The guidelines of _Scientia et Fides_ can be found on: https://www.chicagomanualofstyle.org/tools_citationguide/citation-guide-2.html or https://apcz.umk.pl/SetF/about/submissions.

Background Intensivists must provide enough analgesia and sedation to ensure dying patients receive good palliative care. However, if it is perceived that too much is given, they risk prosecution for committing euthanasia. The goal of this study is to develop consensus guidelines on analgesia and sedation in dying intensive care unit patients that help distinguish palliative care from euthanasia. Methods Using the Delphi technique, panelists rated levels of agreement with statements describing how analgesics and sedatives should be given to (...) dying ICU patients and how palliative care should be distinguished from euthanasia. Participants were drawn from 3 panels: 1) Canadian Academic Adult Intensive Care Fellowship program directors and Intensive Care division chiefs (N = 9); 2) Deputy chief provincial coroners (N = 5); 3) Validation panel of Intensivists attending the Canadian Critical Care Trials Group meeting (N = 12). Results After three Delphi rounds, consensus was achieved on 16 statements encompassing the role of palliative care in the intensive care unit, the management of pain and suffering, current areas of controversy, and ways of improving palliative care in the ICU. Conclusion Consensus guidelines were developed to guide the administration of analgesics and sedatives to dying ICU patients and to help distinguish palliative care from euthanasia. (shrink)

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)

Technologies to rapidly alert people when they have been in contact with someone carrying the coronavirus SARS-CoV-2 are part of a strategy to bring the pandemic under control. Currently, at least 47 contact-tracing apps are available globally. They are already in use in Australia, South Korea and Singapore, for instance. And many other governments are testing or considering them. Here we set out 16 questions to assess whether — and to what extent — a contact-tracing app is ethically justifiable.

Covid‐19 confronts us with tragic choices, in which every option is unacceptable. On the New York State Task Force on Life and the Law, I worked on guidelines for such situations. We did not envision the scale or character of Covid‐19. To minimize fear that the decisions made in these situations might be unfair, we all must know what guidelines or mandates inform them. Only with transparency about how decisions will be made, by whom, and according to what (...) requirements can we have confidence that fairness prevails. We now face many related questions about process, goals, leadership, and trust. For example, how might ethical guidelines evolve as scientific understanding advances? Should guidelines vary with different venues? And if, as I have argued, judgment is necessary even with the best of guidelines, how can we prepare clinicians to make good judgments? Are there implications for better training of personnel in nonemergency times for what they might face in the worst of times? (shrink)

Ontologies are being used increasingly to promote the reusability of scientific information by allowing heterogeneous data to be integrated under a common, normalized representation. Definitions play a central role in the use of ontologies both by humans and by computers. Textual definitions allow ontologists and data curators to understand the intended meaning of ontology terms and to use these terms in a consistent fashion across contexts. Logical definitions allow machines to check the integrity of ontologies and reason over data annotated (...) with ontology terms to make inferences that promote knowledge discovery. Therefore, it is important not only to include in ontologies multiple types of definitions in both formal and in natural languages, but also to ensure that these definitions meet good quality standards so they are useful. While tools such as Protégé can assist in creating well-formed logical definitions, producing good definitions in a natural language is still to a large extent a matter of human ingenuity supported at best by just a small number of general principles. For lack of more precise guidelines, definition authors are often left to their own personal devices. This paper aims to fill this gap by providing the ontology community with a set of principles and conventions to assist in definition writing, editing, and validation, by drawing on existing definition writing principles and guidelines in lexicography, terminology, and logic. (shrink)

Clinical guidelines are special types of plans realized by collective agents. We provide an ontological theory of such plans that is designed to support the construction of a framework in which guideline-based information systems can be employed in the management of workflow in health care organizations. The framework we propose allows us to represent in formal terms how clinical guidelines are realized through the actions of are realized through the actions of individuals organized into teams. We provide various (...) levels of implementation representing different levels of conformity on the part of health care organizations. Implementations built in conformity with our framework are marked by two dimensions of flexibility that are designed to make them more likely to be accepted by health care professionals than standard guideline-based management systems. They do justice to the fact 1) that responsibilities within a health care organization are widely shared, and 2) that health care professionals may on different occasions be non-compliant with guidelines for a variety of well justified reasons. The advantage of the framework lies in its built-in flexibility, its sensitivity to clinical context, and its ability to use inference tools based on a robust ontology. One disadvantage lies in its complicated implementation. (shrink)

Current guidelines treat palliative sedation to unconsciousness as an effective medical treatment for terminally ill patients who need relief from severe symptoms, yet also restrict its use in ways that are extraordinary for medical treatments. A closer look at the kinds of cases in which palliative sedation is used suggests a way of adjusting the guidelines to resolve this seeming contradiction.

