The dominance of the modern concept of risk and calculability is challenged by and has to be distinguished from “manufactured uncertainties.” Typically today, conflict and controversy flare up around this particular type of new manufactured risk. Neither natural disasters – threats – coming from the outside and thus attributable to God or nature have this effect any longer. Nor do the specific calculable uncertainties – “risks” – which are determinable with actuarial precision interms of a probability (...) calculus backed up by insurance and monetary compensation fall in this category. At the centre of attention today, by contrast, are “manufactured uncertainties.” They are distinguished by the fact that they are dependent on human decisions, created by society itself, immanent to society and thus non-externalizable, collectively imposed and thus individually unavoidable. (shrink)

Recent criticisms of traditional understandings of risk, responsibility and the division of labour between science and politics build on the idea of the co-produced character of the natural and social orders, making a case for less ambitious and more inclusive policy processes, where questions of values and goals may be addressed together with questions of facts and means, causal liabilities and principled responsibilities. Within the neo-liberal political economy, however, the contingency of the world is depicted as a source of (...) unprecedented opportunities for human craftsmanship, rather than of possibly unmanageable surprises. Gene technologies offer a vantage point for reflecting on the consequences of the drift from discovery to invention as a master frame in the appraisal of human intermingling with the world. Biotech patenting regulations carve out a sovereign agency which, by crafting nature, also crafts the distinction between the manufactured and non-manufactured world. Difficulties in ascribing responsibility stem as a consequence. It is likely that politics and economy can be democratized and responsibilities rearranged not by ‘democratizing’ knowledge production, but rather the reverse. (shrink)

For manufacturing enterprises to successfully enter the “Industry 4.0” era and establish advantages in the new wave of the Industrial Revolution, they must use Internet thinking to transform manufacturing enterprises and promote the in-depth integration of informatization and industrialization under the premise of managing and controlling risks, to achieve transformation and upgrading. Research on and management of the risks of manufacturing enterprises’ Internet strategic transformation directly affects the success or failure of enterprises’ transformation. This study constructed a risk evaluation (...) model for a manufacturing enterprise’s Internet strategic transformation based on the back propagation artificial neural network and conducted a case study on one enterprise. (shrink)

With environmental issues increasingly becoming prominent in today’s business world, firms may need to pay extra attention to developing their environmental strategies and capabilities in response to environmental concerns and achieving sustainable growth. While a broad consensus exists on the value of green innovation, current empirical research on how different types of green innovation strategies may account for the international performance of a firm remains scant. Addressing this gap is important because determining how to better manage a firm’s green innovation (...) strategies nowadays has become increasingly important for firms hoping to achieve and maintain their sustainable performance advantages. This study aims to bridge this gap by systematically examining how various types of green innovation strategies can be beneficial to firms in an emerging market economy. This study also examined the important role that potential risks of supply chain play in shaping the relationships between various types of green innovation strategies and firm performance. This study proposes that the effective management of supply chain risks may be important to the successful implementation of green innovation strategies because green innovation has increasingly become a collaborative effort. This study empirically tested the hypotheses by gathering survey data from a sample of 337 firms in China’s manufacturing industries. Results demonstrate that the green innovation strategies of firms are positively related to their firm performance. Additionally, the potential risks faced by the firms in efficiently and effectively managing their supply chain significantly moderate the impact of green product innovation and green process innovation strategies on their firm performance. This study not only offers useful theoretical implications for the green innovation strategy research and for better and effective supply chain risk management. It also provides important practical guidelines and managerial actions that practicing managers can implement to accelerate their green innovation strategy, assess the effect of supply chain risks, and thus improve firm performance in the post-pandemic era. (shrink)

The construction of a secure and safe society using information and communication technology is recognised as an urgent issue in Japan. This recognition is based on public fear about crime related to manufactured risk caused by modernisation or industrial civilisation. This fear has created a social atmosphere that has led to the rapid development and implementation of security systems using ICT, such as security cameras, smart IC cards and mobile phones, to establish security and safety in Japanese society. (...) However, the never-ending quest for social security and safety with ICT will inevitably cause further manufactured risk, which could lead to serious problems in the future. We have to recognise such risk and control it appropriately. (shrink)

