Bio-X: Removing Bodily Contingency in Regenerative Medicine

This paper addresses the social, cultural, and ethical dynamics of research in regenerative medicine. The author turns to both science fiction and recent developments in regenerative medicine for clues about the future of the body and medical practice, suggesting that regenerative medicine uses the body as its own resource for the purposes of preserving life, and that by attempting to remove the body from the limitations of both mortality and contingency, regenerative medicine fundamentally alters the meaning of “human.”     

Authorship and Publication Practices in the Social Sciences: Historical Reflections on Current Practices

An historical review of authorship definitions and publication practices that are embedded in directions to authors and in the codes of ethics in the fields of psychology, sociology, and education illuminates reasonable agreement and consistency across the fields with regard to (a) originality of the work submitted, (b) data sharing, (c) human participants’ protection, and (d) conflict of interest disclosure. However, the role of the professional association in addressing violations of research or publication practices varies among these fields. Psychology and sociology provide active oversight with sanction authority. In education, the association assumes a more limited role: to develop and communicate standards to evoke voluntary compliance. With respect to authorship credit, each association’s standards focus on criteria for inclusion as an author, other than on the author’s ability to defend and willingness to take responsibility for the entire work. Discussions across a broad range of research disciplines beyond the social sciences would likely be beneficial. Whether improved standards will reduce either misattribution or perceptions of inappropriate attribution of credit within social science disciplines will likely depend on how well authorship issues are addressed in responsible conduct of research education (RCR), in research practice, and in each association’s ongoing efforts to influence normative practice by specifying and clarifying best practices.     

Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities.     

The European Clinical Specialization on Fluency Disorders (ECSF)

The European Clinical Specialization on Fluency Disorders (ECSF) project consists of one-year post-qualification fluency specialization training and a harmonized graduate fluency program. It was developed by eight European universities/colleges to provide the means whereby graduates would meet comparable standards of competence to practice in the field of fluency disorders. In this paper we describe criteria that guided the consortium in their decision making process to create an optimal learning environment for participants. A review of the first completed course cycle, with 23 international participants, is discussed.Educational objectives: After reading this article, the reader will be able to: (1) articulate the rationale for development of the ECSF-course; (2) summarize the content of both the harmonized undergraduate fluency course and the postgraduate fluency specialization course; (3) summarize the benefits of the suggested model for fluency specialization.     

国家内部地域文化差异及其对组织的影响

近年来,跨文化管理研究越来越关注国家内部（次国家层面）地域文化差异。在类似中国这样幅员辽阔历史悠久的多民族国家中,经济发展带来的人口流动和企业的跨地域布局使得员工与管理者都需要面对不同外部地域文化环境和组织内部人员地域多样化的挑战,研究国家内部地域文化差异及其对组织的影响有重要意义。 现有实证研究的一个重要共识是国家内部地域文化差异普遍存在于亚洲、欧洲和南北美洲各国。覆盖的国家类型多样,既有美国、巴西等地理跨度较大或有多民族多宗教历史文化背景的国家,也有日本、德国等地理跨度较小或历史上民族和信仰成分较单一的国家;既包括高度工业化的发达国家,也有发展中国家;既有集体主义倾向的东南亚和南美国家,也有个人主义倾向的北美和西欧国家。差异的内容主要包括霍夫斯泰德和施瓦茨的文化价值观维度,尤其是个人主义-集体主义。此外,不同国家之间内部地域文化差异的程度也显著不同。 聚焦中国大陆的研究主要关注了大陆地域文化区的划分和地域文化差异的内容维度。研究早期主要是从理论上根据影响文化的外部因素（如地理环境特征）讨论了文化差异的存在和文化区域划分,后来直接根据价值观相似度对不同省市或地区进行聚类;近年来,少数研究进一步依据多个指标综合划分地域文化区,并开始假设和验证不同区域价值观对个人和组织的影响。本文整合现有的几种中国大陆地域文化区划,用层次聚类法,获得了有较大共识的8个文化区。现有实证研究结果表明,中国大陆在集体主义、长期导向、风险偏好、儒家价值观等文化价值观维度存在地域差异。 有关国家内部地域文化差异如何影响组织行为和企业经营管理的实证文献仍然非常有限。 从跨地区文化比较的视角看,国家内部不同地区的文化价值观有可能影响当地人群的消费模式、员工行为、管理风格和决策（如投资）,进而影响企业生产效率和创新。从跨地区文化互动研究看,母公司企业文化与子公司所在地文化互动融合的模式有可能影响子公司经营绩效。最后,国家内部地域文化差异的程度不仅有可能影响本国企业跨地区布局的方式,还有可能影响企业跨境投资方式、企业国际化程度和经营绩效。 未来研究应更多的关注个人主义-集体主义以外的文化维度,探索主位视角来丰富研究理论和测量方法,尤其亟需更多对地域文化差异和跨地域互动在个人,团队和组织层面的结果的研究。最后,文化随着经济活动、政治变化、人口流动、对外交流互动而不断演化。在经济持续发展、商业活动地理布局不断拓展、人员流动极大增加、改革开放进一步深化的大背景下,我国大陆各区域及港澳台地区的地域文化价值观的演变,及其组织中不同层面的行为和结果的影响也值得探究。     

