The Report of the Ad Hoc Adivisory Group on the Operation of NHS Research Ethics Committees has resulted in a strange mixture of the timid, the revolutionary, and the bizarre.The Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees is a curious document.1 The remit of the review was focused on the workings and effectiveness of NHS research ethics committees and the multicentre committees ). The Group was primarily set up in response to (...) a series of complaints from medical researchers about the new research governance regime in the UK as a result of the Clinical Trials Directive2 and the Governance Arrangements for NHS Research Ethics Committees.3 The opportunity was also taken to consider the role of research ethics committees in a wider context, and take account of recent developments in relation to the ethics review of social care research,4 student projects,5 as well as recent legislation such as the Human Tissue Act,6 and the Mental Capacity Act.7 However, the resulting report is a strange mixture of the timid, the revolutionary, and the bizarre.A good example of the report’s timidity is its reluctance to propose fundamental change to the process of review or seriously limit the type of research that requires REC review. To its credit AHAG does suggest that some research ‘especially surveys and many studies on NHS staff, could normally be conducted safely without a requirement for REC review’ .1 This is, of course, to be welcomed. However, the report ultimately seems dismissive of the general complaint from researchers that the current process is inappropriately uniform. For example, in section 3.2, it is argued that the ‘common perception that the NHS REC system is dominated …. (shrink)

In 2005 the new Governor of Puerto Rico appointed a panel of experts to evaluate the healthcare system of Puerto Rico and make recommendations. Among other things, the panel recommended the creation of an advisory board on bioethics for the commonwealth of Puerto Rico.

We have national guidelines for the responsible conduct of research (RCR) and procedures for handling allegations of misconduct in Finland. The guidelines have been formulated and updated by the Finnish Advisory Board on Research Integrity (TENK). In this article, we introduce and evaluate the national RCR guidelines. We also present statistics of alleged and proven RCR violation cases and frequency of appeals to TENK on the decisions or procedures of the primary institutions. In addition, we analyze the available data (...) on seven investigated cases in more detail. Positive aspects in the Finnish system are a fairly good infrastructure to investigate suspected RCR violations and a wide concept of RCR violations, which consists of fabrication, falsification, plagiarism, misappropriation, and other misbehaviors. However, the guidelines contain poorly elaborated definitions, do not treat the complainant and the suspect in an equal way, and need to be revised. Confusion about the concepts and criteria of the RCR violations seems to be common in primary institutions and among the complainants. Even if research institutions and universities have officially adhered to the national RCR guidelines, slipping from the guidelines occurs quite commonly. All these factors lead to frequent dissatisfaction with the decisions or procedures applied, high rate of appeals to TENK, and far from optimal functionality of the system. (shrink)

This article compares two science advisory organizations: the Intergovernmental Panel for Climate Change (IPCC) and the International Council for the Exploration of the Seas (ICES), with a special focus on how their respective policy systems absorb the knowledge delivered for use in decision processes. The science-policy processes of these two organizations differ in important respects; ICES delivers highly specified knowledge to a specified uptake mechanism, while the IPCC produces unspecified knowledge for an unspecified uptake mechanism. Since both environmental governance (...) areas are criticized for lack of needed action, a comparison is of interest asking how this might relate to the organization of science advice. As theoretical resources for this explorative comparison we utilize two approaches from the field of science and technology studies: the co-production approach, which focuses on the entanglements of scientific and political processes, and the systems-theory-oriented multiple-worlds model, which assumes a clear difference in institutional logics between the scientific and the political field. Since the IPCC has been critically analysed by several studies utilizing resources from the two approaches, we contribute with new insights by bringing in ICES, which is a much less studied organization exposing a different science-policy structure. One important finding is that the two theoretical approaches focus on different aspects, exposing ‘links’ and ‘integration’, both of which we argue are important for analysing and assessing science advisory organizations. Moreover, these aspects can be advantageously integrated into a single theoretical framework. (shrink)

1. Any statutory definition of inherent patentability or other threshold exclusion from patentability should have a clear normative basis. In the case of inherent patentability, that basis should relate to the patent system’s aim of encouraging and rewarding inventive activity for the benefit of society.