Global fatalities related to COVID-19 are expected to be high in 2020–2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods—that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and (...) against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made. (shrink)

Human embryo models formed from stem cells—known as embryoids—allow scientists to study the elusive first stages of human development without having to experiment on actual human embryos. But clear ethical guidelines for research involving embryoids are still lacking. Previously, a handful of researchers put forward new recommendations for embryoids, which they hope will be included in the next set of International Society for Stem Cell Research guidelines. Although these recommendations are an improvement over the default approach, they are (...) nonetheless unworkable, because they rely on a poorly conceived notion of an embryoid’s ‘potential’ to trigger stringent research regulations. (shrink)

The COVID-19 pandemic has been overwhelming public health-care systems around the world. With demand exceeding the availability of medical resources in several regions, hospitals have been forced to invoke triage. To ensure that this difficult task proceeds in a fair and organised manner, governments scrambled experts to draft triage guidelines under enormous time pressure. Although there are similarities between the documents, they vary considerably in how much weight their respective authors place on the different criteria that they propose. Since (...) most of the recommendations do not come with ethical justifications, analysing them requires that one traces back these criteria to their underlying theories of distributive justice. In the literature, COVID-19 triage has been portrayed as a value conflict solely between utilitarian and egalitarian elements. While these two accounts are indeed the main antipodes, I shall show that in fact all four classic theories of distributive justice are involved: utilitarianism, egalitarianism, libertarianism, and communitarianism. Detecting these in the documents and classifying the suggested criteria accordingly enables one to understand the balancing between the different approaches to distributive justice—which is crucial for both managing the current pandemic and in preparation for the next global health crisis. (shrink)

Historically, scientists in training have learned the rules of ethical conduct by the example of their advisors and other senior scientists and by practice. This paper is intended to serve as a guide for the beginning scientist to some fundamental principles of scientific research ethics. The paper focuses less on issues of outright dishonesty or fraud, and more on the positive aspects of ethical scientific behavior; in other words, what a scientist should do to maintain a high level of ethical (...) conduct in research.There are a number of fairly specific rules, guidelines, or commonly accepted operating principles that have evolved for the ethical conduct of science. In order to discuss this code of ethics, this paper is divided into sections dealing with specific areas of scientific ethics. These areas are: data collection and storage, ownership of data, confidentiality, communication, authorship, collaboration, the peer review system, and rules of dealing with ethical complaints. Illustrative case histories are presented to provide examples of the type of ethical dispute or problem being discussed. If scientific trainees learn the accepted rules of behavior that govern the conduct of science, ethical problems that arise out of ignorance, misunderstanding, or poor communication can be avoided. (shrink)

Although guidelines to regulate user involvement in research have been advocated and implemented for several years, literature still describes the process as challenging. In this qualitative study, we take a critical view on guidelines that are developed to regulate and govern the collaboration process of user involvement in research. We adapt a social constructivist view of guidelines and our aim is to explore how guidelines construct the perception of users and researchers and thus the process of (...) involvement. Twenty‐two guidelines published between 2006 and 2019 were analyzed iteratively. The analysis focuses on values which are emphasized in the guidelines on the distribution of entities, knowledge, and tasks between users and researchers. The analysis indicates that users and researchers are constructed differently; researchers are mainly constructed as responsible initiators and caretakers, while users are constructed as powerless and vulnerable. The guidelines portray the collaboration process as harmonious and assume a normative perspective. In doing so, challenges described in the literature related to power imbalances are not addressed. Based on these findings, we ask if these guidelines might function to maintain existing power imbalances between users and researchers. (shrink)

In the face of a perceived lack of widespread understanding of the theoretical issues underlying the development, dissemination and implementation of clinical guidelines, the Royal College of General Practitioners Guidelines Group developed a 2-day course aimed at teaching the theory in these areas. The course was targeted at potential opinion formers and ran on six occasions. Postal questionnaire assessment of the course revealed high levels of satisfaction with all aspects of the course and high levels of reported use (...) of the knowledge gained. Further developments of the course are discussed. (shrink)

