BackgroundIn this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants.DiscussionWe first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then (...) elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials.ConclusionThe fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished. (shrink)

International research is an essential means of reducing health disparities between and within countries and should do so as a matter of global justice. Research funders from high-income countries have an obligation of justice to support health research in low and middle-income countries that furthers such objectives. This paper investigates how their current funding schemes are designed to incentivise health systems research in LMICs that promotes health equity. Semi-structured in-depth interviews were performed with 16 grants officers working for 11 funders (...) and organisations that support health systems research: the Alliance for Health Policy and Systems Research, Comic Relief, Doris Duke Foundation, European Commission, International Development Research Centre, Norwegian Agency for Development Cooperation, Research Council of Norway, Rockefeller Foundation, UK Department of International Development, UK Medical Research Council, and Wellcome Trust. Thematic analysis of the data demonstrates their funding schemes promote health systems research with five key features that advance health equity: being conducted with worst-off populations, focusing on research topics that advance equitable health systems, having LMIC ownership of the research agenda, strengthening LMIC research capacity, and having an impact on health disparities. The different types of incentives that encouraged proposed projects to have these features are identified and classified by their strength. It is suggested that research funders ought to create and maintain funding schemes with strong incentives for the features identified above in order to more effectively help reduce global health disparities. (shrink)

Slot machines gained a high popularity despite a specific element that could limit their appeal: non-transparency with respect to mathematical parameters. The PAR sheets, exposing the parameters of the design of slot machines and probabilities associated with the winning combinations are kept secret by game producers, and the lack of data regarding the configuration of a machine prevents people from computing probabilities and other mathematical indicators. In this article, I argue that there is no rational justification for this secrecy by (...) giving two reasons, one psychological and the other mathematical. For the latter, I show that mathematics provides us with some statistical methods of retrieving the missing data, which are essential for the numerical probability computations in slots. The slots case raises the problem of the exposure of the parametric configuration and mathematical facts of any game of chance as an ethical obligation. (shrink)

Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for (...) intervention trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007. Results: We collected data from 312 trials. Fifty-eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI = 53 to 64) of trials report active controls. Almost no trials (1%, 95% CI = 0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI = 16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI = 2.70 to 9.35, p = < 0.001). Pharmaceutical companies are involved in 28% (CI = 23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI = 1.18 to 5.09, p = 0.31). Conclusion: We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings. (shrink)

At Shantou University in 2008, a stand-alone engineering ethics course was first included within a Conceive–Design–Implement–Operate curriculum to address the scarcity of engineering ethics education in China. The philosophy of the course design is to help students to develop an in-depth understanding of social sustainability and to fulfill the obligations of engineers in the twenty-first century within the context of CDIO engineering practices. To guarantee the necessary cooperation of the relevant parties, we have taken advantage of the top-down support (...) from the STU administration. Three themes corresponding to contemporary issues in China were chosen as the course content: engineers’ social obligations, intellectual property and engineering safety criteria. Some popular pedagogies are used for ethics instruction such as case studies and group discussions through role-playing. To impart the diverse expertise of the practical professional practice, team teaching is adopted by interdisciplinary instructors with strong qualifications and industrial backgrounds. Although the assessment of the effectiveness of the course in enhancing students’ sense of ethics is limited to assignment reports and class discussions, our endeavor is seen as positive and will continue to sustain the CDIO reform initiatives of STU. (shrink)

The debate on whether and how the Internet can protect and foster human rights has become a defining issue of our time. This debate often focuses on Internet governance from a regulatory perspective, underestimating the influence and power of the governance of the Internet’s architecture. The technical decisions made by Internet Standard Developing Organisations that build and maintain the technical infrastructure of the Internet influences how information flows. They rearrange the shape of the technically mediated public sphere, including which rights (...) it protects and which practices it enables. In this article, we contribute to the debate on SDOs’ ethical responsibility to bring their work in line with human rights. We defend three theses. First, SDOs’ work is inherently political. Second, the Internet Engineering Task Force, one of the most influential SDOs, has a moral obligation to ensure its work is coherent with, and fosters, human rights. Third, the IETF should enable the actualisation of human rights through the protocols and standards it designs by implementing a responsibility-by-design approach to engineering. We conclude by presenting some initial recommendations on how to ensure that work carried out by the IETF may enable human rights. (shrink)

