At the center of medical morality is the healing relationship. It is defined by three phenomena: the fact of illness, the act of profession, and the act of medicine. The first puts the patient in a vulnerable and dependent position; it results in an unequal relationship. The second implies a promise to help. The third involves those actions that will lead to a medically competent healing decision. But it must also be good for the patient in the fullest possible sense. (...) The physician cannot fully heal without giving the patient an understanding of alternatives such that he or she can freely arrive—together with the physician—at a decision in keeping with his or her personal morality and values. In today's pluralistic society, universal agreement on moral issues between physicians and patients is no longer possible. Nevertheless, a reconstruction of professional ethics based on a new appreciation of what makes for a true healing relationship between patient and physician is both possible and necessary. (shrink)

At the center of medical morality is the healing relationship. It is defined by three phenomena: the fact of illness, the act of profession, and the act of medicine. The first puts the patient in a vulnerable and dependent position; it results in an unequal relationship. The second implies a promise to help. The third involves those actions that will lead to a medically competent healing decision. But it must also be good for the patient in the fullest possible sense. (...) The physician cannot fully heal without giving the patient an understanding of alternatives such that he or she can freely arrive—together with the physician—at a decision in keeping with his or her personal morality and values. In today's pluralistic society, universal agreement on moral issues between physicians and patients is no longer possible. Nevertheless, a reconstruction of professional ethics based on a new appreciation of what makes for a true healing relationship between patient and physician is both possible and necessary. (shrink)

Background To describe the preferences for disclosure of individual biomarker results among mothers participating in a longitudinal birth cohort. Methods We surveyed 343 mothers that participated in the Health Outcomes and Measures of the Environment Study about their biomarker disclosure preferences. Participants were told that the study was measuring pesticide metabolites in their biological specimens, and that the health effects of these low levels of exposure are unknown. Participants were asked whether they wanted to receive their results and their child's (...) results. In addition, they were asked about their preferred method (letter vs in person) and format (more complex vs less complex) for disclosure of results. Results Almost all of the study participants wanted to receive their individual results (340/343) as well as their child's results (342/343). However, preferences for receiving results differed by education level. Mothers with less than a college degree preferred in-person disclosure of results more often than mothers with some college education or a college degree (34.3% vs 17.4% vs 7.9%, p<0.001). Similarly, mothers with less than a college education preferred a less complex disclosure format than mothers with some college education or a college degree (59.7% vs 79.1% vs 86.3%, p<0.0001). Conclusion While almost all study participants preferred to receive results of their individual biomarker tests, level of education was a key factor in predicting preferences for disclosure of biomarker results. To ensure effective communication of this information, disclosure of biomarker results should be tailored to the education level of the study participants. (shrink)

BackgroundAccurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience (...) health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants.MethodsWe searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second.ResultsThe search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12–6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined “sex” and/or “gender.” No publication carried out a comprehensive sex and gender analysis.ConclusionsFindings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research. (shrink)

The study ascertained (1) whether an observer's scope of justice with reference to either the moral agent or the target person of a moral act, would affect his/her judgements of the ethicality of the act, and (2) whether observer judgements of ethicality parallel the moral agent's decision processes in systematically evaluating the intensity of the moral issue. A scenario approach was used. Results affirmed both research questions. Discussions covered the implications of the findings for the underlying cognitive processes of moral (...) judgements, for the link between judgements of fairness and ethicality, as well as for the debate of ethical absolutism versus relativism. (shrink)

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in (...) clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research. (shrink)

Many leading management scientists have advocated ethicalism: the incorporation of social and ethical concerns into traditional "rational" OR-MS techniques and management decisions. In fact, elementary forms of decision analysis can readily be augmented, using ethical theory, in ways that sweep in ethical issues. In addition, alternative conceptual models of Decision-Analysis, Game-Theory and Optimality are now available, all of which have brought OR-MS and Business-Ethics into a closer alignment.

BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as (...) a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women. (shrink)

The study of civilizations is largely motivated by a single question—what drives and defines a culture or civilization? In an effort to locate a civilization—or, in the case of this chapter, three civilizations—historically, perhaps the best way is to call this drive and defining quality the cultural “sovereign.” Historically, in almost every case, this sovereign takes on a spiritual and religious form in the earliest and most vitalized period of any civilization’s lifespan. Conceptualizing civilizations in two phases, this chapter will (...) seek to show that, as a rule, at some point this spiritual sovereign is usurped and replaced by a human and corrupted sovereign. This transition precipitates the decay of Civilization, first explored by Oswald Spengler, examined here with a focus on the point at which the original and eternal sovereign ceases to be the arbiter of moral and cultural questions, and the State takes over this sovereignty. To understand “sovereignty,” the chapter appeals to Schmitt; the sovereign is one who has the power “to decide the exception.” In this way, the ethos of a culture begins as something in which no exceptions can be made by a human being—the point at which the eternal is sovereign. As civilization declines, however, one witnesses human beings making exceptions,as morality ceases to be binding, social propriety becomes a luxury rather than a necessity, and religion becomes a fixture rather than the core of society. This state of collapse is highlighted in three separate civilizations—the Civic (i.e. Graeco-Roman), the Pharaonic (i.e. Egyptian), and the Ecclesiastic (i.e. Western). The viability of any project aimed at “revival” or “regeneration” is also examined and, the author hopes, soundly denied. (shrink)

