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)

Mucopolysaccharidosis type I (MPS I) is a rare lysosomal storage disorder treated with bone marrow transplantation or enzyme replacement therapy with laronidase, a high-cost orphan drug. Laronidase was approved by the US Food and Drug Administration and the European Medicines Agency in 2003 and by the Brazilian National Health Surveillance Agency in 2005. Many Brazilian MPS I patients have been receiving laronidase despite the absence of a governmental policy regulating access to the drug. Epidemiological and treatment data concerning MPS I (...) are scarce. This study aims to present a demographic profile of Brazilian patients with MPS I, describe the routes of access to laronidase in Brazil, and discuss associated ethical issues relating to public funding of orphan drugs. (shrink)

Childhood obesity has become a public health epidemic, and currently a battle exists over how to frame and address this problem. This paper explores how public policy approaches can be employed to address obesity. We present the argument that obesity should be viewed as the consequence of a “toxic environment” rather than the result of the population failing to take enough “personal responsibility.” In order to make progress in decreasing the prevalence of obesity, we must shift our view of obesity (...) away from the medical model to a public health model . At the same time, we must be sensitive to the problem of weight bias.Potential obstacles to taking a public policy approach are identified, as well as suggestions on how to overcome them. (shrink)

After years of near total neglect, the problem of childhood obesity is now in the limelight. Terms like “epidemic,” “crisis,” and “emergency” are used frequently when describing the trend. Progress is defined with strong language and fueled by statistics such as the observation that this generation of children will be the first to live shorter lives than their parents. Multi-disciplinary journals such as the Journal of Law, Medicine & Ethics have dedicated symposiums to the issue, and conferences have been convened (...) not only by health professionals but by government agencies, the food industry, and even professionals who market to children. The seriousness of childhood obesity is no longer in doubt, and finally attention has turned to the more complex question – what must be done? (shrink)

Although nature of science and nature of scientific inquiry are related to each other, they are differentiated as NOS is being more related to the product of scientific inquiry which is scientific knowledge whereas NOSI is more related to the process of SI. Lederman et al. determined eight NOSI aspects for K-16 context. In this study, a science camp was conducted to teach scientific inquiry and NOSI to 24 6th and 7th graders. The core of the program was guided inquiry (...) in nature. The children working in small groups under guidance of science advisors conducted four guided-inquiries in the nature in morning sessions on nearby plants, animals, water, and soil. NOSI aspects were made explicit during and at the end of each inquiry session. Views about scientific inquiry questionnaire was applied as pre- and post-test. The results of the study showed that children developed in all eight NOSI aspects, but higher developments were observed in “scientific investigations all begin with a question” and “there is no single scientific method,” and “explanations are developed from data and what is already known” aspects. It was concluded that the science camp program was effective in teaching NOSI. (shrink)

Background: The use of race as a category in medical research is the focus of an intense debate, complicated by the inconsistency of presumed independent variables, race and ethnicity, on which analysis depends. Interpretation is made difficult by inconsistent methods for determining the race or ethnicity of a participant. The failure to specify how race or ethnicity was determined is common in the published literature.Hypothesis: Criteria by which they assign a research participant to racial or ethnic categories are not reported (...) by published articles.Methods: Methods were reviewed for assigning race and ethnicity of research participants in 268 published reports reporting associations among race , health outcome and genotype.Results: Of the 268 published reports reviewed, it was found that 192 did not explain their methods for assigning race or ethnicity as an independent variable. This was despite the fact that 180 of those reports reached conclusions about associations among genetics, health outcome and race or ethnicity.Conclusions: More attention needs to be given to the definition of race and ethnicity in genetic studies, especially in those diseases where health disparities are known to exist. (shrink)

