Aims: The aims of the study were to explore expert opinion on the distinction between “research” and “audit”, and to determine the need for review by a National Health Service (NHS) Research Ethics Committee (REC). Background: Under current guidelines only “research” projects within the NHS require REC approval. Concerns have been expressed over difficulties in distinguishing between research and other types of project, and no existing guidelines appear to have been validated. The implications of this confusion include unnecessary REC applications, (...) and crucially, the potential for ethically unsound projects to escape review. Methods: A three-stage Delphi method was chosen to explore expert opinion and develop consensus. Stage 1 comprised ten semi-structured interviews gathering opinion on distinguishing between types of project and how to determine need for ethical review. Stages 2 and 3 were questionnaires, asking 24 “experts” to rate levels of ethical concern and types of project for a series of questions. Anonymised responses from stage 2 were fed back in stage 3. The final responses were analysed for consensus. Results: Of 46 questions, consensus was achieved for 14 (30.4%) for level of ethical concern and for 15 (32.6%) for type of project. Conclusions: Several ideas proved discriminatory for classifying the type of project and assessing level of ethical concern, and they can be used to develop an algorithm to determine need for ethical review. There was little relationship between assessment of the level of ethical concern and classification of the project. There was inconsistency in defining and classifying studies as something other than “research” or “audit”. (shrink)

BackgroundThe role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues.MethodsWe conducted seven (...) day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly.ResultsBroad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research.ConclusionBecause no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research. (shrink)

Introduction: Variation across research ethics boards in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study (...) with open-ended responses. Interviews were recorded, transcribed and coded manually.Results: Fourteen sites required individual patient consent for the study to proceed as proposed. Three indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites did not require consent. Two suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites required full committee review. Sixteen allowed an external research assistant to abstract information from the health record.Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions. (shrink)

BackgroundStigma refers to a distinguishing personal trait that is perceived as or actually is physically, socially, or psychologically disadvantageous. Little is known about the opinion of those who have more or less stigmatizing health conditions regarding the need for consent for use of their personal information for health research.MethodsWe surveyed the opinions of people 18 years and older with seven health conditions. Participants were drawn from: physicians' offices and clinics in southern Ontario; and from a cross-Canada marketing panel of individuals (...) with the target health conditions. For each of five research scenarios presented, respondents chose one of five consent choices: (1) no need for me to know; (2) notice with opt-out; (3) broad opt-in; (4) project-specific permission; and (5) this information should not be used. Consent choices were regressed onto: demographics; health condition; and attitude measures of privacy, disclosure concern, and the benefits of health research. We conducted focus groups to discuss possible reasons for observed consent choices.ResultsWe observed substantial variation in the control that people wish to have over use of their personal information for research. However, consent choice profiles were similar across health conditions, possibly due to sampling bias. Research involving profit or requiring linkage of health information with income, education, or occupation were associated with more restrictive consent choices. People were more willing to link their health information with biological samples than with information about their income, occupation, or education.ConclusionsThe heterogeneity in consent choices suggests individuals should be offered some choice in use of their information for different types of health research, even if limited to selectively opting-out. Some of the implementation challenges could be designed into the interoperable electronic health record. However, many questions remain, including how best to capture the opinions of those who are more privacy sensitive. (shrink)

The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying (...) legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. (shrink)

BackgroundThe boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as “non-research” are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and (...) determination of risk level across a broad range of projects and health-related contexts. This paper describes the development of the Public Health Ontario Risk Screening Tool.MethodDevelopment of the PHO Risk Screening Tool included: preparation of a draft risk tool ; expert appraisal; internal stakeholder validation; external validation; pilot testing and evalution of the draft tool; and revision after 1 year of testing.ResultsA risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool.ConclusionsThe PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions. (shrink)