The aim of this paper is to address the neglected but important problem of differentiating between epistemically beneficial and epistemically detrimental dissent. By “dissent,” we refer to the act of objecting to a particular conclusion, especially one that is widely held. While dissent in science can clearly be beneficial, there might be some instances of dissent that not only fail to contribute to scientific progress, but actually impede it. Potential examples of this include the tobacco industry’s funding of studies that (...) questioned the link between smoking and lung cancer, and the attempt by the petroleum industry and other groups to cast doubt upon the conclusion that human consumption of fossil fuels contributes to global climate change. The problem of distinguishing between good and bad dissent is important because of the growing tendency of some stakeholders to attempt to delay political action by ’manufacturing doubt’. Our discussion in this paper focuses on climate science. This field, in our view, is rife with instances of bad dissent. On the basis of our discussion of climate science, we articulate a set of sufficient conditions for epistemically problematic dissent in general, which we call “the inductive risk account of epistemically detrimental dissent.”. (shrink)

In a series of writings in recent years, Anthony Giddens has pursued two broad interconnected themes: reflection on the future of radical politics in a world in which, it is claimed, received political ideologies of Right and Left are exhausted; and, analysis of the character of what Giddens calls ‘second-phase’ modernisation. The connection between the two themes is straightforward: it is because the world has changed in profound ways that radical politics cannot be continued in the old way. Both of (...) these themes are analysed at length in Beyond Left and Right. In this work, Giddens describes a long-run shift in our relationship to social and technological change manifest in the advance of ‘manufactured uncertainty’ or risk. This has been accelerated by a shift from ‘simple’ to 'reflexive’ modernisation which is a compound of a related series of developments during the post-war period – the ‘social revolutions of our time’. (shrink)

Additive manufacturing has spread widely over the past decade, especially with the availability of home 3D printers. In the future, many items may be manufactured at home, which raises two ethical issues. First, there are questions of safety. Our current safety regulations depend on centralized manufacturing assumptions; they will be difficult to enforce on this new model of manufacturing. Using current US law as an example, I argue that consumers are not capable of fully assessing all relevant risks and (...) thus continue to require protection; any regulation will likely apply to plans, however, not physical objects. Second, there are intellectual property issues. In combination with a 3D scanner, it is now possible to scan items and print copies; many items are not protected from this by current intellectual property laws. I argue that these laws are ethically sufficient. Patent exists to protect what is innovative; the rest is properly not protected. Intellectual property rests on the notion of creativity, but what counts as creative changes with the rise of new technologies. (shrink)

The use of foster children as subjects in the pediatric HIV/AIDS clinical trials has been the subject of media controversy, raising a range of ethical and social dimensions. Several unsettled issues and debates in research ethics underlie the controversy and the lack of consensus among professional researchers on these issues was neither adequately appreciated nor presented in media reports. These issues include (1) the tension between protecting subjects from research risk while allowing them access to the possible benefits of (...) research; (2) the blurring of the potentially conflicting roles of investigator and physician and the boundaries between research and therapy; (3) the adequacy of Institutional Review Board oversight; and (4) trust and the relationships among physicians, investigators and industry. The media controversy about the pediatric HIV/AIDS clinical trials can be seen as a means of “manufacturing mistrust” in health care, research and social services that have not always met the needs and expectations of the public. In an era of emerging infections, it is critical to the public’s health that people understand the role of rigorous and ethical research in the development of safe and effective care. Investigators, journalists and the public need to become knowledgeable about major ethical issues in the conduct of research in order to engage in dialogue about balancing research risks and benefits and to be able to distinguish fact from distortion in an era of multiple and rapid transmission of information. (shrink)