The process of obtaining informed consent in a teaching hospital in a developing country (e.g. Nigeria) is shaped by factors which, to the Western world, may be seen to be anti‐autonomomous: autonomy being one of the pillars of an ideal informed consent. However, the mix of cultural bioethics and local moral obligation in the face of communal tradition ensures a mutually acceptable informed consent process. Paternalism is indeed encouraged by the patients who prefer to see the doctor as all‐powerful and (...) all‐knowing, and this is buttressed by the cultural practice of customary obedience to those ‘above you’: either in age or social rank. The local moral obligation reassures the patients that those in authority will always look after others placed in their care without recourse to lengthy discussions or signed documentation, while the communal traditions ensure that the designated head of a family unit has the honor and sole responsibility of assenting and consenting to an operation to be carried out on a younger, or female, member of the family. Indeed it is to only a few educated patients that the informed consent process is deemed a shield against litigation by the doctors. This paper later addresses the need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses, which should highlight socio‐cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting. (shrink)

There exists in academic medicine a core ethical issue that is seldom pursued: trainees are frequently not the best person in the operating room at a given intervention being performed, and yet as a profession we understand a fundamental need to afford them opportunities to perform. Academic centres are traditionally associated with a higher quality of care than non-academic centres, suggesting that practical measures exist within teaching hospitals that effectively mask the clinical discrepancies between trainees and their preceptors. Nonetheless, we (...) are bound by our ethical commitments as physicians to balance the obligations of care with the duty to teach. In order to ethically validate the model of ‘surgeon as teacher’, we propose that there must be a reconciliation of the tensions between traditional professional values in medicine with the constraints inherent in a time-bound utilitarian medical system. Ultimately, we must consciously accept that ensuring the longitudinal availability of skilled surgeons in society aligns more closely with our core ethical obligations as outlined in the social contract that medical professionals maintain with the general public than does the ethical demand to provide unreservedly individual-focused patient care. It is the duty of individual practitioners, as a necessity of lineage to maintain and fulfil our greater duties to society, to foster deontological relationships where possible within this utilitarian system while accepting short-term imperfection in our practice. There are no data in this manuscript. (shrink)

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The process of obtaining informed consent in a teaching hospital in a developing country (e.g. Nigeria) is shaped by factors which, to the Western world, may be seen to be anti-autonomomous: autonomy being one of the pillars of an ideal informed consent. However, the mix of cultural bioethics and local moral obligation in the face of communal tradition ensures a mutually acceptable informed consent process. Paternalism is indeed encouraged by the patients who prefer to see the doctor as all-powerful and (...) all-knowing, and this is buttressed by the cultural practice of customary obedience to those ‘above you’: either in age or social rank. The local moral obligation reassures the patients that those in authority will always look after others placed in their care without recourse to lengthy discussions or signed documentation, while the communal traditions ensure that the designated head of a family unit has the honor and sole responsibility of assenting and consenting to an operation to be carried out on a younger, or female, member of the family. Indeed it is to only a few educated patients that the informed consent process is deemed a shield against litigation by the doctors. This paper later addresses the need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses, which should highlight socio-cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting. (shrink)

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

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not (...) yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. (shrink)

To build a relationship between Tax Administration and taxpayers based on trust, law science must provide the necessary information related to policies or institutions but also inform taxpayers about their rights and obligations. This information must be known but, above all, understood.The objective is to introduce a paradigm shift in the way legal studies are approached through Legal Design thinking techniques. Specifically, starting from the need for the jurist to study the law, collaborating with other disciplines to design mechanisms (...) that allow the communication of complex information that helps both the understanding of the law and decision-making process. (shrink)

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial (...) drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

Mandatory reporting of various forms of abuse, from violence to corruption, is an attempt by the state to intervene in circumstances where there is a public or a private interest that ought to be protected. This intrusion of the state into what is often a very personal space, such as the home, is largely justified on the basis of the need to provide protection to prevent further harm, and in services to vulnerable populations such as children, the disabled or the (...) elderly. In some instances, researchers and other members of the study team may encounter reportable information requiring the consideration of mandatory reporting in the design, implementation and review of health research. This is not simple. There are complex and competing interests at play, particularly as there are differing approaches in law and ethical guidelines. This article aims to describe the mandatory reporting obligations in South African law, discussing the ways in which these provisions apply within the context of health research, and to propose some factors that could be used to determine whether it is ethical or not to report information. (shrink)

