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Bioethics is best viewed as both a second-order discipline and also part of public discourse. Since their goals differ, some bioethical activities are more usefully viewed as advancing public discourse than academic disciplines. For example, the 'Universal Declaration on Bioethics and Human Rights' sponsored by the United Nations Educational, Scientific, and Cultural Organization seeks to promote ethical guidance on bioethical issues. From the vantage of philosophical ethics, it fails to rank or specify its stated principles, justify controversial principles, clarify key terms, or say what is meant by calling potentially conflicting norms 'foundational.' From the vantage of improving the public discourse about bioethical problems and seeking ethical solutions in the public arena, however, this document may have an important role. The goals and relations between bioethics as a second-order discipline and public discourse are explored. Keywords: bioethics, ethics, law, rights, UNESCO

A new analysis of the Best Interests Standard is given and applied to the controversy about testing children for untreatable, severe law-onset genetic diseases, such as Huntington's disease or Alzbeimer's disease. A professional consensus recommends against such predictive testing, because it is not in children's best interest. Critics disagree. The Best Interests Standard can be a powerful way to resolve such disputes. This paper begins by analyzing its meaning into three necessary and jointly sufficient conditions showing it: 1. is an 'umbrella' standard, used differently in different contexts, 2. has objective and subjective features, 3. is more than people's intuitions about how to rank potential benefits and risks in deciding for others but also includes evidence, established rights, duties and thresholds of acceptable care, and 4. can have different professional, medical moral and legal uses, as in this dispute. Using this standard, support is given for the professional consensus based on concerns about discrimination, analogies to adult choices, consistency with clinical judgments for adults, and desires to preserve of an open future for children. Support is also given for parents' legal authority to decide what genetic tests to do. Keywords: Alzheimer's disease, best interest, children, ethics, genetics, Huntington's disease, law, pediatrics, rights

A dispute exists about whether bioethics should become a new discipline with its own methods, competency standards, duties, honored texts, and core curriculum. Unique expertise is a necessary condition for disciplines. Using the current literature, different views about the sort of expertise that might be unique to bioethicists are critically examined to determine if there is an expertise that might meet this requirement. Candidates include analyses of expertise based in 'philosophical ethics,' 'casuistry,' 'atheoretical or situation ethics,' 'conventionalist relativism,' 'institutional guidance,' 'regulatory guidance and compliance,' 'political advocacy,' 'functionalism,' and 'principlism.' None succeed in identifying a unique area of expertise for successful bioethicists that could serve as a basis for making it a new discipline. Rather expertise in bioethics is rooted in many professions, disciplines and fields and best understood as a second-order discipline. Keywords: bioethics, codes, ethics, professionalism, interdisciplinary, multidisciplinary

To the Editor.-- As a nurse whose background is in newborn intensive care, I deeply appreciate the guidelines (1-3) of the American Academy of Pediatrics (AAP) that address the issue [...]

Two incompatible policies exist for guiding medical decisions for extremely premature, sick, or terminally ill infants, the Best Interests Standard and the newer, 20-year old 'Baby Doe' Rules. The background, including why there were two sets of Baby Doe Rules, and their differences with the Best Interests Standard, are illustrated. Two defenses of the Baby Doe Rules are considered and rejected. The first, held by Reagan, Koop, and others, is a 'right-to-life' defense. The second, held by some leaders of the American Academy of Pediatrics, is that the Baby Doe Rules are benign and misunderstood. The Baby Doe Rules should be rejected since they can thwart compassionate and individualized decision-making, undercut duties to minimize unnecessary suffering, and single out one group for treatment adults would not want for themselves. In these ways, they are inferior to the older Best Interests Standard. A 'negative' analysis of the Best Interests Standard is articulated and defended for decision-making for all incompetent individuals. Keywords: American Academy of Pediatrics, Baby Doe, Best Interests Standard, end of life treatment, ethics, infants, Koop, law, neonatal, right-to-life, Reagan, sanctity of life

ABBREVIATION. AAP, American Academy of Pediatrics. The current set of federal regulations about how to treat extremely ill, premature, or terminally ill infants Yet, 20 years later these Baby Doe [...]