The study of civilizations is largely motivated by a single question—what drives and defines a culture or civilization? In an effort to locate a civilization—or, in the case of this chapter, three civilizations—historically, perhaps the best way is to call this drive and defining quality the cultural “sovereign.” Historically, in almost every case, this sovereign takes on a spiritual and religious form in the earliest and most vitalized period of any civilization’s lifespan. Conceptualizing civilizations in two phases, this chapter will (...) seek to show that, as a rule, at some point this spiritual sovereign is usurped and replaced by a human and corrupted sovereign. This transition precipitates the decay of Civilization, first explored by Oswald Spengler, examined here with a focus on the point at which the original and eternal sovereign ceases to be the arbiter of moral and cultural questions, and the State takes over this sovereignty. To understand “sovereignty,” the chapter appeals to Schmitt; the sovereign is one who has the power “to decide the exception.” In this way, the ethos of a culture begins as something in which no exceptions can be made by a human being—the point at which the eternal is sovereign. As civilization declines, however, one witnesses human beings making exceptions,as morality ceases to be binding, social propriety becomes a luxury rather than a necessity, and religion becomes a fixture rather than the core of society. This state of collapse is highlighted in three separate civilizations—the Civic (i.e. Graeco-Roman), the Pharaonic (i.e. Egyptian), and the Ecclesiastic (i.e. Western). The viability of any project aimed at “revival” or “regeneration” is also examined and, the author hopes, soundly denied. (shrink)

In most theories of the quantum measurement process changes in an observer’s perception of a state can take place without forces, as for example if a state is prepared in an eigenstate of \ but \ is measured. In the “special state” theory any change in wave function requires forces. This allows experimental tests to distinguish these ideas and in the present article two examples of such tests are considered. The first is a kind of double Stern–Gerlach experiment, the second (...) a check for angular momentum changes in a polarizer. (shrink)

In most theories of the quantum measurement process changes in an observer’s perception of a state can take place without forces, as for example if a state is prepared in an eigenstate of \ but \ is measured. In the “special state” theory any change in wave function requires forces. This allows experimental tests to distinguish these ideas and in the present article two examples of such tests are considered. The first is a kind of double Stern–Gerlach experiment, the second (...) a check for angular momentum changes in a polarizer. (shrink)

BackgroundLarge-scale, centralized data repositories are playing a critical and unprecedented role in fostering innovative health research, leading to new opportunities as well as dilemmas for the medical sciences. Uncovering the reasons as to why citizens do or do not contribute to such repositories, for example, to population-based biobanks, is therefore crucial. We investigated and compared the views of existing participants and non-participants on contributing to large-scale, centralized health research data repositories with those of ex-participants regarding the decision to end their (...) participation. This comparison could yield new insights into motives of participation and non-participation, in particular the behavioural change of withdrawal.MethodsWe conducted 36 in-depth interviews with ex-participants, participants, and non-participants of a three-generation, population-based biobank in the Netherlands. The interviews focused on the respondents’ decision-making processes relating to their participation in a large-scale, centralized repository for health research data.ResultsThe decision of participants and non-participants to contribute to the biobank was motivated by a desire to help others. Whereas participants perceived only benefits relating to their participation and were unconcerned about potential risks, non-participants and ex-participants raised concerns about the threat of large-scale, centralized public data repositories and public institutes, such as social exclusion or commercialization. Our analysis of ex-participants’ perceptions suggests that intrapersonal characteristics, such as levels of trust in society, participation conceived as a social norm, and basic societal values account for differences between participants and non-participants.ConclusionsOur findings indicate the fluidity of motives centring on helping others in decisions to participate in large-scale, centralized health research data repositories. Efforts to improve participation should focus on enhancing the trustworthiness of such data repositories and developing layered strategies for communication with participants and with the public. Accordingly, personalized approaches for recruiting participants and transmitting information along with appropriate regulatory frameworks are required, which have important implications for current data management and informed consent procedures. (shrink)

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This (...) framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)