This study analyzes the ideals of responsibility and accountability, asking such questions as when it is legitimate to blame top officials of an organization for mistakes made by personnel below them in the bureaucratic hierarchy; when things go wrong in a large and complex organization like the Canadian Forces, who is responsible and accountable; and whether a plea of ignorance is a good excuse. The study also analyzes the doctrine of ministerial responsibility in both the British and Canadian parliamentary (...) traditions, asking whether it is realistic to expect that a government minister should be held responsible for everything that goes wrong in his/her department. Finally, traditional military values are examined, considering the kinds of attitudes and values expected from Canada's armed forces and the differences between the military and civilian sectors. (shrink)

In this study, we discuss the role of senior nurses who sit on clinical commissioning groups that now plan and procure most health services in England. These nurses are expected to bring a nursing view to all aspects of clinical commissioning group business. The role is a senior level appointment and requires experience of strategic commissioning. However, little is known about how nurses function in these roles. Following Barrientos' methodology, published policy and literature were analysed to investigate these roles and (...) National Health Service England's claim that nursing can influence and advance a nursing perspective in clinical commissioning groups. Drawing on work by Berg, Barry and Chandler on ‘new public management’, we discuss how nurses on clinical commissioning groups work at the alignment of the interests of biomedicine and managerialism. We propose that the way this nursing role is being implemented might paradoxically offer further evidence of the devaluing of nursing rather than the emergence of a strong professional nursing voice at the level of strategic commissioning. (shrink)

The paper explores how several commissions of inquiry established in Quebec, Canada, have, over time, contributed in redefining the meaning of quality in health-care and its management. Adopting an interpretive analysis of commissions’ reports, the paper examines the particular ‘conceptual boxes’ used by their members to tackle quality and the embedded nature of their work. It is shown that although quality was always considered, this was generally done by bringing into focus specific quality domains and issues, some new, others (...) not so new. In addition, the various management approaches to quality featured in the reports were informed by evolving templates; although this evolution was not as straight and unwavering as some retrospective studies of quality in health-care seem to indicate. A common thread to all commissions is the fact that, beyond the definition of general principles, responsibility for quality oversight was not clearly assigned and criteria on whether quality initiatives should be voluntary or compulsory were often left unspecified. Further, quality was never regarded by the commissions as a strategic aspect of health-care. It is speculated that these failings on the part of commissions may partly explain the unassertive course of action taken by the provincial government in the area. (shrink)

Outsourcing of Public-Services - Forms and Limitations Purpose of the article is to show how public services can be outsourced from communities and what legal, organizational or other limitations may have to be taken into account.Methodology used for this article is literature research, analysis and comparison. An in-depth look into the present status of research and literature will be interconnected to the basic research in this matter that has been done from the 1970's to the 1990's.Scientific aim is (...) to show the potential of the process as being important and helpful in creating better community-service and meanwhile relieve the communities from organizational and financial burdens that are more difficult to carry than ever before.Findings are that we have to determine between the different municipal economic activities and the legal basis of these activities. The intervening public-service is a prominent example for the restrictive regulatory system it is set in but also is seen as having a big potential for cooperation and outsourcing by contracting-out. Contrary to that the service-rendering public-service is less regulated and more open to a market approach.There are different spheres for these economic activities to take place. Different reasons for outsourcing depend on the specific sphere a certain task belongs to and can include economic, fiscal and political aspects. Two big groups of tasks are annex-tasks from within the public-service and characteristic public-services. There can be outsourcing by commissioning or by using submissions.With different legal forms of the outsourced entities and the legal limits that are set for every different kind of structure, it is clear that there is no solution that always fits all the needs and that this has to be carefully taken into account.Conclusions are that there is a high potential and big successes when outsourcing is done well planned and as a strategic activity. A number of legal issues and other limitations always has to be respected. (shrink)

This investigation examines ‘teasing’ of non-combatant children by US military service personnel in occupied Iraq and Afghanistan. The majority of existent investigations of teasing and related practices place significant conceptual importance on the intentions of the teaser – such that a target can understand that the tease is not true. However, in data examined here it appears that targets do not understand the language in which the teasing is undertaken. Drawing from publicly available video footage posted on the (...) video sharing website Liveleak, we provide an ethnomethodological and conversation analytic informed examination of how persons initiating teasing strategically exploit asymmetries in the sequential and preferential organization of interactions when tease recipients do not have sufficient English skills to redress the negative assessments being made of them. Three types of candidate teasing practices are identified: soldier initiated negative other-assessments; target parroting negative other-assessments; and offer-withdrawal games. Analysis examines how such interactions effectively fail as teases and explores how children can resist soldiers’ pursuit of degrading responses. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:President’s Council on BioethicsEdmund D. Pellegrino (bio) and F. Daniel Davis (bio)Approximately two weeks before what was to have been its final meeting, the White House dissolved the President’s Council on Bioethics by terminating the appointments of its 18 members. The letters of dismissal, dated 10 June 2009, informed the members that their service on the Council would end with the close of business the next day.The Council’s (...) term was set to expire on 30 September 2009. After President Obama’s election in November and during the transition, we were advised to proceed on the assumption that the Council would be permitted to cease on that date. Reasons for the abrupt move to disband the Council are unknown. We have accepted the fact that we Council members served at the pleasure of the President and that he simply exercised his rightful prerogative. No explanation is therefore required.Some observers have speculated that the action was retaliatory. They related to the fact that several members of the Council disagreed with the President’s stem cell policy in a signed statement published in the Hastings Center’s Bioethics Forum. Others have speculated that the move was pre-emptive. At its final meeting, scheduled for 25–26 June, the Council was set to sign-off on two of its final publications. One was a comprehensive report on the ethics of organ transplantation, and the other a white paper entitled Health Care and the Common Good. The aim was immediately to release the latter as a contribution to the intensifying debate about health care reform. Health Care and the Common Good could well have aided rather than impeded the President’s drive to better control health care costs and achieve universal coverage. The Council report attempted to ground both goals in the ethical framework of, as the title indicates, the common good of all Americans.In his letter terminating the members’ appointments, Assistant to the President for Presidential Personnel Don Gips said that the President “recognizes the values of having a commission of experts in bioethical issues to provide objective and non-ideological bioethics advice to his administration.” Gips went on to say that the President is “currently rethinking the purposes and goals of such a bioethics commission, and is carefully considering a revitalized mission and mandate.” And, [End Page 309] responding to media enquiries, White House press officer Reid Cherlin explained that the President’s Council was terminated because it was a “philosophically leaning advisory group” and, according to a New York Times account by Nicholas Wade, “because it favored discussion over developing a shared consensus.” As for the ultimate outcome of the President’s “rethinking,” Cherlin indicated that President Obama will appoint a new commission with the mandate of offering “practical policy options” in bioethics.In the light of our experiences with the Council, we leave it with hopes that certain questions of national importance will be addressed. In light of the nature of federal advisory commissions, what is or are the proper roles of a national bioethics commission? If the aim is to provide advice and counsel to the President or, perhaps to the U. S. Congress, is that advice best rendered as a group consensus or as an in-depth exploration of the inevitably conflicting ethical perspectives on a given issue? How should such a commission be constituted—with what sorts of individuals? And what is the nature of the expertise that they individually and collectively bring to the commission’s functions? If the commission is to promote public debate and discussion, how exactly should it go about that task? And how is the efficacy of a commission to be assessed? Such questions inevitably lead us deep into contested territory, as the experience of this Council has shown: into the intersections of politics, religion, and science and into the relations between practice and theory—between policy and what some seem to deride as “philosophy.” Indeed, policy without an underlying philosophy is an edifice without a foundation; philosophy without policy is a foundation without an edifice.At the last meeting of the Council in March 2009, we launched a discussion of these questions with the... (shrink)

The impact of recent changes in public health insurance on community‐based health‐care in the USARecent changes in US government‐funded healthcare insurance are having profound impacts on all types of community‐based health‐care, reducing access to care by vulnerable populations. This article traces the impacts of recent policies on a range of community institutions in which nurses play a critical role, such as health centers, highlighting the effects on access to care and the survival of non‐profit services in less‐advantaged communities. In (...) general, the new policies shifted revenues into fixed payment per client contracts (capitation) paid to for‐profit managed care organizations and away from non‐profit community services. The full impact of this competitive, market‐oriented system of health services has just begun to be felt. The uncertainties and dissatisfactions assure continued activity to change current conditions, including efforts by groups that seek greater access to health services for all populations and security for committed providers and personnel, including nurses. (shrink)

Ethics is an attempt to guide human conduct and it is also an attempt to help man in leading good life by applying moral principles. Ethics refers to well based standards of right and wrong that prescribe what humans ought to do, usually in terms of rights, obligations, benefits to society, fairness, or specific virtues. Ethics is related to issues of propriety, rightness and wrongness. What is right is ethical and what is wrong is unethical. Value is an important conception (...) in ethical discussion. Values relate to the norms of a culture, but they are more global and abstract than norms. In certain cultures norms reflect the values of respect and support of friends and family. Different cultures reflect different values. Over the last three decades, traditional-age college students have shown an increased interest in personal well-being and a decreased interest in the welfare of others. Recently, the department of personnel and training has decided to change the pattern of the Civil Services Examination by stressing more on general studies and aptitude skills. A notification has been issued is this regard. From this year the Civil Services (Mains) will also have a separate paper on “ethics, integrity and aptitude”. The notification for the 2013 exam said the “paper (on ethics, integrity and aptitude) will include questions to test the candidate’s attitude and approach to issues relating to integrity, probity in public life and his problem-solving approach to various issues and conflicts in dealing with society”. There are six major sections (i) Ethics and Human Interfaith, (ii) Attitude, (iii) Emotional Intelligence, (iv) Contributions of Moral thinkers and philosophers of India and World, (v) Public/Civil Service Values and Ethics in Public Administration and (vi) Probity in Governance. In this paper an attempt is made to describe the values needed in public service sector and ethical principles might use in public administration and related to the V section of this syllabus. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated in the (...) United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