Although a safe, effective, and licensed coronavirus vaccine does not yet exist, there is already controversy over how it ought to be allocated. Justice is clearly at stake, but it is unclear what justice requires in the international distribution of a scarce vaccine during a pandemic. Many are condemning ‘vaccine nationalism’ as an obstacle to equitable global distribution. We argue that limited national partiality in allocating vaccines will be a component of justice rather than an obstacle to it. For there (...) are role-based and community-embedded responsibilities to take care of one’s own, which constitute legitimate moral reasons for some identity-related prioritisation. Furthermore, a good form of vaccine nationalism prioritises one’s own without denying or ignoring duties derived from a principle of equal worth, according to which all persons, regardless of citizenship or identity, equally deserve vaccine-induced protection from COVID-19. Rather than dismissing nationalism as a tragic obstacle, it is necessary to acknowledge that a limited form of it is valuable and expresses moral commitments. Only then can one understand our world of competing obligations, a world where cosmopolitan duties of benevolence sometimes conflict with special obligations of community membership. Once these competing obligations are recognised as such, we can begin the work of designing sound ethical frameworks for achieving justice in the global distribution of a coronavirus vaccine and developing practical strategies for avoiding, mitigating or resolving conflicts of duty. (shrink)

The phrase sacra mensae appears in only a select number of instances from the first century a.d. onwards. This paper seeks to demonstrate that references to sacra mensae are not coincidental, and that they were employed deliberately by authors such as Valerius Maximus and, after him, Quintilian, Tacitus and Seneca, based on an assumed shared understanding of their significance on the part of Roman audiences. Although it appears across a variety of literary works and in a range of contexts, the (...) phrase does not seem to have been used in reference to a specific rite or rites performed at the table. Instead, sacra mensae appears to have been used primarily in a metaphorical sense, designed to epitomize the customs and respect attached to dining in Roman culture. Religion certainly played an important part in creating the aura surrounding the table, which was subject to various rituals and superstitions that were discussed by ancient authors. However, beyond the sphere of religion there was the equally important social emphasis on dining, which enforced notions of conviviality and personal obligation between hosts and guests. Disregard of such traditions came to be identified as a hallmark of tyranny, which provided the writers of the Principate with an opportunity to use the sacra mensae as a powerful literary device against those who failed to respect established customs of hospitality. (shrink)

Establishing the nature of genetic parenthood is an important task. This is, firstly, because many people desire that relationship and it is in their interest to know what that is, and secondly, because there is a view that it may incur certain moral obligations between the genetic parent and their child. Many theorists have made attempts to define exactly what genetic parenthood is. I show that these definitions are deficient if they wish to fully capture all reproductive scenarios in (...) ways that are intuitive and/or meaningful. Through a series of cases involving technologies such as cloning and genome editing, we see that in lieu of the traditional two parents, there are possible beings who have no genetic parents, one genetic parent, or many genetic parents. Establishing these cases complicates our understanding of genetic parenthood. From this, we must reconsider current definitions, as well as the usefulness of defining genetic parenthood in these complex cases. Here I do not aim to establish a new definition, but rather to suggest that this complexity makes it necessary to re‐assess the importance of the connection between genetic parenthood and parental obligations and authorities. (shrink)

Physicians and families need to interact more meaningfully to clarify the values and preferences at stake in advance care planning. The current use of advance directives fails to respect patient autonomy. This paper proposes using the family covenant as a preventive ethics process designed to improve end-of-life planning by incorporating other family members—as agreed to by the patient and those family members—into the medical care dialogue. The family covenant formulates advance directives in conversation with family members and with the assistance (...) of a physician, thereby making advance directives more acceptable to the family, and more intelligible to other physicians. It adds the moral force of a promise to the obligation of respecting a patient’s preferences about end-of-life care. These negotiations between patient, family, and physician, from early planning phases through implementation, should greatly reduce the incidence of family disagreements on what the patient would have wanted. The family covenant ensures advance directive discussions within the family, promotes and respects the autonomy of other family members, and might even spur others in the family to complete advance directives through additional covenants. The family covenant holds the potential to transform moral quagmires into meaningful moral conversation. J Am Geriatr Soc 51:1155–1158, 2003. (shrink)

According to Wringe 2006 we have good reasons for accepting the existence of Global Collective Obligations - in other words, collective obligations which fall on the world’s population as a whole. One such reason is that the existence of such obligations provides a plausible solution a problem which is sometimes thought to arise if we think that individuals have a right to have their basic needs satisfied. However, obligations of this sort would be of little interest (...) – either theoretical or practical – if they did not give rise, either directly or indirectly, to any kinds of reasons for individuals to behave in certain ways. -/- In this paper, I shall argue that in many situations, forward-looking global obligations give rise to an obligation on individuals to work towards bringing into existence and support an institutional system which will enable their obligations to be met. My argument for this conclusion involves two steps. In the first step, I address a general question about how collective obligations can give rise to individual obligations without being reducible to them, and which obligations they give rise to. Here I give a Kant-inspired argument, based on the principles that ‘ought implies can’ and that the content of the moral law is given by reflecting on how agents should legislate in a kingdom of ends, which is designed to show that collective obligations can give rise to individual obligations. In the second step I apply this principle to the case of global forward-looking obligations. (shrink)

