In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- (...) cause the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

ANNOTATION Sardak S.E. Global Regulatory System of Human Resources Development. – Manuscript. Thesis for the Doctor of Economic Science academic degree with major in 08.00.02 – World Economy and international economic relations. – SHEE «Kyiv National Economic University named after Vadym Hetman», Kyiv, 2014. The preconditions and factors of the global economic system with the identified relevant subjects areas and mechanisms of regulation instruments have been investigated. The crucial role of humans in the global economic system as a key (...) factor of production, the main resource, the producer and the consumer of economic and social benefits that are exposed to global threats, problems, challenges, trends and subjects has been confirmed. There have been revealed the causes and consequences of the public institutions transformation under the influence of globalization, which formed a qualitatively new conditions for social and economic development that determine the need for further changes in the areas of conceptual guideline for the management of human resources development, optimization of tasks, state and international institutions activity forms, integration of efforts as for monitoring, planning and forecasting. The modern major instruments and spheres of international cooperation to ensure human development have been determined. The integrated characteristic of human resources and their role in social development both from the standpoint of their use in labour processes and as a medium of civilization and social utility with the help of the categorical classification system organizing and expanding which enables to design and apply the appropriate approaches at all managerial levels have been defined. The necessity and the concept of human resources development in the context of the content of managerial influence identifying (self-development, self-management and external control of development) at different administrative levels that ensures the growth of human capital to the limits of its potential have been analysed. The survey of human activity system aspects in the global world, taking into account the parametrization of the global environment, its structure, management and development have been realized. The formed methodology principles of managerial influence on the development of human resources with scientific schools, hardness degrees, available models, research and providing theoretical and practical implementation peculiarities for groups of countries and territories of the world taken into consideration have been examined. There have been noted civilization and national differences in the forms of managerial influence on the development of human resources, which lead to the formation of human resources development national control systems conditioned by different value public strategic guidelines, especially in relation to social security, education, national management and state migration policy. The current and future requirements for global human resources development which are proposed to be achieved by the development and formalization of global civilizational paradigm of social development due to social coordination interaction have been given. The influence of the institute of state on the human resources development has been evaluated and it has been proved that in the beginning of the XXI century in the global environment the institute of state is the ultimate guarantor of its citizens’ labour ability and vital activity renewal, that makes it the main instrument of managerial influence on human development. The methodology of countries and territories matrix positioning by human development qualitative criteria and population size quantitative parameters which allows to design unified managerial measures as for human resources for similar national economies in the context of global regulatory trends has been proposed. The strategic trends of improvement of human resources development in the national economy, taking into account the differences in the development of human resources in different countries and areas which vary and differ in their focus, content and ways of implementation for such groups. The varying criteria for evaluating the effectiveness of the global impact on human resources development, taking into account the natural, biological, technological, economic, social and management dimensions and the results of human resources development management in social and economic systems at various levels have been revealed. The periodization and the forecast of the global dynamics of human resources development by analyzing and modeling the values of the absolute and relative terms correlation character have been carried out, which enables to make their retrospective and prospective comparison and to find chronological boundaries of qualitatively different periods. The configuration of the human resource development global coordinate system as a set of interrelated principles, components, fields, tools, frameworks, management levels and forms of managerial influence that allows with the help of institutional means to adapt the state of human resources development to a globally varying environment. (shrink)

Today’s education system needs to be global. ‘World Class Education’ involves a globally accepted high standard of education. Every country needs an increasing number of highly educated people and skilled professionals in order to integrate into the globalization process. These professionals include scholars, philosophers and leaders with vision. Leaders are our human capital. The state must provide opportunities for higher education to create human capital that meets global standards. The overall development of a society is largely determined by (...) the quality of its education, especially higher education. A well-educated, well-trained population could propel a nation towards rapid economic growth. Despite lack of natural resources, countries such as Japan, Korea and Singapore have made rapid economic progress. This was because they invested heavily in education and training. On the other hand, countries such as Nigeria or Congo, despite enormous natural resources, are poor and backward because of large-scale illiteracy and lack of skilled workforce. The aim of education is to create well-trained, competent and progressive individuals who can perform all kinds of tasks and take on a lot of responsibilities. Higher education is the stage of education that takes place at the post-secondary level, and is provided mostly and most meaningfully by universities. A university introduces its students to discussions and debates that prevail in various disciplines and fields of knowledge. The objective of a university is not only to create and disseminate knowledge but also to develop human resources that will accelerate the socio-economic development of the nation. This is possible only when the employees working in these universities are motivated and empowered. To achieve this objective, universities must restructure and redesign their HRD practices and processes. In this background, the present article analyzes the existing HRD practices and processes in 10 leading universities in India and how should these universities go about transforming their HR systems and mechanisms to meet the rapidly changing environmental demands. The research approach and methodology adopted to carry out this study includes collection of primary and secondary data. Primary data has been collected by administering a well-structured and well-designed questionnaire on HRD climate survey developed by XLRI Jamshedpur. The questionnaire had been administered to 1,000 respondents selected from the 10 leading universities of India. Data from both the sources were analyzed statistically by applying various statistical tools and techniques to find the conclusions, based on which the guidelines, recommendations and policy implications were made for the improvement of HRD practices in the universities. (shrink)

