As evidenced by high-throughput sequencers, genomic technologies have recently undergone radical advances. These technologies enable comprehensive sequencing of personal genomes considerably more efficiently and less expensively than heretofore. These developments present a challenge to the conventional framework of biomedical ethics; under these changing circumstances, each research project has to develop a pragmatic research policy. Based on the experience with a new large-scale project—the Genome Science Project—this article presents a novel approach to conducting a specific policy for (...) personal genome research in the Japanese context. In creating an original informed-consent form template for the project, we present a two-tiered process: making the draft of the template following an analysis of national and international policies; refining the draft template in conjunction with genome project researchers for practical application. Through practical use of the template, we have gained valuable experience in addressing challenges in the ethical review process, such as the importance of sharing details of the latest developments in genomics with members of research ethics committees. We discuss certain limitations of the conventional concept of informed consent and its governance system and suggest the potential of an alternative process using information technology. (shrink)

It now seems technically feasible to culture human embryos beyond the “fourteen‐day limit,” which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen‐day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that (...) doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen‐day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high‐quality research and public confidence in it. (shrink)

Since the 1980s, two different paradigms have reshaped industrial societies: the Neoliberal paradigm and a Research and Innovation paradigm. Both have been conceptualized and translated into strong policies with massive economic and social consequences. They provide divergent responses to the environmental transition. The Neoliberal paradigm is based on economic models and geopolitical solutions. The Research and Innovation paradigm's goal is to manage knowledge differently in order to reorient the evolution of society. Since the mid-1990s, a version of the (...) Research and Innovation paradigm has led to the design of large-scale research and innovation policies. This book examines how these policies have evolved and how they can be extended and reformed to respond to present and future environmental constraints. It studies the transformation of the conception, organization and role of science and technology in the evolution of industrial societies and explores the future of these developments. The book offers three unique lines of enquiry. The first is to focus not specifically on economics, sociology, political science or history, but on knowledge creation from an institutional and reflexive point of view. The second is to establish a convergence between the British school of science and technology studies and the research trends opened by the work of Michel Foucault. Both introduced trans-disciplinary and policy-oriented research associating case studies, long-term perspectives and theory. The third is to consider climate change as the overwhelming challenge of our time. The book is an insightful guide for students, scholars and researchers across the humanities and social sciences, including philosophy, political science, law, economics, business and media. (shrink)

Historically, scientific and engineering expertise has been key in shaping research and innovation policies, with benefits presumed to accrue to society more broadly over time. But there is persistent and growing concern about whether and how ethical and societal values are integrated into R&I policies and governance, as we confront public disbelief in science and political suspicion toward evidence-based policy-making. Erosion of such a social contract with science limits the ability of democratic societies to deal with challenges presented (...) by new, disruptive technologies, such as synthetic biology, nanotechnology, genetic engineering, automation and robotics, and artificial intelligence. Many policy efforts have emerged in response to such concerns, one prominent example being Europe's Eighth Framework Programme, Horizon 2020, whose focus on “Responsible Research and Innovation” provides a case study for the translation of such normative perspectives into concrete policy action and implementation. Our analysis of this H2020 RRI approach suggests a lack of consistent integration of elements such as ethics, open access, open innovation, and public engagement. On the basis of our evaluation, we suggest possible pathways for strengthening efforts to deliver R&I policies that deepen mutually beneficial science and society relationships. (shrink)

It now seems technically feasible to culture human embryos beyond the “fourteen‐day limit,” which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen‐day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that (...) doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen‐day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high‐quality research and public confidence in it. (shrink)

The use of nonhuman animals as models in research and drug testing is a key route through which contemporary scientific knowledge is certified. Given ethical concerns, regulation of animal research promotes the use of less “sentient” animals. This paper draws on a documentary analysis of legal documents and qualitative interviews with Named Veterinary Surgeons and others at a commercial laboratory in the UK. Its key claim is that the concept of animal sentience is entangled with a particular imaginary (...) of how the general public or wider society views animals. We call this imaginary societal sentience. Against a backdrop of increasing ethnographic work on care encounters in the laboratory, this concept helps to stress the wider context within which such encounters take place. We conclude that societal sentience has potential purchase beyond the animal research field, in helping to highlight the affective dimension of public imaginaries and their ethical consequences. Researching and critiquing societal sentience, we argue, may ultimately have more impact on the fate of humans and nonhumans in the laboratory than focusing wholly on ethics as situated practice. (shrink)

