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PubMed1984

Experiences in the application of NONMEM to pharmacokinetic data analysis.

Ethical issues arising from the use of patients in medical research have stimulated pharmacokinetic research in population kinetics, which requires only a few concentration samples of each individual. Using historical maprotiline data, the new approach of population kinetics was investigated and compared to individually estimated kinetics. Two different population kinetic methods were applied. The naive approach, a quick and dirty method, was compared to the nonlinear mixed-effects method, which was applied by the NONMEM package. Based on the results we obtained from actual maprotiline data as well as from simulated data, NONMEM is a reasonable tool for the estimation of population pharmacokinetic parameters. The main advantage of NONMEM over the naive approach lies in the possibility of obtaining standard deviations of random effects related to the variability between subjects.

Computers↗
PubMed1982

Reflections: ethics and the recombinant DNA debate.

This essay is an attempt to apply a mode of ethical reflection to questions related to the recombinant DNA debate. The author suggests that adequate ethical analysis must include at least five aspects of a moral situation 1) the nature of the act itself; 2) consequences that result from an action or decision; 3) civil and criminal laws; 4) moral principles; and 5) motivation or intention. This paradigm for analysis is applied to the recombinant DNA scene, particularly as these factors relate to 1) risks vs benefits; 2) laws and regulations; 3) the marketplace; and 4) human genetic intervention. The analysis does not provide answers to these vexing questions, but attempts to raise the consciousness level of the reader concerning significant ethical issues. Undergirding the discussion is the humanistic theme of the primacy of the concern for the public good, and that freedom of inquiry can only survive in a socially conscious context. Fear of the unknown is no reason for prohibiting DNA research, but since the stakes are high as new developments emerge that pertain to the genetic restructuring of the human species, the author suggests that caution and responsible judgment are mandatory. Since ethics is concerned with ideal moral judgments, and applied ethics relates to the real world in which we function, the demand for clear and careful thought concerning the short-term and long-term consequences of our work is a primary ingredient of what it means to be responsible. In the final analysis, ethical responsibility rests on the individual; without a sense of personal integrity and what that implies about oneself and society, blatant opportunism can easily become the generally accepted mode of behavior and decision. If this occurs, traditional ethical concerns become irrelevant.

DNA, Recombinant↗
PubMed1991

Cost analysis and ethical aspects of hospital-based home-care for terminal cancer patients.

A study was undertaken to measure the costs of caring for 20 terminally ill/dying cancer patients at home, within a hospital-based home-care system. A new method was used, by which all staff expenses were registered and the work costs per minute were calculated for each personnel category (e.g. nurses, physicians). The total number of care days amounted to 857. The average daily cost was 509 Skr. (range 87-2999), but it was higher for patients with the shortest periods of home-care ( = the dying patients). Comparisons were made between the costs of hospital-based home-care and those of hospital care in 1) a geriatric unit, 2) other somatic departments, and 3) those departments from which the patients had been referred. The costs of hospital-based home-care were 40%, 55%, and 67% lower than the three different forms of hospital care, respectively. All the patients had relatives at home and were intensely dependent on their families. The important part played by the relatives contributed to the relatively low costs. The ethical aspects of caring for dying cancer patients at home are discussed.

Aged↗
PubMed1991

Longitudinal studies on environmental factors and disease. A model for analysis of ethical conflicts.

The use of individual-based data in research has recently come in for much discussion. The basic issue of the discussion is how to balance between different legitimate interests: the interest in improving knowledge on matters important to human health and the interest in respecting individual autonomy. In this paper we will use a model for description and analysis of ethical conflicts in individual-based research. The model consists of two dimensions: the first specifies the persons involved in the conflict, the second specifies the relevant ethical principles. We have chosen the case of the Rönnskär study as an example. For illustration we distinguish between: no study, a study without informed consent and a study with informed consent. In the Rönnskär study the decision between the three situations rests upon an assessment of the conflict between two obligations: to improve the working environment and to respect autonomy.

Conflict, Psychological↗
PubMed2002

A retrospective analysis of ethics knowledge in physical therapy (1970-2000).

