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In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system.
Facial transplantation is emerging as a therapeutic option for self-inflicted gunshot wounds. The self-inflicted nature of this injury raises questions about the appropriate role of self-harm in determining patient eligibility. Potential candidates for facial transplantation undergo extensive psychosocial screening. The presence of a self-inflicted gunshot wound warrants special attention to ensure that a patient is prepared to undergo a demanding procedure that poses significant risk, as well as stringent lifelong management. Herein, we explore the ethics of considering mechanism of injury in the patient selection process, referring to the precedent set forth in solid organ transplantation. We also consider the available evidence regarding outcomes of individuals transplanted for self-inflicted mechanisms of injury in both solid organ and facial transplantation. We conclude that while the presence of a self-inflicted gunshot wound is significant in the overall evaluation of the candidate, it does not on its own warrant exclusion from consideration for a facial transplantation.
Since 1997, execution in China has been increasingly performed by lethal injection. The current criteria for determination of death for execution by lethal injection (cessation of heartbeat, cessation of respiration, and dilated pupils) neither conform to current medical science nor to any standard of medical ethics. In practice, death is pronounced in China within tens of seconds after starting the lethal injection. At this stage, however, neither the common criteria for cardiopulmonary death (irreversible cessation of heartbeat and breathing) nor that of brain death (irreversible cessation of brain functions) have been met. To declare a still-living person dead is incompatible with human dignity, regardless of the processes following death pronouncement. This ethical concern is further aggravated if organs are procured from the prisoners. Analysis of postmortem blood thiopental level data from the United States indicates that thiopental, as used, may not provide sufficient surgical anesthesia. The dose of thiopental used in China is kept secret. It cannot be excluded that some of the organ explantation surgeries on prisoners subjected to lethal injection are performed under insufficient anesthesia in China. In such cases, the inmate may potentially experience asphyxiation and pain. Yet this can be easily overlooked by the medical professionals performing the explantation surgery because pancuronium prevents muscle responses to pain, resulting in an extremely inhumane situation. We call for an immediate revision of the death determination criteria in execution by lethal injection in China. Biological death must be ensured before death pronouncement, regardless of whether organ procurement is involved or not.
This paper investigates the role of additional regulation in mitigating the ‘adverse scale effect’ associated with daily driving restrictions, which has become a popular regulatory tool used to control episodic air pollution internationally, especially in developing countries. We find that although an annual vehicle registration tax reduces the incentive to purchase additional vehicles among households whose sole purpose for doing so is to ‘cheat’ the restriction (i.e., the ‘adverse scale effect’), it does so with an external cost. The cost occurs because households whose purpose for purchasing an additional vehicle is not to cheat the restriction are given the same disincentive with the tax. We show how simple one- and two-stage lotteries can be used to not only discriminate between cheater and non-cheater households (in particular, to avoid providing a disincentive to the latter type of household), but also to provide an even stronger disincentive to the former.
In 1968, the definition of death in the United States was expanded to include not just death by cardiopulmonary criteria, but also death by neurologic criteria. We explore the way the definition has been modified by the medical and legal communities over the past 50 years and address the medical, legal and ethical controversies associated with the definition at present, with a particular highlight on the Supreme Court of Nevada Case of Aden Hailu.
In this series of essays, The Road Less Traveled, noted bioethicists share their stories and the personal experiences that prompted them to pursue the field. These memoirs are less professional chronologies and more descriptions of the seminal touchstone events and turning points that led—often unexpectedly—to their career path.
We use parametric and nonparametric methods to estimate correlations between average control cost and three field-level characteristics—field size and delivered phosphorous per field and per acre—as proxies for economies of scale in controlling nonpoint pollution. We combine load and delivery-ratio estimates for more than 12,000 fields in the Bear River Basin, Utah, with estimates of control costs and effectiveness of management practices from the literature. Results suggest a negative relationship between control cost and delivered phosphorous per field and per acre. Ranking fields by phosphorous load therefore prioritizes management-practice subsidies by economies of scale.
Consider this hypothetical scenario involving a choice not to vaccinate a child. Ms. S has a niece who is autistic. The girl's parents are suspicious that there is some relationship between her autism and her Measles Mumps and Rubella (MMR) vaccination. They have shared their concerns with Ms. S. She then declines to have her own daughter, Jinny S., vaccinated with the MMR vaccine. To bypass the state's mandatory vaccination requirement, Ms. S claims a state-legislated philosophical exemption, whereby she simply attests to the fact that she is opposed to vaccinating her daughter due to a conscientiously held belief. At the age of four, Jinny goes on a trip by airplane to Germany with her mother. After returning to the United States, she attends daycare despite having some mild cold symptoms. Subsequently, she develops a classic measles rash, at which point her mother brings her to a pediatrician and keeps her home from daycare.
This document serves as an update and companion piece to the 2005 Society for Healthcare Epidemiology of America (SHEA) Position Paper entitled “Influenza Vaccination of Healthcare Workers and Vaccine Allocation for Healthcare Workers During Vaccine Shortages.” In large part, the discussion about the rationale for influenza vaccination of healthcare personnel (HCP), the strategies designed to improve influenza vaccination rates in this population, and the recommendations made in the 2005 paper still stand. This position paper notes new evidence released since publication of the 2005 paper and strengthens SHEA's position on the importance of influenza vaccination of HCP. This document does not discuss vaccine allocation during times of vaccine shortage, because the 2005 SHEA Position Paper still serves as the Society's official statement on that issue.
