 So, I am going to attempt to distill a 45-page law review article into a 15-minute talk, which me luck. And it is still a work in progress, so there's a lot. I encourage feedback, at least offline, if not after I speak, no relevant disclosures. I have three goals that I wanted to lay out in front. The first is that I want to highlight the disconnect between the legal doctrine of informed consent and the practice of informed consent in the clinical context. I then like to address the arguments that may be justified or used to justify the eliminating legal liability for informed consent, and then third, to consider alternatives to liability for informed consent. And I'm not offering any definitive answers at this point, as I mentioned, it is a work in progress, but I do want to highlight the role of the law in guiding medical practice and hopefully raise questions about who we want making decisions about how to ensure that patients and the doctor-patient relationship are appropriately protected. So, as a brief background, less than a century ago, courts sought to ensure patients' autonomous decision-making by affirming a citizen's right to sue and recover from a doctor who failed to ensure that the patient's informed consent was not fulfilled. In essence, courts established a new tort, the tort of informed consent, and this is a brief timeline, although there's a lot more to it than this, but in doing so, courts underscored the principle of respect for persons with the understanding that autonomy is achieved by respecting individual self-determination and voluntary decision-making. So the legal doctrine of informed consent therefore endeavors to formalize the clinical practice of informed consent in medicine. This private right of action, the right to sue your doctor in court for informed consent developed via the common law, judge-made law, under the rubric of negligence law, beginning in around the 1950s. So the decades that followed witnessed a proliferation of litigation in which patients claimed that their patients had an ethical obligation to disclose the nature and risks of a proposed intervention. The tort of informed consent is intended to compensate or to make the patient whole. Although it is a new cause of action by historical accounts, it's probably one of the newest causes of action in U.S. case law, this tort is now firmly entrenched in law. And today, almost all, actually no all, United States jurisdictions have adopted some form of the doctrine of informed consent either by statutory enactment or by judge-made law, by judicial decision. Despite the fact that the legal doctrine of informed consent is one of the most widely accepted efforts to encapsulate ethical principles in the law, and despite the fact that it focuses, it emphasizes the primacy of autonomous voluntary and informed decision-making, governments and scholars are increasingly recognizing the deficiencies in relying on informed consent to realize the clinical goals of the process of informed consent. So I consider a rather radical response to the inadequacies of the legal doctrine of informed consent, the elimination of liability for failure to provide informed consent. This in no way is advocating or even considering eliminating informed consent in the clinical context. We're strictly talking about liability, legal liability. So several justifications for eliminating the tort of informed consent have been offered and I'm not inventing the wheel here. So one of the most common arguments against legal liability for informed consent is that the informed consent process in the medical context has been co-opted by the legal community in an effort to protect healthcare providers from liability. So therefore, rather than protecting patient autonomy in its current incarnation, it's really only there to serve to protect the physician. And rather than strengthening the doctor-patient relationship, it contributes to its deterioration. So to this point, since the establishment of the tort of informed consent, it's been accused of both being needlessly adversarial and backward-looking, resulting in the process of obtaining informed consent to treatment becoming a defensive endeavor. Instead of focusing on informing patients and ensuring patient self-determination, the principles upon which the Canterbury decision and many of the other legal decisions back from the early 1970s were presumably based, the practice of obtaining informed consent to treatment may be centered on protecting healthcare providers from litigation. So this argument's not new. In 1984, Jay Katz distinguished between the legal doctrine of informed consent as promulgated by judges and the idea of informed consent based on a commitment to individual self-determination. And the 1982 study by the President's Commission for the Study of Ethical Problems in Medicine recognized the deep disconnect between the legal doctrine of informed consent and the presumed goals of the informed consent process. In condemning the increasing legalism of the discussions on informed consent, the commission concluded that actual patient consent bears little resemblance to legal doctrines and descriptions of informed consent, and that the imposition of legal liability for medical informed consent resulted in the over-provision of information for the purpose of avoiding liability. And recent literature is rife with the same concerns, highlighting the disconnect between the legal doctrines of informed consent in theory