With the rapid development of the market economy, there are more and more projects in the financial industry, and their complexity and technical requirements are getting higher and higher. The development of computer technology has promoted the birth of robot consultants, and it is of great significance to use robot consultants to manage and supervise financial industry projects. In order to further analyze the development and supervision of robo-advisors under the digital inclusive financial system, this paper uses complex systems (...) and clustering algorithms as technical support to carry out research. First, the traditional K-means algorithm is used to select the initial clustering center, to improve the noise and outlier processing capabilities, and to build a data mining system based on the improved algorithm. Then, a product design model for robo-advisors is built and the risks of robo-advisors are analyzed from three aspects: technology, market, and law. Analyzing the performance of the improved K-means algorithm, in the operation of the experimental dataset B, the accuracy of the clustering result after 6 iterations reached 97.08%, which shows that the algorithm has good performance. During the trial operation of the data mining system, the four types of customers of financial institutions were accurately clustered, and it was concluded that the main type of customers who brought benefits to financial institutions was high-income customers accounting for 10.75%. Robo-advisory product models are used to build five risk-level investment portfolios and conduct risk backtests. Except for the growth and income portfolio, other portfolios have consistently outperformed the performance benchmark during the analyzed time period. Running the research system of this paper in a financial institution, comparing the capital budget before and after the operation, found that the system can improve the accuracy of the budget and reduce the risk of the robo-advisor for the financial institution. (shrink)

The current proxy voting system in the United States has become the subject of considerable controversy. Because institutional investment managers have the authority to vote their clients’ proxies, they have a fiduciary obligation to those clients. Frequently, in an attempt to fulfill that obligation, these institutional investors employ proxy advisory services to manage the thousands of votes they must cast. However, many proxy advisory services have conflicts of interest that inhibit their utility to those seeking to discharge (...) their fiduciary duties. In this article, we describe the current proxy advisory network as an example of how current notions of conflicts of interest fall short when explaining the behavior of an interconnected set of market players whose remit is to act in the best interests of their investors. We discuss what participants in this system should do to bring transparency and accuracy to the proxy advice industry. (shrink)

As demand for locally grown food increases there have been calls to ‘scale-up’ local food production to regionally distribute food and to sell into more mainstream grocery and retail venues where consumers are already shopping. Growing research and practice focusing on how to improve, expand and conceptualize regional distribution systems includes strategies such as value chain development using the Agriculture of the Middle framework. When the Ohio Food Policy Advisory Council asked how they could scale-up the distribution of Ohio (...) fresh fruits and vegetables to Ohioans, we decided to use this practical opportunity to not only provide recommendations to this council, but to simultaneously contribute to the literature on AOTM, value-based and spatially–proximate relationships, and conceptualizations of food system hybridity. We do this while examining an entire sub-sector of the Ohio agricultural economy, namely fruit and vegetables and applying the AOTM framework beyond the farm, namely to distributors and retailers. Through interviews with Ohio retailers and a survey of all fresh fruit and vegetable distributors Ohio we: Describe current distribution systems within the state; Identify firms interested in scaling-up distribution, and; Inform state-level policy efforts by identifying opportunities to better target any state-level policy and program efforts. We demonstrate support for the concept of AOTM applied beyond the farm, for value chain development strategies that can transmit ‘quality’ via spatially proximate supply chains, and support for considering hybrid solutions, such as piggybacking for scaling-up local food systems. This work highlights the role a statewide food policy council can have in facilitating market development and their unique position to provide public sector and institutional support to facilitate meaningful connections in the food system. (shrink)

In the late seventies at the Centre for Computers and Law research was started to find means for supporting lawyers' work with the aid of a computer. The research project was called JURICAS. In 1982 a prototype of a JURICAS system was produced and since 1986 seven advisory packages have been brought out on the market in the Netherlands. These packages consist of two main parts, an author's shell and an advisory program. The user cannot make changes (...) to either the shell or the program.In 1988 the JURICAS author's shell became commercially available. A buyer has to make his own advisory program and fill it with his expertise to produce an advisory package. To facilitate the designing, the typing in and the testing of a package a number of utility programs are included in the author's system. (shrink)

The recently published Report of theAHAG on the Operation of NHS Research Ethics Committees advocates major reforms of the NHS research ethics committees system. The main implications of the proposed changes and their probable effects on the major stakeholders are described.The Ad Hoc Advisory Group on the operation of NHS research ethics committees, set up in November 2004 by Lord Warner on behalf of the Department of Health, submitted its report in June 2005.1 The report advocates major reforms (...) of the research ethics committee system. The primary aim of the report is to streamline the processes around the approval of research projects and to pursue conformity of governance across Europe. Implicit in the report is the contention that failure to achieve this objective would be harmful to everyone with vested interests in improving health and social care. Moreover, it is stated that the reforms will enhance the mechanisms that protect the interests of all parties concerned.1Being mindful of two published critiques of the Warner Report, we suggest that its alleged benefits should not be taken at face value.2,3 In fact, the reformed system will give rise to moral failings akin to those of the existing system, but will differ from the existing system in its effect on the stakeholders. Thus, whereas the outgoing system has given each stakeholder a unique mixture of benefit and harm, the incoming system offers benefit only to sponsors and researchers and nothing but detriment to participants in research and consumers of its products.In the light of this conclusion, we finally suggest that the Warner Report be construed not merely as an ill-considered document, but rather as an ideological reflection of a long-established hegemonic contract fine-tuning itself to contemporary global challenges.To avoid …. (shrink)

