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Letter From the Editor
Letter from the Editor
ASLME - [PDF]

It has been my signal professional honor to serve as the Editor of the Journal of Law, Medicine & Ethics since 2003. For nearly fifteen years my co-editors and I have viewed ourselves as caretakers and stewards of a publication that has roots stretching back more than four decades. The last ten years of that stewardship has been shared with my friend and fellow editor Courtney McClellan, and together we work every day to ensure the journal meets the high standards set by our many predecessors. However, we can't do it alone. No relationship is more important to us in meeting these lofty goals than our vitally important partnership with our Editor-in- Chief (EIC).
Introductions
Introduction: Under Attack: Reconceptualizing Informed Consent
Valerie Gutmann Koch and Nanette R. Elster - [PDF]

In 2014, the American Bar Association (ABA) Special Committee on Bioethics and the Law ("Special Committee") sponsored a presidential showcase at the ABA Annual Meeting entitled Forging New Frontiers: The Intersection of Bioethics and Biotechnology Law. The showcase explored the bioethical and legal issues that arise with the development of cutting edge technologies, addressing genomics, stem cell research, and nanotechnology. Despite its technological focus, however, one of the most provocative statements was made about one of the most established processes in medicine and ethics - informed consent. George Annas, our first author in this special issue of JLME, stated that "informed consent is under attack." He argued that written consent should be dispensed with when doing clinical research. Because of the ever changing nature, purpose and process of informed consent, in its current form it no longer serves the goal of protecting patients and ensuring autonomous, informed decision-making.
Symposium Articles
Informed Consent: Charade or Choice?
George J. Annas - [PDF]

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), and indirect from new information technologies, especially the use of computer screens during doctor-patient encounters. Even the law has helped undermine informed choice by replacing doctor-patient conversations with legal forms.
Certified Patient Decision Aids: Solving Persistent Problems with Informed Consent Law
Thaddeus Mason Pope - [PDF]

A giant chasm lies between the theory and the practice of informed consent. On the one hand, in terms of theory, scores of appellate court opinions and medical ethics codes describe informed consent in terms of honoring and supporting patient autonomy and self-determination. After all, the doctrine of informed consent is supposed to assure that the patient's preferences and values match the medical interventions the patient gets.
Informed Consent as Societal Stewardship
Nadia N. Sawicki - [PDF]

In the landscape of American health care in the twenty-first century, individual patients' medical decisions cannot be viewed in isolation. Each treatment decision a patient makes is situated within a broad societal context, and thus contributes to population-level trends that have an impact on all participants in the health care system. In the public health sphere, for example, individual decisions about whether to vaccinate can contribute to the resurgence of communicable diseases that were until recently considered eradicated. At a systemic level, individual decisions to pursue resource-intensive treatments can contribute to the rising societal costs of health care, higher insurance premiums, and increases in governmental expenditures on Medicare and Medicaid.
Flying Too Close to the Sun: Lessons Learned from the Judicial Expansion of the Objective Patient Standard for Informed Consent in Wisconsin
Arthur R. Derse - [PDF]

In the Greek myth of Icarus, Daedalus created for himself and his son, Icarus, pairs of wings with waxed feathers that could be used to fly. The father warned his son not to fly too high, close to the sun. For if he did, the hotter air would melt the waxed wings. Despite his father's admonition, Icarus flew too high, his wings melted, and he plunged into the ocean to his death.
A New Age of Patient Transparency: An Organizational Framework for Informed Consent
Kenneth Campbell and Kayhan Parsi - [PDF]

A patient seeks treatment for recurring back pain. The physician at the immediate care facility recommends X-ray imaging. The orthopedic physician at an outpatient clinic recommends an MRI. The pain specialist at a pain center recommends an epidural. And the spine surgeon at a large health system recommends spine surgery. Informed consent is treated by the clinicians in a cursory manner in most of these encounters (except for the spine surgeon). The patient is given some boilerplate informed consent document with little conversation (again, except for the spine surgeon). Whose responsibility is it to inform the patient of the risks, benefits and alternatives of any proposed treatment? The physicians in this scenario? Or the health care organization? Moreover, should other information be shared with the patient (e.g., outcomes data, quality data)? Who should share this information? The physician? The organization? Both?
Living Organ Donation and Informed Consent in the United States: Strategies to Improve the Process
Macey L. Henderson and Jed Adam Gross - [PDF]

