Gaining informed consent among marginalized groups that include decisionally incapacitated individuals and those outside of the researcher's own geo-social and ethnic background still challenges many researchers. We suggest that there is a need for consideration of a different approach to research ethics in international settings. Based on extensive field work in West Africa on medical knowledge transfers and patient–healer relationships, this paper will discuss the challenges posed in obtaining informed individual consent in international settings. It is argued that (...) while being on the whole convincing, the top-down approach of the proposed solutions, which clearly dominates the participative approach, fails in building sustainable capacity, decision-making competency, and empowerment in the communities in which the research is conducted. Using appropriate decision aids can help resolve these issues. (shrink)

In this paper, I examine global public reason as a method of justifying a global state. Ultimately, I conclude that global public reason fails to justify a global state. This is the case, because global public reason faces an unwinnable dilemma. The global public reason theorist must endorse either a hypothetical theory of consent or an actual theory of consent; if she endorses a theory of hypothetical consent, then she fails to (...) justify her principles; and if she endorses a theory of actual consent, her theory will lead to a highly unstable political system. On either side of the dilemma, global public reason faces untenable implications. Although similar criticisms have been advanced against domestic public reason, my argument is not repeating points made before me. My argument is new, in that it raises these objections specifically against global public reason, and in that it shows how, due to increased diversity of belief in the global arena, these problems are more pressing for global public reason than they are for domestic public reason. (shrink)

Informed consent is the legal instrument that purports to protect an individual's autonomy and defends against medical arbitrariness. Informed Consent and Health highlights that possession of complete information about all relevant aspects of a proposed treatment is integral to the ability of a patient to make an informed choice. With patient choice at both legislative and judicial levels rising to greater levels of prominence, this timely book examines how the tensions between the rights of patients to make choices (...) and the duties of doctors to provide health care are managed.This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community.Containing an in-depth discussion on this fundamental right, this thought-provoking book will be of value to academics and practitioners alike. Providing fascinating insight into new solutions and interpretations, this book will also prove a key resource for clinicians and health care workers. (shrink)

The modern ethical framework demands informed consent for research participation that includes disclosure of material information, as well as alternatives. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic (COVID-19) results in illness that often involves rapid deterioration. Despite the urgent need to find therapy, obtaining informed consent for COVID-19 research is needed. The current pandemic presents three types of challenges for investigators faced with obtaining informed consent for research participation: (1) uncertainty over key information to informed (...) consent, (2) time and pressure constraints, and (3) obligations regarding disclosure of new alternative therapies and re-consent. To mitigate consenting challenges, primary investigators need to work together to jointly promote urgent care and research into COVID-19. Actions they can take include (1) prior plan addressing ways to incorporate clinical research into clinical practice in emergency, (2) consider patients vulnerable with early deliberation on the consent process, (3) seek Legally Authorized Representatives (LARs), (4) create a collaborative research teams, (5) aim to consent once, despite evolving information during the pandemic, and (6) aim to match patients to a trial that will most benefit them. The COVID-19 pandemic both exacerbates existing challenges and raises unique obstacles for consent that require forethought and mindfulness to overcome. While research teams and clinician-investigators will need to be sensitive to their own contexts and adapt solutions accordingly, they can meet the challenge of obtaining genuinely informed consent during the current pandemic. (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)

Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of (...) surgeons at University teaching Hospitals in a low resource setting. (shrink)

Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection. A (...) class='Hi'>global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses. The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits. The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts. (shrink)

Background Rapid ethical access to personal health information to support research is extremely important during pandemics, yet little is known regarding patient preferences for consent during such crises. This follow-up study sought to ascertain whether there were differences in consent preferences between pre-pandemic times compared to during Wave 1 of the COVID-19 global pandemic, and to better understand the reasons behind these preferences. Methods A total of 183 patients in the pandemic cohort completed the survey via email, (...) and responses were compared to the distinct pre-pandemic cohort ; all were patients of a large Canadian cancer center. The survey covered broad versus study-specific consent; opt-in versus opt-out contact approach; levels of comfort sharing with different recipients; perceptions of commercialization; and options to track use of information and be notified of results. Four focus groups were subsequently conducted to elucidate reasons motivating dominant preferences. Results Patients in the pandemic cohort were significantly more comfortable with sharing all information and biological samples, sharing information with the health care institution, sharing information with researchers at other hospitals, sharing PHI provincially, nationally and internationally compared to the pre-pandemic cohort. Discomfort with sharing information with commercial companies remained unchanged between the two cohorts. Significantly more pandemic cohort patients expressed a wish to track use of PHI, and to be notified of results. Thematic analysis uncovered that transparency was strongly desired on outside PHI use, particularly when commercialization was involved. Conclusions In pandemic times, patients were more comfortable sharing information with all parties, except with commercial entities, where levels of discomfort remained unchanged. Focus groups identified that the ability to track and receive results of studies using one’s PHI is an important way to reduce discomfort and increase trust. These findings meaningfully inform wider discussions on the use of personal health information for research during global crises. (shrink)

