The research ethics committee is a key element of university administration and has gained increasing importance as a review mechanism for those institutions that wish to conduct responsible...

This, the third seminar organised by the AREC university sector committee, included short presentations followed by parallel workshops. These proposed and explored basic principles for ethical review in the context of current models within the university REC sector. In this report, following an introduction, each of the speakers/workshop leaders summarizes their own perspective on the issues raised and discussed.

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine of University Eduardo Mondlane and the Maputo Central Hospital established a joint Institutional Committee on Bioethics for Health. This study examines the experience of the first 4 years of the (...) CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee’s respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master’s degree research. Descriptive cross-sectional studies were the most frequently reviewed research. The majority were prospective and used quantitative methodologies. The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS’s average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens. (shrink)

Conducting large multi-site research within universities highlights inconsistencies between universities in approaches, requirements and responses of research ethics committees. Within the context of a social science research study, we attempted to obtain ethical approval from 101 universities across England to recruit students for a short online survey. We received varied responses from research ethics committees of different universities with the steps to obtaining ethics approval ranging from those that only required proof of approval from our home institution, (...) to universities that facilitated fast-track applications to those that required a full ethics review. Some universities also completely refused. After contacting all 101 universities in England, 60 universities gave clearance to our study. In this article, we present the different approaches universities adopted in response to our application to sample from students in their institution. We consider a number of conceptual and ethical issues pertinent to considering ethics approval for researchers from other universities in England and critically discuss three possible models of ethics governance that would cover all universities in England. (shrink)

This article responds directly to an article published in Research Ethics in 2011 where Schrag argued against ethics review for social science and humanities research. He argued that review committees offer solutions in search of a problem, impose silly restrictions and apply inappropriate principles. He suggests that review committees typically lack appropriate expertise and argued that the process harms the innocent. This article refutes these claims and offers a case study of the ethical review (...) process at Queen Mary University of London (QMUL) to offer counter claims. The discussion highlights the way in which the QMUL process is sensitized to the challenges posed by social science and humanities research and is a process that, rather than focusing upon avoiding harm, emphasizes notions of care to both participants and researchers. (shrink)

BackgroundInternational guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.MethodsWe obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to (...) 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.ResultsOf 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.ConclusionOnly one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. (shrink)

This survey has been designed as a multinationalcollaboration to collect data from several countries focusing ondeveloping countries. The main purpose was to elaborate thefunctions of ethics committees regarding externally-sponsoredresearch . In March 2004 a total of 89 open-endedquestionnaires were sent to ethics review committees inmedical schools, medical research institutes and hospitalsaffiliated to the public and private medical universities inJapan.Twenty two ECs replied , and among them five ECshad reviewed eleven ESR proposals in 2002-3. Five of thoseESR proposals (...) have been approved and four proposals havebeen approved after some revisions. Two proposals weredeferred but not resumed. In their review, respondents weremore concerned about “individual consent” than “communityconsent”. Post-trial access to effective interventions was not areal concern. As for “Standard of care”, seven ECs replied thatthey review the ESR proposal based on the internationalstandards and four based on the local standards. WhetherESR proposal is matched with the national health prioritieswas not a great concern. Respondents expressed theirconcern about socio-cultural issues.Ethics in research especially dealing with externallysponsoredresearch is a relatively new subject and underdevelopment in Japan. Although Japan is not a developingcountry, in order to protect individual human subjects and localcommunity, capacity building in ethics review especially inresearch collaboration with other developed and developingcountries is crucial and it has to be included in ethics inresearch programs through out the country. (shrink)

In the United Kingdom, there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has (...) been created in which a top-level university research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of ethics review. (shrink)

The history of the National Health Service research ethics system in the UK and some of the key drivers for its change into the present system are described. It is suggested that the key drivers were the unnecessary delay of research, the complexity of the array of processes and contradictions between research ethics committee (REC) decisions. It is then argued that the primary drivers for this change are and will be replicated by the systems of research ethics (...) review being put in place at UK universities in response to the Economic and Social Research Council research ethics framework. It is argued that this is particularly problematic for multi-centre review and for researchers who switch institutions. Finally, some potential solutions to this problem and their feasibility are discussed. (shrink)

Background:Research Ethics Committees (RECs) or their equivalent review applications for prospective research with human participants. Reviewers use universally agreed principlesi to make decisions...