The topic of Ron Paterson’s book which was recently reviewed by Deborah Oyer only scratches the surface of a disturbing problem that is not confined to medicine, as health care delivery is a multidisciplinary experience for patients. I hear stories from patients about bullying dieticians, callous nurses, and institutions that espouse patient-centred care yet fail to deliver it to individuals who are unwell, worried, and vulnerable in an unfamiliar environment into which they have come for help. Maybe being conversant with (...) standard guidelines and care pathways for specific health conditions makes it too easy forget that, for individual patients, ill health is a unique experience within their life-world. It could and should be our default approach as clinicians (and ancillary personnel) to acknowledge the fundamental competence that patients bring to health service encounters and to help them comprehend their options and the ramifications of their preferences within their life-world. Unl. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Future of Environmental PhilosophyBen A. Minteer (bio)I think we should be deeply concerned about the future of environmental philosophy. It is the most marginalized of the applied ethics fields (which are often marginalized as a whole within traditional philosophy departments) and with few exceptions, it still has not made significant inroads into neighboring territories—including schools of public policy, natural resources/environment, planning, life sciences, and so on. In (...) my opinion, this is partly due to the general ideological pitch of the field and its narrow methodological orientation, at least historically. The neglect of alternative methods of inquiry, especially qualitative and quantitative work in the social sciences, is particularly troubling.Environmental ethics also has an image problem. In my experience, most natural resource professionals, policy scholars, engineers, and life scientists view our field with considerable skepticism, shaking their heads at what they see as arcane debates that do not touch upon the issues and challenges that motivate their own work. Many of our colleagues in the natural and environmental social sciences, for example, have little patience for the kind of metaethical discussions about intrinsic value, moral pluralism, etc., that have captured much of our attention in the past. They do not see what these kinds of arguments contribute to the scientific, policy, and management curricula, or what they add to their graduate students' training, or to their own research proposals. Typically, if a role for an environmental ethicist is recognized in such settings, it is often just to plug a personnel hole in an National Science Foundation proposal or to serve as a third or fourth reader on a graduate studies committee. Environmental ethics is at best an elective pursuit, it is not seen as essential.I'll be the first to admit that I have blood on my hands here (as do all of us, at least to the extent we have spent time and energy on debates over metaphilosophical issues in the field). And, of course, just because our environmental science and policy colleagues often do not see the true value of the field does not mean that it has no value. Still, I worry that the field seems to be falling into the chasm between traditional philosophy departments and environmental science, policy, and management programs. It is frequently deemed too applied and practical by many [End Page 132] philosophy departments, and too esoteric for schools of public policy, life sciences, and so on. This is not a good situation.How can we fix the image problem? Perhaps one approach would be to develop more solid links with our bioethics cousins (both philosophically and institutionally). There is a revealing story here about the different fortunes of bio- and environmental ethics, and I think we might learn from the success of the former. There will be barriers to such an alliance, however, some of which are intellectual (e.g., the rejection of conventional ethical categories and theories by many environmental ethicists is not shared by most bioethicists) while others are institutional (e.g., What practical shape would a "clinical" model of environmental ethics take? What is the market for this service? and so on).Another route would be to provide more organized and systematic attention to emerging, large-scale environmental science and policy issues—climate change, sustainability, poverty alleviation, and biodiversity loss, to name a few—that are (unfortunately, given their seriousness) viewed as "growth areas" in environmental science and policy studies. At my own institution (Arizona State University) we are moving away from an older departmental and disciplinary model to a more integrative institutional form and a transdisciplinary research culture. So, for example, we have a new school of global studies, a new school of sustainability, and so on. These are composed of a range of disciplines cutting across the natural, technical, and social sciences. There is certainly room in these initiatives and programs for a practical and progressive environmental ethics, but it must be conversant in subjects such as intergenerational equity, conservation science, economic valuation, environmental justice, and the normative dimensions of environmental science policy. I think there is an important role for us to play in these sorts of endeavors (which are popping... (shrink)

Systems of universal health coverage may aspire to provide care based on need and not ability to pay; the complexities of this aspiration call for normative analysis. This special issue arises in the wake of a judicial inquiry into preferential access in the Canadian province of Alberta, the Vertes Commission. I describe this inquiry and set out a taxonomy of forms of differential and preferential access. Papers in this special issue focus on the conceptual specification of health (...) system boundaries and on the normative questions raised by complex models of funding and delivery of care, where patients, providers, and services cross system boundaries. (shrink)

Dialectic IV convenes contributions with new takes on the long held proposition that architects are providers of design services. They service everyone from the status quo all the way to the subaltern. We know well how architects have historically fashioned themselves to be able to procure the most valued building commissions a people have to offer. There are temples, churches, and shrines, palaces and private villas, and surely monuments, state institutions, and corporate headquarters. But how have the members of (...) the same profession managed to fashion themselves as the custodians of the public good? (shrink)

The crisis in Darfur (Sudan), which sparked in February 2003, only caught the United Nations’ attention in Spring 2004. Questions emerged as to whether the conflict between the rebels and the government was simply insurgency warfare or, in fact, concealed a genocide carried out by the Arab, Muslim-led government against the Animist and Christian-African population. The issue became so divisive that the Security Council requested the creation of an investigation team, the International Commission of Inquiry on Darfur, which (...) amongst other tasks had to examine whether genocide had taken place. This article analyzes the facts as well as the legal reasoning that guided the International Commission of Inquiry in drawing the conclusion that a governmental policy to commit genocide had not been formed. (shrink)

In the aftermath of allegations of the misuse of human eggs in the United States, questions are being raised about whether profitable reproductive services should continue to function in a free market under the aegis of physicians or should be regulated. Other countries in which reproductive technologies are employed to a significant degree have developed regulations governing their use, many as a result of recommendations made by inter‐disciplinary commissions that solicited public input. Policy makers in the United States have (...) been reluctant to regulate reproductive technologies, however, because their use is politically controversial, they want to whittle down government, some do not consider infertility an illness, and some believe regulation would interfere with the right to reproduce. Yet the unfettered use of reproductive technologies can create such harms as lack of informed consent, providing procedures not medically indicated for financial gain, practice by unqualified personnel, injury to patients and donors, failure to screen donated gametes, and inadequate medical record keeping. Americans place special value on the welfare of children and those who bring them into the world. Such values can outweigh individual procreative liberty when new reproductive technologies are at issue. Although the optimal course would be to establish a regulatory body to govern reproductive technologies, this is not politically feasible now. The newly established National Bioethics Advisory Commission provides a forum in which issues surrounding reproductive technologies should be addressed at this time in the United States. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Bioethics ConsultationPat Milmoe McCarrick (bio)(John La Puma, M.D., from the Department of Medicine at Lutheran General Hospital in Chicago, contacted the National Reference Center for Bioethics Literature and suggested bioethics consultation as a topic for the Scope Note Series. He provided an extensive list of citations about ethics consultations collected by him and by David Schiedermayer, M.D., for their new book Ethics Consultation: A Practical Guide.)In Ethics Consultation in (...) Health Care, editors John Fletcher, Norman Quist, and Albert R. Jonsen (I, 1989) define ethics consultation as "the provision of specialized help in identifying, analyzing, and resolving ethical problems that arise in clinical care. In medical ethics the area of consultation has grown rapidly since 1978 when Edmund D. Pellegrino (II, 1978) noted, "we cannot separate technical-moral decisions from the philosophic principles we use to justify them. Medicine and ethics must be engaged with each other at every level."In 1980 Albert Jonsen raised the question of whether an ethicist could be a consultant and said that the ethicist as consultant is a casuist, one whose moral reasoning is based on a system of reasoning that is applied to particular cases. He describes historical casuistry in Western culture, comparing it to modern moral philosophy, and suggests that a "new casuistry seems timely" for ethics consultation (II, Jonsen 1980). By 1984 ethicist Ruth Purtilo recorded her thoughts following an ethics consultation. She raised questions about the ethicist's place on a hospital staff and how to make that role appropriate and beneficial to all concerned, saying that "the ethicist retreats after the consultation; under no circumstances would the outcome of an ethics consultation be that the ethicist became the primary care giver or assumed ongoing responsibility for the clinical management of a case" (II, Purtilo 1984). Nevertheless, in 1992 two physician-ethicists who had been called as ethics consultants for a patient who had requested that he be removed from his ventilator reported that they became the persons who turned off the ventilator and administered the drugs that eased his dying (II, Edwards and Tolle 1992).In recognition of the growing number of persons identifying themselves as [End Page 433] consultants, the Society for Bioethics Consultation was founded in October 1985 as a professional society of persons engaged in bioethics consultation. It encourages and supports consultation, assists in establishing clinical education programs, and raises funds for consultation education. Although the Society has no permanent office, the president (currently, George Kanoti in the Cleveland Clinic Foundation's Bioethics Department) conducts its work and plans an annual meeting.The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) established new criteria concerning ethics in its 1992 Manual (III, JCAHO 1992) and in a special issue of QRB devoted to ethics consultation (I, Defining Quality 1992). These publications undoubtedly have contributed to the increased use of experts in medical ethics. The Manual notes that all organizations seeking accreditation should have some sort of "mechanism for the consideration of ethical issues arising in the care of patients and to provide education to care givers and patients on ethical issues in health care." A health care institution's eligibility for JCAHO accreditation, which is required for federal reimbursement, requires adherence to this specification (III, JCAHO 1992).The new International Directory of Bioethics Organizations provides an index of 129 different groups that indicated to the authors that they offer bioethics consultations. Of these, 83 are in the United States and 46 are in other countries. The ethics consultants included in the directory encompass a broad group of professionals who will assist patients, families, and primary care medical staff in finding solutions to ethical dilemmas resulting from use of new technologies or new treatments in health care. Consultants often come from the health fields: physicians, nurses, and other health personnel, but other professionals are also active as ethics consultants. Lawyers, pastoral counselors, philosophers, and social workers also offer bioethics consultation services (III, Nolen and Coutts 1993).Drs. Siegler, Pellegrino, and Singer wrote in 1990 that "Physician-ethicists and professional ethicists will continue to work side by side in the future. One is not likely to replace the other, nor is this desirable, because... (shrink)