This paper explores the role of ‘community’ in the context of global bioethics. With the present globalization of bioethics, new and interesting references are made to this concept. Some are familiar, for example, community consent. This article argues that the principle of informed consent is too individual-oriented and that in other cultures, consent can be community-based. Other references to ‘community’ are related to the novel principle of benefit sharing in the context of bioprospecting. The application of (...) this principle necessarily requires the identification and construction of communities. On the global level there are also new uses of the concept of community as ‘global community.’ Three uses are distinguished: (1) a diachronic use, including past, present, and future generations, (2) a synchronic ecological use, including nonhuman species, and (3) a synchronic planetary use, including all human beings worldwide. Although there is a tension between the communitarian perspective and the idea of global community, this article argues that the third use can broaden communitarianism. The current development towards cosmopolitanism is creating a new global community that represents humanity as a whole, enabling identification of world citizens and evoking a sense of global solidarity and responsibility. The emergence of global bioethics today demonstrates this development. (shrink)

_Querying Consent_ examines the ways in which the concept of consent is used to map and regulate sexual desire, gender relationships, global positions, technological interfaces, relationships of production and consumption, and literary and artistic interactions. From philosophy to literature, psychoanalysis to the art world, the contributors to _Querying Consent_ address the most uncomfortable questions about consent today. Grounded in theoretical explorations of the entanglement of consent and subjectivity across a range of textual, visual, multi- and digital (...) media, _Querying Consent_ considers the relationships between consent and agency before moving on to trace the concept’s outcomes through a range of investigations of the mutual implication of personhood and self-ownership. (shrink)

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term (...) nature of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa’s current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template. (shrink)

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources.

Informed consent is valid only if the person giving it is competent. Although allegedly informed consents are routinely tendered, there are nonetheless serious problems with the concept of competence as it stands. First, conceptual work upon competence is incomplete: the concept is unanalyzed and no logic of competence has been identified. It is thus virtually impossible to reliably discern who is competent. ;Traditional work on competence has explicated three dichotomies from which the necessary conditions for the possibility of competence (...) will be identified, viz., that competence is either a global or a specific notion; is present in varying degrees or in virtue of a threshold; and may or not include appeals to consequences. Past efforts have failed to notice a fourth dichotomy: competence as an affective or cognitive notion. Failure to designate the appropriate arms of these dichotomies is responsible for there being, at present, no reliable test for competence. The inadequacies of a highly regarded particular test for competence, the mental status examination, are examined in light of this failure. ;Competence is located within the rule-governed practice of informed consent. That practice and hence, competence, is justified through a Kantian analysis of respect for persons. This analysis reveals that the logic of competence requires assessment in terms of specific rather than global concerns; degrees of ability rather than a threshold; both cognitive and affective abilities; and no appeal to consequences. ;Based upon the analyses of consent as an example of decision making within the practice of informed consent and of respect for persons, the capacities which jointly comprise competence are identified. These are the capacities to receive, recognize, and retrieve information; to reason about, relate to oneself, and rank options; to choose among alternatives; and, under certain circumstances, to defend one's choice. ;Identification of the logic of competence and explication of and justification for the capacities that comprise competence to consent provide a conceptual foundation for the crucial concept of competence that the informed consent process currently lacks. It should facilitate construction of a test for competence. (shrink)

The risk posed to the community by possible xenozoonosis after xenotransplantation suggests that some form of 'community consent' is required before whole organ animal-to-human xenotransplantation should take place. I argue that this requirement places greater obstacles in the path of ethical xenotransplantation than has previously been recognised. The relevant community is global and there are no existing institutions with democratic credentials sufficient to establish this consent. The distribution of the risks and benefits from xenotransplantation also means that (...) consent is unlikely to be forthcoming. Proceeding on the basis of hypothetical consent to a package of global health measures that includes xenotransplantation, as Rothblatt has recently advocated, is more problematic than she acknowledges. Given that it may place the lives of citizens of poor nations at risk to benefit the citizens of wealthy nations, xenotransplantation raises significant questions of international justice. (shrink)

