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From these rulings, legal scholar Marjorie Shultz argues, autonomy is primarily recognized in terms of contact between bodies, “as a byproduct of protection for two other interests—bodily security as protected by rules against unconsented contact, and bodily well-being.” Elaine Scarry builds on this apparent confusion ...
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That informed consent is a fundamental requirement for research with human subjects is firmly established. Again, this process was for a long time reactive—a collective and political response to horror—it is only now entering a phase where ongoing maintenance and revision of policy are prioritized, as a means of addres...
The 1947 Nuremberg Code provides a foundation for informed consent in international law, outlining the basic requirements for science involving human subjects. The code provides that research participants should be given “sufficient knowledge and comprehension of the elements of the subject matter involved, as to enabl...
The first principle of ‘Respect for Persons’ defines an autonomous person as “an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” A capacity for making decisions, based on goals, leading to action. Taken together, these processes constitute the right to ...
Codified in 1991 as the ‘Common Rule’, a set of federal regulations (45 CFR 46) designed to protect human subjects taking part in research, the ethical framework of the Belmont Report was also formative for bioethics research in the US. These regulations are now continuously updated, while leaving the core ethics of th...
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The practice of consent is culturally-informed and behavioral. It is an activity of daily life that is learned and practiced. As intimacy coordinator and consent educator Mia Schachter writes: “Consent is a practice of deep listening, not just for words, but also for body language, gaze, speech patterns and other non-v...
Planned Parenthood promotes a widely-accepted definition of sexual consent, a practical and juridical category of interpersonal relationships, using the ‘F.R.I.E.S.’ acronym, as: Freely given, reversible, informed, enthusiastic, and specific.
Critiques of this model tend to focus on the flattening of desire, in all its complexity, to enthusiasm. An alternative term that has been proposed is ‘engaged.’ This modification acknowledges the necessity of continued analysis of desire, by assessing whether it serves one’s own curiosity, or it serves a sense of duty...
Schachter, building on Betty Martin’s Wheel of Consent, formalizes the shifting gradients of self-appraisal as the Yes-to-No Spectrum. In this pedagogical frame, Schachter poses important qualifiers for engaged consent: is this a learning opportunity? Am I deferring to someone else’s judgment? Does my sense of potentia...
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Consent, as a reversible commitment, happens in shared time. It is an ongoing and changeable action. A consensual agreement requires ongoing attention, and attending to.
Correspondingly, attention requires our consent. As the world confronts us, through sensory and logical channels, with decisions about what to pay attention to, we open or close ourselves to witnessing, participating, or reciprocating.
Writing in Consent with Touch: Manual for Practitioners, Schachter outlines how to maintain a focus on consent through changing circumstances, and the importance of “narrating what you are doing, why, what it might feel like, and what you are looking for,” crucial advice for all clinical encounters, out of respect for ...
The idea that a misplaced emphasis on autonomy leads to a neglect of necessary aspects of communication in the consent process has been widely discussed. Bioethicists Neil Manson and Onora O’Neill, in surveying the current limitations of informed consent, locate the ways in which the notion of information itself is dis...
The culture and the technology must shift. One recent change is to shift the standard for what information is relevant: “The reasonable-patient standard views the informed consent communication process from the patient’s perspective. It requires physicians and other health care practitioners to disclose all relevant in...
Traditionally, courts have “tacitly reinforced paternalism by calling on physicians as expert witnesses in informed-consent lawsuits,” resulting in a self-replicating system where “physicians decided how much information a physician should disclose to patients.”
In 2015, the UK Supreme Court found, in Montgomery v Lanarkshire Health Board, that the standard for what information should be provided to patients to constitute informed consent “will no longer be determined by what a responsible body of physicians deems important but rather by what a reasonable patient deems importa...
Information needs, even when determined by what is imagined as a reasonable patient (a term I’d like to call into question), are not always considered in the context of other needs. The threshold for informed consent should address both how information is offered and how it is received, including such person-centered f...