Animal research in the United Kingdom is regulated by the Animals Act 1986, which requires a government minister to weigh the expected suffering of animals against the expected benefits of a proposed animal research project—the “cost-benefit assessment”—before licensing the project. Research into the implementation of this legislation has been severely constrained by statutory confidentiality. This paper overcomes this hindrance by describing a critical case study based on unprecedented primary data: pig-to-primate organ transplantation conducted between 1995 and 2000. (...) It reveals that researchers and regulators significantly underestimated the adverse effects suffered by the animals involved, while overestimating the scientific and medical benefits likely to accrue. Applying dynamic policy network analysis to this case in the context of the evolution of animal research policy indicates that an elitist, policy community type network has persisted since shortly after the network’s formation in 1876. Animal research interests have repeatedly withstood pressure for change from animal protection groups because of their greater resources, structural advantages, and a culture of secrecy that facilitates an implementation gap in animal research regulation. (shrink)

In den letzten anderthalb Jahrhunderten ist die bedeutende Entfaltung der Geisteswissenschaften in den deutschsprechenden Ländern maßgeblich durch jene Universitätsreform ermöglicht worden, die mit dem Namen Humboldts verknüpft wird. Seit den sechziger Jahren nimmt man auch in der Bundesrepublik von dieser Universität Abschied; die jetzige Hochschulgesetzgebung setzt auch eine äußerliche Zäsur. Zugleich setzt sich auch im Bereich geisteswissenschaftlicher Arbeit bei Basisaufgaben wie der Materialsammlung und der Edition die "Forschung" durch, das heißt die langfristig organisierte und institutionell abgesicherte wissenschaftliche Tätigkeit. Im politischen (...) wie im kirchlichen Bereich wird die unmittelbare Weitergabe und Darstellung von Tradition immer stärker entmächtigt, und so können wissenschaftlich distanzierte, kompensatorische Hinweise auf Tradition - etwa in den großen kulturhistorischen Ausstellungen - Bedeutung bekommen. Eine Forschungspolitik wird auch gegenüber den Geisteswissenschaften nötig, die ihre Grenzen kennt und die geisteswissenschaftliche Arbeit, die in ihrem Kern Individualforschung war und bleiben muß, nicht durch Übertragung unangemessener forschungspolitischer Direktiven aus anderen wissenschaftlichen Bereichen stört. (shrink)

There is a growing interest in the ethics of Health Policy and Systems Research, and especially in areas that have particular ethical salience across HPSR. Hyder et al provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies (...) involved qualitative work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential ‘solutions’ to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications. (shrink)

Whats human rights got to do with it? That is, whats human rights got to do with the June 2004 report of the Social Sciences and Humanities Research Ethics Special Working Committee to the Inter-Agency Advisory Panel on Research Ethics. The disturbing answer is not enough. Certain key recommendations of the working committee, it is suggested, would unacceptably weaken the researchers legal and moral accountability to research participants. Those particular recommendations rely on misguided references to academic freedom (...) and the nature of the non-medical research context. In fact, universal human rights, and the legal instruments in which they are embodied ought to inform the research endeavor at every stage; from problem selection to analysis and conclusions. This will lead us closer to shared truths rather than simply to the academic elites vision of truth. Without sufficient regard for the human rights of research participants academic freedom itself is not possible. (shrink)

Scientific misconduct includes the fabrication, falsification, and plagiarism (FFP) of concepts, data or ideas; some institutions in the United States have expanded this concept to include “other serious deviations (OSD) from accepted research practice.” It is the absence of this OSD clause that distinguishes scientific misconduct policies of the past from the “research misconduct” policies that should be the basis of future federal policy in this area. This paper introduces a standard for judging whether an action should (...) be considered research misconduct as distinguished from scientific misconduct: by this standard, research misconduct must involve activities unique to the practice of science and must have the potential to negatively affect the scientific record. Although the number of cases of scientific misconduct is uncertain (only the NIH and the NSF keep formal records), the costs are high in terms of the integrity of the scientific record, diversions from research to investigate allegations, ruined careers of those eventually exonerated, and erosion of public confidence in science. Existing scientific misconduct policies vary from institution to institution and from government agency to government agency; some have highly developed guidelines that include OSD, others have no guidelines at all. One result has been that the federal False Claims Act has been used to pursue allegations of scientific misconduct. As a consequence, such allegations have been adjudicated in federal courts, rather than judged by scientific peers. The federal government is now establishing a first-ever research misconduct policy that would apply to all research funded by the federal government regardless of which agency funded the research or whether the research was carried out in a government, industrial or university laboratory. Physical scientists, who up to now have only infrequently been the subject of scientific misconduct allegations, must nonetheless become active in the debate over research misconduct policies and how they are implemented since they will now be explicitly covered by this new federal wide policy. (shrink)

