Among those who criticize the concept of a common refrain is that we really have no idea what futility means. For example, physicians seem to disagree on whether a treatment being futile means that it has a less than 5% chance of working or a 20% chance of working. If the concept is so unclear, then it seems a thin reed upon which to base a momentous ethical decision—namely, that the physician's judgment should be allowed to override the wishes of (...) the competent patient or the patient's duly appointed surrogate. (shrink)

"Written by a well-known and respected author, this book reflects careful scholarship by someone who has extensive experience in the field and creative insights.

A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of (...) possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its implementation, and (v) synthesis of community characteristics and possible protections to define protections appropriate for each type of community. Depending on the particular community, consent and consultation, consultation alone, or no added protections may be required for research. (shrink)

Law provides a rich language for thinking about bioethical issues and is a tool for action as well as talk. But the language of the law, often inapt, regularly fails to achieve its desired effect.

Does respect for autonomy imply respect for precedent autonomy? The principle of respect for autonomy requires us to respect a competent patient’s treatment preference, but not everyone agrees that it requires us to respect preferences formed earlier by a now‐incapacitated patient, such as those expressed in an advance directive. The concept of precedent autonomy, which concerns just such preferences, is problematic because it is not clear that we can still attribute to a now‐incapacitated patient a preference which that patient never (...) disaffirmed but can no longer understand. If we cannot make that attribution, then perhaps we should not respect precedent autonomy – after all, how can you respect patient autonomy by giving patients what they no longer want, even if they never disaffirmed those wants? I argue that whether an earlier preference can still be attributed to a now‐incapacitated patient depends on the reasons behind the preference, for a preference includes (and is not merely supported by) the reasons behind it. When the considerations that served as reasons no longer exist, neither does the preference which included those reasons. In particular, if the considerations that served as reasons for the patient exist only under conditions where the patient retains full mental capacity, then once that capacity is lost, so are those reasons and the preference based upon them. I use this analysis of precedent autonomy to ascertain the merits of various approaches to advance medical decisionmaking, including Nancy Rhoden’s approach, approaches based on a Parfitian personal identity analysis, approaches based on soft paternalism, and approaches based on the stability and longevity of preferences. Despite the apparent absurdity of respecting patient autonomy by giving patients what they no longer prefer but have never disaffirmed, I conclude with some programmatic remarks on when and why respect for (precedent) autonomy nonetheless requires us to respect former preferences. (shrink)

Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same (...) oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration. (shrink)

The treatment of pregnant women addicted to drugs provides an especially important and illustrative example of how political and popular demands can successfully challenge professional ethical norms associated with clinical medicine — norms such as confidentiality, patient autonomy, and the right to consent to and to refuse treatment. One increasingly popular policy approach is to limit patient autonomy by coercing women in an attempt to change their behavior, either by involuntary civil commitment or by imprisoning them for drug abuse or (...) child neglect. Thirty-five states have criminally prosecuted women for substance abuse or alcohol use during pregnancy. Other states aggressively use involuntary civil commitment as a means to protect the yet-to-be-born from harm during pregnancy. Medical professionals have been forced to participate in these programs by mandatory reporting requirements. (shrink)

Scholarship has intrinsic value, of course; but when good scholarship can stimulate change for the better in an area as fundamental to human dignity as health care and the relief of suffering, there is a special satisfaction. This has been our experience since 1996, when the first of now four special issues of this journal focused on legal, regulatory, ethical, professional, and financial issues in medical treatment for pain.With the generous and steadfast support of the Mayday Fund, the American Society (...) of Law, Medicine & Ethics has generated a significant body of scholarship published in the Journal of Law, Medicine & Ethics. This research has proven absolutely essential in changing public policy to support better care for those who suffer pain.Over these years, the Mayday Project at ASLME has tackled many of the real and perceived barriers to effective pain relief. In pain management, both real and perceived obstacles can have a powerful negative effect. (shrink)

Timely and provocative essays on bioethical questions brought to the forefront by the bioterrorist threat.

The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.