The Toronto experience suggests that there may be several general lessons for academic health sciences complexes to learn from the Olivieri/Apotex affair regarding the ethics, independence, and integrity of clinical research sponsored by for profit enterprises. From a local perspective, the OAA occurred when there already was a focus on the complex and changing relationships among the University of Toronto, its medical school, the fully affiliated teaching hospitals, and off campus faculty because of intertwined interests and responsibilities. The OAA became (...) a catalyst that accelerated various systemic reforms, particularly concerning academic/industry relations. In this article, the evolving governance framework for the Toronto academic health sciences complex is reviewed and these policy and process reforms discussed. These reforms have created collaborative activity among research ethics boards and contract research offices of the partner institutions, and allowed the joint university/hospital ethics centre to play a role in governance and policy, while respecting the missions and mandates of the involved institutions. Although few of the policies are dramatically innovative, what is arguably novel is the elaboration of an overarching governance framework that aims to move ethics to a central focus in the academic complex. Time alone will tell how sustainable and effective these changes are. (shrink)

Research ethics committees—animal ethics committees for animal-based research and institutional research boards for human subjects—have a key role in research governance, but there has been little study of the factors influencing their effectiveness. The objectives of this study were to examine how the effectiveness of a research ethics committee is influenced by committee composition and dynamics, recruitment of members, workload, participation level and member turnover. As a model, 28 members of AECs at four universities in western Canada were interviewed. Committees (...) were selected to represent variation in the number and type of protocols reviewed, and participants were selected to include different types of committee members. We found that a bias towards institutional or scientific interests may result from a preponderance of institutional and scientist members, an intimidating atmosphere for community members and other minority members, recruitment of community members who are affiliated with the institution and members joining for reasons other than to fulfil the committee mandate. Thoroughness of protocol review may be influenced by heavy workloads, type of review process and lack of full committee participation. These results, together with results from the literature on research ethics committees, suggested potential ways to improve the effectiveness of research ethics committees. (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)

What critical characteristics do firms have that determine the scale and scope of corporate social responsibility activities they undertake? This paper examines two disparate predictors of corporate social performance. First, using the lens of the resource-based view, we examine the role of alliance network centrality on corporate social performance. We find that centrality enhances corporate social performance. Second, we investigate how board composition affects corporate social performance. Specifically, drawing on stakeholder theory, we find that the percentage of female directors (...) predicts greater corporate social performance. In addition, we look at the influence of outside directors on this relationship. Our findings show that the presence of more outside directors positively moderates the relationship between female directors and corporate social performance. (shrink)

Background: The offer of aggregate study results to research participants following study completion is increasingly accepted as a means of demonstrating greater respect for participants. The attitudes of research ethics board chairs towards this practice, although integral to policy development, are unknown.Objectives: To determine the attitudes of REB chairs and the practices of REBs with respect to disclosure of results to research participants.Design: A postal questionnaire was distributed to the chairs of English-language university-based REBs in Canada. In total, 88 (...) REB chairs were eligible. The questionnaire examined respondents’ attitudes towards offering participants completed study results, methods for delivering this information, and barriers to disclosing results.Findings: The response rate was 89.8%. Chairs were highly supportive of offering results to research participants. Only 19.5% of chairs responded that a policy or guideline that governed the return of research results to participants existed at their institution. Most chairs supported the idea of their REB instituting a set of guidelines recommending that researchers offer results to participants in a lay format. Chairs identified the major impediments to the implementation of programmes offering to return results to participants as being financial cost and retaining contact with research participants .Conclusions: University-based REB chairs overwhelmingly support the offer of research results to participants. This is incongruent with the frequent lack of existing REB guidelines recommending this practice. REBs should support guidelines that diminish identified barriers and promote consistency in offering to return results. (shrink)

Institutional review board delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear (...) in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improv... (shrink)

No one who attended the 2010 national public health law conference hosted by the Public Health Law Association and the American Society of Law, Medicine & Ethics could miss the sense of excitement and momentum. The revival of this annual public health law meeting, with the support of the Robert Wood Johnson Foundation, the energetic leadership of the PHLA president and board, ASLME’s expert guidance, and a rousing address by Dr. Tom Frieden, Director of the Centers for Disease Control (...) and Prevention, symbolize the continued commitment of a wide range of important individuals and institutions to the proposition that law is of substantial importance to public health. But there is more than just symbolism to be excited about. CDC’s public health law program continues to champion efforts to promote the use and understanding of law as a public health tool. (shrink)

