Extent of non-publication in cohorts of studies approved by research ethics committees or included in trial registries

BACKGROUND: The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries. METHODS AND FINDINGS: Four bibliographic databases were searched for methodological research projects (MRPs) without limitations for publication year, language or study location. The searches were supplemented by handsearching the references of included MRPs. We estimated the proportion of studies published using prediction intervals (PI) and a random effects meta-analysis. Pooled odds ratios (OR) were used to express associations between study characteristics and journal publication. Seventeen MRPs (23 publications) evaluated cohorts of studies approved by RECs; the proportion of published studies had a PI between 22% and 72% and the weighted pooled proportion when combining estimates would be 46.2% (95% CI 40.2%-52.4%, I2 = 94.4%). Twenty-two MRPs (22 publications) evaluated cohorts of studies included in trial registries; the PI of the proportion published ranged from 13% to 90% and the weighted pooled proportion would be 54.2% (95% CI 42.0%-65.9%, I2 = 98.9%). REC-approved studies with statistically significant results (compared with those without statistically significant results) were more likely to be published (pooled OR 2.8; 95% CI 2.2-3.5). Phase-III trials were also more likely to be published than phase II trials (pooled OR 2.0; 95% CI 1.6-2.5). The probability of publication within two years after study completion ranged from 7% to 30%. CONCLUSIONS: A substantial part of the studies approved by RECs or included in trial registries remains unpublished. Due to the large heterogeneity a prediction of the publication probability for a future study is very uncertain. Non-publication of research is not a random process, e.g., it is associated with the direction of study findings. Our findings suggest that the dissemination of research findings is biased.

Professional Responsibility and Legal Ethics in Queensland

With the commencement of the Legal Profession Act 2007 (Qld) and the establishment of the Legal Services Commission, the legal profession and legal services market in Queensland has experienced significant changes to its regulatory environment. Professional Responsibility and Legal Ethics in Queensland provides a detailed explanation and analysis of these changes. The book will assist lawyers to plan for successful practice within this new environment by examining such topics as: • The scope and application of key provisions within the Legal Profession Act; • The role, functions and policies of the Legal Services Commission; • The ethical and regulatory implications of operating as an Incorporated Legal Practice or as a Multi-Disciplinary Partnership; • Developments affecting trust accounts and client money dealings more generally; • Recent case law, Tribunal decisions and Legal Services Commission guidelines in relation to the new conduct standards of Unsatisfactory Professional Conduct and Professional Misconduct; and • The impact of the new legislation and regulatory environment on a range of traditional ethical duty categories such as the duty to communicate, costs and billing practices, as well as the paramount duties to the court and to the administration of justice. An invaluable reference for legal professionals, this book is also an important resource for law students grappling with questions raised by legal ethics and their application to the workplace.

Truth, obligation and ethics in the propagation of democracy

In this paper I present an analysis of the language used by the National Endowment for Democracy (NED) on its website (NED, 2008). The specific focus of the analysis is on the NED's high usage of the word “should” revealed in computer assisted corpus analysis using Leximancer. Typically we use the word “should” as a term to propose specific courses of action for ourselves and others. It is a marker of obligation and “oughtness”. In other words, its systematic institutional use can be read as a statement of ethics, of how the NED thinks the world ought to behave. As an ostensibly democracy-promoting institution, and one with a clear agenda of implementing American foreign policy, the ethics of NED are worth understanding. Analysis reveals a pattern of grammatical metaphor in which “should” is often deployed counter intuitively, and sometimes ambiguously, as a truth-making tool rather than one for proposing action. The effect is to present NED's imperatives for action as matters of fact rather than ethical or obligatory claims.

Communication ethics in public health

As new diseases and medical conditions emerge, new community groups appear in the public health arena as consumer advocates or lobby groups seeking to affect policy or to represent ‘communities’ formed around these new diseases and conditions. The role of these groups in public health, their political status, and the extent to which they are actually representative are highly problematic for public health. These new constellations of social groups and activities challenge traditional ideas about public health decision-making and demand a rethinking of the constituency and limits of public health. Using discourse theory, symbolic interactionism, and ethological theory, the authors examine one case, exploring the perspectives of various communities on hepatitis C, and explore some issues that this raises for public health.

