Law Of Informed Consent Research Articles

The Politics of Informed Consent and the Limits of the First Amendment

This Viewpoint discusses the expansion of politically motivated informed consent laws and identifies opportunities for the medical profession to challenge them.

Tort Law Implications of Compelled Physician Speech

Abortion-specific informed consent laws in many states compel physicians to communicate state-mandated information that is arguably inaccurate, immaterial, and inconsistent with their professional obligations. These laws face ongoing First Amendment challenges as violations of the constitutional right against compelled speech. This Article argues that laws compelling physician speech also pose significant problems that should concern scholars of tort law. State laws that impose tort liability on physicians who refuse to communicate a state-mandated message often do so by deviating from foundational principles of tort law. Not only do they change the substantive disclosure duties of physicians under informed consent law, but many modify or even reject the procedural requirements for tort liability. Most significantly, these laws relieve prospective plaintiffs of the burden of proving two fundamental elements of negligence - causation in fact and proximate causation. Thus, when states compel physician speech for political reasons, their actions challenge not only constitutional principles, but tort principles as well.

Informed Consent and Medical Artificial Intelligence: What to Tell the Patient?

Imagine you are a patient who has been diagnosed with prostate cancer. The two main approaches to treating it in the United States are active surveillance versus the surgical option of radical prostatectomy. Your physician recommends the surgical option, and spends considerable time explaining the steps in the surgery, the benefits of (among other things) eliminating the tumor and the risks of (among other things) erectile dysfunction and urinary incontinence after the surgery. What your physician does not tell you is that she has arrived at her recommendation of prostatectomy over active surveillance based on the analysis of an Artificial Intelligence (AI)/Machine Learning (ML) system, which recommended this treatment plan based on analysis of your age, tumor size, and other personal characteristics found in your electronic health record. Has the doctor secured informed consent from a legal perspective? From an ethical perspective? If the doctor actually chose to “overrule” the AI system, and the doctor fails to tell you that, has she violated your legal or ethical right to informed consent? If you were to find out that the AI/ML system was used to make recommendations on your care and no one told you, how would you feel? Well, come to think of it, do you know whether an AI/ML system was used the last time you saw a physician? This Article, part of a Symposium in the Georgetown Law Journal, is the first to examine in depth how medical AI/ML interfaces with our concept of informed consent. Part I provides a brief primer on medical Artificial Intelligence and Machine Learning. Part II sets out the core and penumbra of U.S. informed consent law and then seeks to determine to what extent AI/ML involvement in a patient’s health should be disclosed under the current doctrine. Part III examines whether the current doctrine “has it right,” examining more openly empirical and normative approaches to the question. To forefront my conclusions: while there is some play in the joints, my best reading of the existing legal doctrine is that in general, liability will not lie for failing to inform patients about the use of medical AI/ML to help formulate treatment recommendations. There are a few situations where the doctrine may be more capacious, which I try to draw out (such as when patients inquire, when the medical AI/ML is more opaque, when it is given an outsized role in the final decision-making, or when the AI/ML is used to reduce costs rather than improve patient health), though extending it even here is not certain. I also offer some thoughts on the question: if there is room in the doctrine (either via common law or legislative action), what would it be desirable for the doctrine to look like when it comes to medical AI/ML? I also briefly touch on the question of how the doctrine of informed consent should interact with concerns about biased training data for AI/ML.

Reclaiming Access to Truth in Reproductive Healthcare After National Institute of Family & Life Advocates v. Becerra

Crisis Pregnancy Centers (CPCs) are antiabortion organizations that seek to “intercept” people with unintended pregnancies to convince them to forego abortion. It is well documented that CPCs intentionally present themselves as medical professionals even when they lack licensure, while also providing medically inaccurate information on abortion. To combat the blatant deception committed by CPCs, California passed the Reproductive FACT Act in 2015. The Act required CPCs to post notices that disclosed their licensure status and informed potential clients that the state provided subsidized abortion and contraceptives. Soon after, CPCs brought First Amendment challenges to these disclosure requirements, claiming that the state could not compel them to speak a message against their will. In 2018, the Supreme Court decided National Institute of Family and Life Advocates (NIFLA) v. Becerra and constitutionalized CPCs’ efforts to evade regulation from state-mandated compelled disclosures—disclosures not dissimilar to those regularly imposed on other businesses and medical professionals. Although CPCs use the guise of professionalism to increase their credibility, they are not held to the same standards as actual medical professionals. States can force abortion providers to violate ethical codes by requiring them to give patients medically inaccurate information as “informed consent,” yet CPCs cannot be compelled to say anything because they are not real professionals. This Note argues that while there are striking parallels between abortion-related informed consent laws and compelled informational disclosures like the CPC disclosures at issue in NIFLA, the Court has refused to treat pro-choice speech in a manner similar to antiabortion speech. Moreover, though NIFLA has drastically limited the types of CPC regulations that pro-choice governments can implement, there are still ways in which these states can and should curb CPCs’ deceptive practices.

