Law Commons^™

Establishing Consent: The Role Of Women Representatives In Passing Informed Consent Laws, Sophia Stockham

Department of Political Science: Dissertations, Theses, and Student Research

What predicts the adoption of informed consent laws for pelvic exams within the United States? As of January 2023, 22 states have adopted informed consent laws for pelvic examinations on women, with eleven being under Democratic control, six being Republican control, and five with divided control between the legislature and gubernatorial level at the time of adoption. Little attention, however, has been given to women’s health mandates outside the issue of abortion and to variation among state partisan adoption regarding informed consent for pelvic exams. This paper examines the impact of partisanship, the percentage of women in the legislature, and …

Patient Decision Aids Improve Patient Safety And Reduce Medical Liability Risk, Thaddeus Pope

Faculty Scholarship

Tort-based doctrines of informed consent have utterly failed to assure that patients understand the risks, benefits, and alternatives to the healthcare they receive. Fifty years of experience with the doctrine of informed consent have shown it to be an abject catastrophe. Most patients lack an even minimal understanding of their treatment options. But there is hope. Substantial evidence shows that patient decision aids (PDAs) and shared decision making can bridge the gap between the theory and practice of informed consent. These evidence-based educational tools empower patients to make decisions with significantly more knowledge and less decisional conflict than clinician-patient discussions …

Crisis At The Pregnancy Center: Regulating Pseudo-Clinics And Reclaiming Informed Consent, Teneille R. Brown

Utah Law Faculty Scholarship

Crisis Pregnancy Centers (CPCs) adopt the look of medical practices — complete with workers in scrubs, ultrasound machines, and invasive physical exams — to deceive pregnant women into thinking they are being treated by licensed medical professionals. In reality, CPCs offer exclusively Bible-based, non-objective counseling. Numerous attempts to regulate CPCs have faced political roadblocks. Most recently, in NIFLA v. Becerra, the Supreme Court held that state efforts to require CPCs to disclose that they are not medically licensed are unconstitutional violations of CPCs’ First Amendment right to free speech. In the wake of that decision, pregnant women in crisis — …

How Can Pennsylvania Protect Itself From Its Own Measles Outbreak?, Megan M. Riesmeyer, Kristen Feemster

Faculty Scholarly Works

When a response to inaccurate information strives to be an informative exercise of its own, it is difficult to balance the desire to respond point by point to mischaracterized, misleading, or untrue information, with the need to simply offer a complete picture of facts. This article is a response to Abigail Wenger’s article regarding

vaccinations. To reply to each mischaracterization or inaccuracy in turn means this response loses its own informative intent and becomes simply a rebuttal. However, to ignore mischaracterizations and inaccuracies is to risk the reader’s acceptance of those points as true. Through illustrative examples in the United …

“Unusual Care”: Groupthink And Willful Blindness In The Support Study, George J. Annas, Catherine L. Annas

Faculty Scholarship

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. …

Can They Do That?: The Limits Of Governmental Power Over Medical Treatment, Paul Jerome Mclaughlin Jr.

Library Faculty Publications

The government’s power over health care is strongest when health care treatments and precautions to protect the public welfare, such as quarantines and vaccinations, are at issue. Governmental power over health care decisions weakens when an individual’s health care decisions are in question. When health care decisions would only affect the individual making them, the government’s power is even less. This article argues that government agents must be cautious in making health care determinations for others and that they should aim to protect an individual’s right to self-determination so long as those choices do not pose a threat to the …

Informed Consent: Charade Or Choice, George J. Annas

Faculty Scholarship

The physicians of ancient Greece valued conversation with their patients. Conversation, however, did not apply to slaves, whose minds and opinions did not matter. More than 2000 years later, slavery has been abolished and the law has joined ethics in setting standards for the doctor-patient relationship. The most important doctrine, in both medical ethics and health law, is the doctrine of informed consent (better termed "informed choice"), including its corollary, the right to refuse treatment. Today this doctrine is under attack. The attack is direct from business models that see genuine doctor-patient conversations as inefficient (and a waste of time), …

Autonomy And Accountability: Why Informed Consent, Consumer Protection, And Defunding May Beat Conversion Therapy Bans, Melissa Ballengee Alexander

Faculty Articles

No abstract provided.