Ethics in Research with Children

Widespread scholarly interest in ethics in research with children, as an extant field of inquiry and practice, is a relatively new phenomenon. The discipline of ethics can be traced back to the Hippocratic school, but its contemporary applications in the everyday worlds of children and those around them are gaining greater attention from theorists, practitioners, and those involved in policy. Heightened international awareness of the United Nations Convention on the Rights of the Child (1979) gave significant impetus to increasing international awareness of children’s rights to provision, protection, and participation in everyday contexts, including those in which research occurs. Understandings of research ethics and of children’s involvement in research relate to broader understandings of children and childhood drawn from developmental science, sociology, human geography, health sciences, and children’s human rights to participation and protection. Key understandings pertain to children’s competence to participate in research, to operate as reliable informants with respect to their own lives, to provide voluntary informed consent and dissent in research, and to make meaningful decisions about the nature and extent of their participation. The field is international and interdisciplinary, although bounded by legislative, policy, and jurisdictional requirements governing research—its conduct and dissemination. So, too, the burgeoning work of ethics committees, whether in relation to health research or social research, is evidence of a sharpened focus on governance of child research. Oxford Bibliographies offers a suite of perspectives, resources, and strategies to guide the researcher, practitioner, and policymaker and serves to challenge readers to interrogate conceptual understandings, methodologies, and dissemination of research with and about children. Exploration of the suite opens up new possibilities for considering children’s rights to participation in matters that affect their lives and for children to be seen and heard in research.

Ethics in project management : some Aristotelian insights

Purpose My aim is to introduce, in the project management field, an Aristotelian ethics lens moving beyond the classical deontological and consequentialism approaches underlying the current ethical practices and codes of ethics and professional conducts. In doing so, I wish to pose the premises of a debate on the implications of a conscious ethical perspective for the structure and agency relationship within the project management field Design/methodology/approach Project management is a knowledge field on its own right. However the current perspectives applied to make sense and develop the field (modernism vs. postmodernism) leads to dichotomous thinking rather than recognizing the merits and contextual validity of both sides. I call for Aristotelian Ethics as a way of moving beyond this dichotomous thinking. I introduce briefly Aristotelian Ethics and its consequences in term of relation theory – practice, means and ends, facts and values, and finally politics (i.e. being part of a community of practitioners). Then I illustrate some consequences for the field taking PMI Code of Ethics and Professional Conduct and APM Code of Professional Conduct as supports for discussion Findings I suggest a need for revisiting and/or redesigning the codes of ethics and professional conducts for project management according to an Aristotelian perspective, in order to move beyond the normative limitations of classical deontological (conflict between competing duties, exemplified by PMI Code) or consequentialism (focusing on the "right" outcome to the detriment of duties, exemplified by APM Code) approaches (both, in fact, leading to a disconnection means and ends, and facts and values). This implicates shifting our view from the question "what is my duty?" to the questions "why should I undertake my duty?" and "how ought I act in this situation?" Practical implications Raising Professional Bodies, Industry and Education institutions awareness and consciousness and leading them to rethink about codes of ethics and the implications for the way they conceive practice and research, bodies of knowledge, credentialing, education... Originality/value To the best of my knowledge, this kind of discussion has not yet been conducted within the project management field, and considering the implication of project management in our life and for the well being of the society, an ethical debate may present some value(s)

Ethics in a Technological World : Framing the Questions and Three Approaches

This study addresses the following question: How to think about ethics in a technological world? The question is treated first thematically by framing central issues in the relationship between ethics and technology. This relationship has three distinct facets: i) technological advance poses new challenges for ethics, ii) traditional ethics may become poorly applicable in a technologically transformed world, and iii) the progress in science and technology has altered the concept of rationality in ways that undermine ethical thinking itself. The thematic treatment is followed by the description and analysis of three approaches to the questions framed. First, Hans Jonas s thinking on the ontology of life and the imperative of responsibility is studied. In Jonas s analysis modern culture is found to be nihilistic because it is unable to understand organic life, to find meaning in reality, and to justify morals. At the root of nihilism Jonas finds dualism, the traditional Western way of seeing consciousness as radically separate from the material world. Jonas attempts to create a metaphysical grounding for an ethic that would take the technologically increased human powers into account and make the responsibility for future generations meaningful and justified. The second approach is Albert Borgmann s philosophy of technology that mainly assesses the ways in which technological development has affected everyday life. Borgmann admits that modern technology has liberated humans from toil, disease, danger, and sickness. Furthermore, liberal democracy, possibilities for self-realization, and many of the freedoms we now enjoy would not be possible on a large scale without technology. Borgmann, however, argues that modern technology in itself does not provide a whole and meaningful life. In fact, technological conditions are often detrimental to the good life. Integrity in life, according to him, is to be sought among things and practices that evade technoscientific objectification and commodification. Larry Hickman s Deweyan philosophy of technology is the third approach under scrutiny. Central in Hickman s thinking is a broad definition of technology that is nearly equal to Deweyan inquiry. Inquiry refers to the reflective and experiential way humans adapt to their environment by modifying their habits and beliefs. In Hickman s work, technology consists of all kinds of activities that through experimentation and/or reflection aim at improving human techniques and habits. Thus, in addition to research and development, many arts and political reforms are technological for Hickman. He argues for recasting such distinctions as fact/value, poiesis/praxis/theoria, and individual/society. Finally, Hickman does not admit a categorical difference between ethics and technology: moral values and norms need to be submitted to experiential inquiry as well as all the other notions. This study mainly argues for an interdisciplinary approach to the ethics of technology. This approach should make use of the potentialities of the research traditions in applied ethics, the philosophy of technology, and the social studies on science and technology and attempt to overcome their limitations. This study also advocates an endorsement of mid-level ethics that concentrate on the practices, institutions, and policies of temporal human life. Mid-level describes the realm between the instantaneous and individualistic micro-level and the universal and global macro level.