If group members aim to fulfill a collective obligation, they must act in such a way that the composition of their individual actions amounts to a group action that fulfills the collective obligation. We study a strong sense of joint action in which the members of a group design and then publicly adopt a group plan that coordinates the individual actions of the group members. We characterize the conditions under which a group plan successfully coordinates the group members' individual actions, (...) and study how the public adoption of a plan changes the context in which individual agents make a decision about what to do. (shrink)

Do citizens of any modern state have a general duty to acknowledge its authority to determine for them, for action guiding purposes, whether certain kinds of conduct are morally permissible, required, or forbidden? That is, is there a duty to obey the law? Moral Contractualism, I contend, entails that citizens of a liberal democratic state have such a duty. ;Treating others morally often requires agents to act collectively, but even agents who accept the moral necessity of collective action will sometimes (...) disagree over the specification of the ends to be achieved, and the means for doing so. I argue that a liberal democratic state can justifiably claim the authority to resolve such disagreements, which it does mainly by enacting and applying laws. Obedience to democratic laws expresses respect for others' autonomy. ;In defending these claims, particular attention is paid to the problem posed by disagreement over the design of democratic decision procedures, conflicts between democratically enacted laws and individual rights, and conflicts of rights. Civil disobedience, conscientious objection, and over-inclusive laws are also addressed. (shrink)

As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS (...) and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices. (shrink)

The correlativity of rights and obligations is one of the few stock topics in the basic repertory of English-speaking philosophy th-t is considered suitable for assignment to philosophers specializing in political philosophy. It is a topic perennially discussed, chiefly for reasons that have little to do with its importance: namely, just because it is a recognized topic and because it appears to be a safely tidy one that lends itself readily to being tidied up further by formal or quasi-formal (...) considerations. For my part, I wish more effort went into discussing less tractable subjects like the individuation of rights and their delimitation vis-à-vis one another.What I have to contribute to the subject of correlativity, returning to the scene of my comments on David Lyons’ paper, “The Correlativity of Rights and Duties,” is mainly a stint of annual or biennial repair-work, designed to restore the obvious — the truth that rights do imply obligations and cannot be understood without accepting this implication. (shrink)

The primary objective of this research was to investigate the impact of Commitment Towards Islamic Banks, Attitude Towards Islamic Bank, Islamic Religious Obligation, trust, and Hijra intention on customer loyalty towards Islamic banks. Additionally, the study aimed to explore the moderating role of customer trust and the mediating effect of hijra intention. The research employed a cross-sectional research design and a quantitative approach, gathering data from customers of Islamic banks in the Kingdom of Saudi Arabia. A questionnaire, based on previous (...) studies, was designed for data collection and distributed to respondents through purposive sampling. The collected data underwent analysis using AMOS. The study revealed that Commitment Towards Islamic Banks, Attitude Towards Islamic Bank, and Islamic Religious Obligation positively influence hijra intention. Furthermore, trust and hijra intention significantly impact loyalty towards Islamic banks. The results also supported the moderating influence of trust and the mediating role of hijra intention. This research contributes to the existing body of literature in religious studies, offering valuable insights that can assist banking strategists in customer retention efforts. (shrink)

This thesis studies some philosophical and ethical issues that economic design raises. Chapter 1 gives an overview of economic design and argues that a crossfertilisation between philosophy and economic design is possible and insightful for both sides. Chapter 2 examines the implications of mechanism design for theories of rationality. I show that non-classical theories, such as constrained maximization and team reasoning, are at odds with the constraint of incentive compatibility. This poses a problem for non-classical theories, which proponents of these (...) theories have not addressed to date. Chapter 3 proposes a general epistemology of economic engineering, which is motivated by a novel case study, viz. the reform of a matching market for medical practitioners. My account makes use of causal graphs to explain how models allow encoding counterfactual information about how market outcomes change if the design of the market changes. The second part of the thesis examines ethical issues. In Chapter 4, I apply tools from matching theory to gain insights into the distribution of refugees, such as among countries of the European Union. There is an ethical trade-off between the fairness of matchings and their efficiency, and I argue that in this context, fairness is the morally weightier criterion. Chapter 5 deals with the ethics of kidney exchange. Against critics, I give two arguments for the implementation of kidney exchange programmes. The first argument is that they are instrumental in meeting a moral obligation, namely to donate effectively. The second is that kidney exchange may increase the motivation for altruistic donations, because the donation of one kidney may trigger > 1 life savings. The final chapter identifies questions for future research and it closes with some thoughts about the future trajectory of economic design. (shrink)