This book's importance is derived from three sources: careful conceptualization of teacher induction from historical, methodological, and international perspectives; systematic reviews of research literature relevant to various aspects of teacher induction including its social, cultural, and political contexts, program components and forms, and the range of its effects; substantial empirical studies on the important issues of teacher induction with different kinds of methodologies that exemplify future directions and approaches to the research in teacher induction.

An analysis of current biomedical research misconduct policy that proposes a new approach emphasizing the context of misconduct and improved oversight. Federal regulations that govern research misconduct in biomedicine have not been able to prevent an ongoing series of high-profile cases of fabricating, falsifying, or plagiarizing scientific research. In this book, Barbara Redman looks critically at current research misconduct policy and proposes a new approach that emphasizes institutional context and improved oversight. Current policy (...) attempts to control risk at the individual level. But Redman argues that a fair and effective policy must reflect the context in which the behavior in question is embedded. As journalists who covered many research misconduct cases observed, the roots of fraud “lie in the barrel, not in the bad apples that occasionally roll into view.” Drawing on literature in related fields—including moral psychology, the policy sciences, the organizational sciences, and law—as well as analyses of misconduct cases, Redman considers research misconduct from various perspectives. She also examines in detail a series of clinical research cases in which repeated misconduct went undetected and finds laxity of oversight, little attention to harm done, and inadequate correction of the scientific record. Study questions enhance the book's value for graduate and professional courses in research ethics. Redman argues that the goals of any research misconduct policy should be to protect scientific capital (knowledge, scientists, institutions, norms of science), support fair competition, contain harms to end users and to the public trust, and enable science to meet its societal obligations. (shrink)

In the article of Bystrytska E. «Eastern policy of the Vatican»: methodological and practical aspects of research», the study examines the extent to problems in the works of ukrainian and foreign scientists, as well as an overview of the source base served.

The starting point for this paper is the ongoing debate about the relation between research and policy in education. Recent developments in England and Scotland are reviewed in the context of political and academic arguments about the nature and function of research activity. The defensiveness of the research community in the face of professional and political attacks is examined critically. A case study of the Higher Still programme is used to illustrate the complexity of the relationships (...) between evidence, ideology, values and professional practice. It is argued that the research community needs to become more politically sophisticated and to advance a clearer vision of its social function in advanced democratic societies if its potential contribution to educational development is to be realised. The dangers of a retreat to a narrow empirical role are highlighted. (shrink)

This book examines historical approaches and current research and practice related to the education of adolescents placed at risk of school failure as a result of social and economic conditions. One major goal is to expand the intellectual exchange among researchers, policymakers, practitioners, and concerned citizens on factors influencing the achievement of poor and minority youth, specifically students in middle and high schools. Another is to encourage increased dialogue about policies and practices that can make a difference in educational (...) opportunities and outcomes for these students. Although the chapters in this volume are not exhaustive, they represent an array of theoretical and methodological approaches that provide readers with new and diverse ways to think about issues of educational equality and opportunity in the United States. A premise that runs through each chapter is that school success is possible for poor and minority adolescents if adequate support from the school, family, and community is available. *The conceptual approach places the research and practice on students placed at risk in a historical context and sets the stage for an important reframing of current definitions, research, policies, and practices aimed at this population. *Multiple research methodologies allow for comparisons across racial and ethnic groups as well as within groups, and contribute to different and complementary insights. Section III, "Focus on African-American Students," specifically addresses gender and social class differences among African-American adolescents. *Current reform strategies presently being implemented in schools throughout the United States are presented and discussed. These strategies or programs highlight how schools, families, and communities can apply research findings like the ones this book presents, thus bridging the often wide gap between social science research and educational practice. (shrink)

