Live attenuated vaccine trials in medically informed volunteers: a special case?
(49/1957)
A group of activist clinicians have offered to volunteer for clinical trials of live attenuated HIV vaccines. This has provided an important conceptual challenge to medical ethics, and to work on the development of HIV vaccines. In exploring these issues, this article highlights how the HIV field has altered the content as well as the tone of ethical discourse. The balance of expertise and authority between research subjects and triallists is profoundly changed, raising questions about the limits of voluntarism and differing perspectives on risk-benefit analysis. Care is needed to ensure that the novelty of the situation does not confuse the central ethical and scientific issues. (+info)
Ethics in the laboratory examination of patients.
(50/1957)
Various value problems are connected with the clinical examination of patients. The purpose of this literature review is to clarify: 1) in which patient examinations ethical problems are generally found; 2) what kind of ethical problems are found in the different phases of the examination process, and 3) what kind of ethical problems are found in connection with the use of examination results. Genetic testing, autopsy, prenatal and HIV examinations were ethically the most problematic laboratory examinations. The most problematic phase in the laboratory examination process proved to be the pre-analytic phase. At present the results of laboratory examination are used more and more often for the prediction of diseases. The problems appear when the examination results are used for discrimination and stigmatization. Because of the lack of empirical ethical research, it is important to chart empirical knowledge about present value conflict situations involved in the laboratory examination process. (+info)
The impact of Mississippi's mandatory delay law on the timing of abortion.
(51/1957)
CONTEXT: Mississippi mandates that a woman seeking an abortion must first receive, in person, information about the fetus and alternatives to abortion. She must then wait at least 24 hours before having an abortion. It is not clear how such mandatory delay requirements affect the timing during pregnancy at which abortion occurs. METHODS: The data for analysis, from the Mississippi Department of Health, are 34,748 abortions obtained by residents in the six-year period surrounding the law's enactment in August 1992 (i.e., from August 1989 through July 1995). The records were stratified by location of the nearest provider, so abortions to women whose nearest provider is in-state comprised the "treatment group" (N = 28,975), while abortions to women whose nearest provider is in a neighboring state with no such law comprised the "control group" (N = 5,773). Probit regressions were used to assess effects on the likelihood of a second-trimester abortion, and ordinary least-squares regressions were used to determine effects on gestational age at the time of the abortion. RESULTS: After enactment of the law, the proportion of second-trimester procedures increased by 53% (from 7.5% of abortions to 11.5%) among women whose closest provider is in-state, but it increased by only 8% (from 10.5% to 11.3%) among women whose closest provider is out-of-state. And although the overall abortion rate declined among women in the treatment group over the period (from 11.3 procedures per 1,000 women aged 15-44 to 9.9), the rate of second-trimester procedures increased among these women (from 0.8 per 1,000 women aged 15-44 to 1.1). The law was independently associated with delays in obtaining an abortion: Once the law went into effect and net of all covariates, the proportion of second-trimester abortions increased by nearly three percentage points more among women living closest to an in-state provider than among those living closest to an out-of-state provider. The law increased the mean gestational age of the fetus at the time of the procedure by approximately four days. Women who live closest to abortion providers in other states were relatively unaffected by the law. CONCLUSIONS: The proportion of abortions performed later in pregnancy will probably increase if more states impose mandatory delay laws with in-person counseling requirements. (+info)
The environmental genome project: ethical, legal, and social implications.
(52/1957)
The National Institute of Environmental Health Sciences is supporting a multiyear research initiative examining genetic influences on environmental response. Proponents of this new initiative, known as the Environmental Genome Project, hope that the information learned will improve our understanding of environmentally associated diseases and allow clinicians and public health officials to target disease-prevention strategies to those who are at increased risk. Despite these potential benefits, the project presents several ethical and social challenges. Of immediate concern is the protection of individual research participants. Other ethical issues relate to the application of research results and how study findings could affect social priorities. Clarifying these emerging areas of concern, many of which have not received adequate attention in the existing bioethics literature, is an important step toward minimizing potential research-related risks and defining research needs. (+info)
A preliminary study on the knowledge and attitudes of physicians at two university hospitals towards the medical insurance system of Japan.
(53/1957)
In this preliminary study, we surveyed the physicians at two academic hospitals on their knowledge of and attitudes toward the medical insurance system in Japan. Most of the physicians had not read the "Ministerial Ordinance on Insurance Medical Institutions' and Insurance Medical Doctors' Medical Treatment under Health Insurance." Of the 433 physicians who filled out the questionnaire completely, 34% had either not read or rarely read the "Medical Fee Point List." Most (89.1%) of the physicians knew that there is a stepwise reduction in the hospitalization fee as the length of a patient's hospital stay increases. However, approximately 30% did not know the stipulation of obtaining an informed consent from the patient prior to blood transfusion. As for the right of patients to see their medical care remuneration statements, which was decided by the government in 1997, 26.8% of the physicians did not know this rule. Physicians who had read the "Ministerial Ordinance on Medical Treatment," were more likely to read the "Medical Fee Point List" frequently; were more likely to know the stipulation about diminishing hospitalization fee; were more likely to know that an informed consent must be obtained prior to blood transfusion; and were more likely to know that patients had a right to see their medical care remuneration statements. The longer the clinical experience of the physician, the more likely that the physician had read the "Ministerial Ordinance on Medical Treatment" and know the other stipulations well. In these two academic hospitals, it is important to establish educational seminars for physicians on the guidelines of the medical insurance system so that physicians will become familiar with the medical insurance system quickly. (+info)
Phase I trials in pediatric oncology: perceptions of pediatricians from the United Kingdom Children's Cancer Study Group and the Pediatric Oncology Group.