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Departure, for Édouard Glissant, is “the moment when one consents not to be a single being and attempts to be many beings at the same time.” In this “passage from unity to multiplicity” that Glissant identifies as characteristic of diaspora, could automated pattern-matching tools such as AI act as a go-between or guide...
The capacity of large language models (LLMs) to summarize and revise content is already being put to use in hospital systems as a guide, making the language of informed consent more accessible. This capacity for summarization and explanation contributes to a broad need for language accessibility, both in terms of trans...
Proxies, or “those who are most likely to understand the [...] subject's situation and to act in that person's best interest,” are an important factor in decisions made by and for people without capacity for self-determination, where mental faculty is either diminished, developing, or in decline. Proxies carry the lega...
Where should AI be situated in supporting informed consent? As go-between and guide, between patient and information, or between patient-as-individual and patient-as-data? Or as a proxy: for patient, caregiver, or health care professional?
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…to shared decision making
Informed consent is a legal concept that requires information to be provided before consent can be made. Articulations of the concept emphasize the importance of autonomy and self-determination. However, problems with poorly implemented consent frameworks lead to a slippage between consent and compliance, and a failure...
Informed consent mechanisms, often lacking specificity, “tend to be generic, containing information intended to protect the physician or hospital from litigation.” Compliance-centered methods that privilege the transfer of information as material, rather than aiding in the process of comprehension, have been described ...
Shared decision making, on the other hand, is an ethical move that recognizes “the need to support autonomy by building good relationships, respecting both individual competence and interdependence on others.” As a result, it has been shown to lead to measurable knowledge gains by patients, increased confidence in deci...
The choice to enter into a shared decision making process is situational: higher risk decisions require a focus on information; lower certainty outcomes require a focus on the decision making process. Nevertheless, the emergence of shared decision making seeks to support full autonomy by balancing the right to self-de...
“As best practice” shared decision making “validates, augments, and enriches the process of informed consent by emphasizing patients’ understanding and prioritizing of different medical interventions in light of their own values and lived experiences.” Shared decision making, as it has been defined by numerous sources,...
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The introduction of AI technologies into medical data practices further erodes the stability of autonomy-based interpretations of informed consent, both positively and negatively.
Researchers and patient advocates alike have positively evaluated the use of generative AI to augment informed consent and decision support—particularly for its summarization and explanation functionality. However, induced belief revision, as a tendency to defer to automated or AI-assisted analysis over intuition, taci...
In December 2023, the Department of Health and Human Services adopted the HTI-1 Final Rule (89 FR 1192). The stated goal of this legislation was to implement requirements already proposed in the 21st Century Cures Act (85 FR 25642) for the interoperability and transparency of AI-based healthcare technologies.
Reading these two pieces of legislation together, it can seem as if interoperability and transparency are the same thing. Both require the safe disclosure—of data, protocols, methods—and means of access to sensitive health information, efficiently achieved through the design and maintenance of a new standard applicatio...
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The HTI-1 Final Rule sets guidelines for, among other things, the use of predictive decision support interventions (DSIs). Predictive DSIs, as defined by the legislation, are tools “that support decision-making by learning or deriving relationships to produce an output, rather than those that rely on pre-defined rules....
This broad, undifferentiated definition contrasts with how AI in medicine is characterized elsewhere.The American Medical Association Current Procedural Terminology’s AI Taxonomy makes a clear high-level distinction between assistive, augmentative, and fully automated technologies. The government rule addresses this ca...
What are these decision aids that are expected to evolve, be applied to more use cases, that humans will interact with in more diverse ways?
Patient reported outcome measures (PROMs) are a key source for analysis that contributes to decision aids, showing how treatment, health status, and quality of life come together in meaningful ways. As discussed in chapter three (“The Validated Instrument”), it is expected that the application of AI tools to PROM data ...