BACKGROUND AND PURPOSE: Purtilo, Guccione, and others have noted that increased clinical autonomy for physical therapists presents more complex ethical dilemmas. The body of literature examining physical therapy ethics, however, is relatively small and has not been analyzed. The primary purposes of this research were: (1) to use multiple perspectives to describe and analyze literature examining ethics in physical therapy from 1970 to 2000, (2) to develop a model to describe the evolution of knowledge of ethics in physical therapy during this period, and (3) to compare the proposed model with the evolutionary models proposed by Purtilo in physical therapy and by Pellegrino in bioethics. SAMPLE: The sample consisted of peer-reviewed journal articles cited in the MEDLINE or Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases between 1970 and 2000 or referenced in Ethics in Physical Therapy. METHODS: A two-phase mixed quantitative and qualitative method was used to analyze publications. In the quantitative phase, the author sorted publications into a priori categories, including approach to ethics, author, decade, country of publication, role of the physical therapist, and component of morality. During the qualitative phase of the research, the author analyzed and sorted the publications to identify common themes, patterns, similarities, and evolutionary trends. These findings were compared with the evolutionary models of Pellegrino and Purtilo. RESULTS: The 90 publications meeting inclusion criteria were predominantly philosophical, using the "principles" perspective; focused on the patient/client management role of the physical therapist; and addressed the moral judgment component of moral behavior. As predicted by Purtilo's model, the focus of identity evolved from self-identity to patient-focused identity, with increasing representation of societal identity. Recurrent themes included the need to further identify and clarify physical therapists' ethical dilemmas, the interrelationship between clinical and ethical decision making, and the changing relationship with patients. DISCUSSION AND CONCLUSION: Although knowledge of ethics grew steadily between 1970 and 2000, this retrospective analysis identified gaps in our current knowledge. Further research is needed to address the unique ethical problems commonly encountered in all 5 roles of the physical therapist; patient perspectives on ethical issues in physical therapy; variety in ethical approaches; factors affecting moral judgment, sensitivity, motivation, and courage; and cultural dimensions of ethical practice in physical therapy.

Ethics, Clinical↗
PubMedDate not supplied

[Analysis of ethical aspects on human experimentation included in the instructions for the authors in 139 Brazilian scientific journals].

UNLABELLED: The concern with ethical standards during research in human subjects has been improving in Brazil during the last decade. Analysis of the ethical recommendations in instructions to authors may contribute to understand Brazilian Scientific Journals policies. OBJECTIVE: To evaluate the recommendations related to the ethics of investigation in human subjects in instructions to authors of Brazilian Scientific Journals. MATERIAL AND METHODS: Instructions to authors of 139 Brazilian Scientific Journals in medicine, biomedicine, nursery, odontology and general sciences were analysed. RESULTS: In one hundred ten (79.1%) of the 139 journals no recommendations related to ethics were found; 17 (12.2%) required previous approval by the institutional committee; 3 (2.1%) the procedures should be in accordance with the Declaration of Helsinki; 1 (0.7%) recommends the application of the informed consent; 5 (3.5%) recommend the use of Uniform requirements for manuscripts submitted to biomedical journals and 3 (2.1%) follow no specified rules. Twenty nine journals ask for references in ethics standards: in 15 (51.7%) the information must be included in the text; in 2 (6.8%) the authors must send a letter informing how the ethics standards were followed; in 1 (3.4%) a copy of the approval by the institutional committee must be included; in 1 (3.4%) believed the authors followed the standards and in 10 (34.4%) no specific reference was made. CONCLUSION: These results indicated that the majority of Brazilian Scientific Journals have little concern related to ethical aspects of research in human subjects included in instructions to authors. Even journals that make references to the ethical aspects the recommendations are quite different.

Brazil↗
PubMed1990

Ethics in health care and medical technologies.

