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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.
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.
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.
Methods.
We mailed anonymous, self-administered questionnaires to directors of 341 American IVF clinics.
Results.
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.
Conclusions.
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
in hospitals.
Glenn McGee argues that the time is now for debating the
morality of patenting human genes. In one sense he is surely
right. While thousands of patents have been issued or are
pending on many gene sequences, public policy with respect
to ownership of the human genome is still far from settled.
So a debate about the ethics of patenting genes is, if nothing
else, timely. In another sense however, Professor McGee is wrong.
The avian eggshell is one of the most rapidly mineralizing biological systems known. By understandi'ng the key components and steps in this process, we hope to provide relevant information for fabrication of ceramic composites. The calcification of the eggshell occurs in three main steps: 1) fabrication of an organic matrix, 2) nucleation of an inorganic phase on the organic matrix, and 3) space-filling growth of the calcite phase. The different layers of an eggshell can be separately isolated and studied. Three approaches have been used in our study of the eggshell: 1) characterization of the organization and chemical composition of the shell, 2) selective removal or blocking of particular components to improve the remineralization of demineralized shells, and 3) addition of new components to produce composite ceramics of different kinds. In this preliminary communication, the organization of the shell matrix and membranes and their association with the crystal phase, the immunohistochemical occurrence and distribution of types I and X collagen, and of different proteoglycans are reviewed. Also the preliminary findings of the remineralization of the intact or modified eggshell are presented. These experiments allow us to identify the essential steps in forming a natural composite ceramic.
Total joint replacement has restored function and provided comfort to many patients who would otherwise have suffered. However, success and widespread diffusion of this procedure pose a number of important questions. The patient's and the doctor's criteria of success may not be the same: Which are to be used? Health resources are becoming limited: Should money be spent to restore function and for pain relief to those late in life or past their work life? Who makes this choice? A medical technology is tested in the best of settings but routinely practiced in many: How should society and health care professionals monitor the results of surgery? Who should do surgery and where should it be done?
This collection of essays examines the ways in which disputes and controversies about the application of scientific knowledge are resolved. Four concrete examples of public controversy are considered in detail: the efficacy of Laetrile, the classification of homosexuality as a disease, the setting of safety standards in the workplace, and the utility of nuclear energy as a source of power. The essays in this volume show that debates about these cases are not confined to matters of empirical fact. Rather, as is seen with most scientific and technical controversies, they focus on and are structured by complex ethical, economic, and political interests. Drs. Engelhardt and Caplan have brought together a distinguished group of scholars from the sciences and humanities, who sketch a theory of scientific controversy and attempt to provide recommendations about the ways in which both scientists and the public ought to seek more informed resolutions of highly contentious issues in science and technology. Scientific Controversies is offered as a contribution to the better understanding of the roles of both science and nonscientific interests in disputes and controversies pertaining to science and technology.
For some time the analysis of science by philosophers, sociologists, historians, and others has been dominated by discussions about theory change and development. Metascientific studies have not progressed far beyond bitter wrangles as to the adequacy of such concepts as “paradigms,” “research traditions,” “themata,” and “theories” for adequately describing developments over time in various fields of scientific inquiry. In many respects these disputes have shed a great deal of light on the manner in which scientific ideas change and evolve, but they have also obscured important questions that need to be asked about conceptual development in science in order to understand this process fully and to facilitate the formulation of public policy with respect to science and technology.
This volume takes as its focus the notion of controversy. Controversies characterize intellectual change and developments within and about science. Disputes among scientists and between scientists and laymen are easy to locate in the history of science. Moreover, controversies play a central role in the way those who do science and those who depend upon its findings approach the subject. By analyzing controversies in and about science, this volume seeks to advance the analysis of scientific change beyond the sterile and confining boundaries of current disputes concerning the role of internal and external factors in fueling scientific change.
Science, ethics, and politics are marked by controversies. As one would expect, the ways in which controversies in each area arise as matters of dispute and approach solution appear to be somewhat divergent. Scientific controversies, for example, are usually seen to be the sorts of disputes that are to be resolved by appeal to facts and to rigorous reasoning concerning facts.