Modernizing Informed Consent: Expanding the Boundaries of Materiality

Informed consent law’s emphasis on the disclosure of purely medical information – such as diagnosis, prognosis, and the risks and benefits of various treatment alternatives – does not accurately reflect modern understandings of how patients make medical decisions. Existing common law disclosure duties fail to capture a variety of non-medical factors relevant to patients, including information about the physician’s personal characteristics; the cost of treatment; the social implications of various health care interventions; and the legal consequences associated with diagnosis and treatment. Although there is a wealth of literature analyzing the merits of such disclosures in a few narrow contexts, there is little broader discussion and no consensus about whether there the doctrine of informed consent should be expanded to include information that may be relevant to patients but falls outside the traditional scope of medical materiality. This article seeks to fill that gap. I offer a normative argument for expanding the scope of informed consent disclosure to include non-medical information that is within the physician’s knowledge and expertise, where the information would be material to the reasonable patient and its disclosure does not violate public policy. This proposal would result in a set of disclosure requirements quite different from the ones set by modern common law and legislation. In many ways, the range of required disclosures may become broader, particularly with respect to physician-specific information about qualifications, health status, and financial conflicts of interests. However, some disclosures that are currently required by statute (or have been proposed by commentators) would fall outside the scope of informed consent – most notably, information about support resources available in the abortion context; about the social, ethical, and legal implications of treatment; and about health care costs.

Confronting Misinformation on Abortion: Informed Consent, Deference, and Fetal Pain Laws

In the last few years, the topic of has become hot one in many state legislatures. Five states now require that some women seeking abortions be told that their fetus may experience pain, with similar bills cropping up around the country. (1) Even Congress has gotten involved, with the outgoing House of Representatives nearly passing national fetal pain bill in late 2006. (2) These measures are the latest in growing body of specific informational requirements for abortion procedures, many steeped in scientific controversy. Nearly all of these measures are titled Woman's Right to Know Acts. (3) These laws abandon well-settled principles of informed consent--which give discretion to medical professionals to determine what information is crucial for patients--in favor of legislative judgments about what particular facts should be told to patients and how these facts should be shared. Informed consent to medical treatment consists of three essential elements: communication of necessary information, comprehension of that information by the patient, and subsequent consent to treatment. (4) The information that must be communicated includes three key elements: the risks of the proposed treatment, viable alternative treatments, and likely outcomes in the absence of treatment. (5) In every doctor-patient relationship, doctors are bound by law to apply these principles on the basis of their best medical judgment: Of necessity, the content of the disclosure rests in the first instance with the physician. Ordinarily, it is only he who is in position to identify particular dangers; always he must make judgment, in terms of materiality, as to whether and to what extent revelation to the patient is called for. (6) These principles, long recognized by the common law, (7) have been codified in state statutes typically requiring that, for any medical treatment, patients be provided with a general understanding of the procedure, the medically acceptable alternative procedures or treatments, and the substantial risks and hazards inherent in the proposed treatment or procedures. (8) Some states have informed consent laws addressing areas as diverse as breast cancer and psychiatric treatment, (9) but the most commonly regulated procedure is abortion. At least thirty-two states have specific informed consent requirements for abortion, (10) and similar provisions have been proposed in other states. (11) While most abortion-specific informed consent laws simply track common law principles, some do more. In handful of states, these laws require that specific risks be discussed with patients; some specify statements that must be made, including controversial statements about fetal pain, breast cancer risk, and psychological harms. (12) In many more states, doctor-patient conversations must be supplemented with literature discussing possible risks in terms mandated by the state. (13) Most recently, states have begun requiring statements like the following, which appears in the statutes of four states: By 20 weeks' gestation, the unborn child has the physical structures necessary to experience pain. There is evidence that by 20 weeks' gestation unborn children seek to evade certain stimuli in manner which in an infant or an adult would be interpreted to be response to pain. Anesthesia is routinely administered to unborn children who are 20 weeks' gestational age or older who undergo prenatal surgery. (14) As will be discussed, each of these statements misrepresents current medical knowledge. (15) Reproductive rights advocates have criticized these provisions, and at times challenged them in court, for removing the discretion traditionally given to doctors and for potentially misleading women. (16) To date, however, litigation on mandated abortion information has been sparse. A few requirements have been invalidated, and others saved by narrowing constructions; across these cases, judicial opinions have been short on clear analysis. …

Anaesthetists’ knowledge of South African Law pertaining to informed consent in an academic centre

Background: Anaesthetists require knowledge of informed consent laws to mitigate the risk of litigation. The knowledge of South African anaesthetists regarding informed consent law is unknown.Metho...