Machine intelligence already helps medical staff with a number of tasks. Ethical decision-making, however, has not been handed over to computers. In this proof-of-concept study, we show how an algorithm based on Beauchamp and Childress’ prima-facie principles could be employed to advise on a range of moral dilemma situations that occur in medical institutions. We explain why we chose fuzzy cognitive maps to set up the advisory system and how we utilized machine learning to train it. We report (...) on the difficult task of operationalizing the principles of beneficence, non-maleficence and patient autonomy, and describe how we selected suitable input parameters that we extracted from a training dataset of clinical cases. The first performance results are promising, but an algorithmic approach to ethics also comes with several weaknesses and limitations. Should one really entrust the sensitive domain of clinical ethics to machine intelligence? (shrink)

BackgroundData processing of health research databases often requires a Data Protection Impact Assessment to evaluate the severity of the risk and the appropriateness of measures taken to comply with the European Union General Data Protection Regulation. We aimed to define and apply a comprehensive method for the evaluation of privacy, data governance and ethics among research networks involved in the EU Project Bridge Health.MethodsComputerised survey among associated partners of main EU Consortia, using a targeted instrument designed by the principal investigator (...) and progressively refined in collaboration with an international advisory panel. Descriptive measures using the percentage of adoption of privacy, data governance and ethical principles as main endpoints were used for the analysis and interpretation of the results.ResultsA total of 15 centres provided relevant information on the processing of sensitive data from 10 European countries. Major areas of concern were noted for: data linkage, access and accuracy of personal data and anonymisation procedures. A high variability was noted in the application of privacy principles.ConclusionsA comprehensive methodology of Privacy and Ethics Impact and Performance Assessment was successfully applied at international level. The method can help implementing the GDPR and expanding the scope of Data Protection Impact Assessment, so that the public benefit of the secondary use of health data could be well balanced with the respect of personal privacy. (shrink)

Flesh of My Flesh is a collection of articles by today's most respected scientists, philosophers, bioethicists, theologians, and law professors about whether we should allow human cloning. It includes historical pieces to provide background for the current debate. Religious, philosophical, and legal points of view are all represented.

Can machine intelligence do clinical ethics? And if so, would applying it to actual medical cases be desirable? In a recent target article (Meier et al. 2022), we described the piloting of our advisory algorithm METHAD. Here, we reply to commentaries published in response to our project. The commentaries fall into two broad categories: concrete criticism that concerns the development of METHAD; and the more general question as to whether one should employ decision-support systems of this kind—the debate we (...) set out to ignite with our target article. (shrink)

The recently retired Homeland Security Advisory System constituted a main means by which the intensity of the terrorist threat was communicated to the United States' public. An examination of its inner workings and its social impact shows the System as part of a modality of government: an encapsulation of intelligence-led governmentality. Informed by the political philosophy of Cornelius Castoriadis, I contextualise this modality as a settling of fundamental tensions inherent in modern sociopolitical culture, those between the principle (...) of social and personal autonomy, and that of rational mastery of people and nature. These principles are strongly connected to democratic and oligarchic political organisation, respectively, and they give rise to different justifications of state authority. In turn, they pertain to the fundamental question of whether scientific expertise on politics is possible. (shrink)

Since the 1970s, a sea change has marked the politics of science in the United States. In the quarter century after World War II, a broad, bipartisan consensus prevailed on the promotion and uses of science in American society: first, that the federal government should support research and training in technically meritorious fields of likely long-term benefit to national defense, the economy, and health; second, that the benefits of this investment should be developed into useful products by the private sector; (...) and that public policy in technically related areas should be shaped by drawing on highly qualified, non-partisan expertise. Since the 1970s, that bipartisan consensus has corroded, ushering in a New Politics of Science in the U.S. Ideological restrictions, largely from the political right, have prohibited or severely constricted federal support of research in areas such as human therapeutic cloning, human stem cells, in vitro fertilization, and human embryo research. The devotion to privatization and entrepreneurship in the name of high technology competitiveness has, in areas such as biotechnology, blurred the lines both intellectually and institutionally between academia and industry, with questionable consequences for the public interest. And nonpartisanship in the scientific advisory system has been succeeded by unashamed partisanship, fueled by the mobilization of expertise on the right in issues ranging from the teaching of evolution in the schools to global warming. The reasons for this sea change can be found in the larger rightward shift over the period on both the foreign and domestic fronts. (shrink)

