Refugees, humanitarian aid and the right to decline vaccinations.

Recent instances of governments and others refusing humanitarian assistance to refugees and IDPs (internally-displaced persons) unless they agreed to polio immunization for their children raise difficult ethical challenges. The authors argue that states have the right and a responsibility to require such vaccinations in instances where the serious vaccine-preventable disease(s) at issue threaten others, including local populations, humanitarian workers, and others in camps or support settings.

Done good.

How did bioethics manage to grow, flourish and ultimately do so well from a very unpromising birth in the 1970s? Many explanations have been advanced. Some ascribe the field's growth to a puzzling, voluntary abnegation of moral authority by medicine to non-physicians. Some think bioethics survived by selling out to the biomedical establishment-public and private. This transaction involved bestowing moral approbation on all manner of biomedicine's doings for a seat at a well-stocked funding table. Some see a sort of clever intellectual bamboozlement at work wherein bioethicists pitched a moral elixir of objective expertise that the morally needy but unsophisticated in medicine and the biological sciences were eager to swallow. While each of these reasons has its defenders, I think the main reason that bioethics did well was that it did good. By using the media to move into the public arena, the field engaged the public imagination, provoked dialogue and debate, and contributed to policy changes that benefitted patients and healthcare providers.

Without an adequate ethical infrastructure, the road to personalized medicine will be rocky at best.

Discovering the genetic variations that create profiles of risk and drive individual responses to drugs and vaccines has proven more difficult than many initially presupposed. Rhetoric about the prospect of personalized medicine has exceeded the ability to deliver on that vision. There also remain significant ethical and policy obstacles that may hinder the arrival of personalized medicine. The emergence of new prenatal genetic tests make the resolution of these ethical challenges imperative.

Clinical trials of drugs and vaccines among the desperately poor in poor nations: ethical challenges and ethical solutions.

Clinical research has been expanding into poor nations in recent years. In doing research in such settings, the response to challenges arising due to the vulnerability and resultant potential exploitation of very poor subject populations is heightened awareness of the need for adequate local oversight and regulation. More regulation, however, often is difficult to implement and may not be practical. The provision of benefit at the conclusion of clinical trials in poor nations or for poor people is a better response to the moral challenge of exploitation.

When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process.

Investigators, sponsors, and institutional review boards have to decide when re-consent of clinical trials' participants must be obtained when new information becomes available. We present an algorithm to help in the decision-making process, which takes into consideration the kind of new information, the risk of exposure (patients could be on the treatment or in the follow-up phases), and the possibility of managing the case. Re-consent should be obtained in three of the eight possible situations.

Lessons from the failure of human papillomavirus vaccine state requirements.

The licensure in 2006 of a vaccine against the subtypes of human papillomavirus (HPV) responsible for the majority of cervical cancers and genital warts was heralded as a watershed moment for vaccination, cancer prevention, and global health. A safe and effective vaccine against HPV has long been viewed as an enormous asset to cervical cancer prevention efforts worldwide. This is particularly true for places lacking robust Pap screening programs where cervical cancer has the greatest prevalence and mortality. Well before its licensure, however, some observers noted significant obstacles that would need to be addressed in order for an HPV vaccination program to succeed. These included the vaccine's relatively high cost, availability, and opposition from socially conservative groups. Such concerns associated with the implementation of HPV vaccination were soon overwhelmed by the furor that followed the unexpectedly early efforts by the US state governments to require the vaccine as a condition of attendance in public schools, proposals imprecisely referred to as "mandates." In this study, we review the controversy surrounding this debate and its effects on important ethical and public health issues that still need to be addressed.

A national study of ethics committees.

Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they have played compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent of ethics committees report that they played a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies.

The role of guidelines in the practice of physician-assisted suicide. University of Pennsylvania Center for Bioethics Assisted Suicide Consensus Panel.

Oregon has legalized and implemented physician-assisted suicide, while observers argue about the moral import of attempting to formulate guidelines; the utility any set of guidelines can have for physician practice, health care providers, patients, or families; and whether guidelines can really protect against harm or abuse. What were once theoretical questions have taken on new urgency. The debate over the value and power of guidelines includes the following questions: What has been the experience of efforts to implement physician-assisted suicide using consensus guidelines? What goals are guidelines intended to serve? Who should formulate guidelines? What features should be reflected in any proposed guidelines to make them practical and to permit achievement of their goals? Are there any fundamental obstacles to the creation or implementation of guidelines? Is dying a process that is amenable to direction under guidelines, be they issued by physicians, departments of health, blue ribbon panels, or other regulatory bodies? This paper explores these questions as physician-assisted suicide becomes legal.