No Selves to Consent: Women’s Prisons, Sterilization, and the Biopolitics of Informed Consent

In 2013, the California State Legislature investigated the reproductive sterilization of at least 144 people in women’s prisons between 2006 and 2010. Responding to what were understood to be illegal sterilization surgeries, state agencies, such as the state auditor, proposed enforcing and strengthening informed consent laws. Activists, however, publicly doubted that noncoercive consent within prisons is possible. This article examines the ways informed consent works in tandem with, not against, state biopolitics. By analyzing comments made by prison doctors about their reasons for performing sterilizations, I argue that informed consent does not resolve the racialized, gendered, and classed anxieties that drive biopower. Parallels between feminist-of-color theory and the arguments made by prisoner advocates suggest that because prisoners have been relegated to a realm of social death, noncoercive informed consent is not actually possible. I therefore consider the role of informed consent in disciplining incarcerated people of color and poor people incarcerated in women’s prisons. The novel Dawn, by Octavia Butler (1987), approaches these questions of biopolitical power, reproductive discipline, and consent from a different perspective, one that renders “alien” state and medical authority. A reading of this novel responds to the paradox of social death described by Lisa Cacho, which makes what Ruha Benjamin calls “biodefection” impossible under the conditions of biopolitical power. Concluding that informed consent is what prison abolitionists call a “reformist reform,” I argue that reproductive justice requires prison abolition.

Certified Patient Decision Aids: Solving Persistent Problems with Informed Consent Law.

The legal doctrine of informed consent has overwhelmingly failed to assure that the medical treatment patients get is the treatment patients want. This Article describes and defends an ongoing shift toward shared decision making processes incorporating the use of certified patient decision aids.

Informed or Misinformed Consent? Abortion Policy in the United States.

Since 2010, the United States has witnessed a dramatic expansion of state-based restrictions on abortion. The most common of these are informed consent statutes, which require that a woman seeking an abortion receive a state-authored informational packet before the abortion procedure can be performed. These laws, in addition to requiring the provision of information about alternatives to and risks of abortion, all also require details of embryological and fetal development. This article presents the findings of a comprehensive study of state-authored informed consent materials regarding embryological and fetal development. To conduct this study, we recruited a panel of experts in human anatomy to assess the accuracy of these materials in the context of the constitutional standard established inPlanned Parenthood of Southeastern Pennsylvania et al. v. Robert P. Casey et al.(505 U.S. 833 (1992)): that such information must be "truthful" and "nonmisleading." We find that nearly one-third of the informed consent information is medically inaccurate, that inaccurate information is concentrated primarily in the earlier weeks of pregnancy and is clustered around particular body systems. We discuss the implications of our findings for the question of the constitutionality of informed consent laws as they have been implemented in practice.

Mandating Disclosure of Religious Limitations on Medical Practice

Stakeholders in law, medicine, and religion are unable to reach consensus as to how best to address conflicts between physicians’ religious objections to treatment and patients’ rights to access medically indicated care. Conscience laws that protect objecting health care providers from liability are criticized as too broad by patient advocates, and as too narrow by defenders of religious freedom. This Article posits that some of the tension between these stakeholders could be mediated by statutory recognition of a duty to disclose religiously-motivated limitations on practice. Imposition of such a limited disclosure duty has foundations in consumer protection law, fiduciary law, and informed consent law. While this solution would not guarantee a patient’s access to treatment, referral, or information from any given provider, it would prevent some of the more egregious cases of denial of treatment – those where patients are not made aware that a medically-indicated treatment is excluded from a provider’s (or institution’s) scope of practice, and so have no opportunity to seek care elsewhere.

Assessment of policy and access to HIV prevention, care, and treatment services for men who have sex with men and for sex workers in Burkina Faso and Togo.