Using relevant encyclicals issued over the last 100 years, the author extracts those principles that constitute the underpinnings of Catholic Social Teaching about the employment relationship and contemplates implications of their incorporation into human resource policy. Respect for worker dignity, for his or her family's economic security, and for the common good of society clearly emerge as the primary guidelines for responsible human resource management. Dovetailing these three Church mandates with the economic objectives of the (...) firm could, in essence, alter the firm's nature because profit motivations would be constrained by consideration for worker and societal welfare. Integration of Church teaching with current corporate goals should therefore impact greatly on a variety of human resource policies. (shrink)

The purpose of the study is to determine the totality and content of key methodological approaches as conceptual foundations for designing the process of improving human resources of physical culture and sports. The article discusses the key provisions of resource, regional, functional, optimization; attention is focused on the concretization of the immanent principles of these approaches in relation to the problem of optimal management of human resources of physical culture and sports in the regional aspect. The scientific (...) novelty lies in the determination of the methodological contribution to the design of the concept of human resources management of physical culture and sports at the regional level of four basic approaches and their pairwise integration. As a result, the methodological contribution of the basic approaches to the developed concept was revealed and the key importance of their pairwise integration as target, meaningful, methodological guidelines for management was determined. (shrink)

This paper explains why it is desirable for employers to have whistleblowing codes, and draws upon professional guidelines and empirical research to suggest the possible contents of whistleblowing policies and procedures. The paper discusses who and what should be covered and examines the issues of confidentiality and anonymity, reprisals and malicious allegations. It also highlights the need to provide advice and assistance to those who have concerns about wrongdoing at work. The author outlines the possible stages in a whistleblowing (...) procedure, indicates how a concern should be raised and handled, and suggests how a procedure might be communicated and monitored. The paper concludes by emphasising that whistleblowing procedures provide an important safeguard against problems being overlooked and may be vital if legal pitfalls are to be avoided. (shrink)

In response to the many changes currently going on in health care, this book offers the combined insight and wisdom of a stellar group of scholars and professionals with extensive experience in the health care field. The book opens with a look at people's actual experience of health care today, from four different perspectives. It then addresses foundational questions, including the nature of medicine, nursing, and justice. Surveyed next are the changing economics of health care as well as the impact (...) of these changes on such areas as mental health care, long-term care, health care for minorities, and legal malpractice. The closing section of the book assesses from a Christian perspective available constructive alternatives, including creative funding strategies with special attention to the needs of poor persons, physician unions, and the use of "alternative medicine" therapies. (shrink)

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on health research conducted (...) in resource-poor settings. I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