Understanding the Trusted Doctor and Constructing a Theory of Bioethics

This paper offers a constructivist account of bioethics as an alternative to previous discussions that explained the ethics of medicine by an extrapolation of principles or virtues from ordinary morality. Taking medicine as a higher and special calling, I argue that the practice of medicine would be impossible without the trust of patients. Because trust is a necessary condition for medical practice, the ethics of the profession must provide the principles for guiding physician behavior and the profession toward promoting trust and being trustworthy. In a phrase, that principle is “seek trust and deserve it.” I sketch out how the concept of trust provides a different justification for common sense principles of bioethics and explain how the concept of trust provides reasonable guidance for resolving moral conflicts within medicine. The trust-seeking approach provides a new and unexpected ordering of some traditional medical values, it reveals the weightiness of previously undervalued bioethical precepts, and illuminates the centrality of some largely ignored obligations of medicine. It also has the power to guide clinical practice and to inform the profession about standards for medical institutions. This revised version was published online in August 2006 with corrections to the Cover Date.     

Religion and Esotericism among Students: A Cross-Cultural Comparative Study

Analysing the results of a study on religious and esoteric beliefs and practice among university students from five European and five American countries, we found that the level of religiousness of students depends very much on their cultural environment: the level of religiosity and esoteric beliefs is significantly higher among North- and South-American students than among European students. On the other hand, Asian spiritual techniques and esoteric methods of healing are practised more frequently by students in North-Western European countries. In the second part of the paper, we examine the relationship between academic discipline and religious worldviews. According to our data, students in the social sciences and the arts are more distanced from religion than students of other areas of science, but they, like students of medicine and languages, are closer to esotericism than students of the 'exact sciences'. Several hypotheses are proposed to explain these results.     

科学分析临床试验结果维护公众健康

近20多年来,循证医学对推动我国疾病访治的科学化、规范化和现代化起到了积极推动作用。但以临床试验为基础的循证医学在我国的20年历程也出现了一些值得关注的问题。本文将向临床医生提供如下信息：如何正确分析临床试验结果,如何合理地将临床试验结果用于临床,以及如何向患者传递科学的医学信息,保护患者利益。     

“It's the Way That You Do It”: Developing an Ethical Framework for Community Psychology Research and Action

In the 50 years since the 1965 Swampscott conference, the field of community psychology has not yet developed a well‐articulated ethical framework to guide research and practice. This paper reviews what constitutes an “ethical framework”; considers where the field of community psychology is at in its development of a comprehensive ethical framework; examines sources for ethical guidance (i.e., ethical principles and standards) across multiple disciplines, including psychology, evaluation, sociology, and anthropology; and recommends strategies for developing a rich written discourse on how community psychology researchers and practitioners can address ethical conflicts in our work.     