Towards Eco-Dharma: The Contribution of Gandhian Thought to Ecological Ethics in India

Ecological concern prompts poor and indigenous people of India to consider how a society can ensure both protection of nature and their rightful claim for a just and sustainable future. Previous discussions defended the environment while ignoring the struggles of the poor for sustenance and their religious traditions and ethical values. Mohandas Karamchand Gandhi addressed similar socio-ecological concerns by adopting and adapting traditional religious and ethical notions to develop strategies for constructive, engaged resistance. The dissertation research and analysis verifies the continued relevance of the Gandhian understanding of dharma (ethics) in contemporary India as a basis for developing eco-dharma (eco-ethics) to link closely development, ecology, and religious values. The method of this study is interpretive, analytical, and critical. Françoise Houtart’s social analytical method is used to make visible and to suggest how to overcome social tensions from the perspective of marginalized and exploited peoples in India. The Indian government's development initiatives create a nexus between the eco-crisis and economic injustice, and communities’ responses. The Chipko movement seeks to protect the Himalayan forests from commercial logging. The Narmada Bachao Andolan strives to preserve the Narmada River and its forests and communities, where dam construction causes displacement. The use of Gandhian approaches by these movements provides a framework for integrating ecological concerns with people's struggles for survival. For Gandhi, dharma is a harmony of satya (truth), ahimsa (nonviolence), and sarvodaya (welfare of all). Eco-dharma is an integral, communitarian, and ecologically sensitive ethical paradigm. The study demonstrates that the Gandhian notion of dharma, implemented through nonviolent satyagraha (firmness in promoting truth), can direct community action that promotes responsible economic structures and the well-being of the biotic community and the environment. Eco-dharma calls for solidarity, constructive resistance, and ecologically and economically viable communities. The dissertation recommends that for a sustainable future, India must combine indigenous, appropriate, and small- or medium-scale industries as an alternative model of development in order to help reduce systemic poverty while enhancing ecological well-being.

Research Ethics in Divided and Violent Societies: Seizing the Ethical Opportunity

This chapter explores how to conduct social research in divided and violent societies by developing the concept of the ‘ethical opportunity’. The ‘ethical opportunity’ is situated in a brief discussion of ‘action’ and feminist approaches to research. It argues that seizing the ethical opportunity requires researchers to: plan for their personal safety, plan for participants’ personal safety and plan how they will communicate and disseminate their results. It draws on the author’s personal experience researching in South Africa, Zimbabwe and Northern Ireland, concluding that it is in the communication and dissemination phase that researchers’ hopes for ‘making a difference’ may be realised or dashed. It cautions would-be researchers to manage their own – and research participants’ – expectations about what social research can achieve. Its effects may not often be as transforming and liberating as idealistic researchers hope for, but that should not dissuade them from striving towards those ends.

Moral reasoning and ethics in educational leadership /

School leaders face difficult decisions regarding discipline matters. Often, such decisions play an important role in determining the moral tone of the school and the health of the school community. Many stakeholders are affected by the outcome of such decisions. Codes of conduct, board and school policies, and discipline meetings are often shrouded under secrecy, making the discipline process mysterious. .; In this study I examined the process of moral reasoning. I sought to determine the extent to which school leaders were aware that they were involved in a process of moral reasoning, and ftirthermore, what kind of moral reasoning they practiced. As well, I investigated the ethical grounds and foundations underlying moral reasoning. Thus, in this study I probed the awareness of the process of moral reasoning and sought to find the ethical grounding of decision making. This qualitative study featured short field research. The process involved individual interviews with three different participants: school leaders of a public. Catholic, and an independent school. It found that each school leader practiced moral reasoning to varying degrees through the discipline process. It also explored the possible democratization of moral reasoning by linking to concepts such as fairness, due process, public accountability, and greater participation in the administering of discipline. This study has implications for practice, theory, and future research. The examination of school leaders as the primary focus for discipline matters opens the door to future research that could explore differences between the school systems and possibly other parties affected by moral reasoning in discipline cases.