The novel COVID-19 pandemic has placed medical triage decision-making in the spotlight. As life-saving ventilators become scarce, clinicians are being forced to allocate scarce resources in even the wealthiest countries. The pervasiveness of air travel and high rate of transmission has caused this pandemic to spread swiftly throughout the world. Ethical triage decisions are commonly based on the utilitarian approach of maximising total benefits and life expectancy. We present triage guidelines from Italy, USA and the UK as well as (...) the Jewish ethical prospective on medical triage. The Jewish tradition also recognises the utilitarian approach but there is disagreement between the rabbis whether human discretion has any role in the allocation of scarce resources and triage decision-making. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Human Genome Project and BioethicsEric T. Juengst, Ph.D. (bio)The fifteen-year "human genome project" at the National Institutes of Health and the Department of Energy officially began on October 1, 1990. With it began a new dimension in federally supported scientific research: concurrent funding for work to anticipate the social consequences of the project's research and to develop policies to guide the use of the knowledge it (...) produces. As a result, the National Center for Human Genome Research (NCHGR) at NIH will support the largest public investment in bioethical analysis to date.NCHGR was established to work with other federal, private, and international organizations on the scientific effort to characterize the form and content of the human genome. The research will yield information—high-resolution genetic linkage and physical maps of all the human chromosomes as well as human DNA sequence data—that will be a resource for studies of gene structure and function. It will greatly increase our understanding of the genetic aspects of human health and disease. That increased understanding will eventually provide insights into the prevention and treatment of the 3,000 known inherited disorders, and of conditions caused by our (gene-governed) physiological reactions to pathogens, toxins, and mutagens of external origin.It has been clear since the conception of the human genome project, however, that professional and public deliberations concerning the responsible use of genetic information must be a part of the process. The most immediate consequence of genome research will be the development of new diagnostic and predictive tests, well in advance of corresponding therapeutic or curative advances. The implications of acquiring and using that knowledge about individuals raise policy questions at many levels within society. The primary purpose of the Ethical, Legal and Social Implications Program at the NCHGR is to anticipate and address these questions early in the life of the scientific project, to help optimize the [End Page 71] benefits to human welfare and opportunity from the new knowledge, and to guard against its misuses.The program has identified three sets of questions as particularly important to pursue as the genome initiative proceeds:1.Issues involved in the integration of new genetic tests into medical practice. Human genome research is expected to increase greatly the number of gene-based diagnostic and prognostic tests available to health professionals. The bioethical policy problems involved in integrating those tests effectively into medical practice include developing standards for:— accuracy and quality control of genetic tests;— medical indications for testing and design of testing protocols;— professional responsibilities of clinicians who perform tests;— confidentiality of information obtained from testing;— access to and use of test results by third parties, such as health insurers; and— reimbursement for testing and test-related counseling.These are problems for both those charged with regulating the use of new genetic tests and for those establishing the standards of practice within the health professions. Thus, in addition to soliciting and funding scholarly research proposals on both the factual and normative questions raised by these problems, the program is commissioning a major new study by the National Academy of Sciences/Institute of Medicine aimed at providing professional guidelines for the integration of genetic services into mainstream medical practice.2. Issues involved in educating and counseling individuals about genetic test results. The primary risk that health professionals will face in using genetic tests is the misinterpretation of their findings and the resulting potential for psychological trauma, stigmatization, and discrimination. Sometimes, out of ignorance, patients, families, and social institutions already stigmatize genetic disorders and treat those with them unfairly. This risk broadens as the genetic elements of more health problems are uncovered and gene-based tests for susceptibilities and carrier states are developed.To protect against these risks, NCHGR is soliciting and supporting projects aimed at improving professional and public understanding of these tests and their implications. For example, a philosopher is leading a team of geneticists and physicians in a scholarly effort to clarify [End Page 72] concepts of genetic susceptibility and draw out the social meaning of their different interpretations. Other projects involve social scientific studies of genetic risk perceptions, stigmatization, and discrimination. The conclusions of these studies, and... (shrink)

Although high-performance human resource practices do not directly affect corporate social performance strengths, they do positively affect CSP strengths in companies that are highly innovative or have high levels of slack. High-performance human resource management practices also directly and negatively affect CSP concerns. Drawing on the resource-based view and using secondary data from an objective, third-party database, the authors develop and test hypotheses about how high-performance HRM affects a company’s CSP strengths and concerns. Findings suggest (...) that HRM and innovation are important capabilities because they create and enhance other capabilities. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for (...) the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

This paper stems from the current global worsening of the scarcity of resources for healthcare, which will deepen even more in future public emergencies. This justifies strengthening the reflection on the allocation of resources which, in addition to considering technical issues, should also involve ethical concerns. The two plans in which the allocation of resources develops—macro and micro—are then systematized, both requiring the identification of ethical criteria for the respective complex decision-making. Then, we describe how the complexity at the macro (...) level focuses on the joint consideration of the rectitude of the principles, the goodness of the ends, and the integrity—respectively the deontological, teleological, and procedural perspectives; and at the micro level, it focuses in prioritizing people, which can result in the exclusion of some, as happened with the elderly during peaks of COVID-19. The main objective of this article is to show that, in public health emergency situations, in which the daily criteria for prioritizing access to health care are not efficient, it is possible not only to ration the available means but also to rationalize them. We argue that rationing and rationalization are different concepts, entail different consequences, have different ethical foundations, and draw different guidelines for patient care. We apply them to the distribution of intensive care and vaccines to the elderly thus demonstrating the ethically legitimate domain of implementation of each of these two prioritization criteria. We conclude that rationalization respects more strictly the core ethical principles of our common morality. (shrink)