(54/1957)
PURPOSE: To identify areas of concern regarding the conduct of phase I trials, the perceived expectations and motivations of the parents of children entered, the expectations of toxicity and benefit, and the ethical concerns of pediatric hematologists and oncologists in the United Kingdom and North America. METHODS: A survey instrument consisting of 19 open- and closed-ended questions was sent to United Kingdom Children's Cancer Study Group (UKCCSG)- and Pediatric Oncology Group (POG)-affiliated pediatricians. RESULTS: Fifty-three UKCCSG- and 78 POG-affiliated pediatricians responded. Thirty-two UKCCSG and 51 POG respondents had previously entered at least one child into a phase I study. Overall, respondents believed that parents entered their children for medical benefit, altruism, and hope of cure. Although many respondents believed that children could benefit from medical improvement, feelings of altruism, and maintenance of hope, the chance of cure or complete remission was thought to be small. Similarly, parents were thought to potentially benefit through altruism and maintenance of hope. Whereas 83% of UKCCSG respondents indicated that phase I trials were associated with ethical difficulties, this was a concern for 48% of POG respondents. The main ethical concerns of respondents were risk of toxicity, consent of the child, unrealistic hope, and coercion. CONCLUSION: The respondents in this survey expressed mainly ethical concerns regarding the conduct of phase I trials and had realistic expectations of the potential for toxicity and benefit for those children who participate in these studies. (+info)
Proposing phase I studies: patients', relatives', nurses' and specialists' perceptions.
(55/1957)
PURPOSE: As of now the primary objective of studies on informed consent in phase I trials has been to assess patients' expectations and reasons for participation. We have previously shown that the quantity of information provided through a procedure of subsequent oral interviews with patients was adequate while the attention paid by the physician to the emotional needs and concerns of patients was not. We wanted therefore to assess and compare the perceptions of the information provided about the investigational study of patients, relatives, the research nurse and the investigator responsible for the phase I trial and the impact this information had on the patients' level of anxiety and depression. PATIENTS AND METHODS: The participation to a phase I study was proposed to patients through two subsequent interviews, the latter attended also by patients' relatives, the research nurse and the investigator coordinating the phase I trial. After the second interview, attendees were requested to complete a questionnaire assessing the principal reason for participating in the study and the informative, emotional and interactive dimension of the information. Patients were also requested to complete the Hospital Anxiety and Depression (HAD) scale before and after the second interview. RESULTS: The completed questionnaires of 31 of 42 patients were retrieved and analysed. The possibility to benefit from the study was indicated as the main reason for participating by 59% of the patients while it was judged to be the case in 78% and 86% of the patients by the nurse and the investigator, respectively. The information was judged to be clear and sufficient in almost all cases by all attendees, while the investigator judged that a lower percentage of patients felt at ease and could express their main worries during the interview, had been helped and were less worried after it than it was judged by the nurse and the relatives. Patients' state of anxiety and depression was not adversely affected by the information provided. CONCLUSIONS: Informing patients on the option of receiving an investigational treatment within a phase I study is feasible and can be done in a way felt appropriate by patients and relatives, nursing and medical professionals. Providing information in an appropriate manner does not increase patients' anxiety and depression. Divergence between the aims and interests of the investigators and patients might explain the difference in the evaluation of physician, a problem which could perhaps be partially overcome by the application of innovative phase I designs. (+info)
Unrelated umbilical cord blood transplantation in infancy for mucopolysaccharidosis type IIB (Hunter syndrome) complicated by autoimmune hemolytic anemia.
(56/1957)
This report describes unrelated umbilical cord blood transplantation for a 10-month-old infant boy with mucopolysaccharidosis IIB (Hunter syndrome), an X-linked metabolic storage disorder due to deficiency of iduronate sulfatase. Two years after transplant approximately 55% normal plasma enzyme activity has been restored and abnormal urinary excretion of glycosaminoglycans has nearly completely resolved. The boy has exhibited normal growth and development after transplant. Nine months after transplant he developed severe autoimmune hemolytic anemia and required 14 months of corticosteroid treatment to prevent clinically significant anemia. Bone marrow transplantation for Hunter syndrome and post-transplant hemolytic anemia are reviewed. Bone Marrow Transplantation (2000). (+info)