Doping use in sport teams: The development and validation of measures of team-based efficacy beliefs and moral disengagement from a cross-national perspective

ObjectivesThe main goal of this research focused on the development and validation of three instruments designed to assess athletes' self-regulatory efficacy in team contexts, team collective efficacy and team moral disengagement with relevance for doping use across three European countries.DesignThe research relied on three distinct studies. A first qualitative study focused on item development. The second study assessed the factor structure and internal reliability of each of the new team instruments. The third study provided evidence for instrument validity by assessing the hypothesis that efficacy measures and moral disengagement would contribute to team athletes' doping intentions. The latter two studies also focused on the relations among measures and on measurement reliability, both within and across countries.MethodThe first study relied on focus group data collected from twenty-one team sport professionals (mean age = 34; SD = 11.65). Four hundred and fourteen adolescent athletes (mean age = 16.69; SD = 1.55) participated in the second study, whereas seven hundred forty-nine adolescent team athletes (mean age = 16.43; SD = 1.69) participated in the third study. For the latter two studies, team athletes were recruited across Italy, Germany and Greece and provided data on the new team measures. Only athletes participating in the third study provided data on doping intentions.ResultsThe findings of the three studies supported the empirical goals of the investigation and provided evidence for the factor structure, reliability and validity of the team instruments. Furthermore, multi-group findings supported the hypothesis that the new instruments would have equivalent measurement and validity characteristics across the three European countries. The conclusions focus on the conceptual and practical implications of these findings.     

Clinical Trial Application in Europe: What Will Change with the New Regulation?

The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC?     

Social Correlates of Church Attendance in Three European Catholic Countries

The sociology of religion literature recognizes secularization as an uneven process complicated by individual and country-level variables. However, considerably less attention has been given to how correlates of church attendance vary across divergent settings within a single religious denomination. Employing recent data from Belgium, Ireland, and Slovenia, we test whether the belief, ideological support for the church, and religious commitment correlates of religious behaviour are similar across these Catholic countries and whether there are any remaining country effects influencing church attendance. The results of ordered logit regression models show, on the one hand, the correlates of church attendance are basically the same across the three countries and, on the other, that country effects remain even when controlling for the key explanatory variables and other covariates. These empirical findings suggest the need to develop a more contextual-based understandings of secularization, focusing on the influence of cultural factors operative in nationally-specific settings.     

The historical foundations of the research-practice distinction in bioethics

The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities and interventions. This model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons.     

A Public Culture For Guinea Pigs: US Human Research Subjects after the Tuskegee Study

Abstract

Tissue engineering is one potential arm of the much-heralded regenerative medicine. We use the concepts of technological zone, risk framing and regulatory jurisdiction to analyse what risks are formulated in the zone of tissue engineering and whether those risks are reflected in emerging regulatory policy in Europe. In the regulatory jurisdictions of the European Union, public health risks have become increasingly important. Tissue engineering challenges pre-existing regulatory frameworks. Scientific–industrial actors formulate the risks of tissue engineering in three primary frames: technological safety risk; therapeutic efficacy risk; and economic risk. Study of the prevailing configuration of European Commission institutions and the EU process of regulatory regime-building for tissue engineering shows that risk frames are mobilized selectively. Whilst the technological safety frame and the economic frame are strongly mobilized, therapeutic efficacy—especially comparative efficacy—is not. Additionally the regime avoids any Europe-level position on the so-called ethics of sourcing and engineering tissues and cells. Efficacy and ethics are defined as the jurisdiction of national authorities, underpinned by the subsidiarity principle. Outcomes include the likely banning of certain therapeutic technologies by European countries that have objections to products deriving from controversial materials and processes, and the prevention of adoption of products due to efficacy concerns, so creating new imbalances in the European therapeutic marketplace. Consequently, the tissue-engineered medical products that European societies consume, at least in the near term, will reflect the medically defined needs of the European population to a limited and patchy extent.     

PHILOSOPHICAL SOURCES FOR MORIN'S SOCIOLOGY

The aim of this work is to show how Edgar Morin chose Vico and Hegel as cultural points of reference while elaborating a new method as an alternative to classical scientific knowledge. The French philosopher did this specifically when he tried to re-propose the problem s of history and the event in human sciences. The origins of sociology arose from the explicit extension of the scientific method to the socio-anthropological world; that is, with the intention of studying society as a natural phenomenon to which the laws of physical and biological sciences must be applied. As a tendency against this, at the end of the 1970s Morin began a process of putting sociology into historical context, which led him to a methodological revolution of sociology itself.     