Can Shared Decision-Making Reduce Medical Malpractice Litigation? A Systematic Review, Marie-Anne Durand, Benjamin Moulton, Elizabeth Cockle, Mala Mann, Glyn Elwyn

Dartmouth Scholarship

Background: To explore the likely influence and impact of shared decision-making on medical malpractice litigation and patients’ intentions to initiate litigation.

Methods: We included all observational, interventional and qualitative studies published in all languages, which assessed the effect or likely influence of shared decision-making or shared decision-making interventions on medical malpractice litigation or on patients ’ intentions to litigate. The following databases were searched from inception until January 2014: CINAHL, Cochrane Register of Controlled Trials, Cochrane Da tabase of Systematic Reviews, EMBASE, HMIC, Lexis library, MEDLINE, NHS Economic Evaluation Database, Open SIGLE, PsycINFO and Web of Knowledge. We also hand …

Informed Consent And The First Amendment, Wendy K. Mariner, George J. Annas

Faculty Scholarship

For more than two decades, states have been adding to the things that physicians must say and do to obtain “informed consent” — and thereby testing the constitutional limits of states' power to regulate medical practice. In 1992, the Supreme Court upheld states' authority to require physicians to provide truthful information that might encourage a woman to reconsider her decision to have an abortion, finding that such a requirement did not place an “undue burden” on the woman.

Should Patient Responsibility For Costs Change The Doctor-Patient Relationship?, Christopher Robertson

Faculty Scholarship

Copays, deductibles, coinsurance, and reference prices all now expose patients to increasingly larger shares of the costs of health care. Extant research on cost sharing has primarily focused on its impact on patients, their health care spending, and their health outcomes. Scholars have paid much less attention to the question of how patient exposure to health care costs may impact physicians and their relationships with their patients. This Essay is given on the occasion of a symposium motivated by two recent books by David Schenck, Larry Churchill, and Joseph Fanning that highlight the relational aspects of health care ethics. Accordingly, …

Heterogeneity In Irb Policies With Regard To Disclosures About Payment For Participation In Recruitment Materials, Christopher Robertson, Megan Wright

Faculty Scholarship

Scholars have documented variation in the way local Institutional Review Boards differently adjudicate identical research proposals. It is unclear whether such heterogeneity is due to variation in positive policies, or variation in human processes of interpretation and enforcement. A particularly interesting question relates to whether investigators are allowed to provide truthful information about research opportunities to potential participants, which some IRBs seem to forbid. We investigated local IRB policies on disclosing the amount of compensation in recruitment materials by conducting a census of the top 100 institutions by receipt of NIH funding in 2012. We downloaded the relevant policies and …

Crowdsourcing Public Health Experiments: A Response To Jonathan Darrow's Crowdsourcing Clinical Trials, Ameet Sarpatwari, Christopher Robertson, David Yokum, Keith Joiner

Faculty Scholarship

We are pleased to have this opportunity to respond to Jonathan Darrow's article, Crowdsourcing Clinical Trials (CCT).' We seek to highlight its important contributions and to commence debate over some of its arguments. In particular, we qualify the ethical arguments that characterize early clinical use of drugs as if they were research, and suggest instead that, in either domain, the ethical (and legal) analysis should remain focused on whether all material information is provided so patients may make informed decisions. We also highlight the limits of what can be gleaned from the observational data collection efforts envisioned by CCT.

Ultimately, …

A Restatement Of Health Care Law, David Orentlicher

Scholarly Works

No abstract provided.