Indigenous Peoples, Consent and Benefit Sharing is the first in-depth account of the Hoodia bioprospecting case and use of San traditional knowledge, placing it in the global context of indigenous peoples’ rights, consent and benefit-sharing. It is unique as the first interdisciplinary analysis of consent and benefit sharing in which philosophers apply their minds to questions of justice in the Convention on Biological Diversity (CBD), lawyers interrogate the use of intellectual property rights to protect traditional knowledge, (...) environmental scientists analyse implications for national policies, anthropologists grapple with the commodification of knowledge and, uniquely, case experts from Asia, Australia and North America bring their collective expertise and experiences to bear on the San-Hoodia case. -/- While much of the focus is on bioprospecting and natural product development, Indigenous Peoples, Consent and Benefit-Sharing also draws important lessons about informed consent and benefit-sharing from the health sciences and sectors such as mining. Policymakers around the world are under significant pressure to resolve the challenges of implementing the CBD. This book’s analysis and recommendations will help them. -/- ‘It is good to see philosophers engaging with the UN Convention on Biological Diversity, and doing so by looking in depth at a real situation in which it has been invoked.’ Peter Singer, Ira W. DeCamp Professor of Bioethics in the University Center for Human Values, Princeton University . (shrink)

This book uses the example of informed consent guidelines for international research on human subjects to demonstrate how a philosophical analysis can assist in understanding how underlying concepts affect public policy; how and why such policies are exclusionary; and what methodology can be used to remedy injustices in public policy and practice. Epidemics, such as AIDS, have resulted in an increase in medical research in less developed countries. In an attempt to be more globally applicable, current international guidelines for (...) research on human subjects have attempted to acknowledge the importance of community. This book explains how these attempts fail to adequately acknowledge the importance community has for many people in less developed countries, and how these guidelines fail to attend to constraints to autonomy that oftentimes get magnified once community is involved in the informed consent process. The book further explains how these problems can be traced to a mistaken underlying notion of autonomy and what policymakers can do to remedy these problems . (shrink)

According to many traditional accounts, one important difference between international and domestic law is that international law depends on the consent of the relevant parties (states) in a way that domestic law does not. In recent years this traditional account has been attacked both by philosophers such as Allen Buchanan and by lawyers and legal scholars working on international law. It is now safe to say that the view that consent plays an important foundational role in international law (...) is a contested one, perhaps even a minority position, among lawyers and philosophers. In this paper I defend a limited but important role for actual consent in legitimating international law. While actual consent is not necessary for justifying the enforcement of jus cogens norms, at least when they are narrowly understood, this leaves much of international law unaccounted for. By drawing on a Lockean social contract account, I show how, given the ways that international cooperation is different from cooperation in the domestic sphere, actual consent is both a possible and an appropriate legitimating device for much of international law. (shrink)

Genomic research and biobanking present several ethical, social and cultural challenges, particularly when conducted in settings with limited scientific research capacity. One of these challenges is determining the model of consent that should support the sharing of human biological samples and data in the context of international collaborative research. In this paper, we report on the views of key research stakeholders in Ghana on what should count as good ethical practice when seeking consent for genomic research and biobanking (...) in Africa. This study was part of a multi-country qualitative case study conducted in three African countries: Ghana, Uganda and Zambia under the auspices of the Human Heredity and Health in Africa initiative. Our study suggests that while participants are willing to give consent for their samples and associated data to be used for future research purposes, they expect to receive feedback about the progress of the research and about the kinds of research being undertaken on their samples and data. These expectations need to be anticipated and discussed during the consent process which should be seen as part of an ongoing communication process throughout the research process. (shrink)

ABSTRACT Genomic research and biobanking present several ethical, social and cultural challenges, particularly when conducted in settings with limited scientific research capacity. One of these challenges is determining the model of consent that should support the sharing of human biological samples and data in the context of international collaborative research. In this paper, we report on the views of key research stakeholders in Ghana on what should count as good ethical practice when seeking consent for genomic research and (...) biobanking in Africa. This study was part of a multi-country qualitative case study conducted in three African countries: Ghana, Uganda and Zambia under the auspices of the Human Heredity and Health in Africa initiative (H3Africa). Our study suggests that while participants are willing to give consent for their samples and associated data to be used for future research purposes, they expect to receive feedback about the progress of the research and about the kinds of research being undertaken on their samples and data. These expectations need to be anticipated and discussed during the consent process which should be seen as part of an ongoing communication process throughout the research process. (shrink)

The government itself, which is the only mode which the people have chosen to execute their will, is equally liable [with the standing army] to be abused and perverted before the people can act through it. Witness the present Mexican war, the work of comparatively a few individuals using the standing government as their tool; for, in the outset, the people would not have consented to this measure. Henry Thoreau, in “Civil Disobedience” It is easy to say — and often (...) is said — that we cannot have tolerable relations with new revolutionary regimes. The problem is that our anticommunist paranoia has made it impossible to find out. We do not know whether Mao's declared interest in a relationship with the Americans in the 1940s or Ho Chi Minh's were sincere. And the reason we don't know is that we never tried to find out. Those who reported it was a possibility were hounded out of the foreign service because of our suspicion and fear of communism. The legacy of that era brings to mind Ivan the Terrible's practice of murdering the bearer of bad news. We are more civilized than that; we have been content simply to ruin people's careers. J. William Fulbright, in The Price of Empire This poisonous thing I'm trying to describe is [a] characteristic way of dealing with criticism. It used to be enough to brand a critic as a radical or a leftist to make people turn away. Now we need only to call him a liberal. Soon “moderate” will be the M word, “conservative” will be the C word and only fascists will be in the mainstream. E. L. Doctorow, Brandeis Commencement, May 21, 1989 We have lived with violence for seven years It was not worth one single life But the patriot's fist is at her throat Her voice is in mortal danger... Adrienne Rich, “Natural Resources,” in Dream of a Common Language. (shrink)

