The controversy over abusive interrogations of prisoners during the war against terrorism spotlights the need for clear ethics norms requiring physicians and other clinicians to prevent the mistreatment of prisoners. Although policies and general descriptions pertaining to clinical oversight of interrogations in United States' war on terror prisons have come to light, there are few public records detailing the clinical oversight of an interrogation. A complaint by the Federal Bureau of Investigation (FBI) led to an Army investigation of an interrogation at the United States prison at Guantanamo Bay. The declassified Army investigation and the corresponding interrogation log show clinical supervision, monitoring and treatment during an interrogation that employed dogs, prolonged sleep deprivation, humiliation, restraint, hypothermia and compulsory intravenous infusions. The interrogation and the involvement of a psychologist, physician and medics violate international and medical norms for the treatment of prisoners.
Progress in gene sequencing could make rapid whole genome sequencing of individuals affordable to millions of persons and useful for many purposes in a future era of genomic medicine. Using the idea of $1000 genome as a focus, this article reviews the main technical, ethical, and legal issues that must be resolved to make mass genotyping of individuals cost-effective and ethically effective. It presents the case for individual ownership of a person's genome and its formation, and shows the implications of that position for rights to informed consent and privacy over sequencing, testing, and disclosing genomic information about identifiable individuals. Legal recognition of a person's right to control his or her genome and the information that it contains is essential for further progress in applying genomic discoveries to human lives.
Life-extension was the focus for the 10th annual Congress of the International Association of Biomedical Gerontology, held last September at Cambridge University. This scientific convention included a panel of several bioethicists, including Art Caplan, John Harris, and others. The presentations on the ethics of life-extension are reviewed here.
Although excess blood collection has characterized U.S. national disasters, most dramatically in the case of September 11, periodic shortages of blood have recurred for decades. In response, I propose a new model of medical philanthropy, one that specifically uses charitable contributions to health care as blood donation incentives. I explain how the surge in blood donations following 9/11 was both transient and disaster-specific, failing to foster a greater continuing commitment to donate blood. This underscores the importance of considering blood donation incentives. I defend charitable incentives as an alternative to financial incentives, which I contend would further extend neoliberal market values into health care. I explain my model's potential appeal to private foundations or public-private partnerships as a means for expanding both the pool of blood donors and the prosocial benefit of each act of blood donation. Finally I link my analysis to the empirical literature on blood donation incentives.
The American Journal of Bioethics 3.4 (2003) 33-34
David Wendler and Seema Shah (2003) argue that a child's ability to assent should be measured by their ability to "understand and appreciate the more abstract elements of informed consent" and state that in the context of nonbeneficial research it is the purpose of the research—"to develop generalizable knowledge that might help future patients"—that is the most abstract element of consent. The proposed "conservative" cutoff age of 14 implies that Wendler and Shah believe that the majority, if not all, 14-year-old children possess the ability to understand the abstract purpose of nonbeneficial research. They provide no empirical evidence to support this particular claim. Wendler and Shah do cite a number of empirical studies in the body of their article that report on children's understanding of some elements of informed consent. They fail to report evidence from these same studies that indicate that children over the age of 14 routinely fail to understand the purpose of research. Susman, Dorn, and Fletcher (1992) found that only 1 in 44 obese patients and patients with cancer under the age of 20 responded correctly when asked to provide the purpose of the trials in which they were enrolled. Nine of the children understood that their enrollment might benefit others. Ondrusek et al. (1998) found that only 4 of the 18 subjects in their sample, which included children up to age 18, reported that the purpose of the nonbeneficial nutrition study in which they were enrolled was to measure normal values for body muscle, fat, and water and to benefit future children. Ondrusek etal. note that none of the four was able to express how these two concepts were linked. More recently, Tait, Voepel-Lewis, and Malviya (2003) found that 50% of children (n = 27) between the ages of 15 and 18 who had assented to enrollment in six different clinical trials of anesthesia or surgery understood the purpose of the study in which they had been enrolled. While Wendler and Shah acknowledge in their proposal that additional empirical evidence is warranted, Nelson and Reynold's (2003) critique of Wendler and Shah's review of the altruism literature also applies here: "sufficient data exist to place their proposal in doubt."