The status of constructivism as a metaethical or metanormative theory is unclear partly due to the lack of a clear semantics for central normative terms such as ‘reason’ and ‘ought’. In a series of recent papers, Sharon Street has attempted to clarify the central commitments of constructivism by focusing on the idea of a practical point of view and what follows from it. We improve upon the informal understanding provided by Street and attempt to provide a semantics for ‘ought’. Our (...) semantics respects the core intuition of the constructivist that normative claims are made true because of our practical commitments as agents and also reflects the constructivist’s commitment to the centrality of practical deliberation to normative truth. On our view, a normative claim of the form ⌜S ought to ϕ⌝ is true if ϕ is entailed from S’s set of evaluative attitudes. We argue that a virtue of our definition is that it allows us to see precisely what is distinctive about constructivism as opposed to realism and expressivism. (shrink)

Curiously, two central areas are unaddressed by Epstein et al.: (i) L1A–L2A differences; (ii) L2 development. Here, findings relevant to (i) and (ii) – as well as their significance – are discussed. Together these form the basis for contesting Epstein et al.'s “Full Access” approach, but nonetheless analyses of the L2 data argue for UG-constrained L2A. Also discussed is the inadequacy of accounts (like Epstein et al.'s) without an explicit and prominent role for the L1.

Neither moral philosophy nor history provides a satisfactory explanation for Oskar Schindler's extraordinary rescue of more than 1,200 Jews during the Holocaust. Thomas Keneally's Schindler's Ark does. Although Schindler's Ark is technically a work of fiction, that generic label obscures its contribution as a fictionalised account of true events. By using a novelist's tools to tell an historical story, Keneally allows us to make inferences as to the motives of his protagonist and thereby helps us to understand what propelled the (...) moral behaviour of Oskar Schindler. (shrink)

The coronavirus disease 2019 pandemic is altering dynamics in academia, and people juggling remote work and domestic demands – including childcare – have felt impacts on their productivity. Female authors have faced a decrease in paper submission rates since the beginning of the pandemic period. The reasons for this decline in women’s productivity need to be further investigated. Here, we analyzed the influence of gender, parenthood and race on academic productivity during the pandemic period based on a survey answered by (...) 3,345 Brazilian academics from various knowledge areas and research institutions. Productivity was assessed by the ability to submit papers as planned and to meet deadlines during the initial period of social isolation in Brazil. The findings revealed that male academics – especially those without children – are the least affected group, whereas Black women and mothers are the most impacted groups. These impacts are likely a consequence of the well-known unequal division of domestic labor between men and women, which has been exacerbated during the pandemic. Additionally, our results highlight that racism strongly persists in academia, especially against Black women. The pandemic will have long-term effects on the career progression of the most affected groups. The results presented here are crucial for the development of actions and policies that aim to avoid further deepening the gender gap in academia. (shrink)

Objective: There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective was to develop a structured ethics framework to accomplish this. -/- Methods: We reviewed existing literature on the ethical and policy issues, developed an ethics framework called a “Points to (...) Consider” (P2C) document, and convened a national expert panel to review and critique the P2C. -/- Results: We developed the P2C to aid informaticists designing an advanced query tool for an electronic health record (EHR) system in Indianapolis. The P2C consists of six questions (“Points”) that frame important ethical issues, apply accepted principles of bioethics and Fair Information Practices, comment on how questions might be answered, and address implications for patient care. -/- Discussion: The P2C is intended to clarify whatis at stake when designers try to accommodate potentially competing ethical commitments and logistical realities. The P2C was developed to guide informaticists who were designing a query tool in an existing EHR that would permit patient granular control. While consideration of ethical issues is coming to the forefront of medical informatics design and development practices, more reflection is needed to facilitate optimal collaboration between designers and ethicists. This report contributes to that discussion. (shrink)

Volume 20, Issue 7, July 2020, Page 150-152.

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)

Résultat des recherches du philosophe allemand positiviste ayant pour objectif d'établir un système logique de constitution des concepts par dérivation, à partir d'un petit nombre de concepts fondamentaux.