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document did (...) not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists. (shrink)

The question of whether AI systems such as robots can or should be afforded moral agency or patiency is not one amenable either to discovery or simple reasoning, because we as societies constantly reconstruct our artefacts, including our ethical systems. Consequently, the place of AI systems in society is a matter of normative, not descriptive ethics. Here I start from a functionalist assumption, that ethics is the set of behaviour that maintains a society. This assumption allows me to exploit the (...) theoretical biology of sociality and autonomy to explain our moral intuitions. From this grounding I extend to consider possible ethics for maintaining either human- or of artefact-centred societies. I conclude that while constructing AI systems as either moral agents or patients is possible, neither is desirable. In particular, I argue that we are unlikely to construct a coherent ethics in which it it is ethical to afford AI moral subjectivity. We are therefore obliged not to build AI we are obliged to. (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)

The two justificatory roles of the social contract are establishing whether or not a state is legitimate simpliciter and establishing whether any particular individual is politically obligated to obey the dictates of its governing institutions. Rawls's theory is obviously designed to address the first role but less obviously the other. Rawls does offer a duty-based theory of political obligation that has been criticized by neo-Lockean A. John Simmons. I assess Simmons's criticisms and the possible responses that could be made to (...) them, including those offered by Samuel Freeman. I conclude they rest on a Rawlsian equivocation and ultimately fail. (shrink)

Barbeyrac's republication of and commentary on Leibniz' attack on Pufendorf's natural-law doctrine is often seen as symptomatic of the failure of all three early moderns to solve a particular moral-philosophical problem: that of the relationship between civil authority and morality. Making use of the first English translation of Barbeyrac's work, this article departs from the usual view by arguing that here we are confronted by three conflicting constructions of civil obligation, arising not from the common intellectual terrain of moral philosophy, (...) but from divergent religious and political cultures. If this approach makes the three constructions less susceptible to theoretical reconciliation, then it opens them to a more revealing historical investigation, in terms of the particular religious and political circumstances in which they arose, and which they were designed to address. The result is that these early modern struggles over the nature of civil obligation confront us again as unfinished historical business. (shrink)

This article proposes a journalism ethics obligation to identify speculation clearly, attribute it to sources, report any basis for it, and offer appropriate qualification, especially when speculation is based on stereotypes of stigmatized groups. Explicitly recognizing this responsibility addresses a gap in the traditional conception of journalistic responsibilities: When journalists fulfill responsibilities corresponding to their gatekeeper and watchdog roles by reporting sources' views, speculation may enter. Examples from major American newspaper and newsmagazine coverage of Andrew Cunanan, an openly gay man (...) who in 1997 allegedly murdered fashion designer Gianni Versace and 4 other men, show how journalists met and failed to meet the proposed obligation when reporting speculation linking Cunanan's sexuality to his crimes. (shrink)

The quality of the educational experience for students may be at risk if they are not taught in ways that are effective and pertinent. While educational institutions (administrators, faculty senates or a combination) may try to compel faculty members to gain knowledge of and utilize up-to-date learning and instructional design strategies, these faculty members may baulk at this mandate, citing academic freedom as their right to design their courses in any way they see fit. Following is a discussion exploring the (...) issue, suggesting that regardless of how academic freedom is interpreted, faculty members have an ethical obligation to deliver instruction in ways that do not violate students' rights to learn. Consequently, institutions have a right as well as a duty to compel their faculty members to follow through with this obligation. (shrink)

In the fifteenth century, the desire of the laity for more convincing religious instruction in the vernacular was not entirely satisfied by wandering preachers like Vincent Ferrer , Bernardino of Siena or Giovanni of Capistrano . Therefore, north of the Alps, particularly in free cities of the Empire, so-called municipal preaching offices were introduced.3 For the most part, cathedral chapters and their bishops exerted a great influence over these foundations. Subsequently, the newly installed preachers were obliged to discipline the urban (...) population. According to the artes praedicandi, the preachers were expected to avoid any criticism of the religious hierarchy and the .. (shrink)