This paper examines the promise of science and its role in shaping research policy. The promise of science is characterized by expectations of science, which are embedded in promissory discourses that envision futures made possible through advances in promising science. Through a single case study of the origins of Genome Canada, the research was guided by the question: How did expectations of genomics shape the creation of Genome Canada? A conceptualization of discursive power and expectations of genomics (...) storylines provide the theoretical and analytical basis for an in-depth examination of the ideational effects and material impacts on research policy decisions over three years that culminated in the creation of Genome Canada. Expectations of genomics storylines functioned in a complex interplay of discursive practices and dynamics among diverse policy actors within a genomics discourse-coalition to produce a range of ideational and material impacts. The expectations of genomics storylines produced powerful genomics subject-positions from which policy actors perceived their interests, identities and preferences and gained agency, which led to various material impacts, such as mobilizing support and funding, coordinating activities and transforming Canada’s research policy framework. With the increasing importance of research policy to a range of broader policy priorities underpinned by expectations that science will resolve societal challenges and contribute to socio-economic benefits, this paper sheds light on how complex research policy decisions are made; it further contributes to understanding the role of promissory discourses in shaping those decisions. (shrink)

As health care systems have been recast as innovation assets, commercial aims are increasingly prominent within states’ health and medical research policies. Despite this, the reformulation of notions of social and of scientific value and of long-standing relations between science and the state that is occurring in research policies remains comparatively unexamined. Addressing this lacuna, this article investigates the articulation of ‘actually existing neoliberalism' in research policy by examining a major Australian research policy and (...) funding instrument, the Medical Research Future Fund. We identify the MRFF and allied initiatives as a site of state activism: reallocating resources from primary and preventive health care to commercially-oriented biomedical research; privileging commercial objectives in research and casting health as a “flow on effect”; reorganising the publicly funded production of health and medical knowledge; and arrogating for political actors a newly prominent role in research grant assessment and funding allocation. We conclude that rather than the state’s assumption of a more activist role in medical research and innovation straightforwardly serving a ‘public good’, it is a driver of neoliberalisation that erodes commitments to redistributive justice in health care and significantly reconfigures science-state relations in research policy. (shrink)

Background: Despite potential benefits of the return of research results to research participants, the TriCouncil Policy Statement , which reflects Canadian regulatory ethical requirements, does not require this. The policies of Canadian research ethics boards are unknown.Objectives: To examine the policies of Canadian university based REBs regarding returning results to research participants, and to ascertain if the presence/absence of a policy may be influenced by REB member composition.Design: Email survey of the coordinators of Canadian (...) university based REBs to determine the presence/absence of a policy on return of research results to research participants both during an ongoing study and at conclusion. REB coordinators were asked to return a copy of the policy or guidelines and to describe the member composition of their REB.Findings: Of 50 REBs that were contacted 34 responded and 22 met the inclusion criteria. Two had a policy that governed the return of research results while on a study, and seven following the completion of a study. Presence of an ethicist or a lawyer on the REB did not influence the presence/absence of such policies. No REBs had specific guidelines describing how participants should be informed of results.Conclusions: Most REBs did not require researchers to disclose study results to research participants either during or following a study. Thus this study identifies an ethical shortcoming in the conduct of human research in Canada. It has also demonstrated that there are no clear recommendations by REBs to facilitate the return of results to participants following research projects. (shrink)

Research ethics regulation in parts of the Global North has sometimes been initiated in the face of biomedical scandal. More recently, developing and recently developed countries have had additional reasons to regulate, doing so to attract international clinical trials and American research funding, publish in international journals, or to respond to broader social changes. In Taiwan, biomedical research ethics policy based on ‘principlism’ and committee- based review were imported from the United States. Professionalisation of research (...) ethics displaced other longer-standing ways of conceiving ethics connected with Taiwanese cultural traditions. Subsequently, the model and its discursive practices were extended to other disciplines. Regulation was also shaped by decolonizing dis- courses associated with asserting Indigenous peoples’ rights. Locating research ethics regulation within the language and practices of public policy formation and transfer as well as decolonization, allows analysis to move be- yond the self-referential and attend to the social, economic and political context within which regulation operates. 研究倫理規範甚至法制化的濫觴,過去在有些北美國家是為了回應其國內發生的醫學研究倫 理醜聞。但近年來,無論是發展中或已開發國家,往往是為了爭取國際醫學臨床試驗計畫能在 其國內執行、爭取美國相關研究經費、能在英語的國際期刊發表文章、或是因應國內相關社會變化。 以台灣來說,基於「原則主義」的醫學領域之研究倫理政策及規範,以及在研究機構內成立 委員會專責倫理審查的運作模式,可說完全移植自美國。這種運作模式及研究倫理的專業化, 不但逐漸取代過去已融合台灣文化的研究倫理觀쳀,且在這種運作模式下的倫理論述及實作, 更從醫學領域擴展至其他研究領域。在此同時,台灣的研究倫理規範之發展,也受到台灣原住 民族的去殖民化及群體權主張等影響。. (shrink)