In Burkina Faso and Togo, key populations of men who have sex with men (MSM) and sex workers (SW) have a disproportionately higher HIV prevalence. This study analyzed the 2 countries' policies impacting MSM and SW; to what extent the policies and programs have been implemented; and the role of the enabling environment, country leadership, and donor support. The Health Policy Project's Policy Assessment and Advocacy Decision Model methodology was used to analyze policy and program documents related to key populations, conduct key informant interviews, and hold stakeholder meetings to validate the findings. Several policy barriers restrict MSM/SW from accessing services. Laws criminalizing MSM/SW, particularly anti-solicitation laws, result in harassment and arrests of even nonsoliciting MSM/SW. Policy gaps exist, including few MSM/SW-supportive policies and HIV prevention measures, e.g., lubricant not included in the essential medicines list. The needs of key populations are generally not met due to policy gaps around MSM/SW participation in decision-making and funding allocation for MSM/SW-specific programming. Misaligned policies, eg, contradictory informed consent laws and protocols, and uneven policy implementation, such as stockouts of sexually transmitted infection kits, HIV testing materials, and antiretrovirals, undermine evidence-based policies. Even in the presence of a supportive donor and political community, public stigma and discrimination (S&D) create a hostile enabling environment. Policies are needed to address S&D, particularly health care provider and law enforcement training, and to authorize, fund, guide, and monitor services for key populations. MSM/SW participation and development of operational guidelines can improve policy implementation and service uptake.

The first amendment and physician speech in reproductive decision making.

Courts are divided as to whether abortion informed consent mandates violate the First Amendment. This article argues that given the doctor's and patient's unique expertise, the patient's strong interests in autonomous decision making, and the fact that these laws regulate speech, rather than conduct, heighted or strict scrutiny should apply to such mandates.

Medical Evidence and Expertise in Abortion Jurisprudence

This paper examines a key but under theorized question in constitutional law: what is the role of medical evidence and expertise in abortion jurisprudence? Drawing on landmark cases from 1973 to 2012, the article shows how the Supreme Court has selectively utilized medical expertise to liberalize or constrain abortion access. The article demonstrates how the Supreme Court began its engagement with medical evidence and expertise with the intent to liberalize abortion and in turn relied on progressive expertise as authoritative, objective, and neutral. These early decisions allowed liberal advocates to rely unquestionably on medical evidence to provide satisfactory judicial outcomes. This has now flipped – the Supreme Court and lower courts often treat conservative medical evidence and expertise as objective and neutral. In doing so, the courts support conservative claims about the impact of abortion on women’s mental health and on the fetus. These newly legitimated facts provide the foundation for the vast proliferation of informed consent laws that attempt to regulate physician-patient interaction at the most minute level – mandating that women look at sonograms, making physicians read scripts, and playing the fetal heartbeat to the woman. This new reality is exemplified in Texas Medical Providers v. Lakey, the Texas Case regarding the Texas 2011 Women’s Right to Know Act, in which the court heralds conservative rationales as objective medical knowledge and discounts progressive advocates and physicians claims that conservative medical claims are ideological.Given this transformation in the use of medical evidence and expertise, I argue for a reworking of progressive lawyering strategies on the issue of abortion that delinks legal advocacy from its reliance on “evidence based approaches.” This is a novel, transformative, and controversial recommendation in constitutional law, public health law, and reproductive rights advocacy and practice.

Another Critical Review of New's Reanalysis of the Impact of Antiabortion Legislation

AbstractIn New's response to our article he concedes that (1) his dataset had over 150 misclassification errors, (2) used an incorrect weight to correct for heteroscedasticity, (3) did not control for interstate travel by women to an out-of-state abortion provider, and (4) some of his empirical results are numerically implausible. Unfortunately, in New's reanalysis he makes many of the same errors as in his original article. Ironically, New's empirical evidence in Table 3 of his reassessment article corroborates our findings that informed consent laws (all statistically insignificant in his Table 3) had no measurable impact on the abortion rate of all women of childbearing age, adult women or teen minors over the period 1985- 2005. Moreover, New fails to acknowledge that he has a conflict of interest. He is an adjunct scholar with the self-proclaimed antiabortion Charlotte Lozier Institute. In addition, on September 15, 2012 at the annual meeting of Value Voters sponsored by the antiabortion Family Research Council, he told an audience of social conservatives that to stop abortions they should support legislation in states that would length the waiting period to have an abortion to nine months (audio available).