In this paper a case is used to demonstrate how ethical analysis enables health care professionals, patients and family members to make treatment decisions which ensure that medical technologies are used in the overall best interests of the patient. The claim is made and defended that ethical analysis can secure four beneficial outcomes when medical technologies are employed: (1) not allowing any medical technologies to be employed until the appropriate decision makers are identified and consulted; (2) insisting that medical technologies be employed not merely to promote the medical interests of the patient but rather on the basis of their ability to contribute to the overall well-being of the patient; (3) challenging caregivers to reflect on the dynamic interplay between their conscious and unconscious values and consequent determinations of what is in the patient's best interests; and (4) providing a justification for selected interventions which makes possible rational dialogue between caregivers espousing different viewpoints about treatment options.

Beneficence↗
PubMed1997

Ethical, social, and legal issues surrounding studies of susceptible populations and individuals.

Calls for professional accountability have resulted in the development of ethics guidelines by numerous specialty and subspecialty groups of scientists. Indeed, guidelines among some health professions now address vulnerable and dependent groups: but these are silent on issues related to biomarkers. In parallel, attention has been drawn to human rights concerns associated with attempts to detect hypersusceptible workers, especially in democratic countries. Despite this, concern for vulnerable populations grows as advances in biomarker technology make the identification of genetic predisposition and susceptibility markers of both exposure and outcome more attainable. In this article, the principles derived from the ethical theory of utilitarianism provide the basis for principle-based ethical analysis. In addition, the four principles of biomedical ethics--respect for autonomy, beneficence, nonmaleficence, and social justice--are considered for biomarker studies. The need for a context in which ethical analysis is conducted and from which prevailing social values are shown to drive decisions of an ethical nature is emphasized; these include statutory regulation and law. Because biomarker studies can result in more harm than good, special precautions to inform research participants prior to any involvement in the use of biomarkers are needed. In addition, safeguards to maintain the privacy of data derived from biomarker studies must be developed and implemented prior to the application of these new technologies. Guidelines must be expanded to incorporate ethical, social, and legal considerations surrounding the introduction of new technologies for studying susceptible populations and individuals who may be vulnerable to environmental exposures.

Biomarkers↗
PubMed2003

Ethical aspects of research into the etiology of autism.

Advances in understanding autism and other developmental neuropsychiatric disorders will come from an integration of various research strategies including phenomenologic, functional neuroimaging, and pharmacologic methods, as well as epidemiologic approaches aimed at identifying genetic and environmental risk factors. The highly heritable nature of autism makes it scientifically valuable to involve parents and siblings as research participants. However, many studies on autism pose ethical challenges because they do not offer the prospect of direct benefit to subjects. In this article, we present an in-depth ethical analysis of current nontherapeutic research strategies that are common in autism research. The ethical analysis applies a proposed ethical framework for evaluating clinical research focusing on seven ethical requirements: (1) social or scientific value, (2) scientific validity, (3) fair subject selection, (4) favorable risk-benefit ratio, (5) independent review, (6) informed consent, and (7) respect for potential and enrolled research participants.

Autistic Disorder↗
PubMed1983

Therapeutic homicide: a philosophic and Halakhic critique of Harris' 'survival lottery'.

In a well-known paper entitled, 'Survival Lottery', published in a philosophical journal, John Harris proposed for discussion an interesting idea for saving the lives of certain kinds of patients who are at the point of death. Let us assume that there are two such patients, one that could be saved by a heart transplant, and the other by the transplantation of a pair of lungs. However, no suitable organs are available for this purpose. Might it perhaps not be immoral to select, by national lottery, a healthy person, who would be sacrificed, his organs used as transplants, and thus two lives be saved through the sacrifice of only one? This proposal is subjected first to a critical philosophical and ethical analysis, and then to a critical analysis from the point of view of Jewish Ethics as embodied in Halakhah.

Ethical Analysis↗
PubMed1993

An ethical justification for emergency, coerced cesarean delivery.