BackgroundArtificial intelligence has been described as the “fourth industrial revolution” with transformative and global implications, including in healthcare, public health, and global health. AI approaches hold promise for improving health systems worldwide, as well as individual and population health outcomes. While AI may have potential for advancing health equity within and between countries, we must consider the ethical implications of its deployment in order to mitigate its potential harms, particularly for the most vulnerable. This scoping review addresses the following question: (...) What ethical issues have been identified in relation to AI in the field of health, including from a global health perspective?MethodsEight electronic databases were searched for peer reviewed and grey literature published before April 2018 using the concepts of health, ethics, and AI, and their related terms. Records were independently screened by two reviewers and were included if they reported on AI in relation to health and ethics and were written in the English language. Data was charted on a piloted data charting form, and a descriptive and thematic analysis was performed.ResultsUpon reviewing 12,722 articles, 103 met the predetermined inclusion criteria. The literature was primarily focused on the ethics of AI in health care, particularly on carer robots, diagnostics, and precision medicine, but was largely silent on ethics of AI in public and population health. The literature highlighted a number of common ethical concerns related to privacy, trust, accountability and responsibility, and bias. Largely missing from the literature was the ethics of AI in global health, particularly in the context of low- and middle-income countries.ConclusionsThe ethical issues surrounding AI in the field of health are both vast and complex. While AI holds the potential to improve health and health systems, our analysis suggests that its introduction should be approached with cautious optimism. The dearth of literature on the ethics of AI within LMICs, as well as in public health, also points to a critical need for further research into the ethical implications of AI within both global and public health, to ensure that its development and implementation is ethical for everyone, everywhere. (shrink)

Health research increasingly relies on organized collections of health data and biological samples. There are many types of sample and data collections that are used for health research, though these are collected for many purposes, not all of which are health-related. These collections exist under different jurisdictional and regulatory arrangements and include: 1) Population biobanks, cohort studies, and genome databases 2) Clinical and public health data 3) Direct-to-consumer genetic testing 4) Social media 5) Fitness trackers, health apps, and biometric data (...) sensors Population biobanks, cohort studies, and genome databases Clinical and public health data Direct-to-consumer genetic testing Social media Fitness trackers, health apps, and biometric data sensors Ethical, legal, and social challenges of such collections are well recognized, but there has been limited attention to the broader societal implications of the existence of these collections. Although health research conducted using these collections is broadly recognized as beneficent, secondary uses of these data and samples may be controversial. We examine both documented and hypothetical scenarios of secondary uses of health data and samples. In particular, we focus on the use of health data for purposes of: Forensic investigations Civil lawsuits Identification of victims of mass casualty events Denial of entry for border security and immigration Making health resource rationing decisions Facilitating human rights abuses in autocratic regimes Forensic investigations Civil lawsuits Identification of victims of mass casualty events Denial of entry for border security and immigration Making health resource rationing decisions Facilitating human rights abuses in autocratic regimes Current safeguards relating to the use of health data and samples include research ethics oversight and privacy laws. These safeguards have a strong focus on informed consent and anonymization, which are aimed at the protection of the individual research subject. They are not intended to address broader societal implications of health data and sample collections. As such, existing arrangements are insufficient to protect against subversion of health databases for non-sanctioned secondary uses, or to provide guidance for reasonable but controversial secondary uses. We are concerned that existing debate in the scholarly literature and beyond has not sufficiently recognized the secondary data uses we outline in this paper. Our main purpose, therefore, is to raise awareness of the potential for unforeseen and unintended consequences, in particular negative consequences, of the increased availability and development of health data collections for research, by providing a comprehensive review of documented and hypothetical non-health research uses of such data. (shrink)

BackgroundThe amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and (...) biobanks.MethodsChairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.ResultsThere was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.ConclusionParticipants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation. (shrink)