No one who attended the 2010 national public health law conference hosted by the Public Health Law Association and the American Society of Law, Medicine & Ethics could miss the sense of excitement and momentum. The revival of this annual public health law meeting, with the support of the Robert Wood Johnson Foundation, the energetic leadership of the PHLA president and board, ASLME’s expert guidance, and a rousing address by Dr. Tom Frieden, Director of the Centers for Disease Control (...) and Prevention, symbolize the continued commitment of a wide range of important individuals and institutions to the proposition that law is of substantial importance to public health. But there is more than just symbolism to be excited about. CDC’s public health law program continues to champion efforts to promote the use and understanding of law as a public health tool. (shrink)

Background Regulations on research ethics in France have evolved considerably over the past four years: the implementation of the Jardé law and of the General Data Protection Regulations have changed the landscape of research ethics for research involving or not involving human persons. In a context of creation of an Institutional Review Board at the University of Bordeaux, France, we sought to explore research ethics practices and perceptions in the medical community of our University Hospital. Methods A short questionnaire (...) was sent to all physicians of the University Hospital of Bordeaux. The questionnaire included closed questions and main topics were: physicians’ education in research ethics, ethics practices concerning researches non implying human persons, and physicians’ perceptions about current regulations. Results 86 questionnaires were sent back. If a majority of physicians have validated Good Clinical Practices trainings, there was a low rate of specific training on fundamental references in research ethics and a high proportion of responders do not consider themselves as educated in research ethics after completion of GCPs. Regulations on research ethics have many implications on medical research, especially by inducing changes in protocols in order to alleviate ethical requirements. Malpractices were acknowledged like false mention of positive opinion from an ethics committee. If If a majority of responders considers regulations as a positive answer to research ethics, a large majority considers it as a constraint and a complexification of research process. For 58%, regulations in research ethics are perceived as a hindrance for research initiatives. Conclusion Because of their impact on research process, regulations seem to constitute a scarecrow for physicians. Lack of training, bad representations and questionable practices highlight the need to improve education and to propose concrete guidance for medical researchers. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

This article recounts the development of the Professional/problem-based Ethics Program, the original physicians’ professional ethics remediation course. Since 1992, more than 1,200 healthcare professionals of many disciplines have been mandated to attend ProBE by licensing boards and other oversight entities. Using a small-group, interprofessional setting, the ProBE Program assists participants to discover and articulate ethical underpinnings violated by their misconduct; appreciate professional responsibilities that are societal, regulatory, and ethical; and recommit to professional ideals. The authors describe the rationale for developing (...) ProBE, its curriculum, participant demographics, and infractions and reconsider medical professionalism in light of two decades of ProBE. (shrink)

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious (...) wrongdoing by physicians. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise (...) in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise (...) in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

Background Implementing person-centred care (PCC) in nursing homes is challenging due to a gap between theory and practice. Bridging this gap requires suitable education, which focuses on learning how to attune care to the values and preferences of residents and take moral, relational, and situational aspects into account. Staff’s stories about the care they provide (i.e. caring stories) may deliver valuable insights for learning about these aspects. However, there is limited research on using staff's narratives for moral learning. Objective This (...) study aims to provide insight into the perspectives of nursing staff on using their caring stories to learn about PCC. Research design In this qualitative research, we conducted two rounds of interviews with 17 participants working in nursing homes. We wanted to obtain nursing staff’s perceptions of working with their caring stories and the impact on PCC. Ethical considerations Participation was voluntary, and participants provided written consent. The study protocol is approved by The Institutional Review Board of the Medical Ethical Committee Leiden-Den Haag-Delft. Findings Working with caring stories enables nursing staff to provide PCC and improves job satisfaction. It increases awareness of what matters to residents, fosters information rich in context and meaning, and enhances voice and vocabulary. Through in-depth team reflections, nursing staff discussed the significant moments for residents, which centralizes the discussions on the moral quality of care. Discussion Working with caring stories fosters dialogue on PCC and enhances reflection on ethical situations in daily encounters, contributing to the moral development of nursing staff. Putting nursing staff’s narratives at the centre of learning suits their daily practice and intrinsic motivation. Therefore, the outcomes of this study are an addition to the existing literature about using narratives in long-term care. Conclusion Using nursing staff's narratives contributes to PCC and positively impacts nursing staff. We recommend using staff's caring stories as a vehicle for moral learning in the transition to PCC. (shrink)