The aim of this article is to articulate and critically discuss different answers to the following question: How should decision-makers deal with conflicts that arise when the values usually entailed in ethical guidelines – such as accuracy, privacy, non-discrimination and transparency – for the use of Artificial Intelligence clash with one another? To begin with, I focus on clarifying some of the general advantages of using such guidelines in an ethical analysis of the use of AI. Some disadvantages (...) will also be presented and critically discussed. Second, I will show that we need to distinguish between three kinds of conflict that can exist for ethical guidelines used in the moral assessment of AI. This section will be followed by a critical discussion of different answers to the question of how to handle what we shall call internal and external values conflicts. Finally, I will wrap up with a critical discussion of three different strategies to resolve what is called a ‘genuine value conflict’. These strategies are: the ‘accepting the existence of irresolvable conflict’ view, the ranking view, and value monism. This article defends the ‘accepting the existence of irresolvable conflict’ view. It also argues that even though the ranking view and value monism, from a merely theoretical point of view, are better equipped to solve genuine value conflicts among values in ethical guidelines for artificial intelligence, this is not the case in real-life decision-making. Keywords: AI; ethical guidelines; algorithm-based sentencing; value conflicts. (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work (...) done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

The World Health Organisation declared COVID-19 a global pandemic on 11th March 2020, recognising that the underlying SARS-CoV-2 has caused the greatest global crisis since World War II. In this chapter, we present a framework to evaluate whether and to what extent the use of digital systems that track and/or trace potentially infected individuals is not only legal but also ethical.

The coronavirus crisis is causing considerable disruption and anguish. However, the COVID-19 pandemic and consequent explosion of telehealth services also provide an unparalleled opportunity to consider ethical, legal, and social issues beyond immediate needs. Ethicists, informaticians, and others can learn from experience, and evaluate information technology practices and evidence on which to base policy and standards, identify significant values and issues, and revise ethical guidelines. This paper builds on professional organizations’ guidelines and ELSI scholarship to develop emerging concerns (...) illuminated by current experience. Four ethical themes characterized previous literature: quality of care and the doctor–patient relationship, access, consent, and privacy. More attention is needed to these and to expanding the scope of ethical analysis to include health information technologies. An applied ethics approach to ELSI would addresses context-specific issues and the relationships between people and technologies, and facilitate effective and ethical institutionalization of telehealth and other health information technologies. (shrink)

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work (...) done since 1990 at the Institute of Medicine and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic? (shrink)

Open peer review (OPR) is moving into the mainstream, but it is often poorly understood and surveys of researcher attitudes show important barriers to implementation. As more journals move to implement and experiment with the myriad of innovations covered by this term, there is a clear need for best practice guidelines to guide implementation. This brief article aims to address this knowledge gap, reporting work based on an interactive stakeholder workshop to create best-practice guidelines for editors and journals (...) who wish to transition to OPR. Although the advice is aimed mainly at editors and publishers of scientific journals, since this is the area in which OPR is at its most mature, many of the principles may also be applicable for the implementation of OPR in other areas (e.g., books, conference submissions). (shrink)

Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to (...) an annual deductible and to a percentage of covered expenses, co-paid by the employee, for each service. In recent years, however, employers in greater numbers have switched to so-called self-insurance plans in which employees’ health care claims are paid directly by the employer. (shrink)

Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to (...) an annual deductible and to a percentage of covered expenses, co-paid by the employee, for each service. In recent years, however, employers in greater numbers have switched to so-called self-insurance plans in which employees’ health care claims are paid directly by the employer. (shrink)

This paper presents a pedagogical framework for teaching cross-cultural clinical ethics. The approach, offered at the intersection of anthropology and bioethics, is innovative in that it takes on the “social sciences versus bioethics” debate that has been ongoing in North America for three decades. The argument is made that this debate is flawed on both sides and, moreover, that the application of cross-cultural thinking to clinical ethics requires using the tools of the social sciences within a principles-based framework for clinical (...) ethics. This paper introduces the curriculum and provides guidelines for how to teach cross-cultural clinical ethics. The learning points that are introduced emphasize culture in its relation to power and underscore the importance of viewing both biomedicine and bioethics as culturally constructed. (shrink)

The paper develops value based management guidelines from the famous Indian treatise on management, Kautilya's Arthashastra. Guidelines are given for individual components of a total framework in detail, which include guidelines for organizational philosophy, value based leadership, internal corporate culture, accomplishment of corporate purpose and feedback from stakeholders.