Decision aids are access tools, in that they “provide balanced, evidence-based information about treatment options and usually are easy to read, often with pictures and figures; some may include patient testimonials about different pathways.”
Patients with access to decision aids were found to have “had greater knowledge of the evidence, felt more clear about what mattered to them, had more accurate expectations about the risks and benefits, and participated more in the decision-making process.”
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Predictive DSIs offer a clear example of what is broadly known as automated decision making (ADM).
Article 22 of the European Union’s General Data Protection Regulation, commonly known as GDPR, protects subjects from the effects of automated decision making as follows:
“The data subject shall have the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her.”
A data subject, in this context, is explained as “one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cu...
What Hito Steyerl refers to as patterns of life.
Performative technologies, from The Coordinator to generative AI, enact what they describe, and create data subjects through repetition. The model trains you. The concern is that the outcome of these processes will impose coherence that is unrecognizable to us, patterns we can’t sense, and explanations whose logic we c...
Performance studies scholars Roberto Alonso Trillo and Marek Poliks, in the introduction to their co-edited collection of texts on performativity after AI, pose a set of framing questions: “Is artificial intelligence (AI) becoming more and more expressive, or is human thought adopting more and more structures from comp...
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Incoherent, unexplainable and uninterpretable outcomes can’t be shared. Nor is their process to be shared in. These are symptoms of a black box.
Black box is a term that “can refer to a recording device, like the data-monitoring systems in planes, trains, and cars. Or it can mean a system whose workings are mysterious; we can observe its inputs and outputs, but we cannot tell how one becomes the other.” A black box is something that is not open to interpretatio...
Media theorist Mark Andrejevic extends the black box metaphor, with its implicit focus on opacity, obscurity, and secrecy, to consider “actionable but non-sharable information:” practical insight, such as material used to support decision making, that is not shareable in the sense that it cannot be explained or interpr...
To put this thought in context, Andrejevic quotes literary theorist Paul Ricouer—I paraphrase here: a text, as an object of interpretation broadly defined, mediates between one reader and another, between readers and the world they occupy, and between readers and their interior selves. Interpretation is a kind of shari...
This narrow focus on inputs and outputs encapsulates what Beatriz Fazi calls the “autonomy of automation,” or, freedom from human modes of abstraction and representation. This autonomy is most evident in the capacity of self-supervised AI models (exemplary black boxes) to produce internal representations “independently...
However, this difference is non-separable. We encounter black box systems as hybrids of automation, abstraction, and storytelling, where “the role of narrative is inseparable from the call for transparency.” Narrative makes systems legible, and this is unavoidable, even if this narrative is about illegibility.
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As with analysis, always return to a situated perspective:
* Who poses the questions?
* Whose well-being is at stake?
* What lived experience is used to frame decisions and reactions?
* Whose imaginary is drawing the field of decisions?
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Compression as Explanation
“The manner and context in which information is conveyed is as important as the information itself [...] It is necessary to adapt the presentation of the information to the subject's capacities.”
What is information?
It is different from raw data, and it is separate from the way data can be modeled. Information, as defined by computer scientist Marcia Bates, consists of all the instances where people interact with their environment in such a way that it leaves some impression on them. Information is found in the interactions that c...
What do people need from information?
Brenda Dervin defined information needs in terms of sense-making: A person, in their time and place, needs to make sense. The sense they need to make is for their own world, their time and place. To do this, they need to inform themselves constantly. Their need for information is oriented by questions that deal with th...
How do people behave with information?
Sense-making is one kind of information behavior. As with other kinds of behavior, information behavior is contextual, it involves some motivating factor, or objective: “People are trying to solve problems in their lives, not ‘seek information’.” Information behavior, as a broadly descriptive term, addresses why we cho...
Information behavior is not always a process of careful assembly and consideration. In the particular case of information seeking under threat, awareness of needs, motivations, and contextual support may shatter as a person copes with the dissonance of too much information. In seeking to understand this coping response...