and the application of informed consent in medical practice. It's often argued that the threat of liability may lead physicians to over-focus on avoiding it, resulting in them neglecting the process of medical informed consent to facilitate discussions and understanding. A second and related critique is that the imposition of legal liability for failure of informed consent results in a substitution of form for process. The emphasis on the form rather than the substance of informed consent demonstrates the inadequacies of and the over-reliance on consent forms in medical practice. These forms often provide legally mandated information without a lot of regard to enhancing patient enhancement of the proposed—understanding of the proposed intervention. So this is a quick example of an informed consent form from 1954. This was found on Twitter. Contrast that with today's—this was for surgical—for surgical consent. This is an example of today's informed consent forms. These are just first pages of surgical consent forms that go on for four, seven, 10, 12 pages. It's widely understood that in order to include all legally mandated information, informed consent forms are often over-long and unintelligible, such that the average patient would not be able to fully understand the potential risks and benefits of the proposed intervention. In over-providing information in an effort to meet legal disclosure requirements, informed consent forms may be poorly drafted, unreadable, overly complicated, and inundated with detail. They may therefore render understanding of the risks and benefits of a proposed intervention nearly impossible. It may also be argued that the legal doctrine of informed consent does not serve the realities of the clinical setting. The law is notoriously vague and shifting—and I'm a lawyer, I'm allowed to say that—and physicians are not provided with specific guidance about how to comply. Moreover, the nature of medical interventions does not actually allow informed consent at every step of the process. The required elements of an informed consent claim may also, in fact, hinder the ability to ensure the patients are able to make informed voluntary medical decisions. Further, the jurisdictional splits regarding the level of disclosures required by a physician may lead to a lack of uniformity and the ability to enforce the legal doctrine of informed consent. So the competing materiality standards, which we talk about in various contexts—and that's really that approximately half the states apply a professional standard of disclosure and about half the states apply a reasonable patient standard—may result in unpredictability in one's ability to recover for a failure of informed consent. And it's impractical in application because the objective causation requirement and the injury requirements undermine the principles of patient autonomy, exactly the goal of the informed consent process. It's been argued that framing the question of causation in terms of the decision of the reasonable rather than the subjective patient standard erodes the rights of individual choice. In other words, the argument goes, even though the principle of informed consent aims to decrease physician paternalism and health care, the legal doctrine of informed consent imposes judicial paternalism in the application of the causation requirement. Furthermore, patients cannot recover from physicians who fail to seek informed consent in the absence of proven actual harm leading to consequential damages. So the physician who provides less information to the patient than the law requires can still rely on the injury elements to absolve them of liability by claiming a lack of physical harm, rendering this entire legal doctrine of informed consent rather meaningless in actually addressing the failures of informed consent we might actually care about in practice. Finally, it's been argued that other, more historically entrenched, torts actually do much of the work that the tort of informed consent is intended to do. So for example, the tort of battery and fraud may ensure deterrence of bad actors, such as concealment of the or bad actions, such as the concealment of risk of a proposed treatment protocol or failure to obtain consent to a particular intervention. So in light of these various arguments regarding the failures of the legal doctrine of informed consent, one must consider then how to ameliorate the situation so that liability or illegal processes match up with what we expect of the medical clinical informed consent process. The most straightforward solution might be to restrict or even eliminate the informed consent claim for medical treatment. Eliminating or restricting existing tort law claims is not without precedent. It's been done before. In fact, other common law torts such as product liability claims and personal injury claims have been contracted or eliminated at the state level. Ideally in the absence of civil liability for failure of informed consent to medical treatment, health care providers will be empowered to provide a robust, unencumbered informed consent process framed not by the law, but by the ethical practice of medicine. It's striking that today, when we address informed consent in various contexts, health care providers often jump straight into discussions about legal precedent and state laws to determine the appropriateness of disclosures in proposing medical interventions and therapies. It might help obviate that immediate jump