More than 120,000 individuals in the United States are currently waiting for a lifealtering solid organ transplant, but usable organs from deceased donors are scarce. As the need for organs has outpaced availability, wait times have increased, particularly in certain geographic regions. Living donor transplantation, offered in some form by most U.S. transplant centers, represents one major strategy for addressing patients' needs amidst this scarcity. Living kidney donation now accounts for approximately one third of all kidney transplants occurring in the U.S. annually. Living donors are comparatively healthy individuals who voluntarily undergo resective surgery to aid a family member, friend, or stranger without any direct physiological benefit to the donor. Typically, the donated organ is a kidney (leaving the donor with a single kidney) or part of the liver (which is capable of regeneration). Informed consent is a critical aspect of living organ donation, as safeguarding the individual donor is a central tenet of safe clinical practice, and protecting the donor's autonomy is a major legal and ethical concern.
Informed Consent in Dentistry
Kevin I. Reid1 - [PDF]

Though this account of informed consent will not address informed consent in the research setting, a brief historical reference to research ethics is necessary to gain some perspective of the development of clinically related informed consent. The crux of the theory of informed consent is respecting the ethical right of an individual to make decisions about his body and whether to have it acted upon - in any way - and only with his authorization and in the absence of undue influence. This right was influenced by revelations about research atrocities conducted during World War II wherein people were subjected to medical experiments without choice. Among these atrocities were the tragic experiments of Josef Mengele in Nazi Germany, which are perhaps most widely known and which gave rise to the Nuremberg Trials in 1946. These highlighted the criminal imposition of medical experimentation on Jews destined for execution. The Nuremberg Code emerged from the trials and included ten principles for morally sanctioned experimentation, the most important of which was that people have the ethical and legal right to freely consent to, or refuse participation in, medical experimentation, though it is important to emphasize that this code has never been adopted as law in the United States. Following the Nuremberg Code, the practice of informed consent in non-experimental, clinical settings evolved having clearly been influenced by the elements of the Nuremberg Code.
Informed Consent Is the Essence of Capacity Assessment
Jeffrey P. Spike - [PDF]

Informed consent is the single most important concept for understanding decision-making capacity (abbreviated DMC in some articles, but abbreviated "capacity" for the rest of this article). There is a steady pull in the clinical world to transform capacity into a technical concept that can be tested objectively, usually by calling for a psychiatric consult. In this article I argue that is a mistake, not just unnecessary but wrong, and explain how to re-normalize capacity assessment. The argument is based on ethical, philosophical, and clinical perspectives.
Beyond Canterbury: Can Medicine and Law Agree about Informed Consent? And Does It Matter?
Marc D. Ginsberg - [PDF]

For those of us whose scholarship focuses on medico-legal jurisprudence, the law of informed consent is a gift. It has been a fertile topic of discussion for decades, with no end in sight. Although it is not difficult to acknowledge that patient autonomy is at the core of informed consent, the doctrine is not static - it has evolved in scope and continues to engage courts in thought provoking analysis.
Independent Articles
Shouldn't Dead Be Dead?: The Search for a Uniform Definition of Death
Ariane Lewis, Katherine Cahn-Fuller, and Arthur Caplan - [PDF]

Prior to 1968, death in the United States was defined as cessation of all vital functions including respiration and heartbeat. In 1968, the Dean of Harvard Medical School, Robert Ebert, formed an ad hoc committee to examine the definition of brain death. The committee was composed of neurologists (Raymond Adams, Derek E. Denny Brown, and Robert Schwab), a physiologist (Clifford Barger), a professor of law (William Curran), a professor of public health (Dana Farnsworth), a biochemist (Jodi Folch Pi), a historian (Everett Mendelson), a transplant nephrologist (John Merrill), a professor of social ethics (Ralph Potter), and a neurosurgeon (William Sweet), and was chaired by anesthesiologist Henry Beecher. Committee members believed that a definition for brain death was needed for medical, moral, ethical, religious, and legal reasons as a result of recent improvements in resuscitative and supportive measures including ventilator support. These new technologies led to the ability to artificially provide organ support and avoid cessation of respiration or heartbeat in patients who had critical irreversible brain damage with no discernible nervous system activity. These patients placed a substantial burden on families, hospitals, and society. Additionally, the Committee noted that patients with critical irreversible brain injury could be organ donation candidates if there were criteria for death based on brain injury.
Research Capacity Strengthening in Low- and Middle-Income Countries: Ethical Explorations
Adnan A. Hyder, Abbas Rattani, and Bridget Pratt - [PDF]

