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. (shrink)

When making decisions for adults who lack decision-making capacity and have no discernable preferences, widespread support exists for using the Best Interests Standard. This policy appeals to adults and is compatible with many important recommendations for persons facing end-of-life choices.Common objections to the policy are discussed as well as different meanings of this Standard identified, such as using it to express goals or ideals and to make practical decisions incorporating what reasonable persons would want. For reasons of consistency, fairness, and (...) compassion, this standard should be used for all incapacitated persons. (shrink)

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. (shrink)

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. (shrink)

ABSTRACT A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, and many other national policies. (...) They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like “minimal risk.” Paths to the improvement of balancing or consequentialist approaches include improving standardizing of risk assessment, rejecting crude utilitarianism, identifying and justifying normative or moral judg-ments, and acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children. (shrink)

A new analysis of the Best Interests Standard is given and applied to the controversy about testing children for untreatable, severe late-onset genetic diseases, such as Huntington's disease or Alzheimer'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: is an "umbrella" (...) standard, used differently in different contexts, has objective and subjective features, 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 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. (shrink)

Clinicians sometimes disagree about how much to honor surrogates’ deeply held cultural values or traditions when they differ from those of the host country. Such a controversy arose when parents requested a cultural accommodation to let their infant die by withdrawing life saving care. While both the parents and clinicians claimed to be using the Best Interests Standard to decide what to do, they were at an impasse. This standard is analyzed into three necessary and jointly sufficient conditions and used (...) to resolve the question of how much to accommodate cultural preferences and how to treat this infant. The extreme versions of absolutism and relativism are rejected. Properly understood, the Best Interests Standard can serve as a powerful tool in settling disputes about how to make good decisions for those who cannot decide for themselves. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks (...) of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks (...) of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the case at (...) the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used. (shrink)

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the case at (...) the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used. (shrink)

Edmund Pellegrino and David Thomasma’s writings have had a worldwide impact on discourse about the philosophy of medicine, professionalism, bioethics, healthcare ethics, and patients’ rights. Given their works’ importance, it is surprising that commentators have ignored their admission of an unresolved and troubling dilemma and inconsistency in their theory. The purpose of this article is to identify and state what problems worried them and to consider possible solutions. It is argued that their dilemma stems from their concerns about how to (...) justify professional rules restricting colleagues from performing acts they view as direct, active, and formal killings, such as physician-assisted suicide, mercy killing, and abortion. It is further argued that their inconsistency is that they both assert and deny that professional colleagues should not use their moral or theological values to impose professional restrictions on other colleagues without adequate philosophical grounds. At risk are their arguments about the nature of an internal morality for medicine, a secular and multicultural basis for medical ethics, and a nonarbitrary way to determine what acts fall outside the ends of medicine. These are arguments they claim also apply to other healthcare professions. The article begins with a brief overview of their key positions to provide the context in which they make their admission. (shrink)

In the summer of 1998, the Wisconsin State legislature amended its child protection laws. Under new child abuse provisions, Wisconsin judges can confine pregnant women who abuse alcohol or drugs for the duration of their pregnancies. South Dakota enacted similar legislation almost simultaneously. The South Dakota statute requires mandatory drug and alcohol treatment for pregnant women who abuse those substances and classifies such activity as child abuse. In addition, the South Dakota legislation gives relatives the power to commit pregnant women (...) involuntarily for two days; a court order can place the pregnant women in custody for up to nine months. These recent legislative “successes” follow scores of failed attempts by legislators in other states to establish fetal protection laws aimed at women who use and abuse drugs and alcohol during pregnancy. (shrink)

"Applied" is a technical term describing a variety of new philosophical enterprises. The author examines and rejects the view that these fields are derivative. Whatever principles, judgments, or background theories that are employed to solve problems in these areas are either changed by how they are used, or at least the possibility exists of their being changed. Hence we ought to stop calling these endeavors "applied", or agree that the meaning of "apply" will have to include the possibility that what (...) is applied may be changed. The socalled applied fields of philosophy, therefore, are not derivative. The strongest cases to the contrary are the foundationalist views that what we apply is epistemically privileged. Different foundationalist views take different principles, judgments, or background theories to be epistemically privileged. Strong and weak versions of each of these foundationalist views are considered but none establish these fields as derivative. Keywords: applied ethics, background theories, casuistry, epistemic privilige, foundationalism, principles, reflective equilibrium CiteULike Connotea Del.icio.us What's this? (shrink)