The American Institute of Certified Public Accountants monitors the misconduct of its members using the AICPA Code of Professional Conduct. To accomplish this task, the AICPA relies on various stakeholders to report known violations of its CPC. We examine the full population of sanctions imposed by the AICPA on its members under its CPC from 2008–2013 to identify recent trends in the misconduct of accounting professionals. While we find that multiple stakeholders identify and report violations, we also find that (...) the most common types of violations remain consistent with those reported in the 1990s. Further, we develop a taxonomy based on prior accounting literature to determine whether the AICPA CPC is being enforced to defend the public interest and/or the private interests of the accounting profession. In contrast to prior studies, our results suggest that as the accounting profession emerges from a recession and period of intense public scrutiny, the AICPA CPC is largely being enforced to defend the public interest. This public interest focus was most pronounced during the recessionary years of 2008–2010, as evident from misconduct reported by parties such as the Internal Revenue Service, Securities and Exchange Commission, Public Company Accounting Oversight Board, and state boards of accountancy. Although key stakeholders have recently focused on reporting misconduct that threatens the public interest, we believe there are still areas in need of improvement, especially around the level of detail provided in the AICPA’s sanction records. We propose some possible solutions to improve public transparency. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.4 (2002) 389-390 [Access article in PDF] IOM Report on the System for Protecting Human Research Participants Tom L. Beauchamp* In response to society's concerns about the use of human subjects in research, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of current systems of research participant protection in the U.S., including recommendations for reform (...) (Committee 2002). Although the committee declared its frustration over the lack of data, it found ample evidence to indicate that there are pivotal weaknesses in the current system. First, it discovered dissatisfaction with the current system from virtually every quarter and at virtually every level. Second, it found evidence that IRBs are under severe strain and performing inadequately. Third, it found that the existing regulatory framework—the IRB system and the Common Rule—has not and probably now cannot react adequately to the constantly evolving research environment. Some of these problems might be handled through federal agencies, but the committee holds that the problems are more extensive and will require additional institutional support and professional attention.The committee found that federal protection requirements should be extended to every research project—private, public, or otherwise. Subjects should be, in this respect, equally protected in privately sponsored research.The committee found that the IRB system is in important respects a failure, especially when it alone is relied upon for ethics reviews in institutions. One set of problems concerns the proper education of IRB members. The committee recommends that all members henceforth be given a specialized knowledge of human research ethics. It finds that IRB deliberations commonly have been dominated by scientists, who often marginalize the perspectives of nonscientist members. It therefore recommends that unaffiliated members, nonscientists, local community representatives, and those representing the participant-perspective comprise at least 25 percent of the membership. It also recommends that no protocol be approved without three-quarters of the voting members concurring. [End Page 389]The committee recommends that institutions distinguish review aimed at (1) scientific merit, (2) conflict of interest, and (3) general Ethics Review. The distinction should more evenly distribute the work of institutional ethics review. The IRB should not conduct the initial scientific review nor should it be spending the bulk of its time purely in examining either scientific merit—as many IRBs now do—or conflict of interest. Instead, the conclusions of the scientific review should be submitted to the IRB for ethics-focused deliberations. Problems of both financial and nonfinancial conflicts of interest should be handled similarly, preferably by a committee properly distanced from the institution's interests.The committee underscores that consent must be understood on the model of an interactive dialogue between research staff and participants and not merely as a signed form or single-disclosure event. Conversations between the participant and the research staff should begin even prior to the point of enrollment and should be reinforced during each stage of the research. The committee finds that informed consent conversations and documents too often are being conceived as risk management tasks gauged to protect the institution from liability.The committee also believes that the system of protections established by a research program should be open to the public in order to foster and maintain the community's trust. Open communication should occur among all relevant stakeholders. The committee notes that currently no centralized system exists for the dissemination of information about clinical trials and other research activities.It urges reconsideration of present policies regarding compensation, finding that many research organizations provide at least short-term medical care for those who are injured, but that few organizations cover all potential risks and that many organizations have no effective policy of compensation. The report holds that providing reasonable compensation for bona fide instances of research harm is the only just system and is necessary to avoid diminished public trust.The committee holds that establishing the appropriate culture in research institutions will require sustained efforts to educate researchers, research administrators, IRB members, and... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:BOOK REVIEWS The Recovery of Virtue: The Relevance of Aquinas for Christian Ethics. By JEAN PORTER. Louisville, Ky.: Westminster/John Knox Press, 1990. Pp. 208. $24.95 (cloth). On Faith: Summa Theologiae 2-2, qq. 1-16 of St. Thomas Aquinas. Translated by MARK D. JoRDAN. Readings in the Summa the· ologiae, Vol. 1. Notre Dame, Ind.: University of Notre Dame Press, 1990. Pp. 208. $9.95 (paper). Two recent publications well serve the (...) growing interest in what Aquinas has to say about virtue, human and divine. First, Jean Porter carefully studies the general " moral theory of Thomas Aquinas's Summa theologiae in the light of the problematics of contemporary Christian ethics, Protestant as well as Catholic " (p. 13). Her work incorporates a readable introduction to the main components of Aquinas's moral philosophy: a realist conception of the good, the instantiation of that good in the world of human actions and goals, and the ordering of choice towards the good through virtue. Secondly, Mark Jordan introduces a new translation in a " spare but accessible English" (p. 18) of the treatise on faith (Summa theologiae Ha-Hae qq, 1-16). Since both volumes concern the secunda pars of Aquinas's Summa theologiae, we can suitably examine their merits in this single review. The Recovery of Virtue aims at drawing the thought of Aquinas into a clearer dialogue with those who write about theological ethics in the English-speaking world. Accordingly, Porter prefaces her fine study with a fair, though brief, survey of Catholic moral theology since Vatican II and summary accounts of the dominant themes in the works of Gene Outka, James Gustafson, and Stanley Hauerwas. She th.en turns to a " reconstruction of the more strictly philosophical components " of Aquinas's moral theory as contained in the Summa theologiae. In chapter 2, Porter explains some basic notions which undergird Aquinas's general theory of morals, for example, his notion of goodness as something real; the premise that what is good or best for anyone is so in virtue of its being of a certain kind; the assertion that the self remains a legitimate " object " of theological charity; the view that one discovers intelligibility and organization within the created order; and finally, the conviction that the final perfection of the ra141 142 BOOK REVIEWS tional creature transcends the limits which creatureliness itself imposes. In chapter 3, Porter gives a fine account of Aquinas's action theory, illustrated by the sorts of good examples that Aquinas himself would have used today. Thomas Gilby once remarked that end so dominates the secunda pars that it should he read through to say what it means. Porter's first three chapters render a clear, organized analysis of Aquinas's moral teleology. Still, I would like to raise two small issues which may suggest lines for further inquiry. First, Porter asks whether Aquinas's teleological frame of reference allows for performing actions " without reference to any wider aim" (p. 76). As examples of those things which one can simply desire for themselves, she proposes engagement in or with: " fine music, a life of service, chocolates, children, religious ecstasy, sexual ecstasy... the list is endless" (loc. cit.). First of all, this list of examples seems to ignore a basic distinction between a finis cui and a finis cuius gratia, or the difference between something that is sought for itself and something which is sought for the sake of a further end. A person may never virtuously subordinate children and (service to) other people to his or her own goals or purposes (including delight). We can render them their due according to the diverse types of justice, even expect to receive something good from them in theological hope, and above all love them in theological charity. But we can never turn them into a finis cnius gratia. On the other hand, fine music, chocolates, and ecstasy both sexual and religious (if by the latter one means created thoughts and feelings about God and not union with God himself) always remain instrumental, that is, they can never virtuously serve as a finis cui. If we take Porter's example, Aquinas's teleological framework includes the chocolate ice-cream... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Global Health Careers:Serving the Navajo CommunityMaricruz Merino, Jonathan Iralu, and Sonya ShinGallup Indian Medical Center (GIMC) sits on a hilltop in Gallup, New Mexico, a town of 20,000 in the four corners region of the Southwestern United States. From its third story windows one can see the red cliffs of the nearby Navajo Nation, a 27,000 square mile reservation that reaches into Arizona, northern New Mexico, and the southern (...) edges of Utah. It is a vast, rural landscape that houses more than 350,000 Navajos. For many on the reservation, healthcare is provided by Indian Health Service hospitals such as GIMC."Are you going to stay?" is a common question for new doctors at GIMC. The Navajo know that their geographic location, while beautiful and attractive to many young providers, will also be the reason they leave. It is hard for doctors to be away from their own homelands. Aging parents get sick, [End Page 86] educational opportunities arise, and children who need to be near extended family are born. But to the Navajo, the story of an individual provider is not so important or memorable. All they know is that providers come and go."Are you here to experiment on us?" is yet another question. Years of exploitation and efforts to destroy traditional ways and language have made many Navajo wary of healthcare providers, no matter how genuine their intentions. Many are so fearful of the hospital—they regard it as "the place to go die."Yet despite this initial suspicion, the Navajo are welcoming people at heart, and tend to develop relationships of trust with their providers. Parents will begin to talk about their grief over a son that has committed suicide or a daughter who died from alcoholic cirrhosis. The elderly will tell you how they care for their five orphaned grandchildren while they can barely take care of their own diabetes. A carpenter tells you he has not worked in a year and feels worthless. An HIV-positive woman will tell you she has been sleeping in a dry river bed because she has no place to go. It quickly becomes apparent that as a physician you will be treating patients with enormous social challenges in addition to complex medical conditions.The origins of the Federal Government's involvement in the healthcare of American Indians and Alaskan Natives (AI/ANs) in the 19th century arose out of both legal obligation and concern for self- preservation. Health services were promised to AI/ ANs in exchange for land, settlements, and agreements. In addition, infectious diseases endemic on reservations as a consequence of crowding and abject poverty, including smallpox and tuberculosis, were seen as a major public health concern. The responsibility of Native American health was first granted to the War Department, then to the Bureau of Indian Affairs, and finally to the Public Health Service in 1955 under the heading of the IHS, or Indian Health Service (U.S. Commission on Civil Rights, 2004; National Library of Medicine, 1994).Since then, the IHS has had many successes. Vaccination rates have gone up, and rates of pneumonia and tuberculosis have gone down significantly. Maternal and infant mortality have declined, and life expectancy has increased (Indian Health Services, 1999). Nonetheless, these improvements remain overshadowed by glaring health disparities among AI/ANs across a broad spectrum of diseases, both communicable and non-communicable, acute and chronic. Native Americans experience higher rates of obesity, diabetes, and cardiovascular disease than the general United States population. They are also more likely to die from alcohol-related causes and in accidents. Life expectancy remains more than five years less than that of the general U.S. population (U.S. Commission on Civil Rights, 2004; U.S. Department of Health and Human Services, 2000).Underlying these health indicators is the continued impoverished status of most AI/ANs. In Navajo, almost half of the population lives below the poverty line. According to the Navajo Nation, the current unemployment rate is 42% (Navajo Nation Department of Economic Development, 2011). Many Navajo on the reservation do not have running water or electricity. They heat with wood, which they chop and haul themselves—regardless... (shrink)

The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research published in March of 1983 its Report, Securing Access to Health Care: The Ethical Implications of Differences in the Availability of Health Services . Concluding that there are "ethical obligations" on behalf of society which are balanced by individual obligations, the Report provides an ethical framework for ensuring "ultimate responsibility" of the Federal government to arrange for equitable access to health and to a (...) fair share of cost. In doing so the Report neither makes justice nor beneficence the prime moral principle in public health care, it rather calls for a common sense approach in "approximating adequacy". But how to define equality without creating uniformity in a society rich in its diversity, including attitudes towards health? Keywords: justice, beneficence, right to health care, equality, distribution CiteULike Connotea Del.icio.us What's this? (shrink)

Public sector institutions are increasingly investing resources in data collection and data analytics to provide better public services at lower cost, to anticipate demand for services, to identify high-risk groups, and to develop targeted interventions. Prior research has shown that the media shape understanding of the possibilities of technology and creates related expectations. In this article we explore how artificial intelligence and emerging data-driven technologies are made familiar and by whose voices they are talked about in the media. (...) Empirically, we explore communication materials and media coverage from the joint AI experiment between the City of Espoo and Tieto Corporation in 2017–18. In this experiment, Tieto Corporation combined customer data from the City of Espoo’s social and health care and early childhood education from 2002–2016 and analysed this data using artificial intelligence methods. Theoretically, we draw on the tradition of the social construction of technology and especially its branch that focuses on the domestication of technologies. The results show that the means of narration used by the media – repetition and highlighting the voice of the representatives of the institutional actors involved in the AI experiment – strengthen the agency and interests of the parties involved as well as their visibility in the media, while reducing the space for possible critical discussion. We argue that this way, AI is made familiar and acceptable to citizens and in public services in Finland. (shrink)