into those conversations so we can really discuss the ethical underpinnings of this process. But so without legal liability for informed consent, what are we doing then to protect patients? What then? Well, one option is a return to the old days. That means no new tort, no new protections. Under this proposal in the absence of civil liability for failure of informed consent, patients would likely be forced to return to our alliance on the common law tort of battery for harms caused due to a failure to disclose information in the course of medical decision making. So despite the sometimes attractive qualities of returning to the old days, scholars have noted that the torts upon which patients relied before the introduction of liability for informed consent would insufficiently protect patients in today's medical circumstances. Unlikely that the albeit imperfect process of informed consent that became more or less standardized after the introduction of the legal doctrine of informed consent has become so institutionalized today that reverting to a system relying on battery that's unwanted touching essentially for failure of consent alone would sufficiently protect patients. So then how do we ensure that the ethical underpinnings and goals of the process in the medical context of informed consent are still achieved? Well, so one of the most obvious responses to a dearth of civil liability for failure to disclose necessary medical interventions, the risks of medical interventions, is the establishment of a new tort, one that ensures that patients are able to make informed voluntary autonomous medical decisions. For example, ever since the early days on the reliance of the claims for informed consent, many have actually proposed allowing recovery for what we call dignitary harms. Establishing a tort to protect patient autonomy would potentially reduce the damages a plaintiff could recover, but would potentially have a sufficient deterrent effect on physicians who would otherwise maybe withhold important information on the medical decision making process. The introduction of a new tort that focuses on autonomous decision making would seem then to ameliorate many of the problems we have with the current tort of informed consent. The legal doctrine of informed consent notoriously emphasizes physician disclosure at the expense of patient understanding. We call it informed consent, but we're really usually only focusing on the informed aspect of it and less on the consent aspect of it. So in contrast, the ethical practice of informed consent, the ethical practice, emphasizes comprehension over the duty to inform. And thus it may make sense to try to craft a right of action, a legal right of action, that underscores the duty to obtain informed consent to treatment. However, in practice, this could actually serve to be quite problematic, particularly because it is much more straightforward, it's just easier to identify an adequate or inadequate level of disclosure to look at what the physician actually said and actually disclosed in his or her forms than it is to measure individual patient comprehension. So and further, despite frequent calls for the recognition of negligence claims allowing recovery for these dignitary harms as we refer to them, American courts have generally been reluctant to allow these such claims. Alternatively, rather than rooting the patient's claim in negligence like informed consent and this other tort that I'm talking about, a claim based on a fiduciary standard of care could avoid some of the well-known obstacles to prevailing on an informed consent claim, such as proving objective causation or damages. A claim based in a fiduciary standard of care might circumvent the difficulties of demonstrating actual injury or causation instead of shifting the focus to the fact that the physician of fiduciary neglected his duty of care. However, not all courts and scholars are eager to find that a doctor-patient relationship is fiduciary in nature. And to the extent that that relationship by some courts is recognized as fiduciary, it raises the question of why reliance on that type of relationship has not, in fact, led then in those jurisdictions to a proliferation of disclosure claims based on the duties that arise from it. Alternatively, in the absence of a civil claim for failure of informed consent, professional societies or licensure bodies could assume the responsibility of ensuring that the physician engaged in a robust shared decision-making process, including making all appropriate disclosures, thereby ensuring voluntary and autonomous decision-making by patients. This proposal would require the bad actor to pay fines or his or her license taken away if she failed to or suspended, if she failed to ensure the informed consent in her practice. However, leaving enforcement of informed consent to professional societies or licensure requirements like all self-regulation could effectively be leaving the fox to guard the henhouse. So physicians, just like in certain professional materiality standard jurisdictions, might be encouraged by their peers to remain quiet regarding colleagues' malfeasance or improperly claim that the individual's level of disclosure actually met the standard of care. So the alternatives to tort liability for failure of informed consent are imperfect and are, in fact, probably less likely at this juncture to ensure voluntary autonomous decision-making than the status quo. I therefore, at this