Even if we had empirical evidence that as soon as children turn 14 they have the capacity to understand the abstract elements of informed consent, I remain skeptical [as do others (Joffe 2003; McGee 2003)] that adding such a cutoff to U.S. federal regulations is the best way to assure that pediatric research subjects are engaged as much as their capacity allows in the deliberations about their participation in research. At the worst, providing an age cutoff gives a message to institutional review boards and research investigators that children under 14 are incapable of being fully engaged in the deliberations and need only be warned of what is about to happen to them. I strongly advocate that additional empirical research be conducted in the area of how to successfully engage children in deliberations about their enrollment in research with the intent of developing best practices rather than pursuing a bright line between those children who are considered worthy of engagement and those who are not. Ashcroft et al. (2003) provide a wonderful example of the type of work that needs to be done in this area.
I would like to return to the quotation from Wendler and Shah's article with which I began this commentary and make an additional point. Assessing children's ability to provide assent based on their understanding of abstract elements of informed consent seems to hold children to a higher bar than we currently hold adults. There is plenty of evidence that adults fail to recall all the elements of informed consent, including the purpose of nonbeneficial research, when quizzed about them afterward. For example, a majority of adults approached to enroll in Phase I oncology trials who believed they understood the information provided about the trial were unable to correctly state the purpose and other details about the trial (Tomamichel et al. 1995; Schaffer et al. 1996; Ihto et al. 1997...
The American Journal of Bioethics 3.4 (2003) 38-40
U.S. federal regulations require the consent of both a parent (sometimes two parents) and the child who is contemplating participating as a human subject in research. The requirement that the child consent, which the regulations call "assent," gives to two different sources of authority—parents and child—the power to veto the child's participation in the research. This requirement might be based on the presumption that it is better to err on the side of not participating as a research subject, at least where the research is nontherapeutic, or it might be based on the presumption that without this requirement children would be insufficiently involved in the decision-making process leading to their participation in research. The first of these is fully discussed by David Wendler and Seema Shah (2003) and the thoughtful commentators who have responded to their article. The second presumption—that children should be more involved in the decision to become research subjects—is also well addressed with regard to children under age 14, where Wendler and Shah would replace the "assent" requirement with a "dissent" requirement.
While we are concerned with the bifurcated research consent/assent process for all children, our primary concern is with the formal legal consent requirement that allows parents to veto the decisions made by children over age 14 who decide to participate in research as human subjects. In fact, at age 14 children generally ought to be recognized as independent agents who are capable of making all of their healthcare decisions, including the decision to participate as a research subject, without the threat of any parental veto. The real reason for the regulatory "assent" requirement for these children is that the legal rule in every state that gives the authority to consent to parents of teenagers under 18 does not reflect the real decision- making capabilities of those young adults. The proper way to address this issue is to recognize the legal authority of those over 14 to make all of their own healthcare decisions, including the decision to participate as a human subject in any kind of research.
As Wendler and Shah and their commentators point out, maturity and the ability to make sound decisions do not suddenly appear on a child's eighteenth birthday. Moral and emotional development are gradual processes. Studies have shown that most children are as mature and emotionally developed at age 14 as they are at age 18. In a 1982 study the decision making of different age groups—9-year-olds, 14-year-olds, and 21-year-olds—were tested with regard to a hypothetical illness and proposed medical treatment. The subjects' understanding of facts, treatment outcomes, choices to be made, and decision-making processes were studied. While the nine-year-olds were a bit more conservative and chose inpatient care more often, the 14-year-olds and the 21-year-olds generally made the same decisions (Schlam and Wood 2000). In another study, one in which children were asked to give health advice to their peers, 12-year-olds were found to be as competent as 19-year-olds (Cauffman and Steinberg 1995).
