The law of informed consent is in a state of flux. Originally a judicially-created doctrine, the doctrine varies from jurisdiction to jurisdiction in its theoretical basis for imposing liability (battery vs. negligence), the scope of the physician's duty to disclose (the “professional” vs. the. “prudent patient” standard), and, where negligence is the basis for the action, the requirement for finding proximate causation (subjective vs. objective basis). Many states have recently enacted statutes on informed consent which differ markedly in their provisions. Coexistent with this uncertainty about the precise form that the law should take, and perhaps underlying it, is a basic uncertainty about the purposes and rationale behind the informed consent doctrine, the feasibility of executing its dictates, and the effects of its application on the delivery of health care.

Assisted reproductive technology has enabled thousands of infertile couples to experience the joys of parenthood. At various times, however, significant problems have come to light concerning the providing of infertility treatment in the United States. An early problem was misleading advertising by some infertility programs, particularly in regard to pregnancy success rates. This unacceptable activity suggested the need for more oversight of assisted reproductive technology and prompted the passage of a federal law requiring the reporting of success rates in a standardized format. Another problem, one that was especially disturbing, was the transfer of preembryos to infertile women at the University of California, Irvine, without the consent of the progenitor couples. Disclosure of these events added fuel to the debate over whether assisted reproductive technology should be subject to greater governmental regulation.

There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article by Rebecca Dresser on preimplantation genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident.

As therapeutic advances in the treatment of AIDS began to emerge in the late 1980s and public health began to have more to offer than just the threat, or the perceived threat, of quarantine or partner notification, fissures began to appear in the alliance against named HIV reporting that had emerged a few years earlier. In 1989, New York City’s Health Commissioner stated that the prospects of early clinical intervention warranted “a shift toward a disease-control approach to HIV infection along the lines of classic tuberculosis practices,” including the “reporting of seropositives.”

Although his proposal met with fierce and effective resistance, it is now clear that his call represented part of a national trend. The CDC continued to press for cases of HIV to he reported by name to health departments, an effort that assumed the dimensions of a campaign. It was supported by a growing number of public health officials.

Several incidents involving the withdrawal of treatment and/or the ordering of supportive care for nursing home residents came to public attention in the spring and summer of 1981, raising serious concerns among advocates, attorneys, and health care professionals about the use of supportive care orders. It appeared that there was little consistency or consensus with respect to the meaning or application of the Supportive care concept.

In response to such concerns, a task force of interested individuals long term care staff and administrators, consumer advocates, medical, legal and social service professionals, and government agency officials was convened to identify and discuss issues raised by the use of supportive care. The task set by the group was to make recommendations and propose a set of guidelines for the provision of supportive care in long term care settings.

Nurses frequently wonder about the legal aspects of using siderails to prevent patient falls from bed. Questions arise as to when siderails are clinically indicated; whether a patient may refuse the use of siderails; whether, when a patient does fall from bed, the fall resulted from negligent failure to use siderails; and whether a decision to use siderails is a medical or nursing judgment. This article examines the legal issues involved in the use of siderails and provides some recommendations for the use of siderails and other restraints.

Liability for a patient's fall from bed is imposed according to the general principles of the law of negligence—when the patient-plaintiff can demonstrate that a particular act or omission on the part of the defendant (usually the hospital, through its nursing staff) did not conform to the accepted standard of care, and that this deviation resulted in harm to the patient.

Buprenorphine is a form of opioid agonist treatment that has been demonstrated to be an effective medication for opioid addiction. It is available in different formulations and marketed under various trade names, including commonly as a buprenorphine/naloxone combination. This paper provides an overview of existing literature on the supply of buprenorphine treatment, the ability of people to access treatment with buprenorphine, and the quality of treatment received. We argue that better data for each of these aspects of treatment could inform policy to expand effective treatment with buprenorphine, and we suggest steps to obtain and act on such data.

This paper reviews common advertising claims by egg freezing companies and evaluates the medical evidence behind those claims. It then surveys legal standards for truth in advertising, including FTC and FDA regulations and the First Amendment right to free speech. Professional standards for medical advertising, such as guidelines published by the American Society for Reproductive Medicine (ASRM), the American College of Obstetricians and Gynecologists (ACOG), and the American Medical Association (AMA), are also summarized. A number of claims, many of which relate to the targeting of younger women for eOC, are found to breach legal and ethical standards for truth in advertising. The ethical implications of misleading advertising claims are also discussed, and the central narrative woven by OC ads — that egg freezing is empowering to women — is examined. The paper concludes that a more balanced approach to the risks and benefits of OC is necessary to truly respect women's autonomy. Moreover, justice requires us to look beyond a medical procedure accessible only to a minority of women in order to address inequities in the workplace.

Many new genetic tests are used in clinical practice, and the number of available tests is growing. Two important health policy questions arise as these genetic tests become available. The first question, whether a new test should be made available, has been the focus of much recent discussion. The second question concerns defining the appropriate standards surrounding the use of these tests, including patient selection, education, informed consent, test interpretation and counseling.

Genetic tests currently move from the research arena, where strategies are put in place to minimize risks,into the clinical context where the practice of medicine is more variable and the risks to patients less understood. In the research setting, risks can be minimized through safeguards including education, consent, and counseling. The frequency and magnitude of psychosocial and clinical risks canbe assessed. In the clinical setting, however, these safeguards may not be used consistently, creating unknown risksfor patients (see table).