The risks of materials containing nanoscale components are in the public debate discussed as if a manufactured nanomaterial will remain invariant with time and environmental exposure, and as if we can identify its risks by the risks of its nanoscale components. Additionally, the debate on mitigation of specific nanorisks by new legislation implicitly assumes that we can have full and accurate knowledge of the distribution and composition of nanomaterials in a product or the environment. In this discussion note, I (...) argue that physical laws intrinsic to the behavior of nanoparticles both lead to limits on the risks to which we are likely exposed and on our technological ability to verify compliance with new regulations. My conclusion is that governmental actors should be careful not to overreact in their response to a technological revolution that only in few areas is likely to lead to increased public exposure, and in doing so using legal measures for which compliance cannot be monitored. (shrink)

In the wake of the current financial crises triggered by risky mortgage-backed securities, the question of ethics and risk-taking is once again at the front and center for both practitioners and academics. Although risk-taking is considered an integral part of strategic decision-making, sometimes firms could be propelled to take risks driven by reasons other than calculated strategic choices. The authors argue that a firm's risk-taking propensity is impacted by its ethical climate (egoistic or benevolent) and its emphasis (...) on output control to manage its marketing function. The firm's long-term orientation is argued to moderate the control–risk propensity relationship. The authors also extend research on risk and performance and argue that the association of risk-taking propensity and firm performance is contingent on the ownership (publicly traded versus privately held) structure of the firm. Based on survey data from a sample of manufacturing industries in the United States, the results show significant impact of ethical climate and marketing output control on a firm's risk-taking propensity; also risk-taking propensity shows a stronger association with firm performance in privately held firms than in publicly traded firms. (shrink)

Responsibility gaps concern the attribution of blame for harms caused by autonomous machines. The worry has been that, because they are artificial agents, it is impossible to attribute blame, even though doing so would be appropriate given the harms they cause. We argue that there are no responsibility gaps. The harms can be blameless. And if they are not, the blame that is appropriate is indirect and can be attributed to designers, engineers, software developers, manufacturers or regulators. The real problem (...) lies elsewhere: autonomous machines should be built so as to exhibit a level of risk that is morally acceptable. If they fall short of this standard, they exhibit what we call ‘a control gap.’ The causal control that autonomous machines have will then fall short of the guidance control they should emulate. (shrink)

The epistemologically distant nature of many of today's environmental risks greatly problematises conventional risk analyses that emphasise objectivity, materiality, factual specificity and certainty. Such analyses fail to problematise issues of ontology and epistemology, assuming a reality that is readily 'readable' and a corresponding knowledge of that reality that is asocial, objective and certain. Under the weight of modern, invisible, manufactured environmental risks, however, these assumptions begin to crack, revealing their tenuous nature. As this paper argues, statements of (...) class='Hi'>risk are ultimately social products that come to us by way of translation. They are statements not of what is but of knowledge expressed in probabilistic terms, and are thus thoroughly social in nature, for it is we – through our actions and social networks – that imbue them with meaning. One way we do this is through our social relations of trust. And it is this relationship – between trust and risk – that this paper seeks to detail both conceptually and empirically. While one could look toward any number of case studies to develop the conceptual details of this project, this paper focuses on the relatively recent case of mad cow disease to have been reported within the United States. Here, we have an epistemologically distant, and thus hotly contested, 'object', which has been the source of much risk debate; a debate that is also, in part, the effect of a deeper erosion of trust, particularly toward those managing our meat supply. (shrink)