In order to be capable of giving informed consent to medical treatment, children (or adults, for that matter) must be able to understand the nature, extent, and probable outcome of treatment. They must be able to understand the information provided and rationally make and voluntarily reach a decision (Schlam and Wood 2000; Furrow 2000). The American Academy of Pediatrics (AAP Committee on Bioethics 1995) has not only supported the finding that children achieve decisional capacity much earlier than is recognized by state laws, but it recommends that adolescents should be more involved than they now are in their own healthcare decision making. Several other studies found that by age 13 or 14 minors can reason abstractly about hypothetical situations, reason about multiple alternatives and consequences, consider multiple variables, combine variables in more complex ways, and use information systematically (Mlyniec 1996). These studies suggest that there is no difference in legal competency between older minors and adults. It would appear from theories of development and empirical evidence that 14...
The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information (PGI) direct-to-consumers. Companies such as 23andme (Mountain View, CA) and Navigenics (Foster City, CA) are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social networking business ventures that market the science of the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information--openly sharing of data with all interested parties, not just the biomedical researcher--for the purposes of pooling data (increasing statistical power) and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis.
When in 2006 the Centers for Disease Control and Prevention issued revised recommendations for HIV testing in health care settings, vocal opponents charged that use of an "opt-out" approach to presenting HIV testing to patients; the implementation of nontargeted, widespread HIV screening; the elimination of a separate signed consent; and the decoupling of required HIV prevention counseling from HIV testing are unethical. Here we undertake the first systematic ethical examination of the arguments both for and against the recommendations. Our examination reveals that the ethical concerns raised by the critics predominantly pertain not to ethically suspect elements of the recommendations themselves, but to suspicions that they will be implemented improperly. It has not been shown that the recommendations cannot be implemented properly. Here we show that in the United States the recommendations are morally justifiable and that safeguards or regulatory oversight may serve to ensure that the recommendations are properly implemented.
We surveyed genetics professionals, patients, and the public about rights to information, to requested services, and to parenthood, posing difficult cases found in practice. In all, 2906 genetics professionals (63%), 499 primary care physicians (59%), 476 North American genetics patients (67%), 394 French patients (51%), 593 German patients (65%), and 988 members of the American public (99%) returned anonymous questionnaires. Results suggest a trend toward increased respect for patient autonomy since an earlier survey in 1985; in most nations more would perform prenatal diagnosis for a couple with 4 daughters who desire a son. A minority (35% in U.S., 14% elsewhere) would perform PND for a deaf couple who want a deaf child, but most (94% in U.S., 62% elsewhere) would do prenatal paternity testing in the absence of rape or incest. About half (51%) would support a woman with fragile X who wants children. The trend to respect patient autonomy was greatest in the U.S. and was least evident in China and India. In general, responses to these cases illustrate a shift away from population or eugenic concerns to a model of genetics focused on the individual.
This study evaluates the editorial policies of a randomized sample of English language peer-reviewed journals that publish original research involving the use of animals. The aim is to identify whether journals have editorial policies relating to the use of animals in the research that they are prepared to publish and whether any policies are likely to promote animal welfare and dissemination of information on the 3Rs (reduction, refinement, replacement) within the scientific community. The results demonstrate that a significant proportion of journals publishing original research involving animals do not have any editorial policy relating to the use of animals. Of those journals that do have policies the majority simply request that the research be carried out in accordance with standard regulatory requirements. This paper aims to provide editors and publishers with the information they need to review their own editorial policies to ensure they are fulfilling their potential to promote animal welfare and dissemination of the 3Rs.