Background Policy decisions about childhood vaccination require consideration of multiple, sometimes conflicting, public health and ethical imperatives. Examples of these decisions are whether vaccination should be mandatory and, if so, whether to allow for non-medical exemptions. In this article we argue that these policy decisions go beyond typical public health mandates and therefore require democratic input.Methods We report on the design, implementation, and results of a deliberative public forum convened over four days in Ontario, Canada, on the topic of childhood (...) vaccination.Results 25 participants completed all four days of deliberation and collectively developed 20 policy recommendations on issues relating to mandatory vaccinations and exemptions, communication about vaccines and vaccination, and AEFI (adverse events following immunization) compensation and reporting. Notable recommendations include unanimous support for mandatory childhood vaccination in Ontario, the need for broad educational communication about vaccination, and the development of a no-fault compensation scheme for AEFIs. There was persistent disagreement among deliberants about the form of exemptions from vaccination (conscience, religious beliefs) that should be permissible, as well as appropriate consequences if parents do not vaccinate their children.Conclusions We conclude that conducting deliberative democratic processes on topics that are polarizing and controversial is viable and should be further developed and implemented to support democratically legitimate and trustworthy policy about childhood vaccination. (shrink)

Epistemic injustice is a harm done to a person in their capacity as an epistemic subject by undermining her capacity to engage in epistemic practices such as giving knowledge to others or making sense of one’s experiences. It has been argued that those who suffer from medical conditions are more vulnerable to epistemic injustice than the healthy. This paper claims that people with mental disorders are even more vulnerable to epistemic injustice than those with somatic illnesses. Two kinds of contributory (...) factors for epistemic injustice in psychiatric patients are outlined: global and specific. Some suggestions are made to counteract the effects of these contributory factors, for instance we suggest that physicians should participate in groups where the subjective experience of patients is explored, and learn to become more aware of their own unconscious prejudices towards psychiatric patients. (shrink)

: The Kehre in Heidegger’s thought has been greatly discussed and debated. The introduction of the notion of metontology in 1927 has fruitfully informed this debate since it entails a concern for the ontic domain on the part of Heidegger that is not present in earlier works. The fact that this notion disappears right after being introduced, however, challenges its contribution to this debate. In this paper, I show that the disappearance of metontology does not imply the disappearance of Heidegger’s (...) concern for the ontic, but the opposite. I will begin by presenting Freeman’s view of a tension between the ontic and the ontological in Heidegger’s thought in the mid-to-late 20s that results in the introduction of metontology in 1927. Later on, I will show that McNeill’s explanation of the disappearance of metontology as a consequence of Heidegger’s mid-30s view that the a priori projection of being is a withdrawal of being, allows saying that this disappearance does not entail Heidegger’s sudden lack of concern for the ontic. By considering Heidegger’s analysis of ‘the mathematical’ in Die Frage nach dem Ding, I will finally argue that metontology disappears from Heidegger’s thought because its dependency upon ontology prevents it to account for his increasing concern for the ontic properly. Resumo: A Kehre no pensamento de Heidegger foi amplamente discutida e debatida. A introdução da noção de metontologia, em 1927, informou proveitosamente esse debate, uma vez que implica uma preocupação com o domínio ôntico, por parte de Heidegger, que não está presente em trabalhos anteriores. O fato de essa noção desaparecer logo após ser introduzida, porém, desafia sua contribuição para esse debate. Neste artigo, mostra-se que o desaparecimento da metontologia não significa o desaparecimento da preocupação de Heidegger com o ôntico, mas o contrário. Começa-se apresentando a visão de Freeman de uma tensão entre o ôntico e o ontológico, no pensamento de Heidegger, em meados da década de 1920, que resulta na introdução da metontologia, em 1927. Mais tarde, evidencia-se que a explicação de McNeill para o desaparecimento da metontologia, como consequência da visão de Heidegger, de meados dos anos 30, de que a projeção a priori do ser é uma retirada do ser, permite dizer que esse desaparecimento não acarreta uma repentina falta de preocupação de Heidegger com o ôntico. Ao considerar a análise de Heidegger de “o matemático”, em Die Frage nach dem Ding, finalmente, argumenta-se que a metontologia desaparece do pensamento de Heidegger, porque sua dependência da ontologia a impede de explicar sua crescente preocupação com o ôntico, de maneira adequada. (shrink)