Virtual enterprise is a dynamic alliance of businesses, in which multiple members undertake joint research, development, manufacturing, operation, etc. The complexity of the relationship between business members, coupled with many new technologies or methods applied in the alliance operation, leads to more uncertain factors and difficulties in the operation and risk management of the virtual enterprise. The distributed decision-making model is a fast and effective decision-making model, in which dispersed intellectual resources and information resources are dynamically integrated through virtual (...) organization forms and operating mechanisms, and the dynamic reorganization, result evaluation, and synthesis of the decision-making system are realized by certain control rules. On the basis of summarizing and analyzing previous research works, this paper expounded the research status and significance of the risk control of virtual enterprise; elaborated the development background, current status, and future challenges of distributed decision-making model; introduced the related works of decision-making variable calculation and constraint determination; constructed a risk control model for virtual enterprise based on distributed decision-making model; analyzed the multiobjective model and interval programming model of risk control; established a risk control approach for virtual enterprise based on distributed decision-making model; performed the optimal allocation of risk control funds and the selective optimization of backup allies; and finally conducted a case analysis. The study results show that, in view of the diversity of relationships between alliance businesses and the complexity of the distribution of cooperative areas, the distributed decision-making model can more reasonably describe the relationship between alliance members and accurately control the risks of virtual enterprise from multiple angles, which can effectively manage the risks of virtual enterprise. The study results of this paper provide a reference for further research on the risk control of virtual enterprise based on distributed decision-making model. (shrink)

Activities of product design and manufacturing are carried out on a worldwide scale. Operations like outsourcing and fabless manufacturing occur frequently in both design and manufacturing processes to stimulate outbreaks of the abovementioned phenomena. In this situation, manufacturing knowledge data, that have been collected and used only by the same enterprise in the same place and within the same ethnic group up to now, are not sufficient or precise enough for making a plan of ongoing manufacturing. This paper tries to (...) suggest an example of manufacturing knowledge data containing an element of production culture and to estimate a risk of manufacturing trouble that could happen between each production culture. (shrink)

Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying (...) manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased. (shrink)

This article examines the home rapid HIV test as a new practice of US biocitizenship. Via an analysis of discourse surrounding self-diagnostics, I conclude that while home HIV tests appear to expand consumer rights, they are in fact the vanguard of a new form of self-testing that carries a moral urgency to protect one’s own body and to manage societal risk. In addition, these tests extend biomedical authority into the private domain, while appearing to do the exact opposite. Furthermore, (...) access to these tests may be stratified, contradicting the intent expressed by the manufacturer to reach populations in need of it most and reinforcing stigma against them. Lastly, diagnostics such as the rapid home HIV test represent new obligations for surveillance of one’s own health and that of others. The new public health effort to test the population at large has given rise to a new ‘risky’ population: the untested bodies. (shrink)

Ten years after the enactment of the Biologics Price Competition and Innovation Act, competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem (...) to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act, which is administered by the Environmental Protection Agency. The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets. (shrink)

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

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

Making decisions with an, often significant, element of risk seems to be an integral part of many of the projects of the diverse profession of engineering. Whether it be decisions about the design of products, manufacturing processes, public works, or developing technological solutions to environmental, social and global problems, risk taking seems inherent to the profession. Despite this, little attention has been paid to the topic and specifically to how our understanding of engineering as a distinctive profession might (...) affect how we should make decisions under risk. This paper seeks to remedy this, firstly by offering a nuanced account of risk and then by considering how specific claims about our understanding of engineering as a social profession, with corresponding social values and obligations, should inform how we make decisions about risk in this context. (shrink)

Purpose: The research explored empirical evidence to assess the impact of cyber security and supply chain risk on digital operations in the UAE pharmaceutical industry. Methodology/Design/Approach: Based on responses from 243 personnel working at 14 pharmaceutical manufacturing companies in Dubai, data were examined for normality, instrument validity and regression analysis. Cyber security and SC risk on digital operations were explored by applying convenient sampling and descriptive and analytical research design. Findings: The findings validated the significant positive association between (...) cyber security and supply chain risk with digital operations. Research implications and Limitations: The research model was developed with three variables evaluated only on the pharmaceutical industry in Dubai. Future research should focus on multiple manufacturing industries by covering a larger geographic area. Practical implications: When suppliers are highly concentrated, customer-focused organisations with uncertain levels of digital transformation could improve their ability to manage supply chain risk by diversifying their clients. Pharmaceutical firms may require a greater focus on technology-based manufacturing firms to build and maintain customer trust. Originality Value: To illustrate how the pharmaceutical industry has explored the relationship between cyber security, supply chain risk and digital operations, the research highlights the significant and convoluted consequences of the relationship model that have not been previously considered. (shrink)