The American Journal of Bioethics 3.4 (2003) 18-19
U.S. federal regulations permit research holding out no prospect of individual benefit to children subjects under two circumstances. Institutional review boards (IRBs) may approve research that represents only a minor increase over minimal risk if the study is likely to yield generalizable knowledge about the subjects' disorder or condition (45 CFR 46.406). Local IRBs cannot approve research that represents more than a minor increase over minimal risk and that does not offer the prospect of any benefit to the subject, but the secretary of Health and Human Services (HHS) can. First, however, the secretary must solicit advice from a specifically convened panel of experts and make the research proposal available for public comment (45 CFR 46.407). Ordinarily, both kinds of research require assent of the children as appropriate and the consent of their parents or guardians.
David Wendler and Seema Shah (2003) recommend assent be required from all children age 14 and older who are involved in nontherapeutic research. They also recommend the adoption of a dissent standard for children of any age. Discomfort and distress during the research interventions, as they see it, disqualify the child from the study. I will focus my remarks here on the significance of these proposals for research that can go forward only with the approval of the HHS secretary. The category of 407 research—as it is coming to be known—opens an interesting window on assent and dissent.
Researchers have only rarely asked for approval to conduct research under the 407 standard. Recently, however, there has been a spike in 407 requests, including a 2002 proposal to study the precursors of diabetes in Japanese-American adolescents and a 2003 proposal to study the dosage effects of a smallpox vaccine. The diabetes study focused on children prior to and through early puberty, while the smallpox study focused on children only a few years of age. Other proposals are under review at HHS.
The approval process required for 407 research is ostensibly in place to balance the protection of children as individuals with research needs serving the well-being of children as a group. HHS can approve 407 research if it offers an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. In other words, some problems—think polio, for example—might be so damaging and so threatening that as an exception some children can justifiably be exposed to degrees of risk that would be otherwise unacceptable. How much risk? The regulations do not define an upper threshold, and the acceptable threshold of risk is open to interpretation. What standard of assent is required? The regulations do not specify any different standard for assent by reason of the greater risks involved in this kind of research.
There is no long lineage of 407 research, and the assent practices used in such studies are not well established. In opening the door to research that holds no benefit to the individual subject, 407 research shifts—in part—to utilitarian justifications. And utilitarian justifications can work to erode the significance of the individual. There is no reason to think, however, that researchers cannot design studies—even those dealing with grave and urgent threats —that still pay attention to assent and dissent with individual children. Federal regulations already require that researchers pay attention to obtaining assent, as appropriate, and it is to be hoped that 407 advisory panels pay close attention to this matter, no matter the age of the children involved. There is nothing in the regulations that stands in the way of advisory panels using age 14 as a threshold for requiring assent, and they might well choose to do so.
The proposed standard of dissent—applicable to children at all ages—might prove a more complicated standard. Federal regulations already provide that assent may be waived if research holds out some therapeutic benefit to children. By implication this suggests that a child's protests may be ignored to a certain extent in the name of the child's own welfare (45 CFR 46.408). The open question with regard to 407 research is whether...
The American Journal of Bioethics 2.4 (2002) 58-59
Arri Eisen and Roberta M. Berry (2002) call for a new approach to teaching research ethics. They argue that ethics education must be integrated, relevant, and visible to be effective. Across the spectrum of ethics education we are learning that the effect of teaching rudimentary ethics through one-time lectures is minimal. I applaud Eisen and Berry's call for a shift in thinking about how we are approaching the mandatory ethics education, and I propose that educators focus attention on the "hidden curriculum" of scientific research.
The hidden curriculum refers to the teaching that happens outside of the formal curriculum taking place in classrooms and lecture halls. Lessons from the hidden curriculum are taught implicitly, through role models, institutional leadership, peers, or during the course of practice. In one professional training context, medical education, educators have come to recognize the impact of the hidden curriculum on the professional development of medical students and trainees (Hundert, Hafferty, and Christakis 1996). Hundert, Hafferty, and Christakis describe the informal curriculum as the information passed down through interpersonal interactions; it is the residents talking in the locker room after surgery or the students carpooling to campus together. In these interactions trainees discover "how it really works." The hidden curriculum is the broader concept of which the informal curriculum is a part; it describes the structure and cultural climate in which medical education takes place. To locate the hidden curriculum in the medical school environment, one examines "commonly held 'understandings,' customs, rituals, and taken-for-granted aspects of what goes on . . . in medical education" (Hafferty 1998). These might include noticing what does and does not get put on the exam or on what basis a resident (or faculty member) is evaluated. The hidden curriculum includes attending to where ethics appears in the formal training: Is it the afternoon slot on Fridays? Are junior and senior people present? Both the informal and the hidden curricula are identified as "hidden" because there is rarely open discussion about the lessons that are taught there.