The discussion concerning the patenting of academic knowledge is already closed for many people. It has become a type of credo, solemnly intoned at all levels: universities must commercially valorize the knowledge that they generate as extensively as possible.The public means that are reserved for universities can never increase at the same rate as the mounting costs for highly specialized research. So universities, if they want to work at the top level, must increasingly appeal to private resources. Universities are (...) increasingly forced to aim at contract research, sponsorships, commercialised service, the patenting of technical findings, and spin-offs: Cash for knowledge!The pressure for the unfettered commercialisation of academic knowledge does not only come from within the universities. The message also comes from the politicians and those who are committed to economic prosperity. They argue that the commercialisation of intellectual property contributes to new employment because it makes new industrial developments possible and reinforces the competitiveness of ventures. They make it seem that universities form the motor of the knowledge economy.In a country without considerable natural resources and with extremely high personnel costs, innovation is of vital importance. Few convictions are equally as expressly avowed at so many differing forums. The direction of the march seems clear.It was once different. The knowledge that was acquired, deepened, preserved, and transmitted within the universities was not for sale. In fact, its sale could present difficulties because academic knowledge has never answered to the properties of a marketable thing. Use does not deplete knowledge and if you consider it your mission to bring to light knowledge, you do not want to exclude anyone from making use of it.Academic knowledge could thus not be an object of trade, at least so long as nobody was intent on keeping that knowledge secret, and so long as nobody appealed to regulations, whereby one could restrict the legal use of that knowledge. Today neither of these strategies are taboo within academic centres. The patenting of all forms of qualifying knowledge is even encouraged.A patent assumes, on the one hand, that one makes public the knowledge upon which a technique rests, while one, on the other hand, can grant use of that technique exclusively to who one gives a licence, whether or not for a fee. This system is put forth as attractive for all parties. The researchers can keep up with technical details, and the entrepreneur can commercialise the finding. Everyone is happy.Or perhaps not? Are there reasons to be concerned that universities must increasingly submit themselves to the laws of the market? Are there arguments for evaluating academic performance differently than the performance of entrepreneurs? Must one regret that knowledge is commercialised as much as possible?The proponents of the commercial orientation point out that all kinds of new incentives will give a new impetus to the old academic system and will increase the relevance of academic research. They seem to dismiss resistance to the renewal as a nostalgic outpouring of a privileged group that used to have it too good, a group that for too long knew to retreat too safely back into a series of unworldly problems.The opponents of the economically oriented approach fear that the proper character of the academic mission will be lost. They fear that the loss of academic autonomy will make the specific function that a university fulfils within society impossible. In what sense?In our society, there is not one type of sphere, and there is not one valid set of standards, the basis upon which performances are evaluated, functions are judged, or objectives commended. There are strongly divergent spheres and each have their own specific function. The laws that apply in one sphere do not necessarily have authority in another sphere, and the standards that apply in one sort of relationship often have little or no meaning in another relationship.Each sphere recognises its own standards and answers to its own system of exchange for compensation, approval, and recognition. What applies in the sphere of law does not necessarily apply in the sphere of someone’s personal friendships, or is not applicable among family members. What applies in trade does not necessarily apply in the sphere of art.Even more, things go wrong when the autonomy of these spheres is not respected. Within the domain of art, love and friendship, monetary laws are not valid, at least in a healthy situation. That is not to say that the rules that apply within the free market would be wrong or unethical – far from it. It seems self evident that these laws are valid under the condition that they apply in the environment to which they belong, and that one respects these limits.This applies for all spheres. It would be unjust if one would apply the standards of friendship to the spheres of jurisprudence or education. Manifestly, it seems self evident not to define justice as a univocal principle that must be extended with the same consistency in every type of sphere. Rather, it is just to respect the individual character of the normative relationship that applies in the diverse spheres of life, and to prevent one sphere from colonising another.Justice assumes that one prevents the political sphere from stipulating what must be said, or concealed, within the academic sphere. Academics must answer alone to that which is expected of them within the academic sphere. Political pressure may exert no influence on this. Why cannot one say the same about economic pressure?Do we run the risk that the economic sphere will colonise the academic sphere just as the economic sphere previously colonised the sphere of media? What must one imagine in this supposed risk? In what sense should economic laws threaten the academic sphere?In the academic sphere, it is traditional to follow one’s own interests and investigate anything whatsoever without having to ask if this knowledge is useful for something or how the fruits of this research fit within the economic context. The academic search for a better understanding of everything has an unconditional character.The manner in which researchers evaluate the performance of each other seldom has to do with the economic effects that their findings have, but with their reliability, the meticulousness with which they were checked, the scrupulousness with which the sources were collected, and the honesty with which they were communicated. The function of the academic is to collect and refine knowledge, and to bring to light the truth.By doing so, universities offer a type of foot-hold within society. They make it possible that a place exists where one can be obedient to what lets itself appear most truthfully today. Nobody has to fear, at least as long as the autonomy of the academic sphere is respected, that the communication of a particular subject was rhetorically coloured in function of a commercial interest, was applied according to the wishes of the sponsor, was brought into conformity with what was agreed upon by the financiers, or answered to the demands of a patent.It is possible that the influence of the commercial sphere shall be less dramatic than pessimistic academics imagine, but nothing indicates the opposite. Today we are giving a new strategy power, and nobody knows how the magician’s apprentice will bring it off.This forms the context of the questions that we shall try to answer together this number of Ethical Perspectives, and we will restrict our discussion to patents. We are aware that the discussion about patents illuminates just one part of the problems, which have to do with the relation of the worlds of academia and commerce. But there is a reason for confining oneself to an aspect of this problematic relationship. If one were to broaden the scope of inquiry further, one would risk missing the complexity of the subject matter already covered, and be consigned to a far too general and aimless debate.We have brought together a number of specialists, jurists, ethicists, and people with practical experience with the field. They shall introduce us into the problematic, confront us with their points of view, and help to answer our questions: Are there moral limits to the patenting of academic knowledge? Is patenting always the most efficient strategy? Does not perhaps the university sell its soul if it gradually leaves itself subject to the laws of the market?We will begin by asking how in particular a university should proceed with the patenting of knowledge. Modern universities were inspired by the ideals of the Enlightenment, which was characterised by the open distribution of unselfishly pursued knowledge.The privatisation and commercialisation of knowledge would seem to conflict with this traditional vision. Jürgen Mittelstrass and Bart Pattyn provide a theoretical and historical basis for protecting the autonomy of university research from the corrupting aspects of the market economy.But, are there reasons for giving up the traditional outlook? Few or no universities have not chosen to patent discoveries, but how is one to proceed within the framework of the university, once one has obtained patent protection? Can one pursue a policy of using these protected intellectual rights to secure the fruits of knowledge for financially weaker groups, or do circumstances compel the universities to be exclusively driven by market forces?Those are the kinds of questions that Gilles Capart and Geertrui Van Overwalle of the KU Leuven will deal with.Sigrid Sterckx of the university of Ghent will answer the question: can patents be morally justified?Paul Belleflamme of the Université Catholique de Louvan La Neuve writes concerning the economic evidence of patents, and the real effect of incentives. Are there any economic facts that can demonstrate the effectiveness of patenting?Then we give the floor to Christopher May of the University of Lancaster, who looks at the question of how universities have to deal with the global information society. (shrink)

This article aims to shed some light on the concepts embedded in the expressions ‘services of general interest’ (‘SGI’), ‘services of general economic interest’ (‘SGEI’), ‘non-economic services of general interest’ (‘NSGI’) and ‘social services of general interest’ (‘SSGI’). It is submitted that the expression ‘SGI’ conveys a general concept which comprises both SGEI and NSGI. SGEI may be distinguished from NSGI in that only the former involve an economic activity. In contrast to SGI, SGEI and NSGI, the expression ‘SSGI’ is (...) nowhere to be found in primary EU law. This means that it is for the EU legislator and, as the case may be, for the Member States to define such expression. Furthermore, this article supports the contention that a definition of the principles and conditions underpinning the operation of SGI must be capable of adapting to changing times and social perceptions, whilst being respectful of the vertical and horizontal allocation of powers set out in the Treaties. Vertically, a definition of SGI must not impinge upon the powers retained by the Member States. In the absence of harmonisation, it is for the Member States to define the services they consider to be of general interest, unless they commit a manifest error of assessment. In the presence of EU harmonising measures, the margin of discretion enjoyed by the Member States is, if still existent, narrowed down, given that national authorities are required to comply with the objectives pursued by the EU legislator. Horizontally, a definition of SGI must not encroach upon the prerogatives of the Commission in the realm of competition law. Moreover, in light of Article 9 TFEU and secondary EU legislation, the specific features of SSGI must be taken into consideration when determining the compatibility with EU State aid rules of public service compensation awarded to the providers of those services. An EU conceptual framework for the SGI must thus be the result of a constructive dialogue between the different levels of governance, as well as of a balanced solution among different policy areas in relation to which the EU enjoys competences. (shrink)

Background: Increasing use of genetic technologies in clinical and research settings increases the potential for misattributed paternity to be identified. Yet existing guidance from the President's Commission for the Study of Ethical Problems in Biomedical and Behavioral Research and the Institute of Medicine (among others) offers contradictory advice. Genetic health professionals are thus likely to vary in their practice when misattributed paternity is identified, and empirical investigation into the disclosure of misattributed paternity is scarce. Given the relevance of this (...) ethical dilemma and its significance to users of genetic services, this study aimed to investigate the attitudes of lay people with regard to the disclosure of misattributed paternity. Methods: An online questionnaire was hosted and advertised through Amazon's Mechanical Turk to 200 United States residents aged 18 years or older. Respondents were asked to rate (via a Likert scale) the ethical permissibility of possible actions a clinician may carry out when misattributed paternity is identified. Data analysis consisted of preliminary descriptive analysis, chi-squared analysis, and Wilcoxon signed-rank tests. Results: There was no clear majority support for many of the options surveyed across different contexts, with only six out of ten scenarios displaying some general consensus. Men were more likely to support scenarios where the father is informed of paternity. Importantly, participants' views varied according to whether the desires of the father were previously expressed, suggesting that perceptions of the permissibility of a clinician's action will depend on the interests of all parties affected. Conclusions: This sample of the general public showed attitudes that were, at least to some degree, at variance with some professional guidelines. We give arguments for why at least some of these attitudes might be justified. We argue that case-specific judgments should be made and outline some of the relevant ethical considerations. While general guidelines ought to be considered, context-specific moral judgments cannot be avoided. (shrink)

20 years ago, the Report of the Commission on Research Integrity was submitted to the Secretary of the Department of Health and Human Services and to House and Senate Committees. As directed in enabling legislation, the Commission had provided recommendations on a new definition of research misconduct, oversight of scientific practices, and development of a regulation to protect whistleblowers. Reflecting the ethos of the time, the Commission recommended that institutions receiving Public Health Service research funding (...) should provide oversight of all but the most egregious misconduct. The suggested definition of research misconduct was organized around misappropriation, interference and misrepresentation, which would have addressed collaborative/authorship disputes and sabotage in scientific laboratories, both of which remain unaddressed in current policy. The Commission also recommended the Whistleblower Bill of Rights and Responsibilities which would have authorized remedies for whistleblowers who experienced retaliation and sanctions against retaliators. Response from the scientific community was highly critical, and none of the Commission’s recommendations was accepted. No new body has examined issues within the Commission’s charge, there has been no significant Congressional or public pressure to do so, institutions have not been able to sustain standards that would have avoided current concerns about bias and irreproducibility in research, and there is still no entity in science capable of addressing issues assigned to the Commission and other urgent issues. (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)