BackgroundIt is becoming increasingly apparent that the COVID-19 pandemic not only poses risks to physical health, but that it also might lead to a global mental health crisis, making the exploration of protective factors for mental well-being highly relevant. The present study seeks to investigate religious/spiritual well-being as a potential protective factor with regard to psychiatric symptom burden and addictive behavior.Materials and MethodsThe data was collected by conducting an online survey in the interim period between two national lockdowns with young (...) adults in Austria. The primary study variables were assessed through the Brief Symptom Inventory 18, the Alcohol, Smoking and Substance Involvement Screening Test and the Multidimensional Inventory for Religious/Spiritual Well-Being short version, with its sub-dimensions Hope, Forgiveness, General Religiosity, and Connectedness.ResultsWe observed HO and FO as substantial negative predictors of psychiatric symptom burden. With regard to addictive behavior, HO in particular but also GR seem to have a protective function. Furthermore, we found positive connections between CO, psychiatric symptom burden, and addictive behavior.ConclusionIn line with our assumptions, HO, FO and to a minor extent GR were confirmed as negative predictors regarding psychiatric symptom burden or addictive behavior in young adults, coping with the psychological threat of COVID-19 pandemic. These dimensions might be further considered as potential resources in clinical treatment. However, the positive prediction of mental illness parameters by increased feelings of CO could also be interpreted as an expression of exhaustion and alienation from the real world. (shrink)

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within (...) academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

Organizations are increasingly finding it challenging to balance economic and environmental performance particularly those that face competitive, regulatory and community pressure. With the increasing pressures for environmental sustainability, this calls for the new formulation of strategies by the manufacturers in order to minimize their products and services negative impact on the environment. Hence, Green Human Resource Management (GHRM) continues to be an important research agenda among the researchers. In Palestine, green issues are new and still developing. Constant study (...) is needed to fully understand and update information regarding this area. Objective: The aim of this paper is to explore the views and level of acceptance of GHRM practices among manufacturing firms in Palestine. Results: Through the use of e-mail survey, 121 responses were obtained to generate the results of the study. The result showed GHRM practices have been practiced to somewhat to a greater extent a firms in Palestine. Findings can be extended to study on the issues in further. Academicians and practitioners can apply this result to their research and business strategies on how to improve sustainable performance and to effectively implement GHRM practices. (shrink)

The research about strategic human resource management (SHRM) has suggested that human resource professionals (HRPs) have the opportunity to play a greater role in contributing to organizational success if they are effective in developing systems and policies aligned with the organization's values, goals, and mission. We suggest that HRPs need to raise the standard of their performance and that the competitive demands of the modern economic environment create implicit ethical duties that HRPs owe to their organizations. (...) We define ethical stewardship as a model of governance that honors obligations due to the many stakeholders and that maximizes long-term organizational wealth creation. We propose that if HRPs adopt an ethical stewardship framework and the qualities of transformative leaders, they will be more aware of their ethical duties to their organizations and more effective in helping their organizations to create increased wealth, achieve desired organizational outcomes, and establish work environments that are more satisfying to employees. (shrink)

According to the orthodox or humanist conception of human rights, individuals have a moral duty to promote the universal realization of human rights. However, advocates of this account express the implications of this duty in extremely vague terms. What does it mean when we say that we must promote human rights satisfaction? Does it mean that we must devote a considerable amount of our time and resources to this task? Does it mean, instead, that we must make (...) occasional donations to charities working to advance human rights realization? In this essay, I argue that this duty can only be constructed as imperfect. This means that it confers agent-relative discretion on us to decide when, how, and to what extent to advance the human rights of others. It also means that it is neither correlative with rights nor enforceable. As I will explain, the main reason for this is that any attempt to construct it as a perfect duty would infringe the dignity of the potential duty bearers and thereby undermine the very values that human rights practice aspires to serve. Finally, I will conclude by providing some guidelines for those who wish to comply with their imperfect duties to improve the situation of those whose human rights are in peril. (shrink)

Over the years, companies have adopted hiring algorithms because they promise wider job candidate pools, lower recruitment costs and less human bias. Despite these promises, they also bring perils. Using them can inflict unintentional harms on individual human rights. These include the five human rights to work, equality and nondiscrimination, privacy, free expression and free association. Despite the human rights harms of hiring algorithms, the AI ethics literature has predominantly focused on abstract ethical principles. This is (...) problematic for two reasons. First, AI principles have been criticized for being vague and not actionable. Second, the use of vague ethical principles to discuss algorithmic risks does not provide any accountability. This lack of accountability creates an algorithmic accountability gap. Closing this gap is crucial because, without accountability, the use of hiring algorithms can lead to discrimination and unequal access to employment opportunities. This paper makes two contributions to the AI ethics literature. First, it frames the ethical risks of hiring algorithms using international human rights law as a universal standard for determining algorithmic accountability. Second, it evaluates four types of algorithmic impact assessments in terms of how effectively they address the five human rights of job applicants implicated in hiring algorithms. It determines which of the assessments can help companies audit their hiring algorithms and close the algorithmic accountability gap. (shrink)