Stakeholder management is an important method for reducing business risk. Recent decades have seen the growth of a new type of stakeholder: social protest stakeholders, individuals engaging in protest action which is directed at other unrelated parties, often the government. However, the actions of social protest stakeholders may negatively affect companies located nearby. This stakeholder category has not received any formal attention in the literature, and this article addresses the knowledge gap by exploring the effects of community-driven protest action (...) in South Africa and the strategies that firms adopt to mitigate the negative consequences of such protests. A multiple case study analysis was used to describe this type of stakeholder group and the management of the consequences of social protest action. Eight manufacturing companies in the Gauteng province participated in the study, the companies varied in size and industry. Among the key findings are that companies need to be highly adaptable if they are to mitigate the impact of protest action. We make practical suggestions about how companies may manage these risks, including the recommendation that companies engage more directly with social protestors to manage risks. The study makes an important contribution to the literature by identifying an additional key category of stakeholder and proposing a risk management approach to avert or minimize loss and damage. (shrink)

In this study, we examine the relation between corporate environmental responsibility and risk in U.S. public firms. We develop and test the risk-reduction, resource-constraint, and cross-industry variation hypotheses. Using an extensive U.S. sample during the 1991–2012 period, we find that for U.S. industries as a whole, CER engagement inversely affects firm risk after controlling for various firm characteristics. The result remains robust when we use firm fixed effect or an alternative measure of CER using principal component analysis (...) or downside risk measures. To address the concern of endogeneity bias, we use a system equations approach and dynamic system generalized methods of moment regressions, and continue to find that environmentally responsible firms experience lower risk. These findings support the risk-reduction hypothesis, but not the resource-constraint hypothesis, along with the notion that the top management in U.S. firms is generally risk averse and that their CER engagement facilitates their risk management efforts. Our cross-industry analysis further reveals that the inverse CER-risk association mainly comes from the manufacturing sector, whereas in the service sector, CER tends to increase firm risk. (shrink)

Although the generation of reactive oxygen species is an activity normally associated with phagocytic leucocytes, mammalian spermatozoa were, in fact, the first cell type in which this activity was described. In recent years it has become apparent that spermatozoa are not the only nonphagocytic cells to exhibit a capacity for reactive oxygen species production, because this activity has been detected in a wide variety of different cells including fibroblasts, mesangial cells, oocytes, Leyding cells endothelial cells, thryroid cells, adipocytes, tumour cell (...) and platelets. Since the capacity to generate reactive oxygen species is apparently so widespread, the risk‐benefit equation for these potentially pernicious molecules becomes a matter of intese interest. In the case of human spermatozoa, the risk of manufacturing reactive oxygen metabolites is considerable because these cells are particularly vulnerable to lipid peroxidation. Indeed, there is now good evidence to indicate that oxygen radicals are involved in the initiation of peroxidative damage to the sperm plasma membrane, seen in many cases of male infertility. This risk is off‐set by recent data suggesting that superoxide anions and hydrogen peroxide also participate in the induction of key biological events such as hyperactiavated motility and the acrosome reaction. Thus, human spermatozoa appear to use reactive oxygen species for a physiological purpose and have the difficult task of ensuring the balanced generation of these potentially harmful, but biologically important, modulators of cellular function. (shrink)