The widespread adoption of radioisotopes as tools in biomedical research and therapy became one of the major consequences of the "physicists' war" for postwar life science. Scientists in the Manhattan Project, as part of their efforts to advocate for civilian uses of atomic energy after the war, proposed using infrastructure from the wartime bomb project to develop a government-run radioisotope distribution program. After the Atomic Energy Bill was passed and before the Atomic Energy Commission was formally established, the Manhattan (...) Project began shipping isotopes from Oak Ridge. Scientists and physicians put these reactor-produced isotopes to many of the same uses that had been pioneered with cyclotron-generated radioisotopes in the 1930s and early 1940s. The majority of early AEC shipments were radioiodine and radiophosphorus, employed to evaluate thyroid function, diagnose medical disorders, and irradiate tumors. Both researchers and politicians lauded radioisotopes publicly for their potential in curing diseases, particularly cancer. However, isotopes proved less successful than anticipated in treating cancer and more successful in medical diagnostics. On the research side, reactor-generated radioisotopes equipped biologists with new tools to trace molecular transformations from metabolic pathways to ecosystems. The U.S. government's production and promotion of isotopes stimulated their consumption by scientists and physicians, such that in the postwar period isotopes became routine elements of laboratory and clinical use. In the early postwar years, radioisotopes signified the government's commitment to harness the atom for peace, particularly through contributions to biology, medicine, and agriculture. (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)

This article introduces to a wider public a hitherto unknown report written by the “Romantic” natural philosopher and mineralogist Henrik Steffens (1773–1845). In the 1811 report Ideas on Medical Meteorology, commissioned by the Prussian Ministry of the Interior via the physician Johann Christian Reil (1759–1813), Steffens argued for a new, “organic” perspective on meteorology focusing on interrelations between the atmosphere and diseases among humans and animals. This new outlook, he argued, was to be realized via a series of observations (...) directed by the state administration. Excerpts from the report are translated and commented upon in order to illuminate their context. These show the report to be part of a significantly older European tradition of inquiry into the connection between changes in the atmosphere and health. A speculative variation of this tradition, for which the general term “Organic Meteorology” is introduced here, was ignited in German-speaking regions through Schelling’s natural philosophy. The report and its context show that the Prussian state was willing to engage with “Romantic” natural philosophy, that Steffens gladly provided expertise for this purpose, and that this was part of a more general effort to professionalize medicine. (shrink)

When Adolf Hitler (1889–1945) came to power in 1933, the new Nazi government focused the German health system on their priorities such as the creation of a racially homogeneous society and the preparation of war. One of the measures to bring nursing under their control was the foundation of a new sisterhood. In 1934, Erich Hilgenfeldt (1897–1945), the ambitious head of the National Socialist People’s Welfare Association (Nationalsozialistische Volkswohlfahrt), founded the National Socialist (NS) Sisterhood (Nationalsozialistische Schwesternschaft) to create an elite (...) group that would work for the goals of the National Socialist German Workers’ Party (Nationalsozialistische Deutsche Arbeiterpartei, NSDAP). Hilgenfeldt proclaimed community nursing as a priority for NS Sisterhood nurses. Catholic and Protestant sisters, who were traditionally dedicated to community nursing, were to be gradually replaced. However, other competing priorities, such as hospital service for the training of junior nurses and work in conquered regions, as well as the lack of NS nursing personnel, hampered the expansion of community nursing. The paper also addresses areas for future research: everyday activities of NS nurses, the service of NS Sisterhood nurses for NSDAP organisations such as the elite racist paramilitary force SS (Schutzstaffel, Protective Squadron), and involvement in their crimes have hardly been investigated as yet. (shrink)