The human resource manager treads a fine line in seeking to reconcile the values of the organisation with professional values about the ethical management of people. This paper seeks to explore this ambiguity. The research findings suggest that the extent to which HR professionals can influence organisational ethics is dependent on the culture and structure of the organisation, as well as on the status and credibility of the HR specialists themselves. In the main there is little evidence that (...) their influence is significant. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for (...) the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

ZusammenfassungEs ist in der Literatur weithin bekannt, dass im Gesundheitswesen auf unterschiedlichen Ebenen Allokationsentscheidungen getroffen werden. Während es auf der Makroebene um gesellschaftlich-politische Strukturfragen geht, stehen die Akteure der Mikroebene vor der Aufgabe, begrenzte Ressourcen in einer Organisation sinnvoll einzusetzen. In den ethischen Analysen der Mikro-Allokationsebene werden zumeist Entscheidungen der Healthcare Professionals thematisiert, weil sie eine unmittelbare Auswirkung auf die konkreten Patienten haben. Weniger in den Blick geraten Allokationen des Managements, welche die Rahmenbedingungen für Ressourcenzuteilungen beim Patienten betreffen. Hierbei geht (...) es nicht bloß um den Einsatz von Sachmitteln, sondern auch um den Personaleinsatz. Das Personalmanagement ist damit in wichtige Allokationsentscheidungen eingebunden und trägt eine dreifache Verantwortung: für die Gesundheit der Patienten, der Mitarbeiter und der Organisation. Der vorliegende Beitrag geht der Frage nach, welche Aspekte der Allokationsethik aus der Sicht des Personalmanagements in einem Krankenhaus zu bedenken sind, um der dreifachen Verantwortung gerecht zu werden. Dadurch zeigt sich, dass Allokationsethik in einem Krankenhaus nicht adäquat erfasst werden kann, ohne sich mit dem Personalmanagement zu beschäftigen, da das Personal die wertvollste Ressource ist, die es in einem Krankenhaus zu allozieren gilt. (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed (...) the REC of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

In this paper I proceed on the assumption that moral philosophers can and should contribute to the resolution of perplexing moral problems. The ones considered here relate to decisions concerning the distribution of scarce medical resources as between those in need of treatment. I draw on considerations of egalitarianism and concern for the maximization of the use of scarce resources in the task of satisfying basic human needs (such as for good health). I propose certain principles and offer some (...) supporting suggestions as guidelines or rules for medical decisions with a view to providing a helpful decision procedure for the various persons (doctors, community panels and so on) whose task it is to make the life-or-death decisions involved in allocating certain scarce medical resources. -/- . (shrink)

The purpose of this study is to examine how workgroup diversity can be managed through specific strategic human resource management systems. Our review shows that ‘affirmative action’ and traditional ‘diversity management’ approaches have failed to simultaneously achieve business and social justice outcomes of diversity. As previous literature has shown, the benefits of diversity cannot be achieved with isolated interventions. To the contrary, a complete organizational culture change is required, in order to promote appreciation of individual differences. The paper (...) contributes to this discussion by exploring the implications of this change for human resource management, and explaining how the systems of practices should be changed when they are directed to diverse groups. The model designed to test this notion includes: (1) demographic and human capital diversity as independent variables, (2) group performance (measured as innovation outcomes) as the dependent variable and, (3) the orientation of the strategic human resource management system as a potential moderator of this relationship. The main conclusion of the empirical analysis developed is that different patterns of human resource management practices can be used, depending on the type of diversity that the organization faces, and the specific effects that it wishes to manage. Concretely, three alternative management systems are identified in this paper, with different moderating effects. This result has interesting implications for human resource management professionals, explained in the last section. The limitations of this study are also discussed, as well as some issues that future research in this field should address. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols (...) informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