Major events such as the COVID-19 pandemic, Olympic Games, and G20 Summit bring about supplier disruption risks and challenges to supply chain management. To help deal with these risks, a virtual dual-sourcing production-inventory system can be deployed. In this paper, we study such a system which consists of a raw material supplier, a manufacturer, and a virtual dual-sourcing contingency supplier. The manufacturer needs to determine the production, procurement, and inventory plan of raw materials. When its supplier is interrupted, the manufacturer (...) may need to adjust the production and inventory plan and work with the contingency supplier. We develop a system dynamics method to simulate the operations in this production-inventory system to identify the approximately optimal order-up-to-level inventory policies. We find that the virtual dual production-inventory strategy can be the optimal contingency policy to deal with supplier dynamic disruption risks. Furthermore, for disruption risk with low frequency and long duration, the manufacturer should increase the safety inventory level before the disruption. Otherwise, it should increase the safety inventory level in every cycle. (shrink)

This paper considers the implications of precautionary restrictions against technologies, in the context of the potential for creating and sustaining rumours. It focuses on the restriction against mobile phone use at petrol stations, based on the rumour that a spark might cause an explosion. Rumours have been substantiated by precautionary usage warnings from mobile phone manufacturers, petrol station usage restrictions, and a general lack of technical understanding. Petrol station employees have themselves spread the rumour about alleged incidents, filling the information (...) gap about the basis for the restriction. (shrink)

The online version of the original article can be found under doi:10.1007/s11948-007-9045-2.

There has been relatively little empirical research into the causes of research misconduct. To begin to address this void, the authors collected data from closed case files of the Office of Research Integrity (ORI). These data were in the form of statements extracted from ORI file documents including transcripts, investigative reports, witness statements, and correspondence. Researchers assigned these statements to 44 different concepts. These concepts were then analyzed using multidimensional scaling and cluster analysis. The authors chose a solution consisting of (...) seven clusters: (1) personal and professional stressors, (2) organizational climate, (3) job insecurities, (4) rationalizations A, (5) personal inhibitions, (6) rationalizations B and, (7) personality factors. The authors discuss the implications of their findings for policy and for future research. (shrink)

Green product innovation has been recognized as one of the key factors to achieve growth, environmental sustainability, and a better quality of life. Understanding green product innovation as a result of interaction between innovation and sustainability has become a strategic priority for theory and practice. This article investigates green product innovation by means of a multiple case study analysis of 12 small to medium size manufacturing companies based in Italy and Canada. First, we propose a conceptual framework that presents three (...) key environmental dimensions of green product innovation such as energy minimization, materials reduction, and pollution prevention as identified in the life cycle phases of products. Based on insights gained from in-depth interviews, we discuss firms' motivations to develop green products, environmental policies and targets for products, different dimensions of green product innovation, and challenges faced during developing and marketing of green products. Results from the study are then synthesized and integrated in a toolbox that sheds light on various aspects of green product innovation and provides solutions to challenges and risks that are faced by firms. Finally, implications for managers, academia and public policy makers are discussed. (shrink)

May lethal autonomous weapons systems—‘killer robots ’—be used in war? The majority of writers argue against their use, and those who have argued in favour have done so on a consequentialist basis. We defend the moral permissibility of killer robots, but on the basis of the non-aggregative structure of right assumed by Just War theory. This is necessary because the most important argument against killer robots, the responsibility trilemma proposed by Rob Sparrow, makes the same assumptions. We show that the (...) crucial moral question is not one of responsibility. Rather, it is whether the technology can satisfy the requirements of fairness in the re-distribution of risk. Not only is this possible in principle, but some killer robots will actually satisfy these requirements. An implication of our argument is that there is a public responsibility to regulate killer robots ’ design and manufacture. (shrink)

Much of the discussion regarding nanotechnology centers around perceived and prosphesied harms and risks. While there are real risks that could emerge from futuristic nanotechnology, there are other current risks involved with its development, not involving physical harms, that could prevent its full promise from being realized. Transitional forms of the technology, involving “microfab,” or localized, sometimes desk-top, manufacture, pose a good opportunity for case study. How can we develop legal and regulatory institutions, specifically centered around the problems of intellectual (...) property, that both stimulate innovation, and make the best possible use of what will eventually be a market in “types” rather than “tokens”? This paper argues that this is the most critical, current issues facing nanotechnology, and suggests a manner to approach it. (shrink)

