Loretta M. Kopelman

The best interests standard for incompetent or incapacitated persons of all ages.

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.

Case method and casuistry: The problem of bias

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 cases 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.

When is the Risk Minimal Enough for Children to be Research Subjects

When should research involving children as subjects be permitted? This difficult and pressing problem is often presented in the form of a dilemma: If we do research involving children as subjects, then we do so using individuals who cannot give informed consent. If we do not, then children as a group are denied many of the benefits of research including therapeutic advances, the possibility of good information about therapies, and the repudiation of dangerous and discredited therapies. Robert Levine shows how the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (The National Commission) tried to find a morally defensible solution to the question of when children may be enrolled as subjects in research. They held that with appropriate review, safeguards, consent from guardians, and assent from the child, children may be enrolled if the study on balance holds out direct and appropriate benefit to them or if the study is not too risky. Levine served as a consultant to the National Commission and shows sympathy (which I share) for the solution proposed.

What Conditions Justify Risky Nontherapeutic or “No Benefit” Pediatric Studies: A Sliding Scale Analysis

M any pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science (CIOMS), 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 (See Table 1). 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 haza r d 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.’ This is not surprising since the key terms to implement these policies are undefined, including “condition,” “minor increase over minimal risk,” “vitally important,” and “comrnensurability.”2 The subject of this article is how we should distinguish conditions that, all things being equal, should allow increased research hazard in no benefit or nontherapeutic pediatric studies from those that should not. By “all things being equal,” I mean to presuppose we are discussing only studies meeting all other criteria for approval of “no benefit, higher hazard studies; namely they are vitally important studies that are designed to understand the child’s condition and commensurate with the child’s experience where parental permission and the child’s assent have been obtained. I hope to clarify this use of “condition“ and discuss a qualified moral justification for this policy afier considering and rejecting some other analyses.

Fetal Protection in Wisconsin's Revised Child Abuse Law: Right Goal, Wrong Remedy

Authors examine Wisconsins recent revision of its child abuse and protection laws to address substance abuse by pregnant women. The new statute enables the state to take the fetus into protective custody. Authors argue that approaching fetal protection using a child abuse model creates a series of symbolic, conceptual, and practical problems of such severity as to undermine its justifiability as a public health measure.

Adolescents as Doubly Vulnerable Research Subjects

Research subjects are judged to be vulnerable if they cannot give informed consent for themselves or if they belong to groups especially subject to coercion or manipulation (Kopelman 2003). Adolescents are typically vulnerable on both counts. First, because adolescents are minors, investigators and institutional review board (IRB) members must follow federal rules specifying additional protections for minors. Older adolescents verge on adult maturity, both developmentally and legally, and many possess the capacity to decide if they wish to participate in research. Nonetheless, they usually cannot be enrolled in studies with more than a minor risk of harm unless the studies are designed to beneat them directly or to study diseases or conditions they have. Parental permission and subject assent is typically needed to enroll minors in research studies (U.S. 45 CFR 46d). Potential subjects might also be vulnerable because they are likely to be coerced or manipulated into enrolling. “Assent” from minors or “consent” from legally competent adults is coerced or manipulated when it is not freely given or when they would otherwise refuse to be a subject in a study but for fear, ignorance, pressure, or undue temptation (Kopelman 2004). Students are often cited as potentially vulnerable to such pressure, as are institutionalized persons, prisoners, members of the military, hospital staff, laboratory assistants, and pharmaceutical personnel (Council for International Organizations of Medical Science 2002). The double vulnerability of adolescent subjects is well illustrated by a controversy over the SATURN (Student Athlete Testing Using Random Notiacation) study. SATURN was designed to study the effects of mandatory, random drug testing among high school students by comparing high schools with mandatory drug testing and those without such testing (Goldberg et al. 2003; Oface for Human Research Protections 2002; 2003). At the beginning and end of the school year, subjects at the control schools complete anonymous questionnaires and student athletes at the experimental schools complete conadential questionnaires. Student athletes at the experimental schools must participate in random testing for drugs or alcohol by urine samples collected by same-sex observers. If tests are positive, parents and the school are notiaed, mandatory counseling begins, and students must sit out some sports events. Adil E. Shamoo and Jonathan D. Moreno (2004) conclude that SATURN violated well-established research policy regarding 1. informed consent: SATURN’s consent form and procedures were oawed, and students and parents were pressured into participating as a precondition of being in sports programs; 2. conadentiality and privacy: SATURN pressured randomly selected student athletes to give urine samples and then returned positive andings to parents and the school; and 3. just selection of research subjects: SATURN singled out student athletes for special burdens.