Freedom of information requests are increasingly used in sociology, criminology and other social science disciplines to examine government practices and processes. University ethical review boards in Canada have not typically subjected researchers’ FOI requests to independent review, although this may be changing in the United Kingdom and Australia, reflective of what Haggerty calls ‘ethics creep’. Here we present four arguments for why FOI requests in the social sciences should not be subject to formal ethical review (...) by ERBs. These four arguments are: existing, rigorous bureaucratic vetting; double jeopardy; infringement of citizenship rights; and unsuitable ethics paradigm. In the discussion, we reflect on the implications of our analysis for literature on ethical review and qualitative research, and for literature on FOI and government transparency. (shrink)

Monshi and Zieglmayer's case study presents Sri Lankan participants as having views on the privacy of health information that differ radically from those commonly found in Western nations. This article explores 2 questions that their case study raises for the ethical review of research in international settings: First, are allegedly universal ethical principles - of the sort promulgated in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978) - useful in international (...) settings?, and second, how should research oversight bodies address the challenges that arise in international behavioral and social science research? (shrink)

This article examines forms of subjectivation propagated through the processes and practices of ethics review in UK Higher Education Institutions. Codified notions of research ethics are particularly prevalent in the university context along with stringent institutional regulation of the procedures surrounding ethics review of research proposals. Michel Foucault’s concept of neoliberal governmentality is argued in this article to help illuminate the combination of power processes reflected in ethics review practices. These operate insidiously (...) in accordance with a neoliberal rationality that champions self-sustaining individuals and the inauguration of human capital. Moreover, ethics review processes and attendant regulatory modes of control compound the construction of the student as a ‘permanent performer’ and the associated requirement for her to self-govern through risk management. A combination of overtly controlling and self-relational mechanisms of neoliberal governmentality are in operation, both of which have the potential to generate particular forms of subjectivation in the university context. Foucault’s conceptualisation of the ethical relation to the self helps indicate alternative, resistant styles of self-confrontation to those correlating with neoliberal governmentality. These are based on autonomous choice-making and self-censoring rather than unquestioning conformity to the regimens of ethics review. (shrink)

This paper is, in part, a response to the model of university-based human subjects ethics review described by Bryn Williams-Jones and Soren Holm in Research Ethics Review [1] and the current ethical review process at the University of Ulster [2]. In this paper the two predominant systems of ethical review within UK universities are described. It is argued that each of these systems has significant deficiencies. Having suggested why these two models are (...) less than ideal, a “third way’ of ethical review is proposed that encapsulates the strengths of these two models while avoiding the weaknesses. (shrink)

This paper considers concerns that social care research may be stifled by health-focused ethical scrutiny under the Mental Capacity Act 2005 and the requirement for an ?appropriate body? to determine ethical approval for research involving people who are deemed to lack capacity under the Act to make decisions concerning their participation and consent in research. The current study comprised an online survey of current practice in university research ethics committees (URECs), and explored through semi-structured interviews the views of (...) social researchers engaged in or exploring work concerning people who may, under the Act, lack the capacity to make decisions to consent to participate in a research programme. The paper concludes that there was a lack of overt knowledge of and reference to the implications of the Act for research and some concerns that a restrictive focus on health-related scrutiny might prevent social care research from taking place. There was also a degree of creativity shown by social care researchers in responding to changing demands and a wish to assist people in making decisions to participate where possible. (shrink)

This article outlines the potential for Research Higher Degree supervisors at universities and similar institutions to use ethical review as a constructive, dynamic tool in guiding RHD students in the timely completion of effective, innovative research projects. Ethical review involves a bureaucratized process for checking that researchers apply risk management strategies when dealing with human participants. Ethical review can also be a powerful instrument for RHD supervisors in the creative arts if they use it to lead students (...) through processes of imagining, articulating, and improving their methodologies and relationships with research participants. Proposed strategies involve adaptation of theories of visualization and imagination from several disciplines—imagined interaction from the social sciences and psychology, dramatic rehearsal from political science, and creative visualization from the health professions, sports coaching and many other personal–professional development contexts. By using creativity and imagination, supervisors can use ethical review to help students to ‘walk through’ the potential, progressive phases of proposed research in order to refine or redesign both ‘big picture’ strategies and specific steps taken to reach research goals. This can stimulate students to unearth possibilities that improve the quality and quantity of knowledge that their research generates and to avoid or manage problems that might disrupt their research. (shrink)