The questions of violence, justice and judgment define one of the most resonant and constant concerns of contemporary thought. In part, this is only a reflection of what are often called the ‘realities on the ground’ . In the few years of this century the logic of violence, and even its aestheticisation – whether as terror or as ‘shock and awe,’ or in the citizen’s daily vocation to be ‘alert but not alarmed’ – have become the familiar data of current (...) experience. They are a kind of weather, felt through the colour-coded threat scale of the Homeland Security Advisory System, or in the casual references to the ‘current climate.’ In view of these realities, and of an acclimatisation to them that informs general popular support for extensions of executive power and legislative activity, the urgency of the turn or return to questions of force and law is to be expected. In the fabric of recent debate, they are seams at which confrontations are staged and positions defined; but also, where the thought that remains closest to the ‘realities on the ground’ is forced into juxtaposition with the mythological and theological schemes that violence, justice and judgment inevitably conjure. Thus, contributors to this issue of Colloquy were invited to consider whether it was possible to account for a difference between violence, terror and revolution, without simplification or banalisation of the relationship between law and force. On the one hand, the editors envisaged that this question would be a provocation to reexamine contemporary representations of sovereignty, jurisdiction and the ‘state of exception,’ in a global context dominated by issues of security and the justification of extra-legal and extra-judicial force – occupation, detention, torture. On the other hand, the reference to the mythological and the theological was inevitable, inasmuch as contributors were invited to organise their reflections around two of the most significant interventions in twentieth-century jurisprudence and political theory, Walter Benjamin’s “Critique of Violence” and Jacques Derrida’s “Force of Law.” For as is well-known, Benjamin and Derrida pursue their distinctive lines of questioning in the direction of a ‘divine violence’ or of a ‘mystical foundation of authority.’ The reception of the two texts suggests that these concepts remain, for many, difficult to the point of being indigestible; at least in the ‘current climate.’. (shrink)

Data-sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under-resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a rich and detailed presentation (...) of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data, ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: The role of HDSSs in research using public health data and data-sharing; Ownership and funding are critical factors influencing data-sharing; Other factors discourage data-sharing; Promoting and sustaining data-sharing; Ethical guidance structures; and Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching ‘share’ as a default. (shrink)

Criminal justice systems have traditionally relied heavily on human decision-making, but new technologies are increasingly supplementing the human role in this sector. This paper considers what general limits need to be placed on the use of algorithms in sentencing decisions. It argues that, even once we can build algorithms that equal human decision-making capacities, strict constraints need to be placed on how they are designed and developed. The act of condemnation is a valuable element of criminal sentencing, and using algorithms (...) in sentencing – even in an advisory role – threatens to undermine this value. The paper argues that a principle of “meaningful public control” should be met in all sentencing decisions if they are to retain their condemnatory status. This principle requires that agents who have standing to act on behalf of the wider political community retain moral responsibility for all sentencing decisions. While this principle does not rule out the use of algorithms, it does require limits on how they are constructed. (shrink)

Definition of the problem: This article describes the communication structure concerning the problems of genetic engineering, in-vitro fertilization and the current debate about „genetic advisory”. Arguments: Proceeding from the social systems theory, two observation types are discriminated: 1st and 2nd orders, which occur here as critical and affirmative positions. The first term refers to specific operations of the social system of medicine, the second to communication of social movements. Neither perspective can deliver total rationality or unity, and the (...) two positions cannot be put together as one rational model. They have to be put into debate structures in order to learn from each other by reciprocal observations. Conclusion: Every kind of observation, taken in a communicative frame like this one, delivers a limited, but necessary contribution to the debate. System rationality will be possible only by coupling asymmetrical observations. This goal will, however, can only be reached, if the communication proceeds in a controversy based mode. This way, the difference between critical and affirmative positions cannot be „solved” but it can be used for further recognition. (shrink)

Although in Italy there is currently no effective law on physician-assisted suicide or euthanasia, Decision No. 242 issued by the Italian Constitutional Court on September 25, 2019 established that an individual who, under specific circumstances, has facilitated the implementation of an independent and freely-formed resolve to commit suicide by another individual is exempt from criminal liability. Following this ruling, some citizens have submitted requests for assisted suicide to the public health system, generating a situation of great uncertainty in the (...) application processes. As a matter of fact, shared and defined procedures are lacking as Decision 242/2019 merely added some principles on which the legislature will have to base its future intervention. This paper analyses the advisory role that the Decision attributes to territorial ethics committees with the aim of stimulating discussions on their role in oversight mechanisms. The proposed conclusion is that the envisaged role does not appear consistent with the functions of these bodies and is ultimately substantially undefined and unjustified. (shrink)