The carbon emissions of global health care activities make up 4–5% of total world emissions, placing it on par with the food sector. Carbon emissions are particularly relevant for health care because of climate change health hazards. Doctors and health care professionals must connect their health care delivery with carbon emissions and minimize resource use when possible as a part of their obligation to do no harm. Given that reducing carbon is a global ethical priority, the informed (...) class='Hi'>consent process in health care delivery must change. I argue that the expanded role of bioethicists in this climate crisis is to promote and support “green informed consent:” the sharing of climate information with patients, offering options for lower-carbon health care, and accepting the patient’s right to decline treatments which are deemed too carbon intensive for their values. (shrink)

The clinical introduction of medical devices often occurs with relatively little oversight, regulation and (long-term) follow-up. Some recent controversies underscore the weaknesses of the current regime, such as the complications surrounding the metal-on-metal hip implants and the scandal surrounding the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. The absence of national registries hampered the collection of reliable information on the risks and harms of the PIP breast implants. To warrant long-term safety, (...) a case can be made for mandatory post-marketing surveillance by means of the establishment of compulsory registries. In this edition of Public Health Ethics, Schofield calls for debate on how such a registry system should be initiated and maintained and how it would relate to the ethical requirement of consent. Here we use breast implant registries as a case to discuss whether and when a so-called ‘thick opt-out’ would be an appropriate method to include people in medical device registries. We conclude that a thick opt-out procedure for medical device registries is only justifiable in cases where inclusion does not involve burdens (or very low), when it does not involve a sensitive subject and when the data are stored anonymously (or at least not directly linked to the medical record). Otherwise, inclusion should be sought by means of an opt-in. (shrink)

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed (...) consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent. Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism. (shrink)

The traditional view that legitimate international law is founded on the consent of the states subject to it has come under increasing attack by liberals, such as Allen Buchanan, who argue for a cosmopolitan order in which the protection of human rights norms is legally foundational. The cosmopolitan argument presupposes that human rights would be better preserved by doing away with the requirement of state consent. However, state consent is seen to be necessary for protecting the rights (...) of individuals in weaker states and preserving global stability. The requirement of state consent preserves individual rights better than attempts to assert non-consensual liberal norms as international law, such that the internationalist system is more legitimate than the cosmopolitan on the latter’s own terms. (shrink)

The traditional view that legitimate international law is founded on the consent of the states subject to it has come under increasing attack by liberals, such as Allen Buchanan, who argue for a cosmopolitan order in which the protection of human rights norms is legally foundational. The cosmopolitan argument presupposes that human rights would be better preserved by doing away with the requirement of state consent. However, state consent is seen to be necessary for protecting the rights (...) of individuals in weaker states and preserving global stability. The requirement of state consent preserves individual rights better than attempts to assert non-consensual liberal norms as international law, such that the internationalist system is more legitimate than the cosmopolitan on the latter’s own terms. (shrink)

The traditional view that legitimate international law is founded on the consent of the states subject to it has come under increasing attack by liberals, such as Allen Buchanan, who argue for a cosmopolitan order in which the protection of human rights norms is legally foundational. The cosmopolitan argument presupposes that human rights would be better preserved by doing away with the requirement of state consent. However, state consent is seen to be necessary for protecting the rights (...) of individuals in weaker states and preserving global stability. The requirement of state consent preserves individual rights better than attempts to assert non-consensual liberal norms as international law, such that the internationalist system is more legitimate than the cosmopolitan on the latter’s own terms. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research (...) in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

The current scandal surrounds the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. An ensuing review recognized that efforts in investigating the distress caused to so many women were hampered by a lack of reliable and comprehensive information about all the adverse incidents relating to PIP breast implants, as well as uncertainty about comparative data on similar products. One of the recommendations following the review was the investigation of the potential for re-establishing (...) a breast implant registry, which could facilitate the availability of adverse incident reporting in cases such as these. The insistence of compulsory inclusion in such registries would override the debate on informed consent in epidemiological studies and public health. The ethics of clinical research with its focus on individual consent is difficult to reconcile with the ethical requirements of research at a population level as in the case of registries. (shrink)