In the US, stem cell research is at a moral impasse—many see this research as ethically mandated due to its potential for ameliorating major diseases, while others see this research as ethically impermissible because it typically involves the destruction of embryos and use of ova from women. Because their creation does not require embryos or ova, induced pluripotent stem cells offer the most promising path for addressing the main ethical objections to stem cell research; however, this (...) technology is still in development. In order for scientists to advance induced pluripotent stem cell research to a point of translational readiness, they must continue to use ova and embryos in the interim. How then are we to ethically move forward with stem cell research? We argue that there is personal integrity and value in adopting a ‘moral compromise’ as a means for moving past the moral impasse in stem cell research. In a moral compromise, each party concedes part of their desired outcome in order to engage in a process that respects the values and desires of all parties equitably. Whereas some contend that moral compromise in stem cell research necessarily involves self-contradiction or loss of personal integrity, we argue that in the US context, stem cell research satisfies many of the key pre-conditions of an effective moral compromise. To illustrate our point, we offer a model solution wherein eggs and embryos are temporarily used until non-egg and non-embryonic sources of pluripotent stem cells are developed to a state of translational readiness. (shrink)

This publication arises in a context in which policy makers and educational researchers are increasingly vocal in their demands that educational policy and prac.

Rosamond Rhodes' evaluation of modern American research ethics emphasizes a need to shift from a protectionist understanding of human subjects to one that focuses more on the conduct of research in...

Reasons underlying retractions of papers authored by the Iran-affiliated highly cited researchers have not been documented. Here, we report that 229 of the Iran-affiliated researchers were listed by the Clarivate Analytics as HCRs. We investigated the Retraction Watch Database and found that, in total, 51 papers authored by the Iran-affiliated HCRs were retracted from 2006 to 2019. Twenty-three of the 229 HCRs had at least one paper retracted. One of the listed HCRs had 22 papers retracted; 14 of the 23 (...) had only one paper retracted. Among the 51 retracted papers, three had been authored by two female authors. Eight retracted papers had international co-authorships. The shortest and longest times from publication to retraction were 20 and 2610 days, respectively. Of the 51 papers, 43 had a single reason for retraction, whereas eight had multiple reasons. Among the 43 papers, 23 were retracted due to fake peer-review, eight were duplications, six had errors, four had plagiarism, and two were labelled as “limited or no information.” Duplication of data, which is easily preventable, amounted to 27%. Any publishing oversight committed by an HCR may not be tolerated because they represent the stakeholders of the scientific literature and stand as role-models for other peer researchers. Future policies supporting the Iranian academia should radically change by implementation of educational and awareness programs on publishing ethics to reduce the rate of retractions in Iran. (shrink)

Although issues of morals and ethics remain largely a national matter, the European Community (EC) and the Council of Europe have taken an increasing interest in identifying and harmonizing the often conflicting policies of the European countries on bioethical matters. This article examines the role these organizations are playing and identifies some of the initiatives that have been taken in specific areas.

I begin with a discussion of the value of privacy and what we lose without it. I then turn to the difficulties of preserving privacy for genetic information and other medical records in the face of advanced information technology. I suggest three alternative public policy approaches to the problem of protecting individual privacy and also preserving databases for genetic research:(1) governmental guidelines and centralized databases, (2) corporate self-regulation, and (3) my hybrid approach. None of these are unproblematic; I (...) discuss strengths and drawbacks of each, emphasizing the importance of protecting the privacy of sensitive medical and genetic information as well as letting information technology flourish to aid patient care, public health and scientific research. (shrink)