The rapid and dynamic nature of digital transformation challenges companies that wish to develop and deploy novel digital technologies. Like other actors faced with this transformation, companies need to find robust ways to ethically guide their innovations and business decisions. Digital ethics has recently featured in a plethora of both practical corporate guidelines and compilations of high-level principles, but there remains a gap concerning the development of sound ethical guidance in specific business contexts. As a multinational science and technology company (...) faced with a broad range of digital ventures and associated ethical challenges, Merck KGaA has laid the foundations for bridging this gap by developing a Code of Digital Ethics (CoDE) tailored for this context. Following a comprehensive analysis of existing digital ethics guidelines, we used a reconstructive social research approach to identify 20 relevant principles and derive a code designed as a multi-purpose tool. Versatility was prioritised by defining non-prescriptive guidelines that are open to different perspectives and thus well-suited for operationalisation for varied business purposes. We also chose a clear nested structure that highlights the relationships between five core and fifteen subsidiary principles as well as the different levels of reference—data and algorithmic systems—to which they apply. The CoDE will serve Merck KGaA and its new Digital Ethics Advisory Panel to guide ethical reflection, evaluation and decision-making across the full spectrum of digital developments encountered and undertaken by the company whilst also offering an opportunity to increase transparency for external partners, and thus trust. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Examining the Ethics of Human Subjects ResearchPaul S. Appelbaum (bio)The work of the Advisory Committee on Human Radiation Experiments confirms once again the value of combining empirical and normative approaches to problems in clinical and research ethics. The Committee, like its predecessor, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, spent relatively modest sums of money gathering targeted data to (...) inform its deliberations. The results of the Committee’s research, which are discussed by Nancy Kass and Jeremy Sugarman in this issue of the Kennedy Institute of Ethics Journal, enhance our understanding of the current ethical status of human subjects research, helping to focus attention on areas of particular concern, and lay the basis for future research and policy development.My comments here focus on the two major empirical studies conducted by the Committee—the Research Proposal Review Project and the Subject Interview Study. I will underscore just a few of the primary findings from these studies, consider their limitations, and explore their implications. Readers interested in the details of the studies should consult the Committee’s Final Report (ACHRE 1995), on which I rely in part and which provides additional information on the methodology and findings of the studies.Research Proposal Review ProjectWhat can be learned from the Committee’s review of 125 federally-funded human research studies? In answering that question, one cannot ignore the irony inherent in the Committee’s decision to review documents related to institutional review board (IRB) consideration of the selected protocols. The single most frequent complaint about the current system for protecting human subjects is that IRBs focus almost exclusively on review of consent forms and other research documents, as if they bore some close relationship to what actually transpires between investigators and potential research subjects. Only a small number of studies examine the research consent process. Nevertheless, existing data strongly [End Page 283] suggest that subject recruitment often involves an extended process of courtship, during which the information contained in consent forms is only a small part of the information passed between investigators and subjects (Benson, Roth, and Winslade 1985; Lidz et al. 1984).Indeed, the second of the Committee’s studies—the Subject Interview Study, which is discussed below—appears to confirm these findings. In-depth interviews with 99 individuals who reported that they were former or current research subjects suggest that “[f]or many, the decision to participate seemed to have been made before the consent form was given to them, and they signed it almost as a formality” (ACHRE 1995 [GPO, p. 742; Oxford, p. 471]). 1 Why, then, did the Committee focus its attention on documents that in many cases seem to play only a tangential role in the consent process? As is the case with IRBs around the country, the answer appears to be that consent forms and related documents are the only easily available window on consent transactions. In addition, under the current system, consent forms constitute the part of the process that IRBs can influence most easily. Consequently, it suits almost everyone’s needs—except perhaps those of the research subjects—to pretend that they reflect what actually transpires in the recruitment process. To the Committee’s credit, it was well aware of this dilemma. Nonetheless, it struggled to wring valid lessons from these limited data in its Final Report.Perhaps the most interesting finding from the Research Proposal Review Project is just how poor so many consent forms are. Given the disproportionate emphasis that many IRBs place on the content of the forms, one would expect that investigators by now would have learned to design documents that meet objective standards of adequacy, such as those applied by the Committee. Indeed, except in the most unusual circumstances, doing so would virtually guarantee that the IRB will ask no further questions about subject recruitment procedures. Although the data justify the inference that many investigators do not yet understand which information is essential to communicate to potential subjects, nor have learned how to do so effectively, they also force us to a still more radical conclusion. If the IRBs were doing their jobs, the Committee... (shrink)

A questionnaire on the attitudes towards the functions of research ethical committees was sent to members of selected research ethical committees in Wessex and some controls. Almost all respondents felt there was a need for ethical review of research projects; 42 per cent thought there was a need for some training before joining a committee; 67 per cent thought the system could be improved and 47 per cent thought that monitoring or follow-up procedures should be adopted. Ethical committees were (...) thought to be purely advisory, as opposed to mandatory, by 33 per cent, and 63 per cent thought they should restrict their review to ethical problems as opposed to scientific or design problems. Views about the function of non-medical members ranged from 'none at all' to 'very important'. Of the 10 controls who were asked whether they would become a member of an ethical committee if asked, seven said that on balance they would and the reasons stated varied from the view that it was a 'very important committee' to the feeling that it was 'a necessary but irksome job'. (shrink)