Table of contentsI1 Proceedings of the 4th World Conference on Research IntegrityConcurrent Sessions:1. Countries' systems and policies to foster research integrityCS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive universitySusan Patricia O'BrienCS01.2 Measures to promote research integrity in a university: the case of an Asian universityDanny Chan, Frederick Leung2. Examples of research integrity education programmes in different countriesCS02.1 Development of a state-run “cyber education program of research ethics” in (...) KoreaEun Jung Ko, Jin Sun Kwak, TaeHwan Gwon, Ji Min Lee, Min-Ho LeeCS02.3 Responsible conduct of research teachers’ training courses in Germany: keeping on drilling through hard boards for more RCR teachersHelga Nolte, Michael Gommel, Gerlinde Sponholz3. The research environment and policies to encourage research integrityCS03.1 Challenges and best practices in research integrity: bridging the gap between policy and practiceYordanka Krastev, Yamini Sandiran, Julia Connell, Nicky SolomonCS03.2 The Slovenian initiative for better research: from national activities to global reflectionsUrsa Opara Krasovec, Renata SribarCS03.3 Organizational climate assessments to support research integrity: background of the Survey of Organizational Research Climate and the experience with its use at Michigan State UniversityBrian C. Martinson, Carol R. Thrush, C.K. Gunsalus4. Expressions of concern and retractionsCS04.1 Proposed guidelines for retraction notices and their disseminationIvan Oransky, Adam MarcusCS04.2 Watching retractions: analysis of process and practice, with data from the Wiley retraction archivesChris Graf, Verity Warne, Edward Wates, Sue JoshuaCS04.3 An exploratory content analysis of Expressions of ConcernMiguel RoigCS04.4 An ethics researcher in the retraction processMichael Mumford5. Funders' role in fostering research integrityCS05.1 The Fonds de Recherche du Québec’s institutional rules on the responsible conduct of research: introspection in the funding agency activitiesMylène Deschênes, Catherine Olivier, Raphaëlle Dupras-LeducCS05.2 U.S. Public Health Service funds in an international setting: research integrity and complianceZoë Hammatt, Raju Tamot, Robin Parker, Cynthia Ricard, Loc Nguyen-Khoa, Sandra TitusCS05.3 Analyzing decision making of funders of public research as a case of information asymmetryKarsten Klint JensenCS05.4 Research integrity management: Empirical investigation of academia versus industrySimon Godecharle, Ben Nemery, Kris Dierickx5A: Education: For whom, how, and what?CS05A.1 Research integrity or responsible conduct of research? What do we aim for?Mickey Gjerris, Maud Marion Laird Eriksen, Jeppe Berggren HoejCS05A.2 Teaching and learning about RCR at the same time: a report on Epigeum’s RCR poll questions and other assessment activitiesNicholas H. SteneckCS05A.4 Minding the gap in research ethics education: strategies to assess and improve research competencies in community health workers/promoteresCamille Nebeker, Michael Kalichman, Elizabeth Mejia Booen, Blanca Azucena Pacheco, Rebeca Espinosa Giacinto, Sheila Castaneda6. Country examples of research reward systems and integrityCS06.1 Improving systems to promote responsible research in the Chinese Academy of SciencesDing Li, Qiong Chen, Guoli Zhu, Zhonghe SunCS06.4 Exploring the perception of research integrity amongst public health researchers in IndiaParthasarathi Ganguly, Barna Ganguly7. Education and guidance on research integrity: country differencesCS07.1 From integrity to unity: how research integrity guidance differs across universities in Europe.Noémie Aubert Bonn, Kris Dierickx, Simon GodecharleCS07.2 Can education and training develop research integrity? The spirit of the UNESCO 1974 recommendation and its updatingDaniele Bourcier, Jacques Bordé, Michèle LeducCS07.3 The education and implementation mechanisms of research ethics in Taiwan's higher education: an experience in Chinese web-based curriculum development for responsible conduct of researchChien Chou, Sophia Jui-An PanCS07.4 Educating principal investigators in Swiss research institutions: present and future perspectivesLouis Xaver Tiefenauer8. Measuring and rewarding research productivityCS08.1 Altimpact: how research integrity underpins research impactDaniel Barr, Paul TaylorCS08.2 Publication incentives: just reward or misdirection of funds?Lyn Margaret HornCS08.3 Why Socrates never charged a fee: factors contributing to challenges for research integrity and publication ethicsDeborah Poff9. Plagiarism and falsification: Behaviour and detectionCS09.1 Personality traits predict attitude towards plagiarism of self and others in biomedicine: plagiarism, yes we can?Martina Mavrinac, Gordana Brumini, Mladen PetrovečkiCS09.2 Investigating the concept of and attitudes toward plagiarism for science teachers in Brazil: any challenges for research integrity and policy?Christiane Coelho Santos, Sonia VasconcelosCS09.3 What have we learnt?: The CrossCheck Service from CrossRefRachael LammeyCS09.4 High p-values as a sign of data fabrication/falsificationChris Hartgerink, Marcel van Assen, Jelte Wicherts10. Codes for research integrity and collaborationsCS10.1 Research integrity in cross-border cooperation: a Nordic exampleHanne Silje HaugeCS10.3 Research integrity, research misconduct, and the National Science Foundation's requirement for the responsible conduct of researchAaron MankaCS10.4 A code of conduct for international scientific cooperation: human rights and research integrity in scientific collaborations with international academic and industry partnersRaffael Iturrizaga11. Countries' efforts to establish mentoring and networksCS11.1 ENRIO : a network facilitating common approaches on research integrity in EuropeNicole FoegerCS11.2 Helping junior investigators develop in a resource-limited country: a mentoring program in PeruA. Roxana Lescano, Claudio Lanata, Gissella Vasquez, Leguia Mariana, Marita Silva, Mathew Kasper, Claudia Montero, Daniel Bausch, Andres G LescanoCS11.3 Netherlands Research Integrity Network: the first six monthsFenneke Blom, Lex BouterCS11.4 A South African framework for research ethics and integrity for researchers, postgraduate students, research managers and administratorsLaetus OK Lategan12. Training and education in research integrity at an early career stageCS12.1 Research integrity in curricula for medical studentsGustavo Fitas ManaiaCS12.2 Team-based learning for training in the responsible conduct of research supports ethical decision-makingWayne T. McCormack, William L. Allen, Shane Connelly, Joshua Crites, Jeffrey Engler, Victoria Freedman, Cynthia W. Garvan, Paul Haidet, Joel Hockensmith, William McElroy, Erik Sander, Rebecca Volpe, Michael F. VerderameCS12.4 Research integrity and career prospects of junior researchersSnezana Krstic13. Systems and research environments in institutionsCS13.1 Implementing systems in research institutions to improve quality and reduce riskLouise HandyCS13.2 Creating an institutional environment that supports research integrityDebra Schaller-DemersCS13.3 Ethics and Integrity Development Grants: a mechanism to foster cultures of ethics and integrityPaul Taylor, Daniel BarrCS13.4 A culture of integrity at KU LeuvenInge Lerouge, Gerard Cielen, Liliane Schoofs14. Peer review and its role in research integrityCS14.1 Peer review research across disciplines: transdomain action in the European Cooperation in Science and Technology “New Frontiers of Peer Review ”Ana Marusic, Flaminio SquazzoniCS14.2 Using blinding to reduce bias in peer reviewDavid VauxCS14.3 How to intensify the role of reviewers to promote research integrityKhalid Al-Wazzan, Ibrahim AlorainyCS14.4 Credit where credit’s due: professionalizing and rewarding the role of peer reviewerChris Graf, Verity Warne15. Research ethics and oversight for research integrity: Does it work?CS15.1 The psychology of decision-making in research ethics governance structures: a theory of bounded rationalityNolan O'Brien, Suzanne Guerin, Philip DoddCS15.2 Investigator irregularities: iniquity, ignorance or incompetence?Frank Wells, Catherine BlewettCS15.3 Academic plagiarismFredric M. Litto16. Research integrity in EuropeCS16.1 Whose responsibility is it anyway?: A comparative analysis of core concepts and practice at European research-intensive universities to identify and develop good practices in research integrityItziar De Lecuona, Erika Löfstrom, Katrien MaesCS16.2 Research integrity guidance in European research universitiesKris Dierickx, Noémie Bonn, Simon GodecharleCS16.3 Research Integrity: processes and initiatives in Science Europe member organisationsTony Peatfield, Olivier Boehme, Science Europe Working Group on Research IntegrityCS16.4 Promoting research integrity in Italy: the experience of the Research Ethics and Bioethics Advisory Committee of the Consiglio Nazionale delle Ricerche Cinzia Caporale, Daniele Fanelli17. Training programs for research integrity at different levels of experience and seniorityCS17.1 Meaningful ways to incorporate research integrity and the responsible conduct of research into undergraduate, graduate, postdoctoral and faculty training programsJohn Carfora, Eric Strauss, William LynnCS17.2 "Recognize, respond, champion": Developing a one-day interactive workshop to increase confidence in research integrity issuesDieter De Bruyn, Bracke Nele, Katrien De Gelder, Stefanie Van der BurghtCS17.4 “Train the trainer” on cultural challenges imposed by international research integrity conversations: lessons from a projectJosé Roberto Lapa e Silva, Sonia M. R. Vasconcelos18. Research and societal responsibilityCS18.1 Promoting the societal responsibility of research as an integral part of research integrityHelene IngierdCS18.2 Social responsibility as an ethical imperative for scientists: research, education and service to societyMark FrankelCS18.3 The intertwined nature of social responsibility and hope in scienceDaniel Vasgird, Stephanie BirdCS18.4 Common barriers that impede our ability to create a culture of trustworthiness in the research communityMark Yarborough19. Publication ethicsCS19.1 The authors' forum: A proposed tool to improve practices of journal editors and promote a responsible research environmentIbrahim Alorainy, Khalid Al-WazzanCS19.2 Quantifying research integrity and its impact with text analyticsHarold GarnerCS19.3 A closer look at authorship and publication ethics of multi- and interdisciplinary teamsLisa Campo-Engelstein, Zubin Master, Elise Smith, David Resnik, Bryn Williams-JonesCS19.4 Invisibility of duplicate publications in biomedicineMario Malicki, Ana Utrobicic, Ana Marusic20. The causes of bad and wasteful research: What can we do?CS20.1 From countries to individuals: unravelling the causes of bias and misconduct with multilevel meta-meta-analysisDaniele Fanelli, John PA IoannidisCS20.2 Reducing research waste by integrating systems of oversight and regulationGerben ter Riet, Tom Walley, Lex Marius BouterCS20.3 What are the determinants of selective reporting?: The example of palliative care for non-cancer conditionsJenny van der Steen, Lex BouterCS20.4 Perceptions of plagiarism, self-plagiarism and redundancy in research: preliminary results from a national survey of Brazilian PhDsSonia Vasconcelos, Martha Sorenson, Francisco Prosdocimi, Hatisaburo Masuda, Edson Watanabe, José Carlos Pinto, Marisa Palácios, José Lapa e Silva, Jacqueline Leta, Adalberto Vieyra, André Pinto, Mauricio Sant’Ana, Rosemary Shinkai21. Are there country-specific elements of misconduct?CS21.1 The battle with plagiarism in Russian science: latest developmentsBoris YudinCS21.2 Researchers between ethics and misconduct: A French survey on social representations of misconduct and ethical standards within the scientific communityEtienne Vergès, Anne-Sophie Brun-Wauthier, Géraldine VialCS21.3 Experience from different ways of dealing with research misconduct and promoting research integrity in some Nordic countriesTorkild VintherCS21.4 Are there specifics in German research misconduct and the ways to cope with it?Volker Bähr, Charité22. Research integrity teaching programmes and their challengesCS22.1 Faculty mentors and research integrityMichael Kalichman, Dena PlemmonsCS22.2 Training the next generation of scientists to use principles of research quality assurance to improve data integrity and reliabilityRebecca Lynn Davies, Katrina LaubeCS22.3 Fostering research integrity in a culturally-diverse environmentCynthia Scheopner, John GallandCS22.4 Towards a standard retraction formHervé Maisonneuve, Evelyne Decullier23. Commercial research and integrityCS23.1 The will to commercialize: matters of concern in the cultural economy of return-on-investment researchBrian NobleCS23.2 Quality in drug discovery data reporting: a mission impossible?Anja Gilis, David J. Gallacher, Tom Lavrijssen, Malwitz David, Malini Dasgupta, Hans MolsCS23.3 Instituting a research integrity policy in the context of semi-private-sector funding: an example in the field of occupational health and safetyPaul-Emile Boileau24. The interface of publication ethics and institutional policiesCS24.1 The open access ethical paradox in an open government effortTony SavardCS24.2 How journals and institutions can work together to promote responsible conductEric MahCS24.3 Improving cooperation between journals and research institutions in research integrity casesElizabeth Wager, Sabine Kleinert25. Reproducibility of research and retractionsCS25.1 Promoting transparency in publications to reduce irreproducibilityVeronique Kiermer, Andrew Hufton, Melanie ClyneCS25.2 Retraction notices issued for publications by Latin American authors: what lessons can we learn?Sonia Vasconcelos, Renan Moritz Almeida, Aldo Fontes-Pereira, Fernanda Catelani, Karina RochaCS25.3 A preliminary report of the findings from the Reproducibility Project: Cancer biologyElizabeth Iorns, William Gunn26. Research integrity and specific country initiativesCS26.1 Promoting research integrity at CNRS, FranceMichèle Leduc, Lucienne LetellierCS26.2 In pursuit of compliance: is the tail wagging the dog?Cornelia MalherbeCS26.3 Newly established research integrity policies and practices: oversight systems of Japanese research universitiesTakehito Kamata27. Responsible conduct of research and country guidelinesCS27.1 Incentives or guidelines? Promoting responsible research communication through economic incentives or ethical guidelines?Vidar EnebakkCS27.3 Responsible conduct of research: a view from CanadaLynn PenrodCS27.4 The Danish Code of Conduct for Research Integrity: a national initiative to promote research integrity in DenmarkThomas Nørgaard, Charlotte Elverdam28. Behaviour, trust and honestyCS28.1 The reasons behind non-ethical behaviour in academiaYves FassinCS28.2 The psychological profile of the dishonest scholarCynthia FekkenCS28.3 Considering the implications of Dan Ariely’s keynote speech at the 3rd World Conference on Research Integrity in MontréalJamal Adam, Melissa S. AndersonCS28.4 Two large surveys on psychologists’ views on peer review and replicationJelte WichertsBrett Buttliere29. Reporting and publication bias and how to overcome itCS29.1 Data sharing: Experience at two open-access general medical journalsTrish GrovesCS29.2 Overcoming publication bias and selective reporting: completing the published recordDaniel ShanahanCS29.3 The EQUATOR Network: promoting responsible reporting of health research studiesIveta Simera, Shona Kirtley, Eleana Villanueva, Caroline Struthers, Angela MacCarthy, Douglas Altman30. The research environment and its implications for integrityCS30.1 Ranking of scientists: the Russian experienceElena GrebenshchikovaCS30.4 From cradle to grave: research integrity, research misconduct and cultural shiftsBronwyn Greene, Ted RohrPARTNER SYMPOSIAPartner Symposium AOrganized by EQUATOR Network, Enhancing the Quality and Transparency of Health ResearchP1 Can we trust the medical research literature?: Poor reporting and its consequencesIveta SimeraP2 What can BioMed Central do to improve published research?Daniel Shanahan, Stephanie HarrimanP3 What can a "traditional" journal do to improve published research?Trish GrovesP4 Promoting good reporting practice for reliable and usable research papers: EQUATOR Network, reporting guidelines and other initiativesCaroline StruthersPartner Symposium COrganized by ENRIO, the European Network of Research Integrity OfficersP5 Transparency and independence in research integrity investigations in EuropeKrista Varantola, Helga Nolte, Ursa Opara, Torkild Vinther, Elizabeth Wager, Thomas NørgaardPartner Symposium DOrganized by IEEE, the Institute of Electrical and Electronics EngineersRe-educating our author community: IEEE's approach to bibliometric manipulation, plagiarism, and other inappropriate practicesP6 Dealing with plagiarism in the connected world: An Institute of Electrical and Electronics Engineers perspectiveJon RokneP7 Should evaluation of raises, promotion, and research proposals be tied to bibliometric indictors? What the Institute of Electrical and Electronics Engineers is doing to answer this questionGianluca SettiP8 Recommended practices to ensure conference content qualityGordon MacPhersonPartner Symposium EOrganized by the Committee on Freedom and Responsibility in the Conduct of Science of ICSU, the International Council for ScienceResearch assessment and quality in science: perspectives from international science and policy organisationsP9 Challenges for science and the problems of assessing researchEllen HazelkornP10 Research assessment and science policy developmentCarthage SmithP11 Research integrity in South Africa: the value of procedures and processes to global positioningRobert H. McLaughlinP12 Rewards, careers and integrity: perspectives of young scientists from around the worldTatiana Duque MartinsPartner Symposium FOrganized by the Online Resource Center for Ethics Education in Engineering and Science / Center for Engineering, Ethics, and Society of the National Academy of EngineeringP13 Research misconduct: conceptions and policy solutionsTetsuya Tanimoto, Nicholas Steneck, Daniele Fanelli, Ragnvald Kalleberg, Tajammul HusseinPartner Symposium HOrganized by ORI, the Office of Research Integrity; Universitas 21; and the Asia Pacific Research Integrity NetworkP14 International integrity networks: working together to ensure research integrityPing Sun, Ovid Tzeng, Krista Varantola, Susan ZimmermanPartner Symposium IOrganized by COPE, the Committee on Publication EthicsPublication without borders: Ethical challenges in a globalized worldP15 Authorship: credit and responsibility, including issues in large and interdisciplinary studiesRosemary ShinkaiPartner Symposium JOrganized by CITI, the Cooperative Institutional Training InitiativeExperiences on research integrity educational programs in Colombia, Costa Rica and PeruP16 Experiences in PeruRoxana LescanoP17 Experiences in Costa RicaElizabeth HeitmanP18 Experiences in ColumbiaMaria Andrea Rocio del Pilar Contreras NietoPoster Session B: Education, training, promotion and policyPT.01 The missing role of journal editors in promoting responsible researchIbrahim Alorainy, Khalid Al-WazzanPT.02 Honorary authorship in Taiwan: why and who should be in charge?Chien Chou, Sophia Jui-An PanPT.03 Authorship and citation manipulation in academic researchEric Fong, Al WilhitePT.04 Open peer review of research submission at medical journals: experience at BMJ Open and The BMJTrish GrovesPT.05 Exercising authorship: claiming rewards, practicing integrityDésirée Motta-RothPT.07 Medical scientists' views on publication culture: a focus group studyJoeri Tijdink, Yvo SmuldersPoster Session B: Education, training, promotion and policyPT.09 Ethical challenges in post-graduate supervisionLaetus OK LateganPT.10 The effects of viable ethics instruction on international studentsMichael Mumford, Logan Steele, Logan Watts, James Johnson, Shane Connelly, Lee WilliamsPT.11 Does language reflect the quality of research?Gerben ter Riet, Sufia Amini, Lotty Hooft, Halil KilicogluPT.12 Integrity complaints as a strategic tool in policy decision conflictsJanneke van Seters, Herman Eijsackers, Fons Voragen, Akke van der Zijpp and Frans BromPoster Session C: Ethics and integrity intersectionsPT.14 Regulations of informed consent: university-supported research processes and pitfalls in implementationBadaruddin Abbasi, Naif Nasser AlmasoudPT.15 A review of equipoise as a requirement in clinical trialsAdri LabuschagnePT.16 The Research Ethics Library: online resource for research ethics educationJohanne Severinsen, Espen EnghPT.17 Research integrity: the view from King Abdulaziz City for Science and TechnologyDaham Ismail AlaniPT. 18 Meeting global challenges in high-impact publications and research integrity: the case of the Malaysian Palm Oil BoardHJ. Kamaruzaman JusoffPT.19 University faculty perceptions of research practices and misconductAnita Gordon, Helen C. HartonPoster Session D: International perspectivesPT.21 The Commission for Scientific Integrity as a response to research fraudDieter De Bruyn, Stefanie Van der BurghtPT. 22 Are notions of the responsible conduct of research associated with compliance with requirements for research on humans in different disciplinary traditions in Brazil?Karina de Albuquerque Rocha, Sonia Maria Ramos de VasconcelosPT.23 Creating an environment that promotes research integrity: an institutional model of Malawi Liverpool Welcome TrustLimbanazo MatandikaPT.24 How do science policies in Brazil influence user-engaged ecological research?Aline Carolina de Oliveira Machado Prata, Mark William NeffPoster Session E: Perspectives on misconductPT.26 What “causes” scientific misconduct?: Testing major hypotheses by comparing corrected and retracted papersDaniele Fanelli, Rodrigo Costas, Vincent LarivièrePT.27 Perception of academic plagiarism among dentistry studentsDouglas Leonardo Gomes Filho, Diego Oliveira GuedesPT. 28 a few bad apples?: Prevalence, patterns and attitudes towards scientific misconduct among doctoral students at a German university hospitalVolker Bähr, Niklas Keller, Markus Feufel, Nikolas OffenhauserPT. 29 Analysis of retraction notices published by BioMed CentralMaria K. Kowalczuk, Elizabeth C. MoylanPT.31 "He did it" doesn't work: data security, incidents and partnersKatie SpeanburgPoster Session F: Views from the disciplinesPT.32 Robust procedures: a key to generating quality results in drug discoveryMalini Dasgupta, Mariusz Lubomirski, Tom Lavrijssen, David Malwitz, David Gallacher, Anja GillisPT.33 Health promotion: criteria for the design and the integrity of a research projectMaria Betânia de Freitas Marques, Laressa Lima Amâncio, Raphaela Dias Fernandes, Oliveira Patrocínio, and Cláudia Maria Correia Borges RechPT.34 Integrity of academic work from the perspective of students graduating in pharmacy: a brief research studyMaria Betânia de Freitas Marques, Cláudia Maria Correia Borges Rech, Adriana Nascimento SousaPT.35 Research integrity promotion in the Epidemiology and Health Services, the journal of the Brazilian Unified Health SystemLeila Posenato GarciaPT.36 When are clinical trials registered? An analysis of prospective versus retrospective registration of clinical trials published in the BioMed Central series, UKStephanie Harriman, Jigisha PatelPT.37 Maximizing welfare while promoting innovation in drug developmentFarida LadaOther posters that will be displayed but not presented orally:PT.38 Geoethics and the debate on research integrity in geosciencesGiuseppe Di Capua, Silvia PeppoloniPT.39 Introducing the Professionalism and Integrity in Research Program James M. DuBois, John Chibnall, Jillon Van der WallPT.40 Validation of the professional decision-making in research measureJames M. DuBois, John Chibnall, Jillon Van der Wall, Raymond TaitPT.41 General guidelines for research ethicsJacob HolenPT. 42 A national forum for research ethicsAdele Flakke Johannessen, Torunn EllefsenPT.43 Evaluation of integrity in coursework: an approach from the perspective of the higher education professorClaudia Rech, Adriana Sousa, Maria Betânia de Freitas MarquesPT.44 Principles of geoethics and research integrity applied to the European Multidisciplinary Seafloor and Water Column Observatory, a large-scale European environmental research infrastructureSilvia Peppoloni, Giuseppe Di Capua, Laura BeranzoliF1 Focus track on improving research systems: the role of fundersPaulo S.L. Beirão, Susan ZimmermanF2 Focus track on improving research systems: the role of countriesSabine Kleinert, Ana MarusicF3 Focus track on improving research systems: the role of institutionsMelissa S. Anderson, Lex Bouter. (shrink)