What happens when a patient researches their own condition?
Patients’ access to their own health records is a protected right under HIPAA (1996). The HITECH act (2009) moved this access into electronic health records (EHR), software-based patient portals and apps. The 21st Century Cures Act (2016) established this right as an obligation for care providers to not withhold their ...
How do patients think about having access to their own health information?
In multisite and international studies, patients tend to agree they prefer to have immediate access to their health information, even when that information is provided without adequate context or explanation. Patients surveyed also tend to agree that improved access to their own health information improves, in turn, th...
In a systematic review of how patients’ respond to having immediate access to their own electronic health records (EHR), benefits were found ranging from reduced anxiety, better doctor–patient relationship, increased awareness of changing health status, adherence to medication, and improved patient outcomes. Patients s...
Across the board, increased access to one’s health information was shown to produce increased patient engagement, confidence in self-management of symptoms, health literacy, and informed participation in shared decision making. It is hoped that more transparent electronic health records will be taken up as a priority o...
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How does information behavior affect how we disclose, answer, make decisions, and navigate our own legibility?
Elfreda Chatman, writing in The Impoverished Life-World of Outsiders, traces how flows of information can break down, contributing to a power gradient that she names information poverty. In this schema, knowledge falls into insider and outsider categories wherever trust is at a minimum, and vulnerability—sense of perso...
It is easy for me to read Chatman’s idea of information poverty in terms of the experience of illness—how patients inform themselves, and how patients relate to their own data. As artist Carolyn Lazard details in their illness narrative How to Be a Person in the Age of Autoimmunity, the insider information of other pat...
While Chatman describes information poverty in terms of how information is sought out, used, and shared within groups, Aimé Césaire names a wider failure of sociotechnical imagination to contend with incoherence as “impoverished knowledge.” Césaire proposes that poetry, and poetic knowledge, fill the gaps: “Scientific ...
Césaire’s notion of poetic knowledge travels well, as a means of “working on and against” sociotechnical systems, in the act of disidentification, in José Esteban Muñoz’s formulation. For both insider and outsider positions, patients and researchers, encounters with new technology produces multiple instances of disiden...
Analyses of “crip legibility”, or the methods with which disabled people interact with, relate to, and slip between legible categories, as a form of information expertise, are crucial to re-imagining the future of health information systems. The call has been issued for “greater acknowledgement of the lived experiences...
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“What is lost in the search for perfect explainability?”
Nora N. Khan poses this rhetorical question in the 2022 compendium Mirror Stage: Between Computability and its Opposite. In the context of AI, explainability, as a summary or high level overview of the processes and justifications used (e.g. why did you do that), is distinguished in common use from interpretation (e.g....
Explainability is widely held up as a guideline for the development of ethical AI, particularly when the technology is used with sensitive data, vulnerable populations, and in decision making processes that have tangible effects on people’s lives. Healthcare is a prime example of this, where a right to justification is...
However, explainability, as policy and as a critical tool, has its discontents. Unlike interpretation, which operates reflexively across incommensurable differences, explainability relies on sometimes clumsy metaphors and re-framings to produce a common legibility around reasons. We bring what we cannot understand into...
These metaphors shape what we are able to imagine about the processes at work, limit the scope of our understanding to what is already familiar, and obscure other important factors and conditions. We don’t learn from these explanations alone. As Khan puts it: “There are vital ways to map and narrate and explain the wor...
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For healthcare providers, the failure to recognize, symbolize, and reflect on the consequences of the emotions they experience in clinical encounters is shown to impede or adversely affect patient care. This is to say, when information seeking is an interpersonal activity, such as in shared decision making, emotion and...
How can we ask better questions?
In advising clinicians on how to prepare for conversations about palliative care in oncology, Back et al. offer a quick litany of questions, conversation starters:
(1) What is happening?
(2) How do you (and I) feel?

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