Ethics in government and business

Canadians appear to hold the activities of those in government and in big business in low esteem. Media reports of several high-profile political and corporate instances of unethical conduct have reinforced the public's concern for the status of ethical conduct and honesty in government and in big business. The response by public and private sector managers to unethical conduct by employees is largely in the form of 'ethical rules' which both sectors agree provide a measure of certainty as to the ethical conduct expected from employees. Since research on ethics in the public and private sectors is limited and since ethics is a topic of increasing concern to both sectors, this thesis provides data that could assist managers in dealing with the issue of ethical conduct within their respective organizations. The purpose of this thesis is to compare the state of ethical conduct within public and private sector organizations in Canada. This is accomplished through a description and analysis of the approaches taken by the public and private sectors as well as the four professions of law, engineering, accountancy and medicine. Ethical conduct within the public sector focuses on the ethical behaviour of public servants rather than elected officials. The underlying intent of this thesis is to discover if contemporary ethical problems are similar in the public and iv private sectors with respect to the four ethical areas of conflict of interest, political activity, problem public comment and confidentiality. The comparative data on both public and private sector ethics are assessed and similarities and differences are identified. One major finding emerges from this study. Codes of ethics in both the public and private sectors are perceived by management to play an important role in the prevention of unethical conduct. A procedure for developing a code of ethics is presented along with recommendations as to the administration of a code of ethics. Finally, recommendations are made as to the role of education in ethics.

Ethics in Health Policy for Allergy : A Practical Approach for Decision-Makers

Comme à l’approche d’un tsunami, l’incidence grandissante des allergies affecte maintenant plus de 30% de la population des pays développés. Étant la cause de nombreuses morbidités et un risque significatif de mortalité, les allergies nécessitent des dépenses exorbitantes au système de santé et constituent une des plus importantes sources d’invalidité. Cette thèse a pour but de contribuer à faciliter la prise de décision éclairée dans le développement de politiques en santé en lien avec cette maladie immunitaire chronique en utilisant des principes d’éthique comme outils pour guider le développement de politiques en santé. Le premier chapitre démontre le présent déficit d’analyses des enjeux éthiques en allergologie et démontre de quelle façon les réflexions en éthique peuvent guider le développement de politiques et l’élaboration de stratégies appliquées aux allergies. Les chapitres qui suivront présentent des applications spécifiques des principes d’éthiques ciblant des contextes précis comme des méthodes qui fournissent des outils de réflexion et des cadres théoriques qui peuvent être appliqués par les décideurs pour guider des interventions en santé concernant les allergies et les conditions de co-morbidité reliées. Le second chapitre présente un cadre théorique pour l’évaluation et la priorisation d’interventions en santé publique par la diminution des allergènes présents dans l’environnement basées sur des théories de justice sociale. Les critères entourant les politiques d’évaluation se concentrent sur les enjeux éthiques référant aux populations vulnérables, sur une distribution plus égale des bénéfices pour la santé, et sur le devoir d’éviter la stigmatisation. Le troisième chapitre offre aux administrateurs et au personnel infirmier du réseau scolaire un cadre décisionnel pour guider le développement de politiques efficaces et éthiquement justifiables concernant les allergies alimentaires pour les écoles. Dans ce contexte, les principes de base d’éthique en santé publique et en bioéthique - par exemple, l’empowerment des populations vulnérables dans la prise en charge de leur santé et la protection de la confidentialité du dossier médical - servent d’outils pour évaluer les politiques. Le dernier chapitre emploie les principes de base de recherche en éthique comme méthode pour développer un argumentaire en faveur de la réforme des réglementations entourant la production de médicaments immunothérapeutiques. La nécessité éthique d’éviter les risques de méfait à l’endroit du sujet humain dans la recherche permettra de servir de guide pour structurer de futures politiques en santé publique en égard à la production d’immunothérapeutiques à l’échelle mondiale.

A Synergistic Approach to Human Rights and Public Health Ethics: Effective or a Source of Conflict?

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