Legally Blind: The Therapeutic Illusion In The Support Study Of Extremely Premature Infants, George J. Annas, Catherine L. Annas

Faculty Scholarship

Physician-researchers follow a protocol to generate generalizable knowledge; physicians have a duty to treat patients in ways they and their patients think best. In both activities, research and treatment, physicians often see themselves simply as physicians, practicing medicine. Sick people have similar perception difficulties, and prefer to think of their physician-researcher simply as their physician, even when their treatment is ² determined by a protocol or the flip of a coin. Almost 20 years ago, in this Journal, one of us suggested that at least some researchers use language "to obscure; to blur or eliminate the distinctions between research …

Mixed Messages: The Intersection Of Prenatal Genetic Testing And Abortion, Rachel Rebouché, Karen H. Rothenberg

Faculty Scholarship

This article, prepared for the 2011 Wiley A. Branton Symposium at Howard Law School, provides a snapshot of how current law and practice generate mixed messages about prenatal genetic testing and abortion. The ability to screen and to test for genetic conditions prenatally is expanding, not only because of technological innovations but also because of increased legal and financial incentives. At the same time that prenatal genetic testing is expanding, abortion – one option pregnant women have after testing – is contracting. Federal and state legislation restricts abortion services, for example, by reducing or prohibiting funding; banning the types or …

Balancing Privacy, Autonomy, And Scientific Needs In Electronic Health Records Research, Sharona Hoffman, Andy Podgurski

Faculty Publications

The ongoing transition from paper medical files to electronic health records will provide unprecedented amounts of data for biomedical research, with the potential to catalyze significant advances in medical knowledge. But this potential can be fully realized only if the data available to researchers is representative of the patient population as a whole. Thus, allowing individual patients to exclude their health information, in keeping with traditional notions of informed consent, may compromise the research enterprise and the medical benefits it produces.

This Article analyzes the tension between realizing societal benefits from medical research and granting individual preferences for privacy. It …

New Therapies, Old Problems, Or, A Plea For Neuromodesty, Stephen J. Morse

All Faculty Scholarship

This article suggests that investigational deep brain stimulation (DBS) for mental disorders raises few new bioethical issues. Although the scientific basis of the procedure may be both complex and largely unknown, addressing informed consent in such situations is a familiar problem. After reviewing the legal and moral background for investigating DBS and the scientific difficulties DBS faces as a potential treatment for mental disorders, the article focuses on informed consent and makes two primary suggestions. The study of DBS may proceed, but "hyper-disclosure" of the complexities should be required for competent subjects or proper surrogates if the candidate is not …

Medical Decision Making By And On Behalf Of Adolescents: Reconsidering First Principles, B. Jessie Hill

Faculty Publications

The school nurse cannot give your teenage daughter an aspirin for her headache without your permission, but that same daughter can get an abortion without even informing you. Or can she? The obligations on medical personnel providing care to adolescents are famously indeterminate.

Two common-law presumptions have long lurked in the background, but, far from elucidating matters, those presumptions have contributed to the state of confusion. The first presumption is that, absent any special rule, children lack the legal authority to consent to medical treatment on their own. A parallel and corresponding presumption is that parents have a legal entitlement …

The Hydra, Carl E. Schneider

Articles

Almost nobody favors long consent forms for prospective research subjects. Almost everybody thinks they interfere with informed consent's purpose-good decisions. Nevertheless, almost everybody believes consent forms have long been getting longer. Years ago, Paul Appelbaum lamented the "tendency to cram ever more information into consent forms." Weeks ago, Ilene Albala and her colleagues (one of them Appelbaum) reported in IRE: Ethics & Human Research that the length of one institutional review board's forms "increased roughly linearly by an average of 1.5 pages per decade. In the 1970s, the average consent form was less than one page long and often only …

Principal Investigator Views Of The Irb System, Simon N. Whitney, Kirsten Alcser, Carl E. Schneider, Laurence B. Mccullough, Amy L. Mcguire, Robert J. Volk

Articles

We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations. There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the …

After Autonomy, Carl E. Schneider

Articles

Bioethicists today are like Bolsheviks on the death of Lenin. They have, rather to their surprise, won the day. Their principle of autonomy is dogma. Their era of charismatic leadership is over. Their work of Weberian rationalization, of institutionalizing principle and party, has begun. The liturgy is reverently recited, but the vitality of Lenin's "What Is To Be Done?" has yielded to the vacuity of Stalin's "The Foundations of Leninism." Effort once lavished on expounding ideology is now devoted to establishing associations, organizing degree programs, installing bioethicist commissars in every hospital, and staffing IRB soviets. Not-so-secret police prowl the libraries …