Introduction -- Invited Remarks from Symposium Participants -- What Are the Fundamental Compliance and Ethics Challenges Facing the C-Suite, and What Oversight Role Should the Board Play? -- How to Overcome the Barriers to High Standards of Integrity in the C-Suite, and What Should Boards, Management, and Policymakers Do Next? -- Appendix A: Symposium Agenda -- Appendix B: Symposium Participants -- Appendix C: Invited Keynote Address by Judge Ruben Castillo -- Appendix D: Invited Papers from Symposium Participants.

This book, first published in 1975, provides critical and comprehensive introduction to the philosophy of Leibniz.

First published in 2000. Routledge is an imprint of Taylor & Francis, an informa company.

In this paper I propose an interpretation of classical statistical mechanics that centers on taking seriously the idea that probability measures represent complete states of statistical mechanical systems. I show how this leads naturally to the idea that the stochasticity of statistical mechanics is associated directly with the observables of the theory rather than with the microstates (as traditional accounts would have it). The usual assumption that microstates are representationally significant in the theory is therefore dispensable, a consequence which suggests (...) interesting possibilities for developing non-equilibrium statistical mechanics and investigating inter-theoretic answers to the foundational questions of statistical mechanics. (shrink)

First published in 2000. Routledge is an imprint of Taylor & Francis, an informa company.

Reeve's classic work provides an interpretation of Republic that makes a case for the coherence of Plato's argument.

This book is an exploration of the epistemological, metaphysical, and psychological foundations of the Nicomachean Ethics. In a striking reversal of current orthodoxy, Reeve argues that scientific knowledge (episteme) is possible in ethics, that dialectic and understanding (nous) play essentially the same role in ethics as in an Aristotelian science, and that the distinctive role of practical wisdom (phronesis) is to use the knowledge of universals provided by science, dialectic, and understanding so as to best promote happiness (eudaimonia) in particular (...) circumstances and to ensure a happy life. Turning to happiness itself, Reeves develops a new account of Aristotle's views on ends and functions, exposing their twofold nature. He argues that the activation of theoretical wisdom is primary happiness, and that the activation of practical wisdom--when it is for the sake of primary happiness--is happiness of a secondary kind. He concludes with an account of the virtues of character, external goods, and friends, and their place in the happy life. (shrink)

Readers familiar with the workhorse of cosmology, the hot big bang model, may think that cosmology raises little of interest about time. As cosmological models are just relativistic spacetimes, time is understood just as it is in relativity theory, and all cosmology adds is a few bells and whistles such as inflation and the big bang and no more. The aim of this chapter is to show that this opinion is not completely right...and may well be dead wrong. In our (...) survey, we show how the hot big bang model invites deep questions about the nature of time, how inflationary cosmology has led to interesting new perspectives on time, and how cosmological speculation continues to entertain dramatically different models of time altogether. Together these issues indicate that the philosopher interested in the nature of time would do well to know a little about modern cosmology. (shrink)

First published in 2000. Routledge is an imprint of Taylor & Francis, an informa company.

I discuss the formal implementation, interpretation, and justification of likelihood attributions in cosmology. I show that likelihood arguments in cosmology suffer from significant conceptual and formal problems that undermine their applicability in this context.

Cosmological inflation is widely considered an integral and empirically successful component of contemporary cosmology. It was originally motivated by its solution of certain so-called fine-tuning problems of the hot big bang model, particularly what are known as the horizon problem and the flatness problem. Although the physics behind these problems is clear enough, the nature of the problems depends on the sense in which the hot big bang model is fine-tuned and how the alleged fine-tuning is problematic. Without clear explications (...) of these, it remains unclear precisely what problems inflationary theory is meant to be solving and whether it does in fact solve them. I analyze the structure of these problems and consider various interpretations that may substantiate the alleged fine-tuning. On the basis of this analysis I argue that at present there is no unproblematic interpretation available for which it can be said that inflation solves the big bang model’s alleged fine-tuning problems. (shrink)