This article considers whether there is a parental obligation to comply with child health advice which is aimed at the general population and grounded in population-based research. Drawing upon the concept of role obligations, I argue that there is a temptation to use child health advice as a set of rules to which parents are morally obligated to comply, but that this temptation should be resisted. Using the case of Safe Sleep recommendations, designed to reduce the risk of sleep-related (...) infant deaths, I present three reasons for doubting that parents are obligated, as a matter of course, to comply with child health advice. I suggest that, rather than compliance, deliberation about child health advice is obligatory, and that parents should have reasons for not following credible child health advice. (shrink)

Human oversight has become a key mechanism for the governance of artificial intelligence (“AI”). Human overseers are supposed to increase the accuracy and safety of AI systems, uphold human values, and build trust in the technology. Empirical research suggests, however, that humans are not reliable in fulfilling their oversight tasks. They may be lacking in competence or be harmfully incentivised. This creates a challenge for human oversight to be effective. In addressing this challenge, this article aims to make three contributions. (...) First, it surveys the emerging laws of oversight, most importantly the European Union’s Artificial Intelligence Act (“AIA”). It will be shown that while the AIA is concerned with the competence of human overseers, it does not provide much guidance on how to achieve effective oversight and leaves oversight obligations for AI developers underdefined. Second, this article presents a novel taxonomy of human oversight roles, differentiated along whether human intervention is constitutive to, or corrective of a decision made or supported by an AI. The taxonomy allows to propose suggestions for improving effectiveness tailored to the type of oversight in question. Third, drawing on scholarship within democratic theory, this article formulates six normative principles which institutionalise distrust in human oversight of AI. The institutionalisation of distrust has historically been practised in democratic governance. Applied for the first time to AI governance, the principles anticipate the fallibility of human overseers and seek to mitigate them at the level of institutional design. They aim to directly increase the trustworthiness of human oversight and to indirectly inspire well-placed trust in AI governance. (shrink)

Sustainability as a concept remains just as challenging and important today as it was when the first edition of this book was published. The Second Edition of Sustainability and Design Ethics explores the ethical obligations of knowledgeable people such as design professionals, taking into consideration the numerous changes that have taken place in recent years. This book expands the growing discussion on the principles of sustainability to further include the role of businesses and governments and considers the general recognition (...) that modern society has occurred at the expense of nature with significant social and environmental impacts. Are there limits to the individual's ethical obligation? How do such obligations change or adapt to a world of sustainable design? As the shift toward sustainability proceeds, designers' ethical underpinnings will be confronted with a wider range of people and concerns whose interests must be weighed. The design professionals are likely to be among the lead in the shift toward sustainability because of the special knowledge and expertise provided to them by their education, experience, and distinctive position in society. The entire world of design is being reassessed and the guiding principles and ethics of design reflect this change. New to the Second Edition: Expanded international scope that includes a comparison of professional organizations in the EU, Australia, Canada, Japan and China Discusses how cultural differences between the West and China result in different underlying foundations for professional ethics Revised analyses to reflect changes in regulatory and technical areas such as the inevitable rise of artificial intelligence in design Updated arguments reflecting the need for sustainability and the designer's role and obligations Updated references pertaining to the progress of sustainable design and development Sustainability and Design Ethics, Second Edition is an attempt to explore the ideas and principles that might contribute to the thinking of thoughtful design professionals. The emergence of "green" design discussed in this book is used to evidence progress, but also to demonstrate the degree to which more is needed. (shrink)

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise—i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention—has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always (...) justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions. (shrink)

The coupled growth of population aging and international migration warrants attention on the methods and solutions available to adult children living overseas to provide distance caregiving for their aging parents. Despite living apart from their parents, the transnational informal care literature has indicated that first-generation immigrants remain committed to carry out their filial caregiving obligations in extensive and creative ways. With functions to remotely access health information enabled by emergency, wearable, motion, and video sensors, remote monitoring technologies (RMTs) may (...) thus also allow these international migrants to be alerted in sudden changes and remain informed of their parent’s state of health. As technological solutions for caregiving, RMTs could allow independent living for older persons while any unusual deviations from normal health patterns are detected and appropriately supported. With a vignette of a distance care arrangement, we engage with concepts such as filial piety, in-absentia caregiving distress, and the social exchange theory, as well as the upholding of shifting cultural ideals to illustrate the complex dynamic of the satisfaction and quality of the informal caregiving relationship. This paper extends the traditional ethical issues in technology-aided caregiving, such as autonomy, privacy, and justice, to be considered within the context of distance care. We also posit newer ethical considerations such as consent in power imbalances, harm to caregivers, and stigma. These known and new ethical issues aim to encourage further ethically conscious design and use of RMTs to support distance care for older persons. (shrink)