The book examines ethics and employment issues in contemporary Human Resource Management (HRM). Written by an international team of academics from universities in the UK, the US, Australia and New Zealand, it examines the problems and opportunities facing employers and employees. The book subdivides into three sections: Part I assesses the context of HRM; Part II analyses contemporary debates, continuity and change in HRM, and Part III proposes likely developments for the future seeking to identify a more proactive (...) HRM approach towards ethical issues arising in employment. Distinctive features include: -/- -Comprehensive analysis of continuity and change in employment and HRM -In-depth assessment of the ethical contribution and potential of HRM -Timely evaluation of the ethical achievements to-date of HRM in: individualized employment relations, HRM partnerships, HRM and employee performance, and strategic HRM -Detailed recommendations for HR managers and general managers encouraging more ethically aware practice -Guidance on ethical approaches to leadership, knowledge management and collective employment relations -Analysis of alternative futures for HRM as a profession and advice on how to create more rigorous and independent professional practice -A vision of a more innovative, cooperative and ethically sensitive set of HRM practices -Clear proposals for HRM on how to attain more ethical conduct. (shrink)

Formulating and translating corporate social responsibility strategy into actual managerial practices and outcome values remain ongoing challenges for many organizations. This paper argues that the human resource management function can potentially play an important role in supporting organizations to address this challenge. We argue that HRM could provide an interesting and dynamic support to CSR strategy design as well as implementation and delivery. Drawing on a systematic review of relevant strategic CSR and HRM literatures, this paper highlights the (...) important interfaces between CSR and HRM and develops a conceptual model, the CSR-HRM co-creation model, which accounts for the potential HRM roles in CSR and identifies a range of outcome values resulting from a more effective integration of the role of HRM within CSR. The paper concludes with relevant theoretical and managerial recommendations that advance our understanding of the potential interfaces between HRM and CSR and how HRM can support a systematic and progressive CSR agenda. (shrink)

Nowadays there is a growing interest in business ethics, both in academia and professionally. However, moral lapses continue to happen in business activities, leading academicians and professionals to rethink what is being done and reinventing new strategies to successfully manage ethics in business organisations. Thus, whereas efforts to promote ethics are basically oriented to using and developing explicit, written formal mechanisms, the literature suggests that other instruments are also useful and necessary to achieve this. Thus, studying the role of the (...) Human Resource Management (hereafter, HRM) in promoting ethics is an emerging research topic due to the heavy influence that HRM practices are thought to have on employees. This paper is aimed at developing a thorough analysis of HRM's role in promoting ethics, and specifically at focusing on one of its practices, training. As an illustrative example of the utility of this practice, an empirical study was conducted on a range of Spanish banking companies in which an impact was found on the employees' ethical behaviour when ethics training was being provided inside the organisation. Finally, the practical implications of these findings and directions for future research are presented. (shrink)

In her groundbreaking work, Elinor Ostrom suggested that communities are able to self-organize and develop rules which allow them to effectively manage common-pool resources while avoiding the “tragedy of the commons”, as proposed by Hardin. Based on empirical case studies of how forests, irrigation, grazing land and fisheries are organized all over the world, Ostrom suggested several principles that can serve as guidelines for managing common-pool resources. In the 21st century new initiatives have been based on sharing. There are (...) various examples such as car and bike sharing in cities, internet platforms such as Wikipedia, community gardens and many others. There is a reason to believe that these efforts will continue to grow and become more popular as people realise the economic, social and ecological benefits. The aim of this paper is to analyse to what extent Ostrom’s findings are relevant to these new, often urbanised or digitalised forms of sharing. Can the famous design principles for which she won the Nobel prize be applied or do we need to search for a different set of principles that are more suitable for these new emerging forms of ‘the commons’? Our findings suggest that although Ostrom’s framework needs to be adapted before being applied to the reality of urban and digitalised environments, some of her findings remain relevant. (shrink)

Drawing on the theoretical insights from the resource-based view of the firm, this paper explores how human resource systems may contribute to competitive advantage by facilitating the development and maintenance of five types of ethical climates, and conversely, how HR systems may hinder competitive advantage by inhibiting the development and maintenance of these climate types. In so doing, this paper contributes to the literature by highlighting the resource worthiness of a firm's ethical climates and showing how (...) HR systems may influence that value. In addition, it advances theory that underpins the concept of competitive advantage sustainability and provides a platform for future empirical research. (shrink)