Science and scientists also have a hidden curriculum. There are implicit practices and behaviors that have become the norm, as honorary authorship is de rigueur and side investments in companies by investigators are common. Institutions and journals are beginning to address these practices, as Eisen and Berry point out, with rules and guidelines for reporting contributions of authors and any conflicts of interest. However, part of the potency of the hidden curriculum is the fact that it is unwritten and largely undiscussed. Trainees observe behaviors but, without understanding the context or having an opportunity for dialogue, can take away less-desirable lessons. An investigator, for example, might possess a legitimate holding in a company funding the investigator's research, a holding approved by his or her university and appropriately disclosed at conferences or journals where the research is presented. The trainee, however, might not witness the inner negotiations or disclosures that take place and might therefore miss an opportunity to learn about ethical relationships with industry.
Addressing the hidden curriculum is therefore one of the challenges that educators in research ethics must face. One educational strategy involves highlighting further the educational model Eisen and Berry borrow from the Poynter Center and moral psychology. This framework for moral education features four components (Rest and Narvaez 1994). Ethics education should address a learner's ability to:
Traditional ethics education programs feature reasoning abilities (component 2 above). And yet the other three components represent important skills that can, and should, be taught. It is not always clear without practice that something might be an ethical issue, or how one should behave in a situation, even after an ethical issue and solution have been identified. Given the implicit nature of the hidden curriculum, attending to ethics education at each of these four levels might enhance trainees' abilities to engage with issues they encounter daily.
Scientific and research communities can learn from past...
The American Journal of Bioethics 3.4 (2003) 9-11
In the United States the ethical and regulatory regime governing children's participation in nonbeneficial research requires both the permission of the child's parent and, where the child is judged capable, his or her affirmative agreement (45 CFR 46.116d; American Academy of Pediatrics Committee on Bioethics 1995). This system combines a historically-grounded protectionist bias, which defaults to nonparticipation unless these two conditions are met, with a desire to maximize respect for children's developing autonomy. As David Wendler and Seema Shah (2003) point out, however, this scheme has serious problems. First, it fails to specify the ethical or practical conditions for valid assent. It is not clear, for example, whether understanding is necessary for assent to be valid (witness how rarely one comes across the term "informed assent"). Second, it provides no guidance as to what role children who are judged incapable of providing affirmative agreement might play in decisions about research participation. Finally, by conceiving of children and their parents as radically separate moral agents (Crouch and Elliott 1999), it neglects the interconnected nature of healthy decision making within families.
In light of these problems, Wendler and Shah propose substantial revisions to our thinking about children's roles in decisions about research participation. Drawing both on studies of children's cognitive development and on a normative analysis of the principles underlying our obligation to solicit a child's agreement, they suggest that affirmative agreement be required only of those children whose capacity for understanding approaches that of adults. They base their recommendation on a skepticism, which I share, about the moral value of children's affirmative but uninformed agreement. Their reading of the empirical literature leads them presumptively to place this capacity boundary at 14 years. They also recommend that we respect the dissent of all children, regardless of whether or not they are judged capable of assent.