Biodiversity is a valuable resource that supports sustainability within agricultural systems, yet in contradiction to this agriculture is recognised as a contributor to biodiversity loss. Agricultural advisory services are institutions that support sustainable agricultural development, employing a variety of approaches including farmer discussion groups in doing so. This study evaluates the impact of a farmland biodiversity management (FBM) communication strategy piloted within Irish farmer discussion groups. A sensemaking lens was applied in this objective to gain an understanding of how (...) this strategy could create an actionable space for FBM promotion amongst farmers. The strategy was piloted with six Irish dairy farmer discussion groups, after which focus groups were conducted with members of these groups. Additionally, baseline and endline surveys were completed by the members to determine their knowledge, attitude and on-farm practices relating to FBM. Analysis of the focus group data identified that the communication strategy supported the affordance of sensemaking with respect to FBM. Analysis of the data from the baseline and endline surveys relating to knowledge, attitudes and practices found that engaging with the communication strategy promoted farmers to improve their attitude in relation to FBM. Results from this study provide important lessons for agricultural advisory services to support farmers in incorporating FBM into the overall management of their farms and, in turn, to promote the improvement of farmland biodiversity and contribute to a sustainable future. (shrink)

Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by (...) the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration. (shrink)

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human (...) gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Future Is Political and TransdisciplinaryAwais Aftab (bio)Philosophy, psychiatry, & psychology (PPP) is a transdisciplinary oasis, one of the few journals in mental health care that facilitate a meaningful dialogue between philosophers, psychiatrists, psychologists, and scholars from related disciplines. The fact that PPP successfully provides such a space is of no small importance, especially from my perspective as a psychiatrist. The multidisciplinary nature of the undertaking has been a (...) central aspect of the identity of the journal from the very beginning. PPP has maintained this transdisciplinary inclusive spirit over the years, and its editorial and advisory boards remain richly representative, but the challenge of ensuring continued participation of clinicians is not insubstantial. After all, the point is not token participation, but a robust and transformative interdisciplinary engagement. Clinicians have much to contribute to philosophical debates, however, such capacity for dialogue requires sustained cultivation (Aftab & Waterman, 2021), and forces in medical education have led to a situation where comparatively fewer psychiatrists have the interest or the ability to engage in such rigorous dialogue with philosophers. Philosophy of mental health has grown and specialized exponentially since the mid-90s. Keeping up with this literature is difficult even for philosophers, it is no small feat for full-time clinicians.This means that PPP and its affiliate organizations have a responsibility to take a more active role in supporting educational initiatives to ensure that future generations of psychiatric clinicians are able to contribute to philosophical debates, and that philosophy of psychiatry does not become divorced from clinical and practical concerns. My advice to clinicians based on my experience would be two-fold: first, it is essential to acquire a basic familiarity with the philosophy of psychiatry literature. Aftab and Waterman (2021) offer a sample list of reading recommendations. At the time of this writing, the International Network for Philosophy and Psychiatry is also undertaking efforts to develop curricula aimed at clinicians. Second, it is important to find ways to interact with others in the philosophy of psychiatry community. Formal avenues to do so include the annual meetings of the Association for the Advancement of Philosophy and Psychiatry and the Philosophy Special Interest Group of the Royal College of Psychiatrists, among others. There are also various online communities active on social media that many find helpful.In recent years, we have seen an unprecedented enthusiasm and support for inclusion of lived experience in mental health care. This is a welcome and much needed development, but we are only just beginning to scratch the surface of [End Page 5] how to philosophically navigate this inclusion. Frameworks such as standpoint epistemology and epistemic justice offer us starting points (Knox, 2022), but much remains to be worked out (Aftab, 2022). There are notable philosophical challenges, such as ascertaining the limits of lived experience, and the biases and errors to which it is vulnerable; the application of scientific method and philosophical criticism to lived experience; methods to resolve disagreements when different forms of lived experience contradict each other; handling discrepancies between knowledge from lived experience and knowledge from other sources be handled; and analyzing the intersection of politics of lived experience with other differentials of power. I anticipate that these topics will be of central importance to the field and to the journal in the coming years.It is also vital that philosophy of psychiatry engage with the sociopolitical dimensions of madness (Kalathil & Jones, 2016). The failure of philosophy to do so in a meaningful way has already been articulated powerfully by commentators such as Nev Jones (2022). An important aspect of acknowledging philosophy's failures in this regard comes from the notion of "elite capture," recently popularized by Olúfẹ́mi O. Táíwò (2022). It refers to how progressive philosophical ideas such as standpoint epistemology are co-opted by the "elite" to serve their own ends. Discussions on social media have already begun to point out that concepts in philosophy of psychiatry such as "epistemic injustice" show signs of elite capture by the psychiatric establishment, resulting in token participation but no systemic changes. Philosophy of psychiatry needs to tackle its own vulnerability to co-option. This will require creative forms of philosophizing and engagement with... (shrink)