moment, am concluding that while tort liability for failure of informed consent to medical treatment is an imperfect solution to concerns about inadequate disclosures leading to involuntary and uninformed medical decision-making, it's possible that there may not be an effective legal remedy to this problem. At the very least, our current approach does serve both a deterrent and compensatory role. So the time, I think, is not really calm yet for a wholesale elimination of the private right of action for informed consent to medical treatment. While extricating the practice of informed consent from the law may be enticing, of course, for all of these reasons that I enumerated, plus probably more that you guys can think of, the reality of medical practice and the doctor-patient relationship continues to necessitate a legal remedy for patients who are denied an opportunity to make voluntary informed decisions and are harmed as a result. Abolishing liability for informed consent and treatment will not only eliminate the deterrent effect for potential bad actors, but it would also remove recourse for those who have suffered harm due to a failure of informed consent. Moreover, the legal doctrine of informed consent may be somewhat effective in providing reliability and structure to the doctor-patient relationship. Physicians and medical institutions learn, early and often, the legal requirements of informed consent and the consequences of not following the law and ensuring that the patient signs that informed consent form. The law demands particular physician behavior. And in turn, providers have become somewhat reliant on this current incarnation of a legal doctrine of informed consent to ensure that they are fulfilling their professional and ethical responsibilities. Thank you. 10 questions? One question. So I have a question. And this is based on my own personal experience. Before, I'm currently an ICU nurse. However, before that, I was a teacher. And I understand that asking someone if they are, they understand the concept is very different from, well, proving to someone that they understand the concept is very different from informing them of this concept. So I would like to propose then that we change the phrase from informed consent to understood consent, where the patient is not saying, yes, I want blood. And I understand that there are consequences of it. But you, first of all, develop a plan of education. You have a lesson plan, for example. This is how you present information over a series of a period of time. And then you evaluate throughout this process whether or not this person is understanding what they're being presented with. And at the end of that process, you no longer go from informed consent to no informed consent. But you now understand that this patient is making a decision because they understand what they're doing and not just because they feel like their life depends on it. So yeah, I think there's, again, I'm very open to different proposals on this. I said it's a work in progress. And I would love to be able to explore other ideas. I do think that change in language can actually be relatively effective in how we think about these issues and how they're presented. One of the things that you seem to be emphasizing is this process. And the law is not focused on process. The law is focused on, in most contexts, a single encounter that culminates with a form and a signature. And so the fact is that that's another way that we can be considering how to change the legal doctrine of informed consent to better reflect what we are looking for in the clinical context to make sure that we are actually continuing this process of information, comprehension, disclosures, et cetera. So with that, I want to also say that as health care providers, we are not only focused on immediate care, but also we influence policy changes as well. So if the law isn't focused on that, then we therefore need to take a stance and ensure that we enact some policy changes so that we can no longer, you know, we can change the direction of this to some extent. One more question. I'd like to complicate the discussion. I'm a psychiatrist and I find myself somewhat, maybe not frequently, but I can tell a grossly disorganized psychotic patient the risks and benefits of anti-psychotic medication, which has potentially significant side effects. The process of telling them this, I'm not really discussing it because they're psychotic and disorganized, I have met the legal JCO hospital criteria for providing informed consent, but I would argue that it isn't a very ethical procedure. I think that's a wonderful example of how the law and clinical practice aren't matching up and how we need to be thinking about this, not just, I think a lot of the examples that are often given in the law are surgical consent and things like that. We're not really thinking about it in psychiatry and in other contexts and I think that's something that we need to be looking at is the nuance of different specialties, different types of practice. So we have them sign the form, we show them where the place is to sign it, we tell them what the date is. On the other hand though, if it's a patient who's grossly disorganized and psychotic, they aren't willing to take the medicine that I think is necessary to keep them being dangerous, I can go to the court and get an order to treat, but that's how the law works. I find myself shaking my head at times. As you probably should be. Thank you.