This article explicates, in a concrete, step-by-step manner, some procedures that can be followed in phenomenologically analyzing interview data. It also addresses a number of issues that are raised in relation to phenomenological research.

Reuse of elements from existing ontologies in the construction of new ontologies is a foundational principle in ontological design. It offers the benefits, among others, of consistency and interoperability between such knowledge structures as well as sharing resources. Reuse is widely found within important collections of established ontologies, such as BioPortal and the OBO Foundry. However, reuse comes with its own potential problems involving ontological commitment, granularity, and ambiguity. Guidelines are proposed to aid ontology developers and curators in their (...) prospective reuse of content. These guidelines have been gleaned over years of practice in the ontology field. The guidelines are couched in experiential reports on designing and curating particular ontologies (e.g., EXACT and EXACT2) and using generally accepted approaches (e.g., MIREOT) in doing so. Various software tools to assist in ontology reuse are surveyed and discussed. (shrink)

Professional statements guide neonatal resuscitation thresholds at the border of viability. A 2015 systematic review of international guidelines by Guillen et al. found considerable variability between statements’ clinical recommendations for infants at 23–24 weeks gestational age (GA). The authors concluded that differences in the type of data included were one potential source for differing resuscitation thresholds within this “ethical gray zone.” How statements present ethical considerations that support their recommendations, and how this may account for variability, has not been (...) as rigorously explored. We performed a mixed-methods exploratory analysis of 25 current international guidelines for neonatal resuscitation at 22+0−25+0 weeks GA. Qualitative analysis using a modified grounded theory yielded 34 distinct codes, eight categories, and four overarching themes. Three themes, consequentialism, principlism, and rights-based, consisted of concepts central to these ethical frameworks. The fourth theme, clinical reasoning, described counseling practices, medical management, outcomes data, and prognostic uncertainty, without any ethical context. The theme of clinical reasoning appeared in 22 of 25 guidelines. Ten guidelines lacked any ethical theme. Guidelines with an identified ethical theme were more likely to recommend comfort care than guidelines without an identified ethical theme, and recommended it at a higher average GA (22.7 weeks vs. 22.0 weeks, p = 0.03). Thus, how ethical concepts are incorporated into guidelines potentially impacts resuscitation thresholds. We argue that inclusion of explicit discussion of ethical considerations surrounding resuscitation in the “gray zone” would clarify values that inform recommendations and facilitate discussions about how neonatology ought to approach periviability as outcomes continue to evolve. (shrink)

The theory of granular partitions (TGP) is a new approach to the understanding of ontologies and other classificatory systems. The paper explores the use of this new theory in the treatment of task-based clinical guidelines as a means for better understanding the relations between different clinical tasks, both within the framework of a single guideline and between related guidelines. We used as our starting point a DAML+OIL-based ontology for the WHO guideline for hypertension management, comparing this with related (...) guidelines and attempting to show that TGP provides a flexible and highly expressive basis for the manipulation of ontologies of a sort which might be useful in providing more adequate Computer Interpretable Guideline Models (CIGMs) in the future. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in (...) local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

In February 1975, a group of leading scientists, physicians, and policymakers convened at Asilomar, California, to consider the safety of proceeding with recombinant DNA research. The excitement generated by the promise of this new technology was counterbalanced by concerns regarding dangers that might arise from it, including the potential for accidental release of genetically modified organisms into the environment. Guidelines developed at the conference to direct future research endeavors had several consequences. They permitted research to resume, bringing to an (...) end the voluntary moratorium that the National Academy of Sciences had instituted several months earlier. They also served to illustrate that the scientific community was capable of self-governance, thereby securing public trust and persuading Congress not to institute legislative restrictions. Finally, they underscored the importance of weighing unforeseen risks inherent in some research against potential benefits that may arise from these same endeavors. (shrink)

This Report examines the ethical implications of electronic communication, focusing on the use of electronic mail (e-mail), considers its impact on a previously established patient-physician relationship, and the limitations in using e-mail to create a new patient-physician relationship. In its recommendations, this report offers guidance to physicians who use electronic mail to communicate with patients and online users. These guidelines maintain that e-mail should not be used to establish a patient-physician relationship, but rather to supplement personal encounters. When using (...) e-mail, physicians hold the same ethical responsibilities to their patients as they do during other encounters and that information must be presented in a manner that meets professional standards. The report requires that physicians notify patients of e-mail's inherent limitations and that patients be given the opportunity to accept these limitations prior to the communication of privileged information. Finally, physicians should be aware of privacy and confidentiality concerns when using e-mail to communicate with patients. (shrink)