Research capacity strengthening (RCS) is defined as "the process by which individuals, organizations and societies develop the ability (individually and collectively) to perform [research] functions effectively, efficiently, and in a sustainable manner to define objectives and priorities, build sustainable institutions and bring solutions to key national problems." That is, RCS can be understood in terms of building or scaling research institutions and systems so that they are able to effectively and adequately generate the knowledge needed to address the health needs of a given population. RCS is typically conceptualized as needing to occur at three levels: individual, institutional, and systems. Building and strengthening research capacity requires a combination of short and long-term strategies directed at individual researchers (junior to senior levels), research institutions, and health research systems in host countries.
Negotiating Commercial Interests in Biospecimens
Jessica L. Roberts - [PDF]

Proposed changes to the Common Rule would require publicly funded researchers to disclose whether a subject's biospecimens could be used for commercial profit and whether the subject will share in those proceeds. Disclosing commercial interests will inform research participants that their tissue may have commercial value, a possibility that those individuals might not have previously considered. The proposed changes may then provide people with an opportunity to negotiate commercial rights in their biospecimens despite the well-accepted legal precedent that individuals maintain no interests in their excised tissue.
Is There a Particular Ethical Practice and Policy Space in North America for Uncontrolled Kidney Donation after Circulatory Death?
Jeffrey Kirby - [PDF]

Despite the ongoing, significant supply-deficit of transplantable kidneys in the U.S. and Canada and the documented success of uncontrolled donation after circulatory determination of death (uDCDD) programs in France, Spain, and the Netherlands, this particular organ donation/transplantation (OD/T) practice has essentially been a non-starter in North America. The lack of operational uptake of uDCDD has been influenced by a number of factors including: (1) the lowyield outcomes of preliminary trial programs in a few American cities including Washington and New York; (2) particular, historical features of the North American OD/T context including traditional privileging of the decision-making authority of the family; (3) lack of acceptance by the public and health professionals of opt-out organ donation regimes such as those that exist in France and Spain; (4) logistical and resource allocation constraints associated with transportation of the dead bodies of potential donors from the community to emergency departments; and (5) technical challenges in the development of optimal, organpreserving interventions. Despite the potential for significant uDCDD-related utility in North America - it has been estimated that this OD/T practice could yield an additional 22,000 potential organ donation opportunities per year in the U.S. - the widespread actualization of this practice will only be feasible if the various identified clinical, ethical, and health law constraints can be effectively addressed.
Columns
Currents in Contemporary Bioethics: Compelled Disclosures of Health Records: Updated Estimates
Mark A. Rothstein and Meghan K. Talbott - [PDF]

In both the popular media and scholarly literature, breaches of health privacy, confidentiality, and security are often associated with unlawful or unethical actions that result in disclosures of health information to individuals or entities with no right to access them. Although it is important to address wrongful access, disclosure, and use of health information, the focus on wrongful acts frequently overlooks the significant threat to health privacy posed by lawful disclosures of health information to individuals and entities with the economic or legal leverage to require individuals to sign authorizations for the disclosure of their health information. We have termed this common practice "compelled disclosures," which often take the form of "compelled authorizations." It includes instances in which individuals are required to sign an authorization as well as times in which individuals are required to obtain their own health records and submit them directly.
Public Health and the Law: Public Health "Preemption Plus"
James G. Hodge, Jr., Alicia Corbett, Kim Weidenaar, and Sarah A. Wetter - [PDF]

Few legal concepts engender more confusion and concern in public health circles than the doctrine of preemption. Simply stated, preemption refers to "how a state or local law may be averted, displaced, or negated by conflicting laws at a higher level of government." Federal laws may preempt state or local laws because federal law is supreme. State laws can preempt local laws because local governments are controlled by sovereign states. Even some local governments may preempt laws among lesser municipalities (e.g., Oregon county law overrode city law approving manufacturing plant within the county's borders).
Calendar
JLME 45.1 Calendar of Events
ASLME - [PDF]