The effects of climate change are far reaching and widespread. As the issue continues to batter the world, the call for mitigation initiatives is becoming louder. In responding to this call we take a multidisciplinary approach to examining board diversity as an innovative solution in tackling climate change. Utilizing data from 69 fossil fuel organizations, our findings suggest that increasing female representation and foreign culture representation on the board can effectively reduce greenhouse gas emissions, the main contributor to climate change. (...) In part, this is achieved through responsible leadership and innovation. Our contributions reach beyond traditional board diversity literature, where the benefits of diversity are confined primarily to a discussion of corporate social responsibilities. Instead, we depict the benefits of board diversity as a direct lever in mitigating climate change. We propose that this is through the diversified board's enhanced ability to identify stakeholder needs and, subsequently, conceive of more effective and responsibly innovative solutions. (shrink)

ABSTRACT There is general agreement that Kant’s thought strongly influenced Heidegger’s. Nevertheless, there is still much work to be done in order to fully appreciate this influence. A central theme to disclose the relation between these authors is the role they give to the transcendental. In this paper I show that Kant’s account of intuition is the focus of Heidegger’s interpretation of Kant in his Die Frage nach dem Ding, since Heidegger interprets Kant’s treatment of intuition as a delimiting of (...) the modern mathematical tendency to determine everything out of pure reason alone. I argue that this interpretation is at the basis of Heidegger’s appropriation of Kant’s synthetic a priori in this work, the aim of which is to take this notion away from the sphere of the objects of mathematical physical science, and place it in the realm of everyday experience. I claim that Heidegger thinks that this move can only be accomplished by removing universality and necessity from Kant’s a priori. Finally, I show that Heidegger’s appropriation of Kant’s synthetic a priori goes together with and illuminates his understanding of transcendence as das Zwischen, ‘the between us and things’. RESUMO É consenso geral que o pensar de Kant influenciou fortemente o pensar de Heidegger. Porém, há ainda muito trabalho a fazer para se conseguir apreciar essa influência plenamente. Um tema crucial para conseguir expor a relação entre esses dois autores é o rol que ambos dão ao transcendental. Neste artigo, vou mostrar que o tratamento que Kant faz da intuição é o foco da interpretação que Heidegger oferece acerca de Kant em sua obra Die Frage nach dem Ding, dado que Heidegger interpreta o jeito como Kant trabalha a intuição como uma delimitação da tendência matemática moderna a determiná- lo tudo pelo só uso da razão pura. Argumento que essa interpretação está na base da apropriação que Heidegger faz do sintético a priori kantiano nesta obra, cujo fim é tirar essa noção fora da esfera dos objetos da ciência físico- matemática e posicioná-la no reino da experiência cotidiana. Sustento que Heidegger pensa que isto só pode ser alcançado ao eliminar a necessidade e a universalidade do a priori kantiano. Finalmente, mostro que a apropriação que Heidegger faz do sintético a priori kantiano vai junto e ilumina sua compreensão da transcendência como o das Zwischen, ‘o entre nós e as coisas’. (shrink)

Heidegger’s stance towards representational thinking has been widely discussed and debated. In this paper I show how based on an analysis of the mathematical in modern science in Die Frage nach dem Ding, Heidegger draws up a distinction between intuitive representations and representations against experience. I argue that this last type of representations corresponds to his understanding of the way in which representational thinking takes place in modernity, that is, modern representations. Based on an analysis of these two types of (...) representation I claim that in the mid-30s Heidegger realizes that thinking being as the a priori carries a danger, which consists in the fact that being can break its relation with that which is given in ordinary experience and become determined by pure reason alone, and that this danger is the decisive factor underlying Heidegger’s critical stance towards modern representations. (shrink)

Within the past few years, the topic of human dignity has demonstrated distinct signs of a revitalization of interest both within and beyond academic discourse. Outside the academy, news headlines and Twitter feeds continue to generate discussions about whose lives matter, both in the United States and abroad. This has served to renject into civil discourse, with a renewed sense of urgency, the question: what does it mean for a human life to matter? What does it mean for a human (...) life to have dignity? Within the academy,1 scholars have recently approached this question by focusing on how to renegotiate and... (shrink)

Abstract:Cristina Crichton speaks with Ramón Rodríguez about ethics in Heidegger (Studies) and Heidegger's influence on his own work.