Group Benefit and Protection of Pediatric Research Subjects: Grimes v. Kennedy Krieger and the Lead Abatement Study

The Maryland Court of Appeals in Grimes v. Kennedy Krieger Institute was sharply critical of the lead abatement study conducted by this Institute, an affiliate of Johns Hopkins University. Grimes ruled that investigators might, given the facts of the case, have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. This ruling has implications for pediatric research practices and long-standing disputes among informed people of good will about what pediatric studies should be permitted.

Using the Best Interests Standard to Generate Actual Duties

This claim is puzzling, because if the best interests standard were difficult to apply in practice, then how could it be the prevailing standard? A standard is useful insofar as it can be applied consistently, and if it cannot, it would not be a “prevailing standard” in any meaningful sense. I agree that the best interests standard is the prevailing standard in making recommendations or decisions in pediatrics as well as in other professions. However, I argue that it is generally clear how this standard should be applied in such disciplines and that it is a useful standard for making professional recommendations and decisions for those unable to decide for themselves about what is in their best interests. Deciding what is in someone’s best interest requires some notion of the good to be gained or the harm to be avoided. In medicine, judging what is better, best, or worse is assessed in terms of the goals of medicine. These goals include preventing or curing diseases, prolonging life, minimizing or eliminating disabilities, and relieving pain and suffering. Perhaps those who argue that the best interests standard is difficult to apply are preoccupied with disputes such as what is best to do when the goals of medicine come into conflict or when no clear evidence exists about how to fulfill them. Yet these disputes about how professionals should use the best interests standard occur against a background of general agreement about expectations, norms, data, goals and means to achieve them, reasoning processes, and methodologies for testing and justification, or so I argue. To understand the role of the best interests standard as a useful standard, it is necessary to distinguish some of the different ways it is used (Kopelman 1997; 2007). In what follows, I focus on its use in making decisions for those

When Can Children With Conditions Be in No-Benefit, Higher-Hazard Pediatric Studies?

Many important pediatric guidelines allow children with disorders or conditions to participate in studies offering no direct benefit to them and having a somewhat higher level of potential harm than studies permitted for other children. Regulations permitting this generally limit the higher level of harm to a minor increase over the minimal risk allowed for other children. The United States federal regulations allow this at regulation §45 CFR 46.406 (Department of Health and Human Services 1991 [2002]) and the Council for International Organizations of Medical Science (CIOMS) at guideline 9 (2002). Although enrolling subjects who have a disorder or condition is a necessary condition for performing these no-benefit, higher-hazard pediatric studies, as I will call them, other criteria must also be fulfilled. Investigators also must obtain parental permission, the child’s assent if possible, and institutional review board (IRB) approval, as well as demonstrate that these studies are intended to gain vitally important and generalizable information about children who have the disorder or condition under investigation. These criteria also require limiting the risks of harm to just slightly more than that permissible for other children and showing the study is commensurable with the children’s experiences. According to these rules, children may be included in these no-benefit, higher-hazard pediatric studies if they have a disorder—an actual disease or illness. But they also can be enrolled in these research studies if they just have a “condition.” Because almost any state of being could be described as a condition, controversies have existed for decades

Medicine’s Challenge to Relativism: The Case of Female Genital Mutilation

Our families, communities, and institutions increasingly include people from different cultural groups. Many of us have parents of different religious and ethnic origins. This diversity enhances our lives as we learn the pleasures of different foods, arts, music, and views. Being open-minded about various attitudes and beliefs challenges and benefits us. We do not want to rule out any unexamined options or suppose our preferences are absolute standards. Consequently, openness is a practical way to test what is true or meritorious in our views. Being open to others’ views also shows that we respect and care about the people expressing those views and are interested in what they think and feel ([21], p. 1; [11]). Being receptive to diversity of thought, however, means that different views should be heard and debated on their merits, not that they should all be accepted. Medicine in the last half of the twentieth century has also experienced the benefits and challenges of cultural diversity. In addition to the growing differences within our nation, people from around the world increasingly seek medical care in the United States. While we ought to be respectful and receptive to other customs, some seem wrong. On what basis do we rationally establish that another culture’s practices should be stopped? For example, Abdalla writes a “. . . custom practiced in Southern Yemen and along the Persian Gulf is to put salt into the vagina after childbirth . . . [because practitioners believe this] induces the narrowing of the vagina . . . to restore the vagina to its former shape and size and make intercourse more pleasurable for the husband” ([1], p. 16). In what follows, I argue that a clear example of interculturally shared values and methods may be found in medicine. These values and beliefs sometimes effectively and rationally challenge deeply embedded moral and cultural beliefs. That is, medicine cannot define or establish our moral values, but it can help evaluate them and the means we use to attain these goals. A consequence of this, however, is the implausibility of those versions of ethical relativism hold-