A Decent Proposal: Ethical Review of Clinical Research Donald Evans and Martyn Evans Centre for Philosophy and Health Care University of Wales Swansea, UK The investigation and development of modern medicines and medical technology can create numerous ethical dilemmas both for clinical researchers and research ethics committees. A Decent Proposal: Ethical Review of Clinical Research seeks to facilitate and encourage good clinical research by exploring the concerns, responsibilities, general issues and particular pitfalls associated with ethical aspects (...) of research. It provides practical guidelines for researchers on how to improve the quality of research design, while for those appointed to scrutinise research proposals it offers advice on how to apply consistent, careful and critical reasoning to the process of assessing ethical standards. As such, it will provide invaluable assistance to clinical researchers and ethics committees alike in understanding the moral challenges posed by modern health care. (shrink)

A growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards _deliberate,_ with particular attention given to the lack of transparency and opportunities for researcher (...) recourse that characterise ethics review processes. Centered specifically on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas’ (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984 ) articulation of ‘communicative action’ and Fraser’s (Social Text, 25(26), 56–80, 1990 ) consideration of ‘strong publics’ to cast consideration of the role that human ethics review boards might play in supporting university research cultures. _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ provide useful conceptual prompts for considering how ethics review boards might undertake their work. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Confronting Aristotle's EthicsDavid DepewConfronting Aristotle's Ethics by Eugene Garver Chicago: University of Chicago Press, 2006. Pp. ix + 290. $49.00, cloth.Readers of this journal are likely to be familiar with Eugene Garver's 1994 Aristotle's Rhetoric: An Art of Character. The main claim advanced in that important book is that for Aristotle rhetoric is an art because it has internal norms and ends. From this, it follows (...) that although any red-blooded rhetor probably does aim at winning a case, advancing a political career, getting rich, and other external goals, what is artful in rhetorical craft (technikos), and hence expressive of the distinctive human capacity for human rationality, is timely argumentation that binds premises to actionable conclusions through displays of good character and apt emotional response. This ordered combination of ethos, pathos, and logos recruits, or if you will interpellates, an audience that is uniquely capable of judging cases, proposals, and performances reasonably. In this way Aristotle defends rhetoric as a genuine art—an intellectual virtue—against Plato's Gorgias.To arrive at this conclusion Garver draws more widely on other parts of the Aristotelian corpus than rhetorical scholars normally do. In particular, he contrasts external with internal ends by using Aristotle's metaphysical distinction between movements, processes, or behaviors (kineseis), of which the world is chock-full, and actualizations or realizations (energeiai) of capacities, which are more rare. Because rhetorical art, qua artful, is an actualization, Garver infers that it is a "practical art" and so brushes up closely against ethical-political praxis. [End Page 184]How closely? To be sure, they are not identical. Praxis actualizes our rational capacities by issuing in deeds done for their own sake rather than in an ordered series of acts whose intelligibility and worth are, in the end, measured by their outcomes or products, as in arts (poiesis) (46). For this reason a rhetor or a doctor can display artfulness by consciously misbehaving as well as by doing his or her job well, whereas willful misbehavior on the part of a moral agent automatically disbars him or her from possessing practical wisdom (phronesis) at all (46; see Nicomachean Ethics [NE] 1140b22–25). Accordingly, even though moral virtues and technical skills are both acquired by slowly internalizing norms that at first aim only at external ends (29) and are both matched to their distinctive ends through their internal rational norms, Aristotle makes it abundantly clear that "the arts, including rhetoric, do not bring the soul into a good condition" (10). They are not the wellspring or protector of the intrinsically good actions that are constituents of happiness. that role is assigned to moral virtues such as prudence, courage, liberality, and, when these are practiced in relation to others, justice and friendship.Confronting Aristotle's Ethics begins by reviewing the above account of rhetorical art in Garver's earlier book. Precisely because that account posits a greater affinity between ethical virtue and craft knowledge than most contemporary analyses of Aristotle's Nicomachean Ethics, Garver feels a need to spell out more carefully than usual why Aristotle thinks that the arts, even at their best, cannot yield the intrinsically good acts that the moral virtues do and why for Aristotle the habitual performance of just such acts is constitutive of happiness (eudaimonia). To answer these questions is the aim of the book.Garver reports that satisfactory answers are surprisingly rare even in otherwise sophisticated contemporary Aristotelian studies (5–7). Now and again he points to one reason why this might be so. Since at least the eighteenth century, Aristotle's ethical theory has been commended by sloughing off its original political integument. Even Hannah Arendt, a devotee of Aristotle's conception of the public life if ever there was one, says that public figures must leave happiness to the private lives of little people. this depoliticization of ethics has allowed contemporary commentators to evade Aristotle's burden of proof. As good readers of Aristotle they may try to distance themselves from people who think that there might be an art of happiness by which one can technically realize one's desires. (Your local Barnes and Noble will... (shrink)

Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites (...) throughout Germany. 8 ethics committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Confronting Aristotle's EthicsDavid DepewConfronting Aristotle's Ethics by Eugene Garver Chicago: University of Chicago Press, 2006. Pp. ix + 290. $49.00, cloth.Readers of this journal are likely to be familiar with Eugene Garver's 1994 Aristotle's Rhetoric: An Art of Character. The main claim advanced in that important book is that for Aristotle rhetoric is an art because it has internal norms and ends. From this, it follows (...) that although any red-blooded rhetor probably does aim at winning a case, advancing a political career, getting rich, and other external goals, what is artful in rhetorical craft (technikos), and hence expressive of the distinctive human capacity for human rationality, is timely argumentation that binds premises to actionable conclusions through displays of good character and apt emotional response. This ordered combination of ethos, pathos, and logos recruits, or if you will interpellates, an audience that is uniquely capable of judging cases, proposals, and performances reasonably. In this way Aristotle defends rhetoric as a genuine art—an intellectual virtue—against Plato's Gorgias.To arrive at this conclusion Garver draws more widely on other parts of the Aristotelian corpus than rhetorical scholars normally do. In particular, he contrasts external with internal ends by using Aristotle's metaphysical distinction between movements, processes, or behaviors (kineseis), of which the world is chock-full, and actualizations or realizations (energeiai) of capacities, which are more rare. Because rhetorical art, qua artful, is an actualization, Garver infers that it is a "practical art" and so brushes up closely against ethical-political praxis. [End Page 184]How closely? To be sure, they are not identical. Praxis actualizes our rational capacities by issuing in deeds done for their own sake rather than in an ordered series of acts whose intelligibility and worth are, in the end, measured by their outcomes or products, as in arts (poiesis) (46). For this reason a rhetor or a doctor can display artfulness by consciously misbehaving as well as by doing his or her job well, whereas willful misbehavior on the part of a moral agent automatically disbars him or her from possessing practical wisdom (phronesis) at all (46; see Nicomachean Ethics [NE] 1140b22–25). Accordingly, even though moral virtues and technical skills are both acquired by slowly internalizing norms that at first aim only at external ends (29) and are both matched to their distinctive ends through their internal rational norms, Aristotle makes it abundantly clear that "the arts, including rhetoric, do not bring the soul into a good condition" (10). They are not the wellspring or protector of the intrinsically good actions that are constituents of happiness. that role is assigned to moral virtues such as prudence, courage, liberality, and, when these are practiced in relation to others, justice and friendship.Confronting Aristotle's Ethics begins by reviewing the above account of rhetorical art in Garver's earlier book. Precisely because that account posits a greater affinity between ethical virtue and craft knowledge than most contemporary analyses of Aristotle's Nicomachean Ethics, Garver feels a need to spell out more carefully than usual why Aristotle thinks that the arts, even at their best, cannot yield the intrinsically good acts that the moral virtues do and why for Aristotle the habitual performance of just such acts is constitutive of happiness (eudaimonia). To answer these questions is the aim of the book.Garver reports that satisfactory answers are surprisingly rare even in otherwise sophisticated contemporary Aristotelian studies (5–7). Now and again he points to one reason why this might be so. Since at least the eighteenth century, Aristotle's ethical theory has been commended by sloughing off its original political integument. Even Hannah Arendt, a devotee of Aristotle's conception of the public life if ever there was one, says that public figures must leave happiness to the private lives of little people. this depoliticization of ethics has allowed contemporary commentators to evade Aristotle's burden of proof. As good readers of Aristotle they may try to distance themselves from people who think that there might be an art of happiness by which one can technically realize one's desires. (Your local Barnes and Noble will... (shrink)

: Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are (...) socially determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approach risk assessment as a technical endeavor bracket from discussion the numerous values that ground risk judgments. Possible reforms are proposed for clinical trial risk review that would render it more inclusive of the different types of risks encountered and more attuned to the priorities of trial subjects. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Searching for a Universal Ethic: Multidisciplinary, Ecumenical, and Interfaith Responses to the Catholic Natural Law Tradition ed. by John Berkman and William C. Mattison IIIStewart D. ClemSearching for a Universal Ethic: Multidisciplinary, Ecumenical, and Interfaith Responses to the Catholic Natural Law Tradition Edited by John Berkman and William C. Mattison III GRAND RAPIDS, MI: EERDMANS, 2014. 339 PP. $35.00Despite its generalist title, this book is the result of (...) a very specific and multilayered textual history. The core of the volume is the official English translation of the International Theological Commission (ITC) document In Search of a Universal Ethic: A New Look at the Natural Law, which alone composes nearly a quarter of the book's text. Following five years of work, the commission first published the document in 2009. The following year, a special session at the annual meeting of the Society of Christian Ethics was convened for the purpose of discussing the document, and this session served as the impetus for the present volume. Along with Berkman and Mattison's introductory chapter, the remainder of the book is composed of responses to the document from no less than twenty-two scholars representing a broad range of religious and philosophical commitments.If there is anything approaching a consensus among the volume's diverse respondents, it is a nearly unanimous verdict that the ITC document offers a more winsome portrayal of natural law theorizing than anything that has been promulgated in official Church documents during the last several decades. As Serge-Thomas Bonino, OP (one of the document's coauthors), explains, the commission endeavored to situate the doctrine of natural law within "a larger theological framework that is both Christological and Trinitarian" (98). Many respondents praise the document's more nuanced and open-ended analysis of the natural law—one that accommodates a wide variety of sociocultural contexts—as well as the document's clarity and boldness in articulating a Christian (and specifically Christological) interpretation of the natural law tradition.The high level of admiration bestowed on the document does not mean that it is without its detractors, however. Some of the more critical respondents maintain that, in spite of the commission's "new look" at the natural law, many of the classical objections to the doctrine still hold. Gilbert Meilaender, for example, lauds the document's Christological commitments but worries that it fails to explain how this facet of the Catholic natural law tradition can help us to develop a universal ethic on which all can agree (226). Others express doubts precisely about what is "new" in this new look at the natural law. This [End Page 202] is perhaps best reflected by Jennifer Herdt's remark that "the note of epistemological modesty repeatedly sounded by In Search of a Universal Ethic seems to ring hollow" (210). In other words, the move toward less specificity regarding moral norms may in fact render the natural law inadequate as a framework for dialogue across cultures.Given the perennial subject matter of this volume, the editors have done an excellent job of balancing a vast range of perspectives and approaches to the natural law, rendering it useful to a wide audience. The sheer number of authors could easily have resulted in a collection that reflected breadth at the expense of depth. Thankfully, however, the presence of the ITC text as the locus of discussion helps to ground the conversation in such a way that all of the authors are fruitfully engaging the same set of questions. For this reason, it is among the best volumes currently available for those who wish to engage the most creative and rigorous thinking within the natural law tradition.Stewart D. ClemUniversity of Notre DameCopyright © 2017 Society of Christian Ethics... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:“Unduly Iterative Ethical Review?”Franklin G. MillerMadam:Renée C. Fox and Nicholas A. Christakis have written a provocative article, “Perish and Publish: Non-Heart-Beating Organ Donation and Unduly Iterative Ethical Review” (KIEJ, December 1995). The language of their argument and some of the implicit assumptions on which it rests deserve critical scrutiny. They describe the articles presenting and commenting on the University of Pittsburgh protocol as “disquieting” because the (...) display “trial-and-error ethics.” To dismiss “trial-and-error ethics” implies that we antecedently possess all the moral knowledge we need to evaluate and regulate developments in medicine. Should we summarily reject experimentation in ethics, particularly with respect to complex issues involving scientific and technological changes? For if we need to reconsider and possibly revise what counts as moral knowledge, the proposing an experimental approach to the ethics of a novel practice, which is presented publicly and made open to revision, as in the Pittsburgh protocol, may be precisely the best way to proceed.Fox and Christakis resort to invidious insinuation in their criticism of ethicists who have written, and journals that have published, articles about non-heart-beating organ donation. Publication on this issue has given ethicists the opportunity of “adding numerous items to their vitae.” Their appraisal of the vitae-boosting behavior represents an interesting rhetorical specimen: “Although there is nothing inherently dishonorable about this it does create tension between two motives: conviction about the importance of perfecting ethical conduct, on the one hand, and the desire to advance one’s professional career, on the other” (p. 340). I am not sure what the authors mean by “perfecting ethical conduct.” Yet they suggest that a group of reputable scholars, who have taken diverse positions on the ethics of non-heart-beating organ donation, have come perilously close to venality.Finally, in order to avoid further legitimating what they consider to be an ethically objectionable practice, the authors advocate that journals exercise “restraint” in publishing articles about this topic. Perhaps in a future pronouncement they will enlighten us about how enforcing a publication policy that avoids the vice of “unduly iterative ethical review” might work without compromising freedom of discussion. Moral dogmatism and censorship have a long history of association.Franklin G. MillerCenter for Biomedical Ethics University of Virginia Charlottesville, VACopyright © 1996 The Johns Hopkins University Press... (shrink)