I am not convinced that a sharp distinction at age 14 makes sense. Recent work by Tait, Voepel-Lewis, and Malviya (2003) suggests that while children between seven and ten manifest limited understanding of their research studies, children aged 11-14 perform only slightly worse than older adolescents. Also, age is a poor proxy for children's abilities to comprehend research (Susman, Dorn, and Fletcher 1992; Dorn, Susman, and Fletcher 1995). Nevertheless, Wendler and Shah are correct in their essential point: without attention to understanding, or at least capacity for understanding, the ethical grounds for requiring children's affirmative agreement are shaky at best. Unfortunately, like most other discussions of assent, their analysis leaves out two important factors that we must take into account with respect to children's roles in research decisions. I will argue that, to be complete, we must consider both the healthy developmental trajectory of shared decision making between children and parents, and the reasons that children hold for their preferences. Finally, I will suggest that whatever we decide to do about affirmative agreement and dissent, we must abandon the word assent as a way to describe it.
How do families ordinarily apportion decision-making authority between parents and their children, particularly with regard to issues that affect the child? Figure 1 proposes a model that seems normatively reasonable and likely empirically correct. Parents assume essentially complete responsibility for decisions of any significance regarding infants and toddlers. However, during early childhood parents begin to involve their children in discussions about at least some decisions and under limited circumstances might even take their children's preferences into account. As their maturity and cognitive abilities grow, children play an increasing role in decisions about their lives, and their parents begin actively to solicit their input. As Figure 1 suggests, there is likely to be a time when the relative weights of the parents' and child's preferences shift rapidly. I imagine, tentatively, that this period of rapid change occurs from approximately age eight to 15, but the precise range will vary from one child to the next and, in any case, is irrelevant to the argument. By mid- to late adolescence, as much responsibility for decisions comes to rest with the child...
Is it justified to detect minor genetic aberrations before birth and terminate pregnancies based upon such information? We present the case of a woman who wanted Prenatal Diagnosis (PND) to detect whether her female fetus was a Haemophilia mutation carrier. Such carriers are usually healthy. She wished to eradicate the Haemophilia mutation from her family to avoid future generations being affected and to protect her children from having to go through PND themselves. We explore existing guidelines, public attitudes and possible objections to providing PND for minor abnormalities. We argue that in a society where couples have considerable autonomy relating to decisions about the fetus at least until viability, the routine restriction of PND for minor genetic abnormalities would be an unjust infringement of individual liberty.
This target article considers the ethical implications of providing prenatal diagnosis (PND) and antenatal screening services to detect fetal abnormalities in jurisdictions that prohibit abortion for these conditions. This unusual health policy context is common in the Latin American region. Congenital conditions are often untreated or under-treated in developing countries due to limited health resources, leading many women/couples to prefer termination of affected pregnancies. Three potential harms derive from the provision of PND in the absence of legal and safe abortion for these conditions: psychological distress, unjust distribution of burdens between socio-economic classes, and financial burdens for families and society. We present Iran as a comparative case study where recognition of these ethical issues has led to the liberalization of abortion laws for fetuses with thalassemia. We argue that physicians, geneticists and policymakers have an ethical and professional duty of care to advocate for change in order to ameliorate these harms.
The article examines the question of whether it is ethical to introduce and provide prenatal diagnosis and antenatal screening in areas where termination of pregnancy for congenital abnormalities is legally prohibited. The article explores the various reasons according to which people seek prenatal genetic information and the factors affecting their decision to continue pregnancy despite congenital abnormalities. It concludes that with a proper emotional support and cultural sensitivity it is ethically justifiable to introduce prenatal diagnostic tests and screening, and that taken as a whole, the benefits of such an introduction outweigh the general harm already associated with restrictive abortion laws.
In 2008, many states sought to pass Human Life Amendments, which would extend the definition of personhood to encompass newly fertilized eggs. If such an amendment were to pass, Roe v. Wade, as currently defended by the Supreme Court, may be repealed. Consequently, it is necessary to defend the right to an abortion in a manner that succeeds even if a Human Life Amendment successfully passes. J.J. Thomson's argument in "A Defense of Abortion" successfully achieves this. Her argument is especially strong when one considers that her central thesis-that one person's right to life does not entail the right to use another's person's body for continued sustenance-is pervasive in legal policies in the U.S.A.