The widespread adoption of radioisotopes as tools in biomedical research and therapy became one of the major consequences of the "physicists' war" for postwar life science. Scientists in the Manhattan Project, as part of their efforts to advocate for civilian uses of atomic energy after the war, proposed using infrastructure from the wartime bomb project to develop a government-run radioisotope distribution program. After the Atomic Energy Bill was passed and before the Atomic Energy Commission (AEC) was formally established, the (...) Manhattan Project began shipping isotopes from Oak Ridge. Scientists and physicians put these reactor-produced isotopes to many of the same uses that had been pioneered with cyclotron-generated radioisotopes in the 1930s and early 1940s. The majority of early AEC shipments were radioiodine and radiophosphorus, employed to evaluate thyroid function, diagnose medical disorders, and irradiate tumors. Both researchers and politicians lauded radioisotopes publicly for their potential in curing diseases, particularly cancer. However, isotopes proved less successful than anticipated in treating cancer and more successful in medical diagnostics. On the research side, reactor-generated radioisotopes equipped biologists with new tools to trace molecular transformations from metabolic pathways to ecosystems. The U.S. government's production and promotion of isotopes stimulated their consumption by scientists and physicians (both domestic and abroad), such that in the postwar period isotopes became routine elements of laboratory and clinical use. In the early postwar years, radioisotopes signified the government's commitment to harness the atom for peace, particularly through contributions to biology, medicine, and agriculture. (shrink)

Kuhnʼs influential book, The Structure of Scientific Revolutions,1 is often viewed as a revolt against empiricist philosophy of science. However, Friedman has reminded us lately2 that the book was commissioned by logical positivists, who were delighted with the result. In fact, the book was part of the International Encyclopedia of United Science initiated by members of the Vienna Circle, whose first volumes were published in 1938.3 The project aimed at providing a systematic positivist perspective on all the sciences, from logic (...) and mathematics through linguistics and on to psychology and sociology. The publication of Structure as volume 12 of the encyclopedia was greeted enthusiastically by the editor, Carnap, as can be learned from the letters he wrote to Kuhn. There are several reasons for this reaction. First, as noted by Friedman, there is a resemblance between Kuhnʼs notion of changing paradigms and Carnapʼs philosophical ideas. Logical empiricism is “logical” because of its central tenet that scientific knowledge is the organization of facts within a conceptual structure; the existence of an appropriate conceptual structure is a precondition for the very possibility of scientific inquiry. Unlike Kant, however, the logical empiricists believed that the conceptual. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Rhetoric and Power: An Inquiry into Foucault’s Critique of ConfessionDave TellOn October 10, 1979, Michel Foucault revised his thesis on confession. On that day, some three years after the publication of his magisterial treatment of confession in the first volume of The History of Sexuality, Foucault argued that the Pythagoreans, Stoics, and Epicureans had, before the advent of Christianity, their own practices of confession. Yet these practices, unlike (...) their Christian variants, were not complicit with practices of domination (OS 310, 312). In the context of Foucault’s thought theretofore, in which the confession consistently figured as an essential component in the exercise of modern power, this is a radical shift. In lectures given at both Berkeley and Dartmouth in the fall of 1980, Foucault made similar arguments. On these occasions he argued that Seneca’s De ira constituted a “stoic confession,” the object of which was to enable the subject to “live differently, better, more happily, than other people” (AB 210, 205). Judith Butler captures the gravity of the shift: “In the last years of his life, Foucault returned to the question of confession, reversing his earlier critique in the first volume of the History of Sexuality, where he indicts confession as a forcible extraction of sexual truth, a practice in the service of a regulatory power” (2005, 112).This reversal was short lived. Although Foucault would celebrate ancient Greek techniques of the self for the rest of his life, he would not [End Page 95] long refer to these techniques in terms of confession. Thus, in another reading of De ira, this one in March 1982, Foucault again noted that the Stoics have “confessional practices” that are “very close to what is found in Christianity” (Herm 482). This time, however, he insisted that the Stoic practices were fundamentally different: “However, all these elements seem to me to be profoundly different from what we should call ‘confession’ in the strict, or anyway, spiritual sense of the word” (Herm 365). In The Care of the Self, Foucault again conceded that De ira—what he now called “the most detailed description” of antique practices of the self—looked “at first glance” like a Christian confession, but he again maintained that it is something quite different: “The purpose of the examination is not therefore to discover one’s own guilt, down to its most trifling forms” (CS 61–62). Foucault concluded that the various “discourses of the self”—the confession and the Greek techniques of the self—could not be placed into a single category (see GE 250). Indeed, the “profound difference” (Herm 299) between these two discourses of the self was perhaps Foucault’s most repeated claim of the 1980s (see Herm 222, 237–44, 299, 308; GE 247–48; WS 237; AB 207–8; RFT 27; UP 89; CS 239; SS 5; FI 5, 12; FS 30, 35, 44, 87, 96, 97, 143–45, 147).It is worth asking why Foucault returned so consistently to the distinction between these two discursive forms. This question gains even more relevance for readers of this journal when we remember that, on at least two occasions, Foucault defined one of these forms, the ancient techniques of the self, in terms of its opposition to rhetoric: the techniques of the self, he claimed, are “nonrhetorical” (Herm 368; FS 20). Thus the question that drives this essay is not so much why Foucault attached such importance to the distinction but rather how rhetoric itself might differentiate the confession from the techniques of the self. Stated differently, Foucault’s work on the confession vis-à-vis the technologies of the self provides a valuable opportunity to study the role of rhetoric in Foucault’s thought—not because they are both rhetorical forms but, curiously, because Foucault insists that one is not.In order to foreground the work of rhetoric in Foucault’s thought, I situate his discourses of the self in the context of Nietzsche’s critique of metonymy. Although this may seem arbitrary, it gains initial plausibility from three facts. First, we know that Foucault understood rhetoric in terms of tropes (OT 84; Cooper 1988, 4). Second, we know too that Foucault had a deep... (shrink)

At present, there are problems in the construction of the tourism public service system such as poor coordination and coordination among various departments, lack of resource integration mechanism, and low level of information of tourism public services. Therefore, by analysing the problems existing in the tourism public service system in the context of smart cities, this paper puts forward strategies to optimize the tourism public service system. First, we build a smart tourism (...) class='Hi'>public service system platform for overall development and optimize the tourism public service platform. Secondly, by focusing on the behaviour of tourists, we construct a big data analysis and management system for the behaviour of smart tourism tourists. Finally, for the traffic situation in the process of tourism, a smart traffic line network based on pheromone ant colony is constructed. The results of the questionnaire survey on tourists show that the optimized public service system platform has achieved great satisfaction. (shrink)