The fast growing interest in the work of university ethics review boards is evident in the proliferation of research and literature in the area. This article focuses on a Research Ethics Board (REB) in the Canadian context. In-depth, open-ended interviews with REB members and findings from a qualitative study designed to examine the ethics review of school-based research are used to illustrate points raised in the paper. The author’s experiences as academic researcher, advisor to (...) student researchers and a 3-year term as an REB member inform the discussion. Macro issues related to the general workings of the board (e.g., maintaining appropriate membership) and micro issues connected to individual REB members’ experiences of reviewing research applications are examined. The author’s goal is to contribute to a fastgrowing conversation related to the issues that influence university ethics review while drawing attention to the contribution that faculty members’ understandings of their work as REB members can make to that conversation. (shrink)

Psychologists live in a globalizing world where traditional boundaries are fading and, therefore, increasingly work with persons from diverse cultural backgrounds. The Universal Declaration of Ethical Principles for Psychologists provides a moral framework of universally acceptable ethical principles based on shared human values across cultures. The application of its moral framework in developing codes of ethics and reviewing current codes may help psychologists to respond ethically in a rapidly changing world. In this article, a model is presented to demonstrate (...) how to use the Universal Declaration as a guide for creating or reviewing a code of ethics. This model may assist psychologists in various parts of the world in establishing codes of ethics that will promote global understanding and cooperation while respecting cultural differences. The article describes the steps involved in the application of the model and provides concrete examples as well as several useful comments and suggestions. This guide for the application of the Universal Declaration may also be used for consultation, education, and training relative to the Universal Declaration of Ethical Principles for Psychologists. (shrink)