This article demonstrates how meditation apps, such as Headspace and Calm, are imbricated within public discourse about technology addiction, exploring the consequences of this discourse on contemporary mental life. Based on ethnographic research with designers and users of meditation apps, I identify a promise put forth by meditation app companies that I call attention by design: a discursive strategy that frames attention as an antidote to technology addiction, which is ostensibly made possible when design is done right. I argue (...) that attention by design is a promise unfulfilled. Meditation app companies construct attention as socially valuable by endlessly pointing out its purported opposite, technology addiction. Attention by design is promissory in that it keeps promising even when it doesn’t deliver what it promises, compelling the user to return to a practice that represents socially desirable traits that can never be fully acquired—and that often recede further from reach as the person becomes distracted by other obligations and communication mediated through the smartphone. Despite this broken promise, users believe they are becoming more attentive. The promissory attention designed into meditation apps reflects a new form of governmentality, in which users receive a mental nudge to reinterpret similarly designed experiences as different. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:160 THE HUMEAN PROMISE: WHENCE COMES ITS OBLIGATION? Introduction David Hume offers an extended analysis of promising, and his observations and conclusions reflect a remarkable insight into the nature and origins of promising and promissory obligation. Hume argues that promising is naturally unintelligible and could only arise via an artifice; that this artifice arises because each person sees his or her mutual advantage in it; and that afterwards a (...) sentiment of morals concurs with interest and becomes a new obligation upon mankind. How, for Hume, do promises obligate, and how are we to understand this new obligation? I shall argue that for Hume the obligations of promising are two: the natural obligation to accept and participate in the artifice itself — this obligation arises from a natural inclination to approve of those artifices which we see as necessary for our survival — and the artificial obligation to faithfully execute a particular service or transaction of property in the future as expressed by the words? promise'. I shall begin with some explanatory remarks on Hume's views of human nature and the artifices which this nature produces, some of which bear directly on our understanding of Hume's treatment of promissory obligation. Background Hume's view of mankind is that it is a selfcorrective species, relying heavily on its penchant for imagination, and that without these traits, particularly imagination, it would be, without doubt, an extinct species. Much of the Treatise is a naturalistic account of human nature: a nature which includes not only instincts and passions, but the 161 ability to transcend and control them with artificial conventions when they become counterproductive and disadvantageous to society; although even these artificial conventions or artifices must be approved by their users and, to this extent, are a natural outcome. "We readily forget," Hume states, "that the designs, and projects, and views of men are principles as necessary in their operation as heat and cold, moist and dry." (T 474) Hume attaches no necessity to the particular form human nature has taken nor to the environment in which it is placed. His aim is to give a naturalistic account of the way things are, both socially and psychologically. Hume uses the word 'natural' in one place to mean what is common to any species, or what is inseparable from the species, and this includes for him the artifices of mankind. (T 484) Unlike Hobbes, he optimistically describes human nature as a combination of self-interest and benevolence, and "...tho' it be rare to meet with one, who loves any single person better than himself; yet 'tis as rare to meet with one, in whom all the kind affections, taken together, do not over-balance all the selfish." (T 487) The natural virtues originate from our kind affections and have no dependence on the contrivance 2 or artifice of man (T 574) nor on the contrivance of a deity. What makes meekness, beneficence, charity, generosity and equity virtuous is simply man's natural approval of them: "virtue is distinguished by the pleasure, and vice by the pain, that any action, sentiment or character gives us by the mere view and contemplation." (T 475) Hume's natural virtues are selected from natural motives which are of the spontaneous instinctive sort. Although Hume believes that selfishness is an overemphasized human trait, he does say that each man 162 (and probably woman) loves himself (herself) better than any other single person. (T 487) This selfishness, however, is not exclusively selfcentered, but manifests itself in a "confined generosity" that moves outward concentrically from the interested self to his or her family and friends. Beyond this circle of friends we are generally distrustful of others and will naturally revert to our individual self-interest when interacting with them. The one trait of which Hume makes great use throughout the Treatise to explain and describe human behavior is imagination. The word 'imagination' has many meanings, three of which are alluded to by Hume. Imagination may take a material or practical shape in the form of an invention, whereby someone imagines some object and then invents it. Examples of imagination qua inventiveness include actual physical inventions and may include the Humean artifices. Imagination... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:160 THE HUMEAN PROMISE: WHENCE COMES ITS OBLIGATION? Introduction David Hume offers an extended analysis of promising, and his observations and conclusions reflect a remarkable insight into the nature and origins of promising and promissory obligation. Hume argues that promising is naturally unintelligible and could only arise via an artifice; that this artifice arises because each person sees his or her mutual advantage in it; and that afterwards a (...) sentiment of morals concurs with interest and becomes a new obligation upon mankind. How, for Hume, do promises obligate, and how are we to understand this new obligation? I shall argue that for Hume the obligations of promising are two: the natural obligation to accept and participate in the artifice itself — this obligation arises from a natural inclination to approve of those artifices which we see as necessary for our survival — and the artificial obligation to faithfully execute a particular service or transaction of property in the future as expressed by the words? promise'. I shall begin with some explanatory remarks on Hume's views of human nature and the artifices which this nature produces, some of which bear directly on our understanding of Hume's treatment of promissory obligation. Background Hume's view of mankind is that it is a selfcorrective species, relying heavily on its penchant for imagination, and that without these traits, particularly imagination, it would be, without doubt, an extinct species. Much of the Treatise is a naturalistic account of human nature: a nature which includes not only instincts and passions, but the 161 ability to transcend and control them with artificial conventions when they become counterproductive and disadvantageous to society; although even these artificial conventions or artifices must be approved by their users and, to this extent, are a natural outcome. "We readily forget," Hume states, "that the designs, and projects, and views of men are principles as necessary in their operation as heat and cold, moist and dry." (T 474) Hume attaches no necessity to the particular form human nature has taken nor to the environment in which it is placed. His aim is to give a naturalistic account of the way things are, both socially and psychologically. Hume uses the word 'natural' in one place to mean what is common to any species, or what is inseparable from the species, and this includes for him the artifices of mankind. (T 484) Unlike Hobbes, he optimistically describes human nature as a combination of self-interest and benevolence, and "...tho' it be rare to meet with one, who loves any single person better than himself; yet 'tis as rare to meet with one, in whom all the kind affections, taken together, do not over-balance all the selfish." (T 487) The natural virtues originate from our kind affections and have no dependence on the contrivance 2 or artifice of man (T 574) nor on the contrivance of a deity. What makes meekness, beneficence, charity, generosity and equity virtuous is simply man's natural approval of them: "virtue is distinguished by the pleasure, and vice by the pain, that any action, sentiment or character gives us by the mere view and contemplation." (T 475) Hume's natural virtues are selected from natural motives which are of the spontaneous instinctive sort. Although Hume believes that selfishness is an overemphasized human trait, he does say that each man 162 (and probably woman) loves himself (herself) better than any other single person. (T 487) This selfishness, however, is not exclusively selfcentered, but manifests itself in a "confined generosity" that moves outward concentrically from the interested self to his or her family and friends. Beyond this circle of friends we are generally distrustful of others and will naturally revert to our individual self-interest when interacting with them. The one trait of which Hume makes great use throughout the Treatise to explain and describe human behavior is imagination. The word 'imagination' has many meanings, three of which are alluded to by Hume. Imagination may take a material or practical shape in the form of an invention, whereby someone imagines some object and then invents it. Examples of imagination qua inventiveness include actual physical inventions and may include the Humean artifices. Imagination... (shrink)