Research misconduct among clinical trial staff

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations.     

European Management Selection Methods: A Comparison of Five Countries

There is some disagreement in the recent literature on how similar or different are the methods used to select employees in different European countries. The confusion comes about in part because different samples and questions have been used in different countries to investigate this issue, making comparison between countries very difficult. This study investigates managerial selection methods in three members of the European Community, Belgium, Germany and Italy, using the same questionnaire and sample characteristics previously used in Britain and France. This allows a direct comparison between the five countries. The samples comprised 250 companies randomly drawn from the top 1,000 in each country. Questionnaires sent to the companies asked a range of questions concerning the frequency of use of selection methods and attitudes towards their use. Results show major differences in frequency of use of different methods. Some of these differences are: British and German companies tend to use assessment centres much more often than other countries, while Germany and Italy are relatively infrequent users of psychological tests. Companies in the Flemish (Dutch speaking) part of Belgium are the most likely to use biodata, while their French speaking compatriots are similar to the French in their liking for graphology. Both Belgium and France make much less use of references than do Britain, Germany and Italy. Results suggest that harmonization of selection practice in Europe is a long way off. Habit, tradition and culture determine the choice of selection method much more than do the relative predictive validities of the techniques.     

Ethical issues in discharge planning for vulnerable infants and children

Discharge planning for vulnerable infants and children is a collaborative, interdisciplinary, decision-making activity that is grounded in the ethical complexities of clinical practice. Although it is a psychosocial intervention that frequently causes moral distress for professionals and has the potential to inflict harm on children and their families, the process has received little attention from ethicists. An ongoing study of the transition of technology-dependent children from hospital to home suggests that the ethical issues embedded in the discharge-planning process may be concealed by dominant cultural values, institutional policies, clinical standards, historical precedents, and legal regulations.     

PROsetta: An R Package for Linking Patient-Reported Outcome Measures

A common problem when using a variety of patient-reported outcomes (PROs) for diverse populations and subgroups is establishing a harmonized scale for the incommensurate outcomes. The lack of comparability in metrics (e.g., raw summed scores vs. scaled scores) among different PROs poses practical challenges in studies comparing effects across studies and samples. Linking has long been used for practical benefit in educational testing. Applying various linking techniques to PRO data has a relatively short history; however, in recent years, there has been a surge of published studies on linking PROs and other health outcomes, owing in part to concerted efforts such as the Patient-Reported Outcomes Measurement Information System (PROMIS^®) project and the PRO Rosetta Stone (PROsetta Stone^®) project (www.prosettastone.org). Many R packages have been developed for linking in educational settings; however, they are not tailored for linking PROs where harmonization of data across clinical studies or settings serves as the main objective. We created the PROsetta package to fill this gap and disseminate a protocol that has been established as a standard practice for linking PROs.     

Cultural foundations of safety culture: A comparison of traffic safety culture in China,Japan and the United States

Understanding how to assess the influence of culture on traffic safety is important for improving traffic safety globally. Traffic safety culture is embedded in the larger context of country’s cultural norms and values, producing different safety outcomes even when other factors are similar. The current work examines how culture influences traffic safety outcomes in three of the largest automobile countries in the world, but which have very different cultural values and which also have very different traffic safety outcomes: China, Japan and the United States. China has an emerging driver population and cultural values that result in aberrant driving behaviors and “scrambling” to gain the right of way, producing a high number of crashes. Japan has an established driver culture, but an emphasis on reducing risk, which results in a lower rate of crashes. The United States, with the most established “car culture”, has an historical and cultural view of the car as a representation of freedom, leading to choices that result in higher crash rates than many countries around the world. The current work explores these cultural underpinnings for traffic safety culture in each country by establishing the historical basis for a traffic culture, examining road, vehicle engineering and legal standards, and reviewing available crash data and data on safety attitudes. These countries are compared across the different dimensions to establish unique cultural influences on traffic safety.