This article examines the potential for moral agency in human resource management practice. It draws on an ethnographic study of human resource managers in a global organization to provide a theorized account of situated moral agency. This account suggests that within contemporary organizations, institutional structures—particularly the structures of Anglo-American market capitalism— threaten and constrain the capacity of HR managers to exercise moral agency and hence engage in ethical behaviour. The contextualized explanation of HR management action directly (...) addresses the question of whether HRM is inherently unethical. The discussion draws on MacIntyre’s conceptualization of moral agency within contemporary social structures. In practice, HR managers embody roles that may not be wholly compartmentalized. Alternative institutional structures can provide HR managers with a vocabulary of motives for people-centred HRM and widen the scope for the exercising of moral agency, when enacted within reflective relational spaces that provide milieus for critical questioning of logics and values. This article aims to contribute to and extend debate on whether HRM can ever be ethical, and provide a means of reconnecting business ethics with longstanding concerns in critical management studies. (shrink)

BackgroundHuman biological materials are usually stored for possible future use in research because they preserve valuable biological information, save time and resources, which would have been spent on collection of fresh samples. However, use of these materials may pose ethical challenges such as unauthorized disclosure of genetic information, which can result in dire consequences for individuals or communities including discrimination, stigma, and psychological harm; has biosecurity implications; and loss of control or ownership of samples or data. To understand these problems (...) better, we evaluated the extent to which tuberculosis (TB) clinical research protocols that were used to collect and store biological materials for future use conform to the requirements stated in the Uganda national guidelines for research involving humans as participants.MethodsThis was a retrospective review of TB clinical research projects approved by the Uganda National Council for Science and Technology (UNCST) from 2011 to 2015, to examine whether they fulfilled the requirements for ethical collection and use of human materials. Data were abstracted through review of the project protocols using a template developed based on the informed consent and the Materials Transfer Agreement (MTA) requirements in the national guidelines.ResultsOut of 55 research protocols reviewed, most of the protocols 83.6% had been used to collect the stored samples (sputum, blood and sometimes urine), 28% had a section on specimen collection and 24% mentioned ownership of the biological materials. With respect to review of the consent forms used in the studies that stored materials for future use, only 9% of the protocols had a separate consent form for storage of materials, 4.5% of the consent forms explained the risks, 11.4% explained the purpose of the study while 6.8% mentioned the place of storage for the collected materials.ConclusionMany of the studies reviewed did not meet the requirements for collection and storage of biological materials contained in the national guidelines, which indicates a need to additional training on this topic. (shrink)

Background Compensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regulated. The objective of this paper is to discuss the current regulations for compensation of research participants in Malawi and how they can be improved in relation to ethical concerns of coercion, undue influence, and exploitation. Main text In Malawi, national regulations recommend that research subjects be compensated with a stipend of US$10 per (...) study visit. However, no guidance is provided on how this figure was determined and how it should be implemented. While necessary to prevent exploitation, the stipend may expose the very poor to undue influence. The stipend may also raise the cost of doing research disadvantaging local researchers and may have implications on studies where income stipend is the intervention under investigation. We recommend that development and implementation of guidelines of this importance involve interested parties such as the research community and patient groups. Conclusion Compensating human research subjects is important but can also act as a barrier to voluntary participation and good research efforts. Deliberate measures need to be put in place to ensure fair compensation of research participants, avoid their exploitation and level the field for locally funded research. (shrink)

The present paper analyses how top managers construct the meaning of sustainable human resource management and its responsibility areas and how they identify and prioritize stakeholders in sustainable HRM. The empirical data were collected as part of the Finnish HR Barometer inquiry. A qualitative analysis reveals four dimensions of sustainable HRM: Justice and equality, transparent HR practices, profitability, and employee well-being. It also reveals four broader responsibility areas: Legal and ethical, managerial, social, and economic. Contrary to the prior (...) green HRM literature, ecological responsibility was largely ignored. The study also reveals a wide range of stakeholders, specifically, owners, managers, employees, customers, and employee representatives, as well as their special roles and requirements for sustainable HRM. These findings contribute to the literature of sustainable HRM by illustrating the dimensions and broader responsibilities of sustainable HRM as seen by top managers. Their conceptions of sustainable HRM are largely neglected in the prior literature despite their crucial role in legitimating HRM and thus sustainable HRM in companies. These results also contribute to the theory of stakeholder salience in the sustainable HRM context from the viewpoint of top managers. (shrink)

This article analyses whether benefits arising for human resource management from environmental management activities drive environmental management system implementation. Focusing on employee satisfaction and recruitment/retention, it tests this for German manufacturing firms in 2001 and 2006 and incorporates a rare longitudinal element into the analysis. It confirms positive associations of the benefit levels for both variables with environmental management system implementation on a large scale. Also it provides evidence that increasing levels of environmental management system implementation result from (...) higher economic benefits in the human resource domain. In doing so the article supplies needed quantitative evidence on important aspects of how sustainability relates to human resource management. (shrink)

It proposed that certain types of human resource (HR) practices can be both normatively rooted and also instrumental in achieving economic goals. Specifically,managers may perceive organizational justice HR practices and work-family conflict HR practices as a legitimate response to these seemingly conflicting interests. Legitimacy evaluations of HR practices by managers are also likely to impact managerial perceptions of organizational reputation.