The study analyzes the influential factors of consumers’ willingness to purchase gray-market smartphones by considering the model of novelty seeking, status consumption, integrity, and perceived risk. Attitude toward counterfeit is used as mediation in the model. The causalities in the model of problematic willingness of consumer to purchase gray-market smartphones are hypothesized. A total sample of 350 respondents with 238 effective samples is collected by interviewing with questionnaires at the service counters of telecommunications operators. Structure equation modeling (SEM) is (...) adopted in the analysis. Consumers’ attitude toward counterfeit goods is found to be positively related to the willingness of consumers to purchase gray-market smartphones, but perceived risk is negatively related to consumers’ willingness to purchase. As for personality constructs, integrity and status consumption are found to be negatively related to consumers’ attitude toward counterfeit goods, but novelty seeking is positively related to the attitude. Further, managerial implications for branded smartphone manufacturers and telecommunications regulators are provided by the research. (shrink)

This study compares and analyzes separate court rulings in three countries on “mini-cup jelly” (a firm jelly containing konjac and packaged in bite-sized plastic cups) from a food ethics perspective. While the Korean and US courts decided that the mini-cup jelly was defective, and that the manufacturers or importers were liable for damages in these cases, the Japanese court took an opposing stance in favor of the manufacturer. However, from an absolute and fundamental viewpoint, the jelly was unacceptable, ethically as (...) well as legally, because it was unsafe, unwholesome, and unfit for children’s consumption. I argue that the ignoring or sidelining of fundamental principles of food ethics, especially “respect for life,” was at the core of these cases. If the manufacturers and importers had considered and prioritized the principles of food ethics over and above big sales and profits, the choking accidents could have been prevented. To conclude, it is very important to minimize risks by applying the principles of food ethics at the outset before any accidents can occur. (shrink)

Our understanding of the complexity of the oral biome and of the role of the various constituent bacteria in the aetiology of dental disease is growing. Probiotics and their relationship with prebiotics, as well as other microbiome‐based interventions, could be useful in preventing and treating dental disease and in promoting oral health. However, given the promise and early stage of this treatment approach, there are also a number of ethical, social and regulatory issues associated with innovative probiotic therapy. In this (...) article, a brief update is given on contemporary theories of the aetiology and management of the two commonest dental diseases, and on the roles of pre‐ and probiotics and oral biome transplant in the management of these diseases. The focus is primarily on four core issues: informed consent, risk–benefit assessment, how to determine suitable healthy donors, and commercialization and regulation. We discuss the safety and benefits of oral probiotics, not only concerning the products and quality control during their manufacture, but also regarding the depth of public knowledge about this topic. We point out that the requirement of listing ingredients honestly might be insufficient, and that the prevalent rhetoric of ‘natural’ and ‘organic’ as well as some health claims in the translational, innovative probiotic industry and markets are themselves misleading and should be carefully scrutinized. Finally, we suggest an ethical imperative to find a balance between scientific research and industry, and public health in the regulation of probiotics. (shrink)

Today, many people have realized that the climate change and biodiversity loss issues lie in how and to what extent humans consume products for their lives in the Anthropocene era. Consumerism has pushed natural resource exploitation to its peak, and the depletion of resources is becoming increasingly prevalent. The beauty and personal care industry has a large market and high profits, especially in the high-income segment. However, this advantage also carries the risk of facing scrutiny, investigations, and criticism from (...) civil society organizations, environmental activists, and consumers. More than anyone else, the industry is vulnerable to the perils of unfavourable societal assessments, particularly the repercussions of consumer-led boycott actions. In this discourse, we suggest that, given the current circumstances, it is imperative for multinational beauty corporations to take a proactive role in allocating resources towards the development of sustainable agriculture practices. This entails not only advocating for the widespread adoption of environmentally conscious production methods but also dedicating efforts towards conducting research and innovation in the area of nature-friendly manufacturing techniques. Doing so will help demonstrate their commitment to the environment and actively provide convincing evidence to consumers of their social responsibility through emission reduction and biodiversity conservation activities. (shrink)

When the manufacturer of a medical device alone bears the responsibility for alerting recipients that the device may be defective, there is a certain temptation to gloss over the risk. The story of the Bjork‐Shiley Convexo‐Concave heart valve is a case in point.

