could accommodate the reality of changes in consent, a dynamic disclosure process could dovetail more precisely to the nature of information and institutional change. Dynamic disclosure could inform consenters to change protocols, institutions, organizations, and information. While research protocols are required to have communication plans in which to communicate with consenters in the case of important changes, only a digital process could make this process more realistic and feasible.

Most People Don’t Really “Get It”: Enhanced Explanation, Linguistic Translation

While digital consent forms reflect larger administrative healthcare shifts, the shift should have occasioned an ethical opportunity: How might a digitally-support process help assist common kinds of misunderstanding? Could digital consent forms be used to “user-test” “best explanations” to patients and prospective research participants? Could dynamic text enable users to get emails with longer, more in-depth explanations of the procedure, research, risks, and underlying science? The research about the massive challenges concerning consenter recollection, terminology, language preferences, etc. Digital innovations have been pioneered in many places in precisely these areas in other arenas. In consumer-facing finance and ride-hailing applications, there is significant thought given to explanation, ease, areas for design improvement and clarity. User interface and human-computer research is dedicated to problem-solving in precisely these areas.

The problem with consenter recollections of consent procedures is a known one and could potentially impact issues of trust. Digital forms could be designed to lessen fatigue—a known problem in research on paperwork. From using forms to test form terminology to opportunities to personalize preferences (including the language in which information is presented), ethical opportunities abound.

Enhancing the Ethics underlying the Consent Process Digital Supports for Known Problems.

The ethical aims which underlay the consent process –autonomy – could not only be helped, through digital processes, but digital processes may provide a critical means by which ethicists and stakeholders on the ground to “bridge” ethical ideals with on-the-ground realities. Far from suggesting that digital systems are a perfect panacea, systems could help ethics in crucial ways—a topic that I will explore further in this blog.

Mark Dennis Robinson

Mark Dennis Robinson

Mark Robinson earned his Masters in Bioethics at Harvard Medical School in 2019, with a project that explored the intersection of technology and ethics. A graduate of the University of Chicago, he also holds a PhD from Princeton University, where he held the Presidential Fellowship. In Summer 2019, Mark will join Georgia Institute of Technology as a visiting scholar. Mark is also the author of a forthcoming book, "The Market in Mind: How Financialization Is Shaping Neuroscience, Translational Medicine, and Innovation in Biotechnology," about the ethical and scientific impacts of the increasing financialization of neuroscience (and of translational science and medicine in general) that will be published by MIT Press in 2019. Mark's fellowship project, "Ethics for a Frail Subject: Systems, Technology, and a Theory of Global Moral Impairment," considered how bioethics might be designed around an understanding of human beings as "impaired subjects" that accounts for biological impediments to human morality.

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