With increasing calls for global health research there is growing concern regarding the ethical challenges encountered by researchers from high-income countries (HICs) working in low or middle-income countries (LMICs). There is a dearth of literature on how to address these challenges in practice. In this article, we conduct a critical analysis of three case studies of research conducted in LMICs. We apply emerging ethical guidelines and principles specific to global health research and offer practical strategies that researchers ought to consider. (...) We present case studies in which Canadian health professional students conducted a health promotion project in a community in Honduras; a research capacity-building program in South Africa, in which Canadian students also worked alongside LMIC partners; and a community-university partnered research capacity-building program in which Ecuadorean graduate students, some working alongside Canadian students, conducted community-based health research projects in Ecuadorean communities. We examine each case, identifying ethical issues that emerged and how new ethical paradigms being promoted could be concretely applied. We conclude that research ethics boards should focus not only on protecting individual integrity and human dignity in health studies but also on beneficence and non-maleficence at the community level, explicitly considering social justice issues and local capacity-building imperatives. We conclude that researchers from HICs interested in global health research must work with LMIC partners to implement collaborative processes for assuring ethical research that respects local knowledge, cultural factors, the social determination of health, community participation and partnership, and making social accountability a paramount concern. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:“Unduly Iterative Ethical Review?”Franklin G. MillerMadam:Renée C. Fox and Nicholas A. Christakis have written a provocative article, “Perish and Publish: Non-Heart-Beating Organ Donation and Unduly Iterative Ethical Review” (KIEJ, December 1995). The language of their argument and some of the implicit assumptions on which it rests deserve critical scrutiny. They describe the articles presenting and commenting on the University of Pittsburgh protocol as “disquieting” because the (...) display “trial-and-error ethics.” To dismiss “trial-and-error ethics” implies that we antecedently possess all the moral knowledge we need to evaluate and regulate developments in medicine. Should we summarily reject experimentation in ethics, particularly with respect to complex issues involving scientific and technological changes? For if we need to reconsider and possibly revise what counts as moral knowledge, the proposing an experimental approach to the ethics of a novel practice, which is presented publicly and made open to revision, as in the Pittsburgh protocol, may be precisely the best way to proceed.Fox and Christakis resort to invidious insinuation in their criticism of ethicists who have written, and journals that have published, articles about non-heart-beating organ donation. Publication on this issue has given ethicists the opportunity of “adding numerous items to their vitae.” Their appraisal of the vitae-boosting behavior represents an interesting rhetorical specimen: “Although there is nothing inherently dishonorable about this it does create tension between two motives: conviction about the importance of perfecting ethical conduct, on the one hand, and the desire to advance one’s professional career, on the other” (p. 340). I am not sure what the authors mean by “perfecting ethical conduct.” Yet they suggest that a group of reputable scholars, who have taken diverse positions on the ethics of non-heart-beating organ donation, have come perilously close to venality.Finally, in order to avoid further legitimating what they consider to be an ethically objectionable practice, the authors advocate that journals exercise “restraint” in publishing articles about this topic. Perhaps in a future pronouncement they will enlighten us about how enforcing a publication policy that avoids the vice of “unduly iterative ethical review” might work without compromising freedom of discussion. Moral dogmatism and censorship have a long history of association.Franklin G. MillerCenter for Biomedical Ethics University of Virginia Charlottesville, VACopyright © 1996 The Johns Hopkins University Press... (shrink)

This article is a response to the challenge with which Zachary Schrag concluded his article, ‘The case against ethics review in social sciences’ − that ‘the burden of proof for its continuation rests on its defenders’ (Schrag, 2011). This article acknowledges that there is substance in the charges he lays against some reviews of social sciences and that these are of sufficient quantity and seriousness to justify his challenge. Instead of favouring abandonment of ethical review of social (...) sciences, the author of this article draws upon his experience as Research Ethics Officer for Social Sciences and Law in a research intensive UK university to identify the sources of some of the problems and suggest potential remedies. These start with reviewing the warrant for ethical review as the basis for understanding reviewer’s role concerning the core ethical issues of rigour, respect and responsibility in the proposed research. This response concludes by considering the implications of a warrant for enhancing trust between scientists and the public as the context in which ethical review is only one component in a number of ethical strategies designed to promote ethical mindfulness as integral to social science research. (shrink)

Protection of study participants is an integral function of the Institutional Review Board. Recently, great efforts were dedicated to enhance investigators’ awareness of ethical principles in conducting human research and to implement reviewing committees’ standards in Jordan to ensure the transparency, versatility, and responsibility in handling human subjects research in the country. The aim of the current study is to evaluate the awareness and attitudes of healthcare investigators in Jordan towards the structure and importance of IRBs. A questionnaire was (...) distributed to 200 investigators and graduate students from the Jordan University of Science and Technology. The majority of the responses indicated positive knowledge towards core ethics guidelines and the importance of IRBs. This includes beneficence, confidentiality, informed consent, and treating participants with respect. In addition, the majority of participants agreed on the importance of the IRB for ensuring the rights, safety, and well-being of the research subjects. Moreover, the majority of participants agreed that the IRB members should be trained on ethics regulations in conducting research and declare any conflict of interest with the investigators. On the other hand, about 30% of participants believed that being reviewed by the IRB would delay research and make it more difficult for the researcher. Jordanian investigators have good awareness of and knowledge about research ethics and the importance of IRBs, though more education is needed. (shrink)