Winner, 2002 French Translation Prize for Nonfiction Murderous Consent details our implication in violence we do not directly inflict but in which we are structurally complicit: famines, civil wars, political repression in far-away places, and war, as it’s classically understood. Marc Crépon insists on a bond between ethics and politics and attributes violence to our treatment of the two as separate spheres. We repeatedly resist the call to responsibility, as expressed by the appeal—by peoples across the world—for the care (...) and attention that their vulnerability enjoins. But Crépon argues that this resistance is not ineluctable, and the book searches for ways that enable us to mitigate it, through rebellion, kindness, irony, critique, and shame. In the process, he engages with a range of writers, from Camus, Sartre, and Freud, to Stefan Zweig and Karl Kraus, to Kenzaburo Oe, Emmanuel Levinas and Judith Butler. The resulting exchange between philosophy and literature enables Crépon to delineate the contours of a possible/impossible ethicosmopolitics—an ethicosmopolitics to come. Pushing against the limits of liberal rationalism, Crépon calls for a more radical understanding of interpersonal responsibility. Not just a work of philosophy but an engagement with life as it’s lived, Murderous Consent works to redefine our global obligations, articulating anew what humanitarianism demands and what an ethically grounded political resistance might mean. (shrink)

ABSTRACT The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were (...) conducted with RHDGen participants (n = 18), study staff (n = 5) and with individuals who refused to participate (n = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use. (shrink)

The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were conducted with RHDGen participants, (...) study staff and with individuals who refused to participate. In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use. (shrink)

The government itself, which is the only mode which the people have chosen to execute their will, is equally liable [with the standing army] to be abused and perverted before the people can act through it. Witness the present Mexican war, the work of comparatively a few individuals using the standing government as their tool; for, in the outset, the people would not have consented to this measure. Henry Thoreau, in “Civil Disobedience”It is easy to say — and often is (...) said — that we cannot have tolerable relations with new revolutionary regimes. The problem is that our anticommunist paranoia has made it impossible to find out. We do not know whether Mao's declared interest in a relationship with the Americans in the 1940s or Ho Chi Minh's were sincere. And the reason we don't know is that we never tried to find out. Those who reported it was a possibility were hounded out of the foreign service because of our suspicion and fear of communism. The legacy of that era brings to mind Ivan the Terrible's practice of murdering the bearer of bad news. We are more civilized than that; we have been content simply to ruin people's careers. J. William Fulbright, in The Price of Empire (1989) This poisonous thing I'm trying to describe is [a] characteristic way of dealing with criticism. It used to be enough to brand a critic as a radical or a leftist to make people turn away. Now we need only to call him a liberal. Soon “moderate” will be the M word, “conservative” will be the C word and only fascists will be in the mainstream. E. L. Doctorow, Brandeis Commencement, May 21, 1989We have lived with violence for seven yearsIt was not worth one single lifeBut the patriot's fist is at her throatHer voice is in mortal danger...Adrienne Rich, “Natural Resources,” in Dream of a Common Language (Norton, 1978). (shrink)

A common criticism of global institutions is that their rules disproportionately favor the political and economic interests of powerful states over those of weaker states. This dissertation consists of three essays that each deal with a specific application of the criticism. In the first essay, I examine the question of whether international human rights law should include a human right to democracy. Joshua Cohen and Charles Beitz offer two kinds of argument for thinking that it should not. First, protecting (...) a human right to democracy would permit outsiders to intervene in domestic political arrangements in objectionable ways. Second, democracy presupposes a conception of persons as equals that cannot be shared internationally. I argue that both these arguments would prove too much: they would rule out from the human rights corpus rights that clearly seem to be human rights. Building on this conclusion, I offer a positive argument for recognizing a human right to democracy. In the second essay, I explore the objection that global economic institutions sustain unacceptable degrees of inequality. On one skeptical response, the rules of global economic institutions are justifiable insofar as states have consented to them. I argue that specific features of global economic institutions make this view implausible. I then articulate several reasons for thinking that inequalities sanctioned by global economic institutions are objectionable. It turns out that the prominent philosophical debate on whether Rawlsian egalitarianism should be globalized addresses one but not the other of these reasons. In the third essay, I examine the practice of universal jurisdiction, which allows states to exercise jurisdiction over a narrow range of international law violations regardless of where, by whom, or against whom the violations occur. On the standard justification for this exceptional category of jurisdiction, what makes the exception justifiable is the moral heinousness of the relevant violations. This justification, I argue, can explain neither the narrow subject matter nor the expansive scope of universal jurisdiction. I offer an alternative justification on which universal jurisdiction is justifiable as a way of filling enforcement gaps to which some but not other international legal norms are prone. (shrink)

For centuries, international trade has been seen as essential to the wealth and power of nations. More recently we have started to understand its problematic role as an engine of distributive justice. In this compelling book Frank J. Garcia proposes a new way to evaluate, construct and manage international trade - one that is based on norms of economic justice, comparative advantage and national interest. Garcia examines three ways to conceptualize the problem of trade and global justice, drawn from (...) Rawlsian liberalism, communitarianism and consent theory. These approaches illustrate specific issues of importance to the way global justice has been theorized, offering a pluralistic mode of arguing for global justice and highlighting the unique modes of discourse we employ when engaging with global justice and their implications for conceptualizing and arguing the problem. Garcia suggests a new direction for trade agreements built around truly consensual trade negotiations and the kind of international economic system they would structure. (shrink)

