: Subpart D of 45 CFR 46 focuses on research involving children. Section 46.407 addresses research that is not otherwise approvable. The research is not otherwise approvable because either (1) it seeks to enroll healthy children, but offers no prospect of direct benefit and entails more than minimal risk; or (2) it seeks to enroll children with a disorder or condition, but offers no prospect of direct benefit and entails more than a minor increase over minimal risk. According to 46.407, (...) such research can be permissible if it is approved by a panel of experts. Prior to 2000, only two 407 panels had been convened, but in 2001, the Office for Human Research Protections received more than 20 protocols for 407 review. The first, entitled "Precursors to Diabetes in Japanese American Youth," serves here as a case study in human subject protections. (shrink)

What is the basis for arguing that a volunteer army exploits citizens who lack civilian career opportunities? How do we determine that a doctor who has sex with his patients is exploiting them? In this book, Alan Wertheimer seeks to identify when a transaction or relationship can be properly regarded as exploitative--and not oppressive, manipulative, or morally deficient in some other way--and explores the moral weight of taking unfair advantage. Among the first political philosophers to examine this important topic from (...) a non-Marxist perspective, Wertheimer writes about ordinary experience in an accessible yet philosophically penetrating way. He considers whether it is seriously wrong for a party to exploit another if the transaction is consensual and mutually advantageous, whether society can justifiably prohibit people from entering into such a transaction, and whether it is wrong to allow oneself to be exploited. Wertheimer first considers several contexts commonly characterized as exploitive, including surrogate motherhood, unconscionable contracts, the exploitation of student athletes, and sexual exploitation in psychotherapy. In a section outlining his theory of exploitation, he sets forth the criteria for a fair transaction and the point at which we can properly say that a party has consented. Whereas many discussions of exploitation have dealt primarily with cases in which one party harms or coerces another, Wertheimer's book focuses on what makes a mutually advantageous and consensual transaction exploitive and analyzes the moral and legal implications of such exploitation. (shrink)

Volume 19, Issue 11, November 2019, Page 9-12.

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Despite a high and growing global average income, billions of human beings are still condemned to lifelong severe poverty, with all its attendant evils of low life expectancy, social exclusion, ill health, illiteracy, dependency, and effective enslavement. This problem is solvable, despite its magnitude.

Arguments against directed altruistic living organ donation are too weak to justify a ban. Potential donors who want to specify the non-related person or group of persons to receive their donated kidney should be accepted. The arguments against, based on considerations of motivation, fairness and (non-)anonymity (e.g. those recently cited by an advisory report of the Dutch Health Council), are presented and discussed, as well as the Dutch Governments response. Whereas the Government argues that individuals have authority with regard to (...) the allocation of their organs, partial considerations have not been sufficiently explored. In addition, it is argued that partial relationships govern human life, are significant and should be valued highly. These relationships are at the core of accepted living kidney donation between relatives (family members, partners, friends). Respecting the particular act of living donation goes beyond respect for autonomy; it touches upon our personal and social identity. Donation, e.g. of a kidney, is not undertaken strictly for the benefit of the recipient, but also to meet the moral standards we wish to set for ourselves. This consideration, rooted in a view of moral identity, provides the basis for many forms of directed donation that are both partial and justified. If the importance of this is not recognized, social policies can be neither adequate nor effective. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...) of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (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)

Bioethics has entered a new era: as many commentators have noted, the familiar mantra of autonomy, beneficence, nonmaleficence, and justice has proven to be an overly simplistic framework for understanding problems that arise in modern medicine, particularly at the intersection of public policy and individual preferences. A tradition of liberal pluralism grounds respect for individual preferences and affirmation of competing conceptions of the good. But we struggle to maintain (or at times explicitly reject) this tradition in the face of individual (...) preferences that we find distasteful, suspect, or even repugnant, especially where the broader social good or respect for equality is at stake. Directed donation presents us with such a dilemma: can we uphold the right of self-determination through respect of individual preferences regarding disposition of transplantable organs while at the same time maintaining an allocation system that reflects values of equity and justice claimed to underlie the socially negotiated practice of transplantation? Or are some preferences simply to be deemed unethical and not respected, even if that leads to a reduction in the number of transplantable organs available and to an apparent disregard for the autonomous decisions of the recently deceased? (shrink)