The Modern Age Of Informed Consent, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

This essay explores the informed consent ramifications of the confluence of these two phenomena: developments in medical technology and emerging adulthood. In particular, it explores consent to medical treatments by emerging adults that are both elective and irreversible. In such cases, policy considerations dictate that additional safeguards be implemented to ensure that the consent given is truly informed. Part II of this essay provides an overview of the informed consent doctrine and outlines a variety of advancements in elective medical technology. Part III explores the concept of emerging adulthood. Part IV suggests that when emerging adults seek medical treatments that …

Getting What We Should From Doctors: Rethinking Patient Autonomy And The Doctor-Patient Relationship, Roger B. Dworkin

Articles by Maurer Faculty

No abstract provided.

Gang Aft Agley, Carl E. Schneider

Articles

In my last contribution to this column (HCR, July-August 2000), I argued that the law of bioethics has repeatedly failed to achieve the hopes cherished for it. I presented evidence, for example, that most doctors breach the duty of informed consent, that advance directives do not direct patients' care, and that repeated legal attempts to increase organ donation have failed to find the success predicted for them. I closed that column by promising to try to explain this chastening experience. It would, of course, take a lifetime of columns to capture all the reasons the law of bioethics …

The Best-Laid Plans, Carl E. Schneider

Articles

It is natural to suppose law is like the centurion and can do as it will: "I say to this man, Go, and he goeth; and to another, Come, and he cometh; and to my servant, Do this, and he doeth it." But a thousand years ago, King Canute tried to disillusion his courtiers about his efficacy by commanding the waves to stop beating. And fifty years ago, Harry Truman predicted of Dwight Eisenhower, "He'll sit here, and he'll say, 'Do this! Do that!' And nothing will happen. Poor Ike-it won't be a bit like the Army. He'll find it …

Mental Health Advance Directives: Having One's Say?, Justine A. Dunlap

Faculty Publications

First, this Article traces the extension of the right to refuse treatment to the psychiatric realm. Next, the Article addresses advance directives for health care and their utility for mental health issues. Then, the Article examines state statutory and judicial responses to mental health advance directives. Finally, the Article analyzes why the right to control future psychiatric treatment, including the right to refuse treatment, has been slow to gain acceptance. Although mental health advance directives present real challenges, legally and otherwise, this Article concludes that they are firmly rooted in the law and their rejection is, more often than not, …

Information, Decisions, And The Limits Of Informed Consent, Carl E. Scheider, Michael H. Farrell

Book Chapters

For many years, the heart's wish of bioethics has been to confide medical decisions to patients and not to doctors. The favoured key to doing so has been the doctrine of informed consent. The theory of and hopes for that doctrine are well captured in the influential case of Caterbury v. Spence: '[t]rue consent to what happens to one's self is the informed exercise of a choice, and that entails an opportunity to evaluate knoledgeably the options available and the risks attendant upon each'.

Twerski & Cohen's Second Revolution: A Systems/Strategic Perspective, Lynn M. Lopucki

UF Law Faculty Publications

In an article published in 1992, Professors Twerski and Cohen suggested that basic principles of the law of informed consent require medical providers to tell their patients about competing providers could perform the same procedures better or more safely. In its 1996 decision in Johnson v. Kokemoor, the Supreme Court of Wisconsin cited Twerski and Cohen's article in holding a neurosurgeon liable for not telling a patient of such a competitor. As a result, Twerski and Cohen now argue, the law of informed consent now stands on the brink of a second revolution. This comment sets forth a systems/strategic analysis …

Testing For Genetic Traits: The Need For A New Legal Doctrine Of Informed Consent , Elizabeth B. Cooper

Faculty Scholarship

Innovative medical technology has made it possible to test whether you are at increased risk for certain types of cancer. The mere processing of a vial of blood can reveal whether you have a genetic predisposition to develop breast, ovarian, or prostate cancer, or other life-threatening conditions. The Human Genome Project, an international endeavor seeking to map our genetic structures, has facilitated this increasing ability to test for genetic flaws. It is expected that as the human genetic map is filled in, and as flaws in our fundamental building blocks are identified, there will be a concomitant drive to test …