Artikkelen undersøker hvordan NIPT ble vedtatt implementert i det norske fosterdiagnostiske systemet gjennom en fagligpolitisk prosess mellom 2012 og 2017. Prosessen innebar at Nasjonalt kunnskapssenter for helsetjenesten, Helsedirektoratet, Bioteknologirådet og Helse- og Omsorgsdepartementet ga sine vurderinger av testen og sine råd omkring en eventuell innføring. Artikkelen viser at det i denne prosessen foregikk en forsiktig tilnærming eller sammensmelting mellom de tradisjonelt helt ulike måtene å forstå og å ramme inn fosterdiagnostikk på i Norge, dvs. i en ‘autonomi/ behandlingsramme’ og en (...) ‘sorteringsramme’. Artikkelen argumenterer videre for at denne tilnærmingen eller konvergensen var mulig fordi prosessen ble holdt innenfor de fagligpolitiske byråkratiene, og de ulike etatene var innstilt på å ‘samarbeide’ om å inkludere både kunnskap og verdier fra begge rammene i sine tilrådninger. Politikk for fosterdiagnostikk er imidlertid et svært politisk betent område i Norge, og denne konvergensen var et skjørt byggverk. Den sprakk da også opp i løpet av tre uker i mai 2020, da Fremskrittspartiet plutselig inngikk et ‘bioteknologiforlik’ med Arbeiderpartiet og SV etter at de hadde gått ut av Solbergregjeringen. Dermed endte spørsmålet om implementeringen av NIPT i Stortinget, hvor konvergensen i den fagpolitiske prosessen ble erstattet av de tradisjonelle frontene, og de gamle innrammingene igjen ble ‘satt i arbeid’. Artikkelen diskuterer avslutningsvis kort de bortimot uløselige dilemmaene disse innrammingene både representerer og produserer. Nøkkelord: NIPT, fosterdiagnostikk, humanmedisinsk bioteknologi, regulering English Title: Fetal diagnostics between medicine and ethics: Implementation of Prenatal Invasive Testing in a turbulent policy area: The article examines how the decision to implement Prenatal Invasive Testing in the Norwegian Fetal Diagnostic System was reached through a professional policy process between 2012 and 2017. The process involved the Norwegian Research Centre for Health Services, the Norwegian Directorate of Health, the Norwegian Biotechnology Advisory Board and the Ministry of Health and Care Services, which provided their individual assessments and advice regarding the potential implementation of the test. The article finds that a careful convergence took place between traditionally opposing ways to understand and frame fetal diagnostics in Norway – either as a ‘treatment frame’ or a ‘sorting frame’. The article further argues that this convergence was possible because the process was kept within these bureaucracies, and that the different agencies were willing to collaborate to include knowledge and values from both frames in their recommendations. However, policy for fetal diagnostics is a very turbulent political area in Norway, and this convergence was a fragile construction. During three weeks in May 2020, the convergence collapsed when the Norwegian Progress Party suddenly entered a “biotechnology settlement” with the Labour Party and the Socialist Left Party after exiting the conservative Government coalition. Hence, the question of implementing NIPT ended up in the Norwegian Parliament, where the convergence from the professional policy process was replaced by the traditional fronts, and the old framings were again set in motion. Lastly, the article briefly discusses the almost unsolvable dilemmas these framings both produce and represent. Keywords: NIPT, non-invasive prenatal testing, fetal diagnostics, medical biotechnology, regulation. (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)