John Berry, a risk manager for a U.S.-based pharmaceutical firm (Best Co.), is assigned additional responsibilities when his territory is expanded to include the South America region. When an employee in one of Best Co.’s South American manufacturing facilities dies in a work-related incident, John must determine an appropriate response. In a business context that is increasingly global, ethical decisions are further complicated by cultural differences. This case considers thefactors influencing John as he weighs his options on how to (...) resolve this incident. The case further considers how cultural differences coupled with John’s limited cross-cultural sensitivities and personal viewpoint might inevitably skew his judgment. San Luis, the disguised name for this South American locale, is less litigious than John’s home country, the U.S. In light of these differences, the case raises a number of ethical questions. For example, how should an international corporation compensate an employee’s family for the employee’s work-related death – if at all? Are John’s own cultural limitations preventing him from doing the right thing? (shrink)

In recent years, counterfeiting has grown exponentially and has now become a grave economic problem. The acquisition of counterfeits poses an ethical dilemma as it benefits the buyer and illegal seller at the cost of the legitimate producer and with fewer taxes being paid throughout the supply chain. Previous research reveals inconsistent and sometimes inconclusive findings regarding whether materialism is associated, positively or negatively, with intentions to purchase counterfeits. The current research seeks to resolve these inconsistencies by investigating previously ignored (...) interactions between three variables: risk of embarrassment, counterfeit detectability and product conspicuousness. First, risk of embarrassment mediates the relationship between materialism and counterfeit purchase intentions. Specifically, materialism negatively predicts counterfeit purchase intentions as mediated by risk of embarrassment. Second, this relationship only holds when the counterfeit can be easily detected. When it is not easily detected, materialism instead leads to positive purchase intentions. Third, these positive effects can be offset when the product is not highly visible. This research has important implications for marketers, manufacturers and academics and contributes to better understanding the antecedents of counterfeit purchases. (shrink)

In this study, we examine investor and firm response to the California Transparency in Supply Chains Act of 2010. The CTSCA requires large retail and manufacturing firms to disclose efforts to eradicate slavery and human trafficking from their supply chains and is a rare example of mandated corporate social responsibility disclosure. Based on a sample of 105 retail companies subject to the CTSCA, we find a significant negative market reaction to the passing of the CTSCA. Furthermore, we find that the (...) reaction is significantly more negative for larger firms and companies facing greater supply chain risks, suggesting that investors place a negative value on exposure to legitimacy threats in the social domain. With respect to company disclosure response, we document relatively high compliance with the legislation, although we also find that the disclosure response appeared to be more symbolic than substantive in nature. Finally, our analysis indicates that both disclosure choice and disclosure extensiveness were significantly higher for the high-supply chain risk companies, suggesting that the response was influenced by concerns with strategic legitimation. Overall, the limited quality of disclosure suggests that, without additional rules and guidance, mandates alone may not lead to meaningful social disclosure. (shrink)

This article develops an account of distributive epistemic justice in the production of scientific knowledge. We identify four requirements: (a) science should produce the knowledge citizens need in order to reason about the common good, their individual good and pursuit thereof; (b) science should produce the knowledge those serving the public need to pursue justice effectively; (c) science should be organized in such a way that it does not aid the wilful manufacturing of ignorance; and (d) when making decisions about (...) epistemic risks, scientists should make sure that there aren’t social groups or weighty interests that are neglected. After discussing these requirements, we examine the relationship between discriminatory and distributive epistemic injustice in science and argue that they often compound each other. (shrink)