ABSTRACTThe Universal Draft Declaration on Bioethics and Human Rights seeks to provide moral direction to nations and their citizens on a series of bioethical concerns. In articulating principles, it ranks respect for human rights, human dignity and fundamental freedoms ahead of respect for cultural diversity and pluralism. This ranking is controversial because it entails the rejection of the popular theory, conventionalist ethical relativism. If consistently defended, this theory also undercuts other United Nations activities that assume member states and people around (...) the world can reach trans‐cultural judgments having moral authority about health, pollution, aggression, rights, slavery, and so on. To illustrate problems with conventionalist ethical relativism and the importance of rejecting it for reasons of health, human rights, human dignity and fundamental freedoms, the widespread practice of female genital circumcision or cutting is discussed. These surgeries are virtually a test case for conventionalist ethical relativism since they are widely supported within these cultures as religious and health practices and widely condemned outside them, including by the United Nations. (shrink)

Case methods of reasoning are persuasive, but we need to address problems of bias in order to use them to reach morally justifiable conclusions. A bias is an unwarranted inclination or a special perspective that disposes us to mistaken or one-sided judgments. The potential for bias arises at each stage of a case method of reasoning including in describing, framing, selecting and comparing of cases and paradigms. A problem of bias occurs because to identify the relevant features for such purposes, (...) we must use general views about what is relevant; but some of our general views are biased, both in the sense of being unwarranted inclinations and in the sense that they are one of many viable perspectives. This reliance upon general views to determine relevancy creates additional difficulties for defenders who maintain that case methods of moral reasoning are not only useful, but more basic, reliable or prior to other forms of moral reasoning. If we cannot identify the case's relevant features and issues independently of our general views or biases, we need further explanation about why a case method or casuistry should be viewed as prior to or more basic or reliable than other forms of moral reasoning. Problems of bias also arise for other methods of reasoning. In medical science, case reviews are regarded as an unreliable way to form generalizations, and methods such as clinical trials are used to address bias. (shrink)

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. (shrink)

Bioethics and humanities (inclusive of medical ethics, health care ethics, environmental ethics, research ethics, philosophy and medicine, literature and medicine, and so on) seems like one field; yet colleagues come from different academic disciplines with distinct languages, methods, traditions, core curriculum and competency examinations. The author marks six related "framework" features that unite and make it one distinct field. It is a commitment to (1) work systematically on some of the momentous and well-defined sets of problems about the human condition (...) that drive our field (such as death and dying, disability, confidentiality, professionalism, informed consent, abortion, euthanasia, assisted suicide, personhood, health-care resource allocation and environmental ethics, as well as the impact of new technologies, including genetic and reproductive); (2) use interdisciplinary approaches to unravel them; (3) employ cases and practical reasoning to understand problems and solve answers; (4) apply teaching methods and goals associated with John Dewey to make students better problem-solvers; (5) find morally justifiable solutions to the problems driving our field; and (6) seek interdisciplinary and collaborative scholarship, service or teaching. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 32-34, January 2012.

The purpose of this paper is to examine whether randomized clinical trial (RCT) methods are necessarily morally problematic. If they are intrinsically problematic, then there may be a dilemma such that tragic choices might have to be made between this socially very useful method for making medical progress on the one hand, and patients' rights and welfare, or physicans' duties on the other. It is argued that the dilemma may be avoided if RCTs can sometimes be viewed as an honorable (...) and cooperative venture between investigators and subjects. Another dilemma may take shape, however, if too few people are willing to cooperate to maintain the structural integrity of many important RCTs. Given their importance, does this method justify easing some of the consent requirements? It is argued that RCT methods are not so ideal that special consideration should be given to them regarding consent requirements. To examine the compatibility of current consent requirements and frequently used RCT schemas, seven RCT designs are discussed. It is found that some, but not all, RCTs, are intrinsically problematic but that sufficient reason has not been found to hold all RCT schemas as intrinsically morally troubling. Keywords: randomized clinical trials, informed consent, randomization CiteULike Connotea Del.icio.us What's this? (shrink)

anonymous tissue samples obtained in hospitals and clinics without donor consent. This can be justified as a response to a public health emergency, but should not be seen as setting a precedent for waiving consent whenever samples are anonymous. The following recommendations grow out of this discussion: (1) Studies using anonymous tissue samples should not be automatically exempt from consent requirements, and consent should not be waived simply to avoid anticipated refusals, low participation rates or self selection bias. (2) The (...) consensus on informed consent favors fulfilling as many of the elements of informed consent as reasonably possible, so studies should be assessed individually to determine if any or all elements of informed consent should be modified or omitted. (3) There is a need for greater regulation of the research use of tissue samples. (4) Investigators seeking approval to waive consent or modify elements of informed consent should document the sort of new findings that they believe would effect their calculations about the benefits and burdens to subjects who are enrolled in the study, and institutional review boards should indicate whether they agree with the investigators' analysis. Keywords: AIDS, Consent, Ethics, HIV, Notification, Privacy, Research, Screening, Surveillance CiteULike Connotea Del.icio.us What's this? (shrink)

(2004). What is the Role of the Precautionary Principle in the Philosophy of Medicine and Bioethics? Journal of Medicine and Philosophy: Vol. 29, No. 3, pp. 255-258.