Australia, along with other countries, has introduced New Public Management (NPM) into public sector hospitals in an effort to contain healthcare costs. NPM is associated with outsourcing of service provision, the meeting of government performance indicators, workforce flexibility and rationing of resources. This study explores the impact of rationing of staffing and other resources upon delivery of care outside of business hours. Data was collected through semistructured interviews conducted with 21 nurses working in 2 large Australian metropolitan (...) hospitals. Participants identified four strategies associated with NPM which add to workload after‐hours and impacted on the capacity to deliver nursing care. These were functional flexibility, vertical substitution of staff, meeting externally established performance indicators and outsourcing. We conclude that cost containment alongside of the meeting of performance indicators has extended work traditionally performed during business hours beyond those hours when less staffing and material resources are available. This adds to nursing workload and potentially contributes to incomplete nursing care. (shrink)

The law often calls on the concept of public interest for assistance. Privacy law makes use of this concept in several ways, including to justify consent waivers for secondary research on health information. Because the law sees information privacy as a means for individuals to control their personal information, consent can only be set aside in special circumstances. Ballantyne and Schaefer argue that only public interest, and only a broad conception of public interest, can do the special (...) ‘normative justificatory work’ to override consent requirements. Other, similar-sounding concepts, such as public benefit, public good and social value, also provide useful services. But none more so than public interest. In fact, they argue, public interest is the superior concept precisely because it can capture those concepts as well as a range of other interests. Our response focuses on this claim. We argue their strategy is not as promising as it might first seem. Ballantyne and Schaefer construe the important role that public interest plays in this context as their endpoint. They claim that unless the concept is open and content-rich, it will lose some of its importance. But by refusing to place limits around it, their inquiry leads us back to a catch-all concept that lacks clear focus or meaning. In reply, we argue that, for practically minded theorists, a narrow conception of public interest is more useful. Further, the narrowing of public interest in this context can be achieved by first analysing it in its legal, rather than ethical, sense. (shrink)

Narrative inquiry in a nursing practicum One approach to creating research‐based nursing education is to think and write narratively about the daily life of a BScN program student and her teacher in diverse settings and over time. Gail, as a nurse‐teacher, and Faith, as a nursing student and now Public Health Nurse, reconstruct their teaching–learning experiences in an integrated practicum in maternal–child health services as a narrative inquiry. After presenting this reconstruction of experience at a conference on (...) maternal scholarship, further inquiry into their experiences shows how narrative inquiry matters to construction of nursing praxis and to life‐long learning as a nurse. Teaching–learning relationships are seen as a template for a student's connections to people experiencing nursing care and to other clinicians. Construction of stories to live by that take into account becoming a nurse, constructing knowledge and enacting caring–healing nursing practices is illuminated through narrative inquiry. (shrink)

The term “globalization” was popularized by Marshall McLuhan in War and Peace in the Global Village. In the book, McLuhan described how the global media shaped current events surrounding the Vietnam War [1] and also predicted how modern information and communication technologies would accelerate world progress through trade and knowledge development. Globalization now refers to a broad range of issues regarding the movement of goods and services through trade liberalization, and the movement of people through migration. Much has also been (...) written on the global effects of environmental degradation, population growth, and economic disparities. In addition, the pace of scientific development has accelerated, with both negative and positive implications for global health. Concerns for national health transcend borders, with a need for shared human security and an enhanced role for international cooperation and development [2]. These issues have significant bioethical implications, and thus a renewed academic focus on the ethical dimensions of public health is needed. Future developments in science and health policy also require a firm grounding in bioethical principles. These core principles include beneficence; nonmaleficence ; respect for persons and human dignity ; and attention to equity and social justice. According to the World Health Organization [3], global ethical approaches should monitor and update ethical norms for research, as necessary; anticipate ethical implications of advances in science and technology for health; apply internationally accepted codes of ethics; ensure that agreed standards guide future work on the human genome; and ensure that quality in health systems and services is assessed and promoted. (shrink)

Speaking of the public response to the deaths of children at the Bristol Royal Infirmary before 2001, the BMJ commented that the NHS would be ‘all changed, changed utterly’. Today, two inquiries into the Mid Staffordshire Foundation Trust suggest nothing changed at all. Many patients died as a result of their care and the stories of indifference and neglect there are harrowing. Yet Bristol and Mid Staffordshire are not isolated reports. In 2011, the Health Services Ombudsman reported on the (...) care of elderly and frail patients in the NHS and found a failure to recognise their humanity and individuality and to respond to them with sensitivity, compassion and professionalism. Likewise, the Care Quality Commission and Healthcare Commission received complaints from patients and relatives about the quality of nursing care. These included patients not being fed, patients left in soiled bedding, poor hygiene practices, and general disregard for privacy and dignity. Why is there such tolerance of poor clinical standards? We need a better understanding of the circumstances that can lead to these outcomes and how best to respond to them. We discuss the findings of these and other reports and consider whether attention should be devoted to managing individual behaviour, or focus on the systemic influences which predispose hospital staff to behave in this way. Lastly, we consider whether we should look further afield to cognitive psychology to better understand how clinicians and managers make decisions? (shrink)

Taking Anthropogenic global warming as its framing example this paper develops an ethics of inquiry and public discourse influenced by Rawlsian public reason. The need to embrace scientific fact during civil discourse on topics of moral and political controversy is stressed as an ethical mandate. The paper argues: (1) ethicists have a moral obligation to recognize scientific consensus when relevant to ethical discussions. (2) The failure to condemn science denialism when it interferes with the public’s understanding (...) of ethical issues is itself a moral failure (especially in an educational setting). (3) The endorsed ethics of inquiry and public discourse encourages epistemic virtues that are desirable among members of a pluralistic society. (shrink)

This paper explores public sentiment towards strike action among healthcare workers, as a result of their perceived inadequate pay. By analysing survey data collected in England between 2022 and 2023, the study focuses on NHS nurses and junior doctors, due to their critical role in delivering essential public services. Results indicate higher public support for strikes by nurses and junior doctors compared to other professions such as postal workers, teachers, rail workers, airport workers, civil servants and university (...) lecturers. However, variation in support for strikes by healthcare workers is observed across societal segments. Significant disparities in support are linked to individual political affiliations, left–right ideological positions and trust in the NHS. In short, nonconservative voters, individuals leaning towards left‐wing politics and those with greater trust in the NHS demonstrate higher likelihoods of supporting strikes by health workers. These findings carry implications for future strike decisions and highlight specific target groups for enhanced communication efforts to garner increased public support. (shrink)

BackgroundIn the 1970s, the Federal Trade Commission declared that allowing medical providers to advertise directly to consumers would be “providing the public with truthful information about the price, quality or other aspects of their service.” However, our understanding of the advertising content is highly limited.ObjectiveTo assess whether direct-to-consumer medical service advertisements provide relevant information on access, quality and cost of care, a content analysis was conducted.MethodTelevision and online advertisements for medical services directly targeting consumers were collected (...) in two major urban centres in Nevada, USA, identifying 313 television advertisements and 200 non-duplicate online advertisements.ResultsBoth television and online advertisements reliably conveyed information about the services provided and how to make an appointment. At the same time, less than half of the advertisements featured insurance information and hours of operation and less than a quarter of them contained information regarding the quality and price of care. The claims of quality were substantiated in even fewer advertisements. The scarcity of quality and cost information was more severe in television advertisements.ConclusionThere is little evidence that medical service advertising, in its current form, would contribute to lower prices or improved quality of care by providing valuable information to consumers. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:An Egg Takes Flight: The Once and Future Life of the National Bioethics Advisory Commission*Alexander Morgan Capron (bio)Attempting to describe the National Bioethics Advisory Commission (NBAC) is comparable to the surreal feat performed by the artist in a famous painting by René Magritte. The artist (Magritte himself) sits with his back to the viewer, a palette in his left hand. The brush in his right hand is (...) raised to a canvas, blank except for a bird in flight that he is in the process of painting. The artist is looking to his left at a tabletop, bare except for a single, plain egg.Having held its second formal meeting in mid-January, NBAC is certainly still embryonic, its future mysterious within its shell. Yet answers to four major questions that will determine not just what kind of bird the Commission turns out to be but the heights to which it will fly should be evident by April or May 1997. First, will the White House take the sort of interest in NBAC that is needed if it is to succeed? Second, will the Commission’s term be extended beyond October 1997—and will the decision come early enough to allow it to start soon on projects that will take more than a single year to complete? Third, will the Commission take a broad view of the issues it addresses, reexamining widely accepted assumptions and going back to basic premises, or will it respond primarily in bureaucratic terms, guided by its charter’s focus on improving the policies and practices of federal departments and agencies? Fourth, will the Commission move beyond its initially mandated topics—the rights and welfare of human research subjects and the management and use of genetic information—and become what its name promises, the nation’s advisory body on the full range of bioethical issues that arise in the organization and management of health services and research?The Origins of the Egg: NBAC’s PredecessorsThe creation of a national bioethics commission has been demanded for years, at the least since its most recent predecessor, the Biomedical Ethics [End Page 63] Advisory Committee (BEAC) finally expired in 1990. BEAC’s statutory authority lapsed after the hapless committee had spent several years itself like an in vitro embryo in a vat of liquid nitrogen. BEAC’s opponents in Congress froze its appropriation and forbad it to meet until the Biomedical Ethics Board of six senators and six representatives to which it was supposed to report resolved the chaos resulting from the Board members’ ideological differences and personal distrust; this never occurred, and the Board proved unable even to choose its chairman. 1 BEAC, which met only twice, had laid preliminary plans to study the issues raised by the new genetics, but the politics of abortion—which had greatly complicated and slowed the Board’s naming of the BEAC members—was strong enough to interfere even with the topic of genetics, on which the difference among committee members actually gave no sign of dividing on pro-life/pro-choice grounds.The disappearance of BEAC left the nation without a mechanism for “public bioethics,” and several efforts were undertaken in the early 1990s to generate a new commission that could carry on in the tradition of the two previous, successful bioethics commissions. (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research operated under a Congressional mandate in the Department of Health, Education, and Welfare from 1974 to 1978, and the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which had been authorized by Congress in 1978, actually operated as an independent body with government-wide purview from January 1980 to March 1983.) The Institute of Medicine established a committee to assess the mechanisms available not only to the federal government but also to states, professional bodies, and the public for deliberating about and resolving ethical issues stemming from developments in biomedicine (Bulger, Bobby, and Fineberg 1995). In September 1992, Senators Mark O. Hatfield (R-OR), Edward M. Kennedy (D-MA), and Dennis DeConcini (D-AZ) requested that the Office of Technology Assessment (OTA) evaluate the... (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)

Based on an analysis of the reports of twenty-eight national-level public commission inquiries into events involving ethno-national violence—drawn from five national contexts and arrayed over the course of the twentieth century—this article demonstrates the strikingly transnational character of these investigatory bodies’ attempts to authoritatively explain episodes of collective violence and to thereby restore governing legitimacy in the wake of violent crises. One of four distinct “logics,” or core explanatory frameworks, each associated with a particular mode of “racial power,” (...) characterized a diverse cross-national pool of violence commission reports during defined periods of the twentieth century. In revealing globally encompassing logics to what has often been framed as a national or case-specific phenomenon, the author shows how global ideational currents compose a key dimension of national political dynamics. (shrink)