Analyzing the Impact of U.S. Antiabortion Legislation in the Post-CaseyEra: A Reassessment

AbstractMarshall Medoff and Christopher Dennis identify some errors in National Abortion Rights Action League's (NARAL) data on the effective start dates of various state-level antiabortion laws. However, they misunderstand the purpose of my 2011State Politics and Policy Quarterlyarticle which was to measure the impact of a range of antiabortion laws—not analyze competing theories as to why the abortion rate has fallen in the United States. Furthermore, their analysis contains a number of critical measurement, and methodological and estimation errors. When these errors are corrected, the empirical results add to the substantial body of peer-reviewed research which finds that public funding restrictions, parental involvement laws, and properly designed informed consent laws all reduce the incidence of abortion.

A Critical Reexamination of the Effect of Antiabortion Legislation in the Post-Casey Era

AbstractMichael J. New, in a recent article in this journal, argues that a major reason for the decline in the incidence of abortion since the U.S. Supreme Court's 1992 Casey decision was the increased number of antiabortion laws—parental involvement laws and informed consent laws—enacted at the state level. However, New's analysis contained critical data, measurement, methodological and estimation errors. This article details all the errors and then reexamines the effect of restrictive state abortion laws on the incidence of abortion over the period 1985–2005. The empirical results find little evidence that the decline in the number of abortions performed since the U.S. Supreme Court's 1992 Casey decision was due to the increase in the number of informed consent and parental involvement laws enacted.

Healthcare provider attitudes, practices, and recommendations for enhancing routine HIV testing and linkage to care in the Mississippi Delta region.

The Mississippi Delta region is one of the communities most heavily impacted by HIV/AIDS in the United States. To understand local provider attitudes and practices regarding HIV testing and care, we conducted 25 in-depth qualitative interviews with local primary care providers and infectious disease specialists. Interviews explored attitudes and practices regarding HIV testing and linkage to care. Most providers did not routinely offer HIV testing, noting financial barriers, financial disincentives to offer routine screening, misperceptions about local informed consent laws, perceived stigma among patients, and belief that HIV testing was the responsibility of the health department. Barriers to enhancing treatment and care included stigma, long distances, lack of transportation, and paucity of local infectious disease specialists. Opportunities for enhancing HIV testing and care included provider education programs regarding billing, local HIV testing guidelines, and informed consent, as well as telemedicine services for underserved counties. Although most health care providers in our study did not currently offer routine HIV testing, all were willing to provide more testing and care services if they were able to bill for routine testing. Increasing financial reimbursement and access to care, including through the Affordable Care Act, may provide an opportunity to enhance HIV/AIDS services in the Mississippi Delta.

What is an "Undue Burden"? The Casey Standard as Applied to Informed Consent Provisions

Author(s): Paulk, Lauren | Abstract: The existing scholarship on abortion rights focuses mainly on what is wrong with the state of legislative or judicial provisions surrounding the right to choose. In addition to highlighting a problem, this article proposes a solution. It argues, in a call to action, that the undue burden standard should be consistently raised by advocates and addressed by courts. Thus, it should run parallel to all other challenges. This article provides a roadmap for advocates, both in text and in hypothetical application to a recent Fifth Circuit case, regarding how to raise the standard in full when dealing with informed consent provisions. This article shows, by example, that a fuller application of the undue standard can and will change the outcome of cases dealing with pre-abortion ultrasound provisions and fetal pain laws. The article is not overly optimistic about what this changed standard may mean for the sheer number of abortion laws proposed, but argues that more attention to all aspects of the standard is necessary for future success in challenging informed consent provisions. My hope is that this piece will contribute to the conversation in the public interest field about taking risks in reproductive rights advocacy, and to the actions taken during the litigation of challenges to informed consent laws.

Translating Rights into Access: Language Access and the Affordable Care Act

More than twenty-four million people in the United States are considered limited English proficient (LEP), and numerous studies have documented the consequences of communication barriers in healthcare. These consequences include: patients’ inability to become engaged and involved in their care; the absence of crucial information—including cultural information—essential to healthcare quality; risks to patient safety arising from the misunderstanding of physician instructions; and ethical and legal lapses stemming from the absence of informed consent. Addressing healthcare rights necessarily entails coming to grips with how to facilitate communication and the exchange of information between the healthcare system and an increasingly diverse patient population.The history of language access services in healthcare is grounded in two distinct bodies of law: the law of informed consent and civil rights law. Modern notions of informed consent law—which have their roots in the Nuremberg trials of the late 1940s—would recognize a cause of action in tort where a lack of adequate communication creates a barrier to an LEP patient's ability to consent to care. In modern healthcare law, the ability of patients to affirmatively give informed consent to treatment is considered a fundamental element of healthcare quality.