This article explores the concept of internationally acceptable codes of ethics within the context of an Egyptian nurse’s PhD studies. Theoretical work, including gaining ethical approval for the project, took place in the UK, while the data collection phase of the study was done in Egypt. This highlighted areas where the Arab Muslim interpretation of some ethical principles, especially around the issue of gaining informed consent, differed from that currently accepted in British research ethics. The authors argue that it (...) may not be possible, or even desirable, to standardize codes of ethics globally in areas such as academic research. Ethical principles develop from a unique mix of culture and religion. It may be more important to develop cultural competence that includes the ability to understand and respect the way in which ethical principles are interpreted by various societies. (shrink)

Community engagement is increasingly recognized as a critical element of medical research, recommended by ethicists, required by research funders and advocated in ethics guidelines. The benefits of community engagement are often stressed in instrumental terms, particularly with regard to promoting recruitment and retention in studies. Less emphasis has been placed on the value of community engagement with regard to ethical good practice, with goals often implied rather than clearly articulated. This article outlines explicitly how community engagement can contribute to ethical (...) global health research by complementing existing established requirements such as informed consent and independent ethics review. The overarching and interlinked areas are respecting individuals, communities and stakeholders; building trust and social relationships; determining appropriate benefits; minimizing risks, burdens and exploitation; supporting the consent process; understanding vulnerabilities and researcher obligations; gaining permissions, approvals and building legitimacy and achieving recruitment and retention targets. (shrink)

Kevin Gray,Kafumu Kalyalya | : In this paper we challenge the role of consent in the global order by discussing current modes of international law making in the global order. We contend that the features of state consent in international law depart substantially from those assumed by theorists of the liberal order, who subscribe, in most cases, to the realist conception of state action. We argue, against those theorists, that state consents to coercive measures, and the (...) state’s role in carrying them out, has ceased to be central to an account of global law. We conclude that international law—often thought of as law beyond the state—now has expanded its scope to reach individuals and corporations, and that this change has important ramifications for theories of global justice. | : Dans cet article, nous interrogeons le rôle de l’accord dans l’ordre global en discutant les modes courants de constitution des lois internationales au sein de cet ordre. Nous prétendons que les fonctions de l’accord étatique en loi internationale s’écartent substantiellement de celles assumées par les théoriciens de l’ordre libéral, qui souscrivent, dans la plupart des cas, à la conception réaliste de l’action étatique. Contre ces théoriciens, nos posons que l’État consent à des mesures coercitives, et que le rôle de l’État d’effectuer celles-ci a cessé d’être central dans l’explication de la loi globale. Nous concluons que la loi internationale – souvent pensée comme une loi hors de l’État – a maintenant étendu son spectre jusqu’aux individus et corporations, et que ce changement a d’importantes ramifications que les théories globales de la justice devraient considérer. (shrink)

This paper discusses how to apply a collective decision model of the principle of voluntary informed consent in African communitarian culture, in a culturally sensitive way, in order to protect research candidates from potential exploitations and abuses. Dismissing cultural and ethical skepticism surrounding the global application of the principle of voluntary informed consent, the paper ultimately concludes that international collaboration on diagnostic and therapeutic medical research in Africa, especially HIV vaccine trials, is a moral imperative.

This article argues from a South African perspective that national experience in attempting to fulfil the right to health supports the need for an international framework. Secondly, we suggest that this framework is not just a matter of good choice or even of justice but of a direct legal duty that falls on those states that have consented to operate within the international human rights framework by ratifying key treaties such as the International Covenant on Economic Social and Cultural Rights (...) (ICESCR), the Convention on the Elimination of all forms of Discrimination Against Women (CEDAW), and the Convention on the Rights of the Child (CRC). States can either accept this duty or face with growing pressure from those who believe in global social justice to find lasting solutions to the terrible inequities in global health standards. (shrink)

New applications in medicine, science and technology are changing our lives. The delicate border between clinical trials and conventional diagnostic / treatment methods is becoming more evident. At this border new questions arise that need both rational and humanistic answers and that affect humankind‘s understanding of self: What are our responsibilities towards human subjects in clinical trials? What are our responsibilities towards patients and decisionally impaired psychiatry patients? What are rules about the routine techniques on decisionally incompetent psychiatry patients? What (...) are the economic parameters‘ affecting decisions?Many current research projects are concerned with the ethical problems of clinical trials of newly used medication, clinical trials of newly used measurement techniques, clinical trials proposed as conventional treatment methods, new measuring methods or conventional measuring methods on irrelevant patient groups; all being concerned with clinical trials of EEG and neuroscience. In 2009, the Ministry of Health of Turkey implemented new legislation on ―clinical trials and newly established independent ethics committees ‖. These independent and multidisiplinary IRBs analyze research projects and make recommendations about them. What should be the rationale about psychiatric patients in Turkey in a global setting? (shrink)

Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities of research-subjects ethical codes (...) become apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically. (shrink)

Scabies is a global problem and is of such concern that in 2013 it was added to the World Health Organization list of neglected tropical diseases.1 Due to its highly contagious nature, it is easily spread where humans are in close living environments, and is therefore of particular concern in nursing homes where it may affect both residents and staff. Hence, prompt diagnosis and appropriate treatment of cases are important to control the spread; however, this is hindered by current (...) difficulties in rapid diagnosis. Conducting research with vulnerable populations involves careful attention to the interest of the individual. It is indisputable that all potential research subjects must have provided consent to participate in research, and it is less clear how to proceed when potential research subjects lack the capacity to provide consent. (shrink)

BackgroundThe issue of stigma is very important in the battle against HIV/aids in Africa since it may affect patient attendance at healthcare centres for obtaining antiretroviral medications and regular medical check-ups. Stigmatization creates an unnecessary culture of secrecy and silence based on ignorance and fear of victimization. This study was designed to determine if there is external stigmatization of people living with HIV and AIDS by health care workers at a tertiary hospital in KwaZulu-Natal province, South Africa. The study investigated (...) the impact of knowledge of HIV/aids by HCWs on treatment of patients, as well as the comfort level and attitude of HCWs when rendering care to PLWHA.MethodsA descriptive cross sectional study was designed to collect data using an anonymous self-administered structured questionnaire from 334 HCWs. The study was conducted in clinical departments of a large multidisciplinary 922-bed tertiary care teaching hospital in Durban, KZN.ResultsOverall HCWs had an above average knowledge about HIV/aids although some gaps in knowledge were identified. Tests of statistical significance showed that there was association between level of education and knowledge of HIV/aids ; occupation and knowledge of HIV/aids ; and gender and knowledge of HIV/aids. Test for comfort level was only significant for gender, with males showing more comfort and empathy when dealing with PLWHA. The study also revealed that patients were sometimes tested for HIV without informed consent before surgery, due to fear of being infected, and there was some gossiping about patients' HIV status by HCWs, thereby compromising patient confidentiality. The majority of HCWs showed a willingness to report incidents of stigmatization and discrimination to higher authorities, for better monitoring and control.ConclusionsAlthough knowledge, attitude and comfort level of HCWs taking care of PLWHA was above average, enforcement of existing antidiscrimination laws and continuing education in medical ethics and healthcare law, would greatly improve the performance of HCWs taking care of PLWHAs. More psychological support and counselling should be provided to HCWs, to further reduce the impact of stigmatization and discrimination against PLWHA. (shrink)