The Mayday Scholars Program for 2001-2002 provided an opportunity to boards of nursing to present their experiences in monitoring the prescribing practices of advanced practice nurses and to research ways for improving their own investigation processes as professional disciplinary agencies for prescribing practices related to pain management. The Alabama Board of Nursing was interested in participating in the program based on its commitment to accountability for public protection. A gradual increase in disciplinary cases involving violations of prescribing practices by certified registered nurse practitioners (CRNPs) prompted our inquiry as to whether a proactive monitoring system was needed to determine compliance with regulations for advanced practice nurses in collaborative practice.

In this article, we discuss selected elements related to pain management and regulatory factors, including nursing, that affect the treatment of pain. We present a brief overview of the evolution of advanced practice nursing, with an emphasis on the nurse practitioners movement, and prescription practices and pain management by nurse practitioners.

Advances in medicine depend not only on the generation of information but also on its dissemination. Clinically relevant data must be transmitted to the practitioners who will use it. Health care professionals in North America are aware of their ethical and legal obligations to inform patients adequately concerning interventions and treatments so that they may make informed choices about medical care. This obligation has been well described and defined by the courts and in the literature of medicine, ethics, and law. But do investigators and others who are responsible for disseminating information have any obligation to divulge adequately the results of clinical trials to practitioners so that the latter might offer the choice of appropriate care to their patients? Can incomplete disclosure of trial outcomes result in harm to patients? If this is the case, what possible avenues are available to avoid such harm?

Wherever we go, we leave behind skin cells containing copies of our DNA molecule – unless we go forth hermetically sealed. This makes construction and maintenance of DNA identification databases enormously useful to crime investigators. DNA databases, linking numerical representations of a tiny portion of individuals' DNA with their names and other identifying information, are useful to identify suspects directly by matching DNA found at a crime scene with a DNA profile in a DNA identification database. They are useful indirectly too, because criminal investigations proceed by a process of elimination; and identifying the person whose DNA was found at a crime scene can make it unnecessary to continue investigating others. When the incriminating crime scene sample does not match the DNA of a “person of interest,” that person is freed from the hassles and risks of criminal investigation, including the risk of false conviction.

Like biotechnology before it, nanotechnology is beginning to provoke opposition from environmentalists concerned about the ethics of the development and application of nanotechnologies. Given the lack of data on environmental health and safety regarding how nanoparticles might impact the environment and effect the health of the human body, some environmentalists have called for limits on the production of nanoproducts until more research can be done to prove their safety. On the other side, while nanotech scientists and engineers agree that additional study of possible harmful effects is in order, they argue it would be unethical to turn our backs on what nanotechnology may do to help clean up the environment and improve health. They argue that a ban on nanomaterials would be shortsighted.

New developments in genetics could affect a variety of real property rights. Mortgage lenders, mortgage insurers, real estate sellers, senior living centers, retirement communities, or other parties in residential real estate transactions begin requiring predictive genetic information as part of the application process. One likely use would be by retirement communities to learn an individual's genetic risk for Alzheimer's disease. The federal Fair Housing Act prohibits discrimination based on disability, but it is not clear that it would apply to genetic risk assessments. Only California law explicitly applies to this situation and there have been no reported cases.

Two Athenians set out to found a city free from the sophistry, power struggles, and litigiousness of Athens in Aristophanes’ play, The Birds. Their creation is to stand as a shining example of a virtuous demos in which reasoned discourse will give birth to goals beneficial to the individual and the community. The city that emerges, “Cloudcuckooland,” turns out to be a replica of Athens, driven by a morality of self-interest and the lust for world conquest. Its founders’ dream fades in a maze of doubtful arguments, crippling red tape, and insatiable litigiousness. Even so, Aristophanes hints, the dream survives, for no Athenian can escape from the restless hubris that leads to daring creation.

Special committees have been created in recent years to address difficult ethical issues in clinical care free from the bureaucratic amorality, professional friction, and litigiousness that can characterize problem-solving within health care institutions.

To assist in resolving ethical questions surrounding unregulated mHealth research, we conducted in-depth qualitative interviews with experts from four key stakeholder groups: patient/research advocates, researchers, regulatory professionals, and mobile app/device developers. They discussed challenges and potential solutions in the context of two hypothetical scenarios involving unregulated mHealth research, including notifications/permissions for research use of mHealth data, data access procedures, new primary data collection, offering individual research results, and data sharing and dissemination.

This special issue of the Journal Law, Medicine & Ethics takes up the concern of informed consent, particularly in times of controversy. The dominant moral dilemmas that frame traditional bioethical concerns address medical experimentation on vulnerable subjects; physicians assisting their patients in suicide or euthanasia; scarce resource allocation and medical futility; human trials to develop drugs; organ and tissue donation; cloning; xenotransplantation; abortion; human enhancement; mandatory vaccination; and much more. The term “bioethics” provides a lens, language, and guideposts to the study of medical ethics. It is worth noting, however, that medical experimentation is neither new nor exclusive to one country. Authors in this issue address thorny subjects that span borders and patients: from matters dealing with children and vaccination to the language and perception of consent.