In lieu of an abstract, here is a brief excerpt of the content:The Veterans Affairs National Center for Clinical EthicsJames L. Bernat (bio)The veterans health administration is the largest health care system in the United States and, indeed, is larger that the health care system of many foreign countries. In February 1991 the Department of Veterans Affairs (V.A.) in Washington, D.C. awarded a contract to the clinical ethics group at the Veterans Affairs Medical Center in White River Junction, (...) Vermont to establish the V.A. National Center for Clinical Ethics. In this article I describe the organizational context, mission, operation, and future direction of the Center, which William A. Nelson, Ph.D., and I co-direct.The Veterans Health AdministrationThe Department of Veterans Affairs operates 171 hospitals providing services ranging from primary, secondary, and tertiary medical care to psychiatric hospitals, rehabilitation centers, and nursing homes. The V.A. also provides outpatient services at all hospitals and at dozens of free-standing outpatent clinics. V.A. medical centers employ over 14,000 physicians and serve approximately 4.5 million veteran patients (Hollingsworth and Bondy 1990; Mirvis 1990).The V.A. serves an important educational function, providing training sites for medical students, postgraduate physicians, and trainees in other health-related fields. Approximately 78 percent of V.A. medical centers are affiliated with medical schools. Over one-third of all American medical students and over 40 percent of interns and residents spend a portion of their training in V.A. medical centers. More than 100,000 students in all health-related fields train in V.A. facilities annually (Hollingsworth and Bondy 1990).Research is another mission of the V.A. Many academic physicians and scientists derive their research and salary funding from V.A contracts and awards. The V.A. Research Career Development Program provides the means for many medical school faculty members to achieve successful careers as scientists and clinical investigators. Although research accounts for only slightly more than 1 percent of the V.A. medical budget, two V.A. researchers have been awarded the Nobel Prize (Hollingsworth and Bondy 1990). [End Page 385]In comparison to other medical care settings, the average V.A. patient is likely to be older, poorer, male, less well-educated, more chronically ill, and more expensive to care for. Many patients first patronize the V.A. system after they have been bankrupted by the costs of a major illness. Unlike young, healthy patients ideally favored by health maintenance organizations, these patients immediately require large expenditures for hospitalizations, medications, and other treatments. Additional burdens have been placed on V.A. facilities by a record of chronic federal underfunding over the past decade, despite expanded patient censuses at every facility.Bioethical issues arise in V.A. facilities with great frequency for several reasons. Older and poorer patients are often sicker, have fewer home-support resources, and have completed fewer advance directives for health care. Chronic operational underfunding requires explicit health care rationing systemwide. Academic physicians within the V.A. system have multiple professional duties that have the potential for conflict. Although their primary duty is to their patients, they also must serve the federal government and their medical school academic supervisors. The practice of medical care rationing pits the physician's professional duty to his patient against his duty to the system (Mirvis 1990).The V.A. has responded to these bioethical demands with several initiatives. Hospital ethics advisory committees have been developed in nearly every V.A. medical center. The V.A. National Bioethics Committee has been empaneled to encourage uniform policies across the V.A. system concerning bioethical issues. Most recently, funds were provided for the V.A. National Center for Clinical Ethics.Functions of the National Center for Clinical Ethics (NCCE)The NCCE has a fourfold mission: 1) to enhance the quality of clinical ethics programs at all 171 V.A. medical centers nationwide; 2) to staff the V.A. National Bioethics Committee; 3) to assist administrators and planners in the V.A. Central Office on policy development concerning bioethical issues; and 4) to study, organize, and coordinate clinical, educational, and research bioethics programs throughout the system.Enhancing the quality of clinical ethics programs at V.A. medical centers is largely an... (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)

Despite recognizing the importance of impact investing in combating complex societal challenges, researchers have yet to examine the capacity of the field to address systemic inequality. While impact investments are intended to benefit vulnerable stakeholders, the voices of those stakeholders are generally overlooked in the design and implementation of such investments. To resolve this oversight, we theorize how the fields’ design—through its tools, organizations, and field-level bodies—influences its capacity to address inequality by focusing on the concept of giving voice, which (...) we define as the inclusive participation of vulnerable stakeholders in decision-making processes. We build from stakeholder engagement research to show how the design of impact investing can address inequality using three illustrative cases: social impact bonds, impact investing funds, and national advisory boards. We conclude with a discussion of how the ethical decision of giving voice to vulnerable stakeholders will determine the capacity of the field to address inequality, as well as provide implications for future research and practice. (shrink)

The social sciences stand at a strange crossroads. There is a greater need for disciplined inquiry into the issues of policy facing the United States. Yet the incentives in the political system, and in the professional guilds of those performing social research, discourage a close involvement of many prominent social scientists with policy. The political system, fearing an elite imposing its values on society, welcomes the natural scientist who seems to conform to the model of the politically neutral (...) expert who solves problems and addresses “facts”. This model also fits the higher ranks of the civil service, made up of specialists rather than generalist administrators, and the outside advisers serving officials concerned with high policy. Likewise, to protect themselves from changes of partisanship, leading academic social scientists forsake policy concerns for topics within the analytic traditions of Weberian Wertfreiheit. Just as Weber sought to avoid censorship by value neutral scholarship, the modern social scientist disdains the normative concerns of policy in favour of more tractable, morally neutral issues defined as the core of the discipline.The country needs to draw some of the best analytical talent in the social science community into the policy process and advisory roles. Disciplined inquiry cannot be left only to technicians whose professional interests are far removed from political, economic, social and other human sciences. To promote better policy and better social science, we should encourage serious, professionally grounded inquiry into social values, the directions of policy, and the role and proper limits of state power. In the clamour of American politics, there is little danger that policy will be monopolised by an elite group, but considerable danger that debate on policy will be impoverished by the absence of those most knowledgeable about social and economic reality. (shrink)