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of 'minimal risk.' If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC. Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of 'minimal risk' are untenable. The 'absolute' interpretation of the 'routine examination' standard is defended as best. Keywords: ethics, minimal risk, precautionary principle, research, regulations, review boards, minors

The US Federal Code limits research with healthy children to no more than a minimal risk of harm; it restricts research with children who have some disorder or condition to no more than a minor increase over minimal risk, unless potential harms are offset by potential benefits to them, as in therapeutic studies. Higher risk studies require "407 approval," named after the relevant section of the code describing requirements. Rarely used until recently, 407 approval requirements include Institutional Review Board approval and authorization by the Secretary of the Department of Health and Human Services after consultation with a panel of experts; a period for public comment; and assurances that there are adequate permission, consent, and assent. This 407-approval mechanism contains both procedural and interpretative ambiguities, which raise ethical concerns about 1) the expertise represented on advisory panels, 2) the scope of the information offered to the public for comment and its potential conflicts with investigators' intellectual property or commercial interests, 3) whether any upper level of risk exists, and 4) how it conforms with other policies such as the best interest of the child standard in the law or in medical decision making. Pediatrics 2004;113:1783-1789; children, ethics, experimentation, health policy, human subjects, IRBs, law, pediatrics, research., ABBREVIATIONS. IRB, Institutional Review Board; DHHS, Department of Health and Human Services; CFR, Code of Federal Regulations; OHRP, Office for Human Research Protections; NIH, National Institutes of Health; HIV, human [...]

The U.S. Supreme Court's seminal 1978 Bakke decision, now 25 years old, has an ambiguous and endangered legacy. Justice Lewis Powell's opinion provided a justification that allowed leaders in medical education to pursue some affirmative action policies while at the same time undermining many other potential defenses. Powell asserted that medical schools might have a 'compelling interest' in the creation of a diverse student body. But Powell's compromise jeopardized affirmative action since it blocked many justifications for responding to increases in political opposition and legal challenges. The Bakke decision and its moral background and legal legacy are traced and analyzed. Despite recent legal setbacks, the framework sketched by Powell can be used to defend diversity in medical education both morally and legally as a 'compelling state interest.' Because trust is a central component of the physician-patient relationship and a prerequisite to the profession's ability to provide effective medical care, the state has a compelling interest in training physicians with whom patients can feel comfortable and safe if the population is (1) distrustful; (2) underserved; (3) faces significant discrimination in the allocation of benefits, goods and services and (4) affirmative action programs would be likely to promote their trust in the system. Similar narrowly-tailored arguments could be used in other professions and for other groups. Bakke is an important background for the pending Grutter case. Keywords: affirmative action, Bakke, bias, justice, medical education, medical school admissions, preferential programs, trust

HIV/AIDS strikes with the greatest frequency in sub-Saharan Africa, a region lacking resources to deal with this epidemic. To keep millions more people from dying, wealthy countries must provide more help. Yet deeply ingrained biases may distance the sick from those who could provide far more aid. One such prejudice is viewing disease as punishment for sin. This 'punishment theory of disease' ascribes moral blame to those who get sick or those with special relations to them. Religious versions hold that God punishes them in order to castigate, encourage virtue, warn, rehabilitate, or maintain some cosmic order. Its various religious and secular forms are untenable; they lack cogency, risk blaming people unjustly, and jeopardize compassionate care for people. These views are not only irrational but also dangerous because they influence policies and cost lives. We need to cooperate and respond as befits this global public-health disaster and not engage in the misguided and bad faith activity of dividing the world into the blameworthy and blameless. Key Words: Africa, AIDS, bioethics, blame, disease, ethics, HIV, moral responsibility, population health, poverty, punishment, religion