The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an (...) occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern. (shrink)
Research using human embryonic stem cells raises an array of complex ethical issues, including, but by no means limited to, the moral status of developing human life. Unfortunately much of the public discussion fails to take into account this complexity. Advocacy for liberal and conservative positions on human embryonic stem cell research can be simplistic and misleading. Ethical concepts such as truth-telling, scientific integrity, and social justice should be part of the debate over federal support for human embryonic stem cell (...) research. Moreover, the debate should be conducted in accord with principles of deliberative democracy, including respect for people holding competing views. (shrink)
Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective treatments. The medical community and (...) federal authorities should more actively promote patients' interests in receiving beneficial off-label treatments. To exercise responsible self-regulation, members of the medical community must determine whether available evidence justifies specific off-label uses and must promote information-gathering when the evidence is inadequate. Physicians should also discuss with patients the uncertainties accompanying off-label uses. Federal authorities should more closely monitor the effects of off-label prescribing and adopt other measures to reduce harm and enhance benefits produced by off-label prescribing. (shrink)
In 2006, I was diagnosed with cancer. This began a crash course in real-world medical ethics. Having cancer was awful, but it was instructive, too. The experience gave me a new understanding of what my profession is about. Individuals in the bioethics field often address topics related to cancer, such as medical decision-making, the patient-physician relationship, clinical trials, and access to health care. Yet few engaged in this work have lived with cancer themselves. Experience as a cancer patient or family (...) caregiver extends and deepens one’s thinking about serious illness and bioethics. During my time as a cancer patient, I kept in touch with several colleagues immersed in their own cancer .. (shrink)
The 21st-century translational science campaign could lead to an increase in first-in-human trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: the requirement for adequate preclinical research; study design safeguards; and choice of subject population. I also examine specific ethical considerations relevant to the three subject populations involved in (...) FIH research. I recommend a variety of actions that could increase subject protection and the value of the information generated in FIH trials. (shrink)
Research subjects do not always conform to research requirements. When their personal interests conflict with the demands of participation, some subjects surreptitiously break the rules. These subjects are subversive — they undermine the research endeavor. In rejecting the restrictions research imposes, subversive subjects diminish the value of research results. From one vantage point, subversive subjects engage in unethical behavior. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At (...) the same time, subversive subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for subject subversion. Intensified policing and guidance are two common strategies for reducing subject subversion, but collaborative reforms are more consistent with the partnership model of clinical research. (shrink)
The term “therapeutic misconception” was coined in 1982 by Paul Appelbaum, Loren Roth, and Charles Lidz. Appelbaum and his colleagues interviewed participants in several psychiatric studies, including a drug trial with a placebo control arm. Appelbaum's group found that many people were unaware of the differences between participating in a study and receiving treatment in the clinical setting. Rather than understanding these differences, study participants tended to believe that therapy and research were governed by the same primary goal: to advance (...) the individual patient's best interests. Appelbaum's group labeled this mistaken belief the therapeutic misconception. (shrink)
Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.
Lynne Rudder Baker, Saving Belief: A Critique of Physicalism Princeton: Princeton University Press, 1987, xii + 177 pp. Daniel C. Dennett, The Intentional Stance Cambridge: MIT Press, 1987, xi + 388 pp. Paul M. Churchland, Matter and Consciousness Cambridge: MIT Press, revised edition, 1988, xii + 184 pp.
It's not unusual to hear someone say, ‘I'd rather be dead than have Alzheimer's’. In ‘Alzheimer Disease and Preemptive Suicide’,1 Dena Davis explains why this is a reasonable position. People taking this position will welcome the discovery of biomarkers permitting very early AD diagnosis, Davis suggests, for this will enable more of them to end their lives while they remain motivated and able to do so. At the same time, Davis observes, people would have less reason to resort to the (...) drastic remedy of pre-emptive suicide if they had absolute authority over the medical treatment they received as patients with dementia; but the threat of pre-emptive suicide is not, in my view, a sufficient reason to grant competent individuals that authority.If preclinical diagnosis of AD becomes possible, some pre-emptive suicides will probably occur. There would be no ethical or practical way to ban such suicides, and it would be silly to try. Clinicians will undoubtedly try to discourage people seeking biomarker information in furtherance of a suicide plan, but savvy individuals will simply conceal their true motivation for having the tests. The real problem for people intent on self-destruction is that biomarkers are unlikely to deliver a clear suicide signal.First, as Davis notes, work on biomarkers remains in the research stage. No one yet knows whether biomarker tests will prove accurate enough to warrant clinical use. Second, even clinically accepted biomarker tests will generate imperfect information about future disease. Biomarkers may produce more accurate estimates of a person's risk of developing AD, but like all predictive tests, they will also yield false positive and negative results. The …. (shrink)
Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies’ internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical (...) companies’ ethics materials and describe shortcomings in the companies’ existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs. (shrink)
Much of the public debate over laboratory animal use has focused on either the scientist's demand for absolute freedom of inquiry, or the abolitionist's demand for an end to animal use in science. Yet many recent proposals for reform seek instead to balance the interests of laboratory animals in avoiding harm against the interests of research beneficiaries in continued animal use. This essay is an analysis of the intermediate reform positions and their underlying ethical principles. Keywords: animal research, animal experimentation, (...) ethics CiteULike Connotea Del.icio.us What's this? (shrink)
Authorising euthanasia and assisted suicide with advance euthanasia directives is permitted, yet debated, in the Netherlands. We focus on a recent controversial case in which a Dutch woman with Alzheimer’s disease was euthanised based on her AED. A Dutch euthanasia review committee found that the physician performing the euthanasia failed to follow due care requirements for euthanasia and assisted suicide. This case is notable because it is the first case to trigger a criminal investigation since the 2002 Dutch euthanasia law (...) was enacted. Thus far, only brief descriptions of the case have been reported in English language journals and media. We provide a detailed description of the case, review the main challenges of preparing and applying AEDs for persons with dementia and briefly assess the adequacy of the current oversight system governing AEDs. (shrink)
Last November, soon after Colorado became the latest state to authorize physician-assisted suicide, National Public Radio's The Diane Rehm Show devoted a segment to legalization of “physician assistance in dying,” a label that refers to both physician-assisted suicide and voluntary active euthanasia. Although the segment initially focused on PAD in the context of terminal illness in general, it wasn't long before PAD's potential application to dementia patients came up. A caller said that her mother had Alzheimer's disease and was being (...) cared for at great expense. Suspecting that she will suffer the same fate, the caller reported that she had included in her will “my specific request that if I should be diagnosed, and it is legal to do so, I would like to opt out of a life and many years of suffering.” A few countries, such as the Netherlands and Belgium, already allow PAD for dementia in certain circumstances. It wouldn't be surprising to see a U.S. legalization effort in the coming years. (shrink)