"Reeve's book is an excellent companion to Plato's Apology and a valuable discussion of many of the main issues that arise in the early dialogues. Reeve is an extremely careful reader of texts, and his familiarity with the legal and cultural background of Socrates' trial allows him to correct many common misunderstandings of that event. In addition, he integrates his reading of the apology with a sophisticated discussion of Socrates' philosophy. The writing is clear and succinct, and the research is (...) informed by a thorough acquaintance with the secondary literature. Reeve's book will be accessible to any serious undergraduate, but it is also a work that will have to be taken into account by every scholar doing advanced research on Socrates." --Richard Kraut, Northwestern University. (shrink)

We introduce a novel point of view on the “models as mediators” framework in order to emphasize certain important epistemological questions about models in science which have so far been little investigated. To illustrate how this perspective can help answer these kinds of questions, we explore the use of simplified models in high energy physics research beyond the Standard Model. We show in detail how the construction of simplified models is grounded in the need to mitigate pressing epistemic problems concerning (...) the uncertainty inherent in the present theoretical and experimental contexts. (shrink)

The transmission of form and soul -- Desire, perception, and understanding -- Theoretical wisdom -- Virtue of character -- Practical wisdom -- Immortalizing beings -- Happiness -- The happiest life.

Eliminative reasoning is a method that has been employed in many significant episodes in the history of science. It has also been advocated by some philosophers as an important means for justifying well-established scientific theories. Arguments for how eliminative reasoning is able to do so, however, have generally relied on a too narrow conception of evidence, and have therefore tended to lapse into merely heuristic or pragmatic justifications for their conclusions. This paper shows how a broader conception of evidence not (...) only can supply the needed justification but also illuminates the methodological significance of eliminative reasoning in a variety of contexts. (shrink)

The conspicuous similarities between interpretive strategies in classical statistical mechanics and in quantum mechanics may be grounded on their employment of common implementations of probability. The objective probabilities which represent the underlying stochasticity of these theories can be naturally associated with three of their common formal features: initial conditions, dynamics, and observables. Various well-known interpretations of the two theories line up with particular choices among these three ways of implementing probability. This perspective has significant application to debates on primitive ontology (...) and to the quantum measurement problem. (shrink)

I present a recent historical case from cosmology—the story of inflationary cosmology—and on its basis argue that solving explanatory problems is a reliable method for making progress in science. In particular, I claim that the success of inflationary theory at solving its predecessor’s explanatory problems justified the theory epistemically, even in advance of the development of novel predictions from the theory and the later confirmation of those predictions.

Philosophical debates on how to account for the progress of science have traditionally divided along the realism-anti-realism axis. Relatively recent developments in epistemology, however, have opened up a new knowledge-understanding axis to the debate. This chapter presents a novel understanding-based account of scientific progress that takes its motivation from problem-solving practices in science. Problem-solving is characterized as a means of measuring degree of understanding, which is argued to be the principal epistemic (or cognitive) aim of science, over and against knowledge. (...) This account is then defended against knowledge reductionism by showing how each plays an important and distinctive role in science. (shrink)

Background:Since 2010, the United States has experienced 228 disasters, affecting over 86 million people. Because of population shifts, the growing number of people living with chronic conditions or disabilities, and the growing number of older citizens living independently, access and service gaps often exist for those without money or other transferable resources. There is a lack of evidence regarding individual community members’ capacity to prepare for emergencies.Research objective:The purpose of this study is to highlight participant experiences in becoming better prepared (...) for emergencies and provide insight from a social justice perspective.Research design:This is a descriptive qualitative study, staying very close to the data as an end product rather than a beginning for interpretation.Participants and research context:A total of 13 low-income, uninsured, or under-insured attendees at a medical outreach clinic were interviewed.Ethical considerations:Institutional Review Board approval was obtained from the University of Texas at Tyler.Findings:Four themes emerged from the interview data: (a) evaluation of the emergency-preparedness education, (b) making emergency plans, (c) challenges in preparing for emergencies, and (d) facilitators of emergency preparedness.Discussion:Identifying the potential challenges to individual emergency preparedness among vulnerable populations is the first step in overcoming them. The capacity to comply with such measures, especially the ability of those with limited incomes and other vulnerable populations, must be considered.Conclusion:Synchronized, well-ordered assistance will close gaps in recovery and enhance efficiency in pre- and post-event aid. Theoretically, doing so will promote engaged and resilient members of society who are better able to withstand adverse events. The importance of the relationship between individual preparedness levels and the resiliency of nations supports the social justice imperative to address the needs of vulnerable populations in the mitigation and planning phase of the emergency management cycle. (shrink)