An Innovative Learning Centre within a Faculty of Education provides the forum to study and give lived expression to the rhythmic workings of experience through documenting a Maker Movement Day for practicing educators. Dewey’s commitment to “the idea that there is an intimate and necessary relation between the processes of actual experience and education” is at the heart of our Maker Day.1 The contemporary Maker Movement’s emphasis on studio-based learning attends to the experiences of meaning making from within the experiences (...) themselves.2 The rootedness of this thinking across time and traditions can be traced to many interested in revealing the experiential terrain.. (shrink)

Orthologic is defined by weakening the axioms and rules of inference of the classical propositional calculus. The resulting Lindenbaum-Tarski quotient algebra is an orthoimplication algebra which generalizes the author's implication algebra. The associated order structure is a semi-orthomodular lattice. The theory of orthomodular lattices is obtained by adjoining a falsity symbol to the underlying orthologic or a least element to the orthoimplication algebra.

Robert Corrington's ever-emerging theory of ecstatic naturalism is dense with possibilities for secondary studies. The task of attending to the rich theoretical territory of Corrington's philosophical world is in itself deserving of many monograph-length treatments. Nam T. Nguyen's Natures Primal Self not only takes on this task but also triples the workload by attempting to compare and contrast Corrington's ideas with the philosophies of Charles Peirce and Karl Jaspers, who are notably difficult to penetrate in their own right and conspicuously (...) disparate from one another. As would be expected, Nguyen's study brings a plethora of interesting philosophical questions to the foreground with respect to these three .. (shrink)

Background In earlier work, we found important selection biases when we tried to obtain consent for participation in a national stroke registry. Recognizing that not all registries will be exempt from requiring consent for participation, we examine here in greater depth the reasons for the poor accrual of patients from a systems perspective with a view to obtaining as representative sample as possible. Methods We determined the percent of eligible patients who were approached to participate and, among those approached, the (...) percent who actually consented to participate. In addition we examined the reasons why people were not approached or did not consent and the variation across sites in the percent of patients approached and consented. We also considered site variation in restrictions on the accrual and data collection process imposed by either the local research ethics board or the hospital. Results Seventy percent of stroke patients were approached, with wide variations in approach rates across sites (from: 41% to 86%), and considerable inter-site variation in hospital policies governing patient accrual. Chief reasons for not approaching were discharge or death before being approached for consent. Seventeen percent of those approached refused to participate (range: 5% to 75%). Finally, 11% of those approached did not participate due to language or communication difficulties. Conclusion We found wide variation in approach and agree rates across sites that were accounted for, in part, by different approaches to accrual and idiosyncratic policies of the hospitals. This wide variation in approach and agree rates raises important challenges for research ethics boards and data protection authorities in determining when to waive consent requirements, when to press for increased quality control, when to permit local adaptation of the consent process, and when to permit alternatives to individual express consent. We offer several suggestions for those registries that require consent for participation. (shrink)

Primarily focused on the theoretical aspects of International Organization, this book provides an in-depth examination of competing theories through thematic chapters. Intended to fill the gap between introductory textbooks and primary sources of theory, International Organization , is useful for upper-level international relations courses with a significant emphasis on theory.

The purpose of this text is to draw attention to eight forgotten heroes: William C. Bagley, Charles DeGarmo, David Felmley, William Torrey Harris, Isaac L. Kandel, Charles McMurry, William C. Ruediger, and Edward Austin Sheldon. They have been marginalized from our profession, and drawing upon their legacy is the best hope for restoring the profession of teaching today. This work also includes a chapter at the end of the book entitled "John Dewey's Forgotten Essays." The audience for this book includes: (...) 1) classroom teachers, 2) school administrators, 3) teacher educators, 4) deans and other university administrators, 5) college and university presidents, 6) legislators, 7) historians of education, 8) curriculum specialists, 9) specialists in teacher training, and 10) the general public. (shrink)