Ethical choice paralysis is a major barrier to the implementation of ethical design materials into the technology design process. Choice paralysis seems to result from tacit background assumptions propagated by humanistic modes of critical inquiry. I propose that one way of obviating choice paralysis at the professional level is to educate STEM students on how to select ethical design materials for a project. In order to advance that endeavor, I propose some obligations especially for humanistically trained STEM ethics educators. (...) Specifically, I propose that these include obligations to affirm that students can indeed select workable ethical design materials for their projects, to avoid using humanistic modes of critical ethical inquiry when instructing on how to make those selections, and to note that maximizing for ideally ethical results may not be a primary selection criterion. (shrink)

Detained immigrants awaiting deportation after criminal convictions have often complained that they are being subjected to double jeopardy since they've already served their sentences. But the truth is their treatment does not even rise to that level: double jeopardy implies being tried twice for the same crime. The immigrants have been tried only once __ and punished twice. The U.S. deports people to countries where they don't even speak the language, having left as young children. And back in Portugal, or (...) Nigeria, or Haiti, or El Salvador, they are often stigmatized as "criminal deportees" __ sometimes, as in Jamaica, publicly and within days of their arrival . A deportee's "alien file" is literally handed from the ICE agent on board the plane to, for example, the security agent at the Lagos airport. Penal and punishment have etymological roots in pain as well as fine, which is the ending of an obligation. For asylum_seekers and established residents, deportation is often not an end at all, but the start of a new and ongoing punishment. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind the (...) Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)