A series of cases have crystallized disputes about when medical treatments are useful or futile, and consequently about the doctor-patient relationship, resource allocation, communication, empathy, relief of suffering, autonomy, undertreatment, overtreatment, paternalism and palliative care. It is helpful to understand that utility and futility are complimentary concepts and that judgments about whether treatments are useful or futile in the contested cases have common features. They are: (1) grounded in medical science, (2) value laden, (3) at or near the threshold of (...) utility, and (4) burdensome. No schema for linedrawing escapes borderline cases and we should focus upon justification of the empirical, ethical and evaluative components underlying these judgments, rather than make an arbitrary decision about whether doctors, patients or societal consensus should be the final arbiter. Keywords: futility, ethics, physician authority, consent CiteULike Connotea Del.icio.us What's this? (shrink)

Sub-Saharan Africa is the epicenter of the HIV/AIDS epidemic, and in this issue of the Journal, seven authors discuss the moral, social and medical implications of having 70% of those stricken living in this area. Anton A. van Niekerk considers complexities of plague in this region (poverty, denial, poor leadership, illiteracy, women's vulnerability, and disenchantment of intimacy) and the importance of finding responses that empower its people. Solomon Benatar reinforces these issues, but also discusses the role of global politics in (...) sub-Saharan Africa, especially discrimination, imperialism and its exploitation by first world countries. Given the public health crisis, Udo Schüklenk and Richard E. Ashcroft defend compulsory licensing of essential HIV/AIDS medications on consequentialist grounds. Keymanthri Moodley discusses the importance of conducting research and the need to understand a moderate form of communitarianism, also referred to as "ubuntu" or "communalism", to help some Africans understand research as an altruistic endeavour. Godfrey B. Tangwa also defends traditional African values of empathy and ubuntu, discussing how they should be enlisted to fight this pandemic. Loretta M. Kopelman criticizes the tendency among those outside Africa to dismiss the HIV/AIDS pandemic, attributing one source to the ubiquitous and misguided punishment theory of disease. The authors conclude that good solutions must be cooperative ventures among countries within and outside of sub-Saharan Africa with far more support from wealthy countries. (shrink)

The forced marriage of minors is child abuse, consequently duties exist to stop them. Yet over 14 million forced marriages of minors occur annually in developing countries. The American Bar Association concludes that the problem in the US is significant, widespread but largely ignored, and that few US laws protect minors from forced marriages. Although their best chance of rescue often involves visits to health care providers, US providers show little awareness of this growing problem. Strategies discussed to stop forced (...) marriages include recommendations from the UN, the ABA, and the UK. The author anticipates and responds to criticisms that first, no duty to intervene exists without better laws and practice guidelines; and second, that such marriages are not child abuse in traditions where parental rights or familism allegedly justify them. (shrink)

The Americans With Disabilities Act (ADA) promotes social justice by protecting disabled persons from discrimination and prejudice. It seeks equality of opportunity for them and protects their well being by giving them fair access to goods, services and benefits. These rights are circumscribed in the ADA, however, by constraints of cost, efficiency, utility, and certain social mores. The ADA offers little direction about how to set priorities when these values come into conflict, or about whether equality of opportunity favors equivalent (...) or preferential treatment for disadvantaged people. Until these ambiguities and potential value conflicts are resolved, a central moral and social problem remains unresolved: How can we demonstrate commitment to the rights and welfare of those with severe disabilities while placing fair limits upon their claims? Five special concerns are discussed: (1) eligibility and the allocation of health care; (2) the meaning of ‘qualified but disabled’ in employing people with mental disabilities; (3) equal opportunity and problems of envy and malingering; (4) ADA accommodation and public protection through testing and licensure; and (5) ADA protection and problems of backlash. Rather than simply wait to see what courts and administrative agencies decide, we should evaluate the moral conflicts, articulate criteria, and help make some difficult choices on morally defensible grounds. Keywords: disabled, health benefit plans, health care rationing, health care reform, health priorities, health services accessibility, Oregon, Rawls, selection bias, social justice CiteULike Connotea Del.icio.us What's this? (shrink)

Health care systems are widely criticized for limiting doctors' roles as patient-advocates. Yet unrestricted advocacy can be unfairly partial, costly, and prejudicial. This essay considers three solutions to the problem of how to reconcile the demands of a just health care system for all patients, with the value of advocacy for some. Two views are considered and rejected, one supporting unlimited advocacy and another defending strict impartiality. A third view suggested by Hume's moral theory seeks to square the moral demands (...) of professional advocacy and just health care systems. A moral basis for limited advocacy exists when it can be justified from a general or moral vantage. Consequently, ethical aspects of professionalism are not necessarily on a collision course with health care systems incorporating managed care. This solution is compatible with goals regarding the importance of humanistic education and professionalism to build patients' trust. (shrink)