OBJECTIVE: To provide an ethical justification for emergency coerced cesarean delivery without a court order when a pregnant woman refuses cesarean delivery. METHODS: Ethical analysis is conducted of the existing literature and an ethical justification illustrated by a clinical example. RESULTS: Absolute and near-absolute objections to coerced cesarean delivery fail for lack of adequate arguments to show that the woman's autonomy is not constrained by obligations to the at-term fetal patient. The ethical justification for emergency coerced cesarean delivery requires that three criteria be satisfied: 1) high reliability of the prognostic judgment that on balance cesarean delivery is expected to prevent serious infant morbidity or mortality, 2) lack of physical resistance that could significantly increase the risks of maternal or fetal harm from coerced cesarean delivery, and 3) insufficient time to consider a court order. CONCLUSION: The obstetrician may justifiably coerce emergency cesarean delivery without a court order only when these three criteria are satisfied on a case-by-case basis.

Adult↗
PubMed2006

Ethics and health technology assessment: handmaiden and/or critic?

OBJECTIVES: This study examines the content and role of ethical analysis in health technology assessment (HTA) and horizon scanning publications. It proposes that ethical analysis in HTA is of at least two different types: an ethics of HTA and an ethics in HTA. METHODS: I examine the critical differences between these approaches through the examples of the analysis of genetic screening for breast cancer and home blood glucose testing in diabetes. I then argue that, although both approaches subscribe to similar views concerning HTA and ethics, they use different theoretical and methodological traditions to interpret and explain them. RESULTS AND CONCLUSIONS: I conclude by suggesting that we need the interpretive insights of both these approaches, taken together, to explain why ethics has not been able yet to contribute fully to HTA and to demonstrate the scope and complexity of ethical work in this domain.

Blood Glucose Self-Monitoring↗
PubMed1998

Ethical and representational issues in qualitative secondary analysis.

Although secondary analysis holds considerable promise for optimizing the health knowledge that can be constructed in relation to existing qualitative databases, methodological developments to guide design and evaluation of this research have not been fully explored in the qualitative research literature. This article extends preliminary methodological explorations to address two specific concerns arising from secondary analysis: ethics and representation. Because secondary research creates the potential for exaggerating certain errors in both ethics and representation, the risks associated with such analyses must be considered in the light of the opportunities. Preliminary strategies for helping secondary qualitative researchers to articulate and resolve the representational and ethical problems that may arise from their work are offered.

Data Collection↗
PubMed2002

Methodological issues in pooled analysis of biomarker studies.

The number of epidemiological studies involving biological markers has dramatically increased in the last years. These studies are generally small sized and this feature has called attention to the need to summarize the individual results, while waiting for the completion of larger studies, designed to answer questions that have been raised by preliminary studies. We describe here some of the methodological issues related to pooling data of biomarker studies, taking advantage of the experience accumulated by conducting two pooled analyses, one of studies of metabolic gene polymorphisms and cancer, the other on cytogenetic damage. Topics that are considered are: data standardization, population selection and bias, statistical analysis, ethical issues. Pooled analysis seems to provide a relevant improvement over meta-analysis in molecular epidemiology studies, though more research on methodology is needed.

Bias↗
PubMed2006

Direct-to-consumer online genetic testing and the four principles: an analysis of the ethical issues.

The development of genetic tests marketed and sold direct-to-consumers (DTC) via the internet raises moral concerns and debate about their appropriateness and ethical and clinical significance. These tests are offered for a wide range of diseases and conditions, and the mutations have variable penetrance and associated risk. A number of these tests lack data on their accuracy and reliability, making interpretation of results difficult. DTC genetic testing is undertaken outside the context of the physician-patient relationship and may lack appropriate individual and family genetic counseling, leaving the consumer vulnerable to potential harms, such as misinterpretation of results, including false positive or false reassurance, with limited or no benefits. Beauchamp and Childress's four principles of biomedical ethics provide a framework for analyzing the ethical issues raised by DTC genetic testing. We argue that the potential harms outweigh the potential benefits of such tests, that respect for autonomy should be limited in light of potential harm from DTC testing, and that the availability of genetic testing over the internet may be considered unfair and unjust and affect resource allocation by placing an unfair burden on primary care physicians. In light of the moral issues posed by these tests, practical responses are suggested in the areas of consumer education, medical education, and interaction with commercial companies.

Beneficence↗