Although well established in developed countries, Ethics review boards in the academia, and specifically for social and behavioral sciences (SBS) research, is a relatively new, and still a controversy inducing endeavor. This study explores the establishment and functioning of ERBs in Israeli academia, serving as a case study for the challenges and progress made in ensuring ethical research practices in non-medical related spheres. A purposeful sample of 46 participants was selected, comprising ERB current or past members and SBS (...) researchers, who each interacted extensively with ERB’s evaluation processes. The participants came from all eight research universities of Israel, as well as seven large public and private academic colleges. Open, semi structured In-depth interviews were conducted in order to facilitate a critical reflective stance among the various participants, exploring their experiences, behaviors and the meanings they assign to ERB processes. Our research revealed two major themes. The first is the developmental trajectories in the construction processes of ERBs in Israel, comprised of the following stages: Initiation, expansion, opposition, and acceptance and assimilation. The second was a typology of participation throughout the ERBs’ construction process. Inspired by Merton’s strain theory, this typology includes conformists, ritualists, ideologists, control-freaks, and insurgents. The findings expose a unique perspective into the initiation, establishment, and development of ERBs, which can shed light on the role of ERBs in general, as well as point out how resistance to ERBs, as well as the different reasons for championing them, affected not only ERBs form and their legitimacy, but also their interaction with researchers. (shrink)

I review this fine collection of articles on ancient ethics ranging from the Presocratics to Sextus Empiricus. Eight of the nine chapters are published here for the first time. Contributors include Charles H. Kahn on "Pre-Platonic Ethics," C. C. W. Taylor on "Platonic Ethics," Stephen Everson on "Aristotle on Nature and Value," John McDowell on "Some Issues in Aristotle's Moral Psychology," David Sedley on "The Inferential Foundations of Epicurean Ethics," T. H. Irwin on "Socratic Paradox (...) and Stoic Theory," Julia Annas on "Doing Without Objective Values: Ancient and Modern Strategies," and Susan Sauvé Meyer on "Moral Responsibility: Aristotle and After." There is also an introductory essay by the editor, Stephen Everson. I summarize and then critique each chapter in this rather lengthy review. (shrink)

Most countries, including Botswana, have established Institutional Review Boards to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income country settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana about the review of research protocols by (...) local IRBs. Data were collected using a web-based survey. This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced hig... (shrink)

Recruiting minorities into research studies requires special attention, particularly when studies involve “extra-vulnerable” participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively.

I review Gabriel Richardson Lear's excellent essay on Aristotle’s conception of the human good. She solves some long-standing problems in the interpretation of Aristotle’s ethics by drawing on resources in his natural philosophy and Plato’s conception of love. Her interpretation is a compelling and, to my mind, largely true account of Aristotle’s view. In this review, I summarize the book's main argument and then explain two fundamental points on which I have concerns.

Intellectual contribution in the form of authorship is a fundamental component of the academic career. While research has addressed questionable and harmful authorship practices, there has largely been no discussion of how U.S. academic institutions interpret and potentially mitigate such practices through the use of institution-level authorship policies. To gain a better understanding of the role of U.S. academic institutions in authorship practices, we conducted a systematic review of publicly available authorship policies for U.S. doctoral institutions, focusing on components (...) such as specification of authorship criteria, recommendations for discussing authorship, dispute resolution processes, and guidance for faculty-student collaborations. We found that only 24% of the 266 Carnegie R1 and R2 Universities had publicly available authorship policies. Within these policies, the majority specified criteria for authorship, but provided less guidance about actual processes for applying such criteria, handling authorship disputes, and managing faculty-student author teams. Further, we found that any discussion of dispute resolution practices typically lacked specificity. Recommendations grounded in these findings are offered for institutions to leverage their ability to guide the authorship process by adopting an authorship policy that acknowledges disciplinary diversity while still offering substantive guidance. (shrink)

The purpose of Sheffield’s careful study is to increase scholarly appreciation of the Symposium as a ‘substantive work in Platonic ethics’ (3). Among the book’s highlights are a persuasive response to Vlastos’ criticism of Plato on love for individuals, an eminently reasonable assessment of the evidence for and against the presence of tripartite psychology in the Symposium, and a delightful interpretation of Alcibiades’ speech at the dialogue’s end—one that reveals elements of satyr play and corroborates rather than undermines Diotima’s (...) account of erôs. My review focuses on Sheffield’s account of Socrates’ speech. She devotes four of seven chapters to it. After summarizing her main argument, I raise two concerns: one about her account of immortality, the other about her interpretation of Plato as a rational eudaimonist. (shrink)