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.