BackgroundDelirium is highly prevalent in the general hospital patient population, characterized by acute onset, fluctuating levels of consciousness, and global impairment of cognitive functioning. Mental capacity, its assessment and subsequent consent are therefore prominent within this cohort, yet under-explored.AimThis study of patients with delirium sought to determine the processes by which consent to medical treatment was attempted, how capacity was assessed, and any subsequent actions thereafter.MethodA retrospective documentation review of patients identified as having a delirium for the (...) twelve months February 2013 to January 2014 was undertaken. Inclusion and exclusion criteria were used; demographic and descriptive data collected. A total of n=1153 patients were identified with n=310 meeting inclusion criteria.ResultA random sample of one hundred patients were subsequently reviewed. One third of patients had documentation relating to consent, while four patients had documentation relating to capacity. Median delirium duration was three days, with treatment refusal occurring in twenty-two patients and “duty of care” being used as an apparent beneficent related treatment framework in twelve patients.ConclusionsWhile impaired decision-making was indicated, the review was unable to indicate what patient characteristics flag the need for capacity assessment. Documentation relating to consent processes appeared deficient for this cohort. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women on the Global Market: Irigaray and the Democratic StateNicole Fermon (bio)Best known for her subtle interrogation of philosophy and psychoanalysis, Luce Irigaray clearly also conducts a dialogue with the political, proposing that women’s erasure from culture and society invalidates all economies, sexual or political. Because woman has disappeared both figuratively and literally from society [see Sen, “More Than 100 Million Women Are Missing”], Irigaray conceives the contemporary (...) ethical project as a recall to difference rather than equality, to difference between women and men—that is, sexual difference. She characterizes relations between men and women as market relations in which women are commodities, objects, but never subjects of exchange, objects to men but not to themselves: women do not belong to themselves but exist “to keep relationships among men running smoothly” [TS 192]. Women under these conditions require imaginative ways to reconfigure the self, to subvert the melancholy and regression of masculinist economies and envisage a future in which women would not be ashamed of the feminine, would experience it as a positivity worth emulating.Irigaray contends that after the gains of egalitarian politics are carefully examined, the inclusion of women in the political arena has failed to take into account women’s distinct and different position from men, and from each other, as well as perpetuating the fiction of the “neutral” citizen, the ahistorical individual citizen of the nation-state. It is that fiction Irigaray dispels in her critique of liberal democratic politics and its creation, “citizens who are neuter in regard to familial singularity, its laws, and necessary sexual difference” [SG 112] in order to benefit the State and its laws. The subject is male; the citizen is neuter. Who is the female citizen in contemporary society? What is the ethical elaboration of the contractual relations between women and men, and between sexed individuals and the community? How do women imagine a distinct set of rights and responsibilities based on self-definition and autonomy, given the particular strictures of contemporary politics—that is, the market-driven, antidemocratic nature of the current economic national and global forces? Irigaray suggests that “the return of women to collective work, to public places, to social relations, demands linguistic mutations” and profound transformations, an embodied imagination with force and agency in civil life [TD 65].Irigaray warns that if civil and political participation is construed in overly narrow terms, if focus is on economic or judicial “circuits” alone, we overlook the symbolic organization of power—women risk losing “everything without even being acknowledged” [TD 56]. Instead an interval of recognition can expand the political to include the concerns and activities of real women, lest silence imply consent to sexual neutrality, or more likely, to women’s obliteration under men’s interests and concerns. Women’s insistence on self-definition and wage labor, on love and justly remunerated work, [End Page 120] testifies to the obduracy of women’s difference, one that is not likely to disappear. The patriarchal family is still the legal norm, even when certain exceptions are made, while enduring questions regarding women’s health and children’s physical welfare as priorities beyond market considerations are consigned to legislative obfuscation, still a political afterthought. Instead, in the US the liberal state removes the slender welfare net specific to women and children, Aid to Families with Dependent Children, and fails to provide medical coverage to those who are among the most vulnerable of its citizens. Women without access to the legal protection of sex-neutral citizenship, poor working women without language (the money for an effective “mouthpiece” to represent their distress in a court of law), are further disempowered by liberal politics’ insistence on sexual neutrality—that is, on repression or amnesia regarding the lived experiences of women.Sexual difference is key to any project of self-definition by women. Irigaray insists on the sexual nature of this self-definition, not solely for its obvious procreative necessity, but because the natural world is a source of renewal and fecundity which requires attentive interrogation and respect [SG 15]. This rebirth seems alien to the structure of male politics, which instead seem to provoke disasters (Bhopal, Chernobyl, or the current runaway... (shrink)

In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important (...) to deploy the most effective HIV prevention tools to young MSM in the USA, to adolescent girls and young women in sub-Saharan Africa, and to any other adolescents and young adults at high risk for HIV as products are proven to be safe and efficacious. Although prevention interventions with proven efficacy, such as oral pre-exposure prophylaxis, are available,3–8 they have not been sufficient to stem the tide and an expanded prevention toolkit is urgently needed to serve these populations. The field of HIV prevention continues to identify promising leads in the development of new biomedical prevention products, either delivering antiviral drug topically or systemically. The dapivirine ring has been shown to provide modest protection and is currently being tested in open label studies while injectable cabotegravir is being tested in a large efficacy trial for preventing HIV acquisition. Advances in the field of HIV prevention mean that scientists and regulators must plan for how they will bring prevention tools to populations at high risk for HIV as they conduct efficacy and effectiveness trials. For instance, safety data from younger age groups can also be used in combination with efficacy data from adult studies, where appropriate, as bridging studies to expand labelling to younger ages. If these …. (shrink)

ABSTRACT The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were (...) conducted with RHDGen participants (n = 18), study staff (n = 5) and with individuals who refused to participate (n = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use. (shrink)

Issues of global justice have received increasing attention in academic philosophy in recent years but the gendered dimensions of these issues are often overlooked or treated as peripheral. This groundbreaking collection by Alison Jaggar brings gender to the centre of philosophical debates about global justice. -/- The explorations presented here range far beyond the limited range of issues often thought to constitute feminists’ concerns about global justice, such as female seclusion, genital cutting, and sex trafficking. Instead, established (...) and emerging scholars expose the gendered and racialized aspects of transnational divisions of paid and unpaid labor, class formation, taxation, migration, mental health, the so-called resource curse, and conceptualizations of violence, honor, and consent. Jaggar's introduction explains how these and other feminist investigations of the transnational order raise deep challenges to assumptions about justice that for centuries have underpinned Western political philosophy. -/- Taken together the pieces in this volume present a sustained philosophical engagement with gender and global justice. Gender and Global Justice provides an accessible and original perspective on this important field and looks set to reframe philosophical reflection on global justice. (shrink)