The Human Heredity and Health in Africa Consortium is a conglomeration of research and infrastructure projects spread throughout Africa whose aim is to apply genomic methodology to diseases affecting the people in the region. Its operation is innovative in the sense that it is doing something new; that is, filling a hitherto existing void in genomic research capability of African scientists and infusing resources and manpower to institutions and investigators across Africa. But aside from developing and sustaining capacity in (...) genomic research and biorepositories, H3Africa is also invested in developing appropriate ethical regulatory regime to govern research in these areas. This latter concern –research ethics governance – is the major subject of this paper. Specifically, the paper discusses protection of research participants as envisaged by H3Africa in the area of consent, safeguarding privacy, maintaining confidentiality of health information and sharing of data/biospecimens. The ultimate goal is to determine whether H3Africa initiatives and processes are consistent or at odds with international guidelines and best practices. (shrink)

South Africa is characterised by rapidly escalating crime, including white-collar crime, and unethical behaviour in public and private organisations. This necessitates innovative ways to deal with the situation. The objective of this conceptual and theoretical research is to investigate ways in which human resource management can be utilised to instil and develop an ethical corporate culture in South African organisations. A theoretical model of ethical behaviour is discussed as a basis for this study. It is indicated that (...) class='Hi'>human resource management can have an effect on organisational factors and is therefore an important tool in developing an ethical corporate culture. (shrink)

Business Ethics, the Environment & Responsibility, Volume 31, Issue 2, Page 524-535, April 2022.

The research about strategic human resource management (SHRM) has suggested that human resource professionals (HRPs) have the opportunity to play a greater role in contributing to organizational success if they are effective in developing systems and policies aligned with the organization’s values, goals, and mission. We suggest that HRPs need to raise the standard of their performance and that the competitive demands of the modern economic environment create implicit ethical duties that HRPs owe to their organizations. (...) We define ethical stewardship as a model of governance that honors obligations due to the many stakeholders and that maximizes long-term organizational wealth creation. We propose that if HRPs adopt an ethical stewardship framework and the qualities of transformative leaders, they will be more aware of their ethical duties to their organizations and more effective in helping their organizations to create increased wealth, achieve desired organizational outcomes, and establish work environments that are more satisfying to employees. (shrink)

This field study investigated the relationship between strategic human resource management, internal environmental concern, organizational citizenship behavior for the environment, and environmental performance. The originality of the present research was to link human resource management and environmental management in the Chinese context. Data consisted of 151 matched questionnaires from top management team members, chief executive officers, and frontline workers. The main results indicate that organizational citizenship behavior for the environment fully mediates the relationship between strategic (...) class='Hi'>human resource management and environmental performance, and that internal environmental concern moderates the effect of strategic human resource management on organizational citizenship behavior for the environment. (shrink)

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable (...) expectation of substantial public benefit should be a necessary condition for regarding research as ethical only when it imposes more than minimal risks on non-consenting subjects; or it is supported by public resources. (shrink)

The purpose of this article is to investigate how Human Resources (HR) contributes to responsible leadership. Although Corporate Social Responsibility (CSR) practices have been embraced by many corporations in recent years, the specific contributions of HR professionals, HR management practices and employees to responsible leadership have been overlooked. Relying on the analysis of interviews with 30 CSR and HR corporate executives from 22 corporations operating in France, we specify the HR contributions to responsible leadership at the functional, practical, and (...) relational levels of analysis. We analyze whether and how HR support employees’ involvement in CSR, and highlight areas of collaboration and tension between HR and CSR functions around emerging practices of responsible leadership. Our findings uncover the multiple yet often implicit roles of HR in responsible leadership as well as the interrelation between functional, practical and relational dimensions of these roles. Finally, this study suggests that the organization of the HR–CSR interface can enable or undermine the HR contributions to responsible leadership and points to underlying cognitive factors that shape the HR–CSR interface. (shrink)

The human resource manager treads a fine line in seeking to reconcile the values of the organisation with professional values about the ethical management of people. This paper seeks to explore this ambiguity. The research findings suggest that the extent to which HR professionals can influence organisational ethics is dependent on the culture and structure of the organisation, as well as on the status and credibility of the HR specialists themselves. In the main there is little evidence that (...) their influence is significant. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)