Realization can be roughly understood as a kind of role-playing, a relationship between a property that plays a role and a property characterized by that role. This rough sketch previously received only moderate elaboration; recently, however, several substantive theories of realization have been proposed. But are there any general constraints on a theory of realization? What is a theory of realization supposed to accomplish? I first argue that a view of realization is viable, in part, to the extent that physical (...) realization under that view explains or accounts for why instances of realized properties are necessitated by how things are physically in a modally strong sense. In this sense, I claim that physical realization should explain physical supervenience. I then call into question two alternative desiderata and raise a challenge for attempts to explicate realization in terms of isomorphism or analogy. Finally, I explain how a causal-functional account of realization, as well as less demanding accounts, can meet the preferred desideratum. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in (...) local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

Stem cell science is advancing at an unprecedented rate, with thousands of research papers being published every year and many clinical trials for a wide range of conditions underway as registered on ClinicalTrials.gov. This rapidly expanding and alluring field has brought with it ever more complex and multifaceted ethical issues, many of which require new guidelines, consent protocols and even change in legislation, since they do not fit comfortably in the existing bioethical regulations and protocols. Keeping up with the (...) ethical implications of stem cell research is daunting to the expert and non-expert. We review the various types of stem cells and then focus on multipotent and pluripotent cell types, since it is these cell types that bring with them the greatest research and therapeutic potential, while concurrently delivering novel ethical conundrums. Certain key considerations are currently lacking and what is needed is how to obtain permission from individuals who donate their biological material for both scientific inquiry and eventually, for their potential therapeutic utility. (shrink)

BackgroundStructured, systematic methods to formulate consensus recommendations, such as the Delphi process or nominal group technique, among others, provide the opportunity to harness the knowledge of experts to support clinical decision making in areas of uncertainty. They are widely used in biomedical research, in particular where disease characteristics or resource limitations mean that high-quality evidence generation is difficult. However, poor reporting of methods used to reach a consensus – for example, not clearly explaining the definition of consensus, or not stating (...) how consensus group panellists were selected – can potentially undermine confidence in this type of research and hinder reproducibility. Our objective is therefore to systematically develop a reporting guideline to help the biomedical research and clinical practice community describe the methods or techniques used to reach consensus in a complete, transparent, and consistent manner.MethodsThe ACCORD project will take place in five stages and follow the EQUATOR Network guidance for the development of reporting guidelines. In Stage 1, a multidisciplinary Steering Committee has been established to lead and coordinate the guideline development process. In Stage 2, a systematic literature review will identify evidence on the quality of the reporting of consensus methodology, to obtain potential items for a reporting checklist. In Stage 3, Delphi methodology will be used to reach consensus regarding the checklist items, first among the Steering Committee, and then among a broader Delphi panel comprising participants with a range of expertise, including patient representatives. In Stage 4, the reporting guideline will be finalised in a consensus meeting, along with the production of an Explanation and Elaboration document. In Stage 5, we plan to publish the reporting guideline and E&E document in open-access journals, supported by presentations at appropriate events. Dissemination of the reporting guideline, including a website linked to social media channels, is crucial for the document to be implemented in practice.DiscussionThe ACCORD reporting guideline will provide a set of minimum items that should be reported about methods used to achieve consensus, including approaches ranging from simple unstructured opinion gatherings to highly structured processes. (shrink)

It is shown in this article that the Gospel of John describes a battle between darkness and light, life and death, chaos and God’s new order. Although the certainty is given right at the beginning of the Gospel that the darkness will not overcome the light, God does not take the possibility of darkness away. Darkness in John is darkness of the mind, not seeing the light, not comprehending, not accepting and not believing the Word. The battle between light and (...) darkness is described at two levels – the visible level that you can see with your eyes and the invisible level that only those who have been regenerated by the Spirit can see. Although it may seem that the contrary is true, God is in control of both levels. Jesus made the invisible visible with his words and deeds and, eventually, with his resurrection. The diakonoi of Jesus are called to follow him in his task to honour the father by speaking the words of the father and doing the work of the father. In doing this, they will make the invisible God visible by their diakonia. Real social change will take place in God’s time, and he will use the diakonia of his children to bring order in the chaos, like he did in the beginning when he created the heavens and the earth. The results of the research are used to suggest guidelines on social change in South Africa. (shrink)