This paper reports results from a contingent valuation based public good experiment conducted in the African nation of Botswana. In a sample of university students, we find evidence that stated willingness to contribute to a public good in a hypothetical setting is higher than actual contribution levels. However, results from regression analysis suggest that this is true only in the second round of the experiment, when participants making actual contributions have learned to significantly lower their contribution levels. As globalization expands markets, and economies such as Botswana's continue to modernize, there is a growing need to understand how hypothetical bias will influence the valuation of public goods.
Every September, millions of parents around the country herd their children into pediatricians’ offices with school immunization forms in hand. Their kids have already received a dozen or more shots before the age of two, and, depending on the state in which they live, a dozen more may await them over the ensuing decade. To protect public health, states require that parents have their children immunized before they are permitted to attend public or private school, but the rules vary for homeschooled children. With the spectacular growth in the number of homeschooled students, it is becoming more difficult to reach these youth to ensure that they are immunized at all. These children are frequently unvaccinated, leaving them open to infection by diseases that have been all but stamped out in the United States by immunization requirements. States should encourage parents to have their homeschooled students vaccinated by enacting the same laws that are used for public school students, enforcing current laws through neglect petitions, or requiring that children be immunized before participating in school-sponsored programs.
Scholars of differing political affiliation and the President's Council on Bioethics have called for regulation of assisted reproductive technology (ART) that would emulate many aspects of the regulatory system of the United Kingdom, in particular that of the Human Fertilisation and Embryology Authority. Specifically, scholars and the Council have argued that research in the U.S. involving gametes and human embryos lacks consistent oversight. While the Centers for Disease Control and Prevention (CDC) produces an annual ART success rate report, submission of data is guaranteed only by the promise that non-responders will be noted as such in the appendix of CDC's report, and most ART clinics publish success rates on the Internet in a much more recognized forum: website advertising. Moreover, U.S. law does not require licensing or accreditation of infertility programs and few regulations govern embryo research. While the large majority of clinics report their success rate data, and many follow practice standards and apply for accreditation from private agencies, these practices are strictly voluntary. Clinics failing to report their success rates face no legal consequence.
An increasingly long line of high-profile scientific misconduct cases raises the question of whether regulatory policy ought to incorporate more rigorous sanctions for investigators and their institutions. Broad and Wade graphically describe these cases through the early 1980s. They continue to recent times with the cases of Evan Dreyer, Kimon Angelides and Robert Liburdy, Justin Radolf, and others. In addition, recent Congressional investigation into conflict of interest concerns surrounding consulting by National Institutes of Health scientists has raised further questions about ethical standards. The record of continuing scandal suggests that current policy may not be optimal for controlling scientific misconduct. Would an alternative policy better minimize its incidence and associated costs?
What should we expect of public policy governing misconduct by American scientists? Surely the public has a right to presume that its tax money is being spent wisely and that any economic rewards from taxpayer funded research are used prudently and in the public interest.
The moral status of the human embryo is particularly controversial in the United States, where one debate has centered on embryos created in excess at in vitro fertilization (IVF) clinics. Little has been known about the disposal of these embryos.
We mailed anonymous, self-administered questionnaires to directors of 341 American IVF clinics.
217 of 341 clinics (64 percent) responded. Nearly all (97 percent) were willing to create and cryopreserve extra embryos. Fewer, but still a majority (59 percent), were explicitly willing to avoid creating extras. When embryos did remain in excess, clinics offered various options: continual cryopreservation for a charge (96 percent) or for no charge (4 percent), donation for reproductive use by other couples (76 percent), disposal prior to (60 percent) or following (54 percent) cryopreservation, and donation for research (60 percent) or embryologist training (19 percent). Qualifications varied widely among those personnel responsible for securing couples' consent for disposal and for conducting disposal itself. Some clinics performed a religious or quasi-religious disposal ceremony. Some clinics required a couple's participation in disposal; some allowed but did not require it; some others discouraged or disallowed it.
The disposal of human embryos created in excess at American IVF clinics varies in ways suggesting both moral sensitivity and ethical divergence.
In 1992, the Joint Commission on the Accreditation of
Healthcare Organizations (JCAHO) passed a mandate that all its
approved hospitals put in place a means for addressing ethical
concerns.Although the particular process the hospital uses to
address such concerns—ethics consultant, ethics forum,
ethics committee—may vary, the hospital or healthcare ethics
committee (HEC) is used most often. In a companion study to
that reported here, we found that in 1998 over 90% of U.S.
hospitals had ethics committees, compared to just 1% in 1983,
and that many have some and a few have sweeping clinical powers
Patients with mood disorders pose ethical challenges for both the clinicians who treat them and the researchers who study them. Depressed patients are often indecisive or resistant to treatment, which raises the dilemma of when to consider such resistance a reasonable refusal of consent and when the resistance is a product of the illness itself. Mood disorders, like many psychiatric illnesses, often provoke a variety of crises in the lives of patients, from loss of relationships and employment to self-destructive behavior and suicidality. The ethical problems most common to mood-disordered patients revolve around the difficult issues of capacity and informed consent. Among patients with mood disorders, there are cases where decision-making capacity is impaired to the point at which others must take over the decision-making role for the patient. The ethical problems with the schizophrenia washout studies are equally applicable to subjects with mood disorders.