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  1. Identifying and Addressing Nonrational Processes in REB Ethical Decision-Making.Simon Nuttgens - 2021 - Research Ethics 17 (3):328-345.
    Ethical decision-making is inherent to the research ethics committee deliberation process. While ethical codes, regulations, and research standards are indispensable in guiding this process,...
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  • Is Ethical Expertise Possible?Jukka Varelius - 2008 - Medicine Health Care and Philosophy 11 (2):127-132.
    Services of ethics committees are nowadays commonly used in such various spheres of life as health care, public administration, business, law, engineering, and scientific research. It is taken that as their members have expertise in ethics, these committees can have valuable contributions to make in solving practical moral problems. It has, however, also been maintained that it is simply absurd to claim that one has some special knowledge and skills in moral matters; in connection with moral questions there is no (...)
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  • The Role, Remit and Function of the Research Ethics Committee — 1. The Rationale for Ethics Review of Research by Committee.Sarah J. L. Edwards - 2009 - Research Ethics 5 (4):147-150.
    This is the first in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. The first considers the rationale for having ethics review by committee at all; seeking to explain why ethics committees, as we currently have them, are so important to the wider system of governing research.
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  • The Role, Remit and Function of the Research Ethics Committee — 5. Collective Decision-Making and Research Ethics Committees.Sarah Jl Edwards - 2011 - Research Ethics 7 (1):19-23.
    Part 5, the concluding essay in the series describing and discussing the role, remit and function of research ethics committees, bases an enquiry into the nature of decision-making by research ethics committees on the processes followed by the committees in their deliberations leading to the final outcome.
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  • Variation in University Research Ethics Review: Reflections Following an Inter-University Study in England.Claudia Vadeboncoeur, Nick Townsend, Charlie Foster & Mark Sheehan - 2016 - Research Ethics 12 (4):217-233.
    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 (...)
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  • IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence-Based Research Ethics Review.Emily E. Anderson & James M. DuBois - 2012 - Journal of Law, Medicine and Ethics 40 (4):951-969.
    Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...)
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  • An Alternative University-Wide Model for the Ethical Review of Human Subject Research.David Hunter - 2006 - Research Ethics 2 (2):47-50.
    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 (...)
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  • A Plea for Consistency in Ethical Review.David D. Pothier & Corné-Louise Bredenkamp - 2006 - Research Ethics 2 (3):109-110.
    When considering submissions ethics committees should be consistent in all aspects of their review. A wide variation in performance is likely to result in the unfair dismissal of good research on the one hand with inadequate ethical review on the other, neither of which is acceptable. The recent annual reports for UK MRECs suggest that the level of unfavourable opinion ranges from 6.9% to 24.2% Although a certain level of inconsistency is inherent in the system of ethical review there is (...)
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  • The Case Against Ethics Review in the Social Sciences.Zachary M. Schrag - 2011 - Research Ethics 7 (4):120-131.
    For decades, scholars in the social sciences and humanities have questioned the appropriateness and utility of prior review of their research by human subjects' ethics committees. This essay seeks to organize thematically some of their published complaints and to serve as a brief restatement of the major critiques of ethics review. In particular, it argues that 1) ethics committees impose silly restrictions, 2) ethics review is a solution in search of a problem, 3) ethics committees lack expertise, 4) ethics committees (...)
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  • In Defence of Governance: Ethics Review and Social Research.Mark Sheehan, Michael Dunn & Kate Sahan - 2018 - Journal of Medical Ethics 44 (10):710-716.
    There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake—protecting researchers’ freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy—raise relevant ethical considerations that are reasonably (...)
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  • Evaluation of the Work of Hospital Districts’ Research Ethics Committees in Finland: Table 1.Ritva Halila - 2014 - Journal of Medical Ethics 40 (12):866-868.
  • Should Research Ethics Committees Be Told How to Think?G. M. Sayers - 2007 - Journal of Medical Ethics 33 (1):39-42.
    Research ethics committees are charged with providing an opinion on whether research proposals are ethical. These committees are overseen by a central office that acts for the Department of Health and hence the State. An advisory group has recently reported back to the Department of Health, recommending that it should deal with inconsistency in the decisions made by different RECs. This article questions the desirability and feasibility of questing for consistent ethical decisions.
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  • Consistency in Decision Making by Research Ethics Committees: A Controlled Comparison.E. Angell, A. J. Sutton, K. Windridge & M. Dixon-Woods - 2006 - Journal of Medical Ethics 32 (11):662-664.
    There has been longstanding interest in the consistency of decisions made by research ethics committees in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An (...)
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  • Research Ethics Committees in Europe: Implementing the Directive, Respecting Diversity.A. Hedgecoe - 2006 - Journal of Medical Ethics 32 (8):483-486.
    With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four cases, (...)
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  • The Job of ‘Ethics Committees’.Andrew Moore & Andrew Donnelly - 2018 - Journal of Medical Ethics 44 (7):481-487.
    What should authorities establish as the job of ethics committees and review boards? Two answers are: review of proposals for consistency with the duly established and applicable code and review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and (...)
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  • Is 'Inconsistency' in Research Ethics Committee Decision-Making Really a Problem? An Empirical Investigation and Reflection.E. L. Angell, C. J. Jackson, R. E. Ashcroft, A. Bryman, K. Windridge & M. Dixon-Woods - 2007 - Clinical Ethics 2 (2):92-99.
    Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research (...)
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  • Reassessing the Role of the Biomedical Research Ethics Committee.Merryn Ekberg - 2012 - Journal of Academic Ethics 10 (4):335-352.
    The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed (...)
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  • National Human Research Ethics: A Preliminary Comparative Case Study of Germany, Great Britain, Romania, and Sweden.Bernard Gallagher, Anne H. Berman, Justyna Bieganski, Adele D. Jones, Liliana Foca, Ben Raikes, Johanna Schiratzki, Mirjam Urban & Sara Ullman - 2016 - Ethics and Behavior 26 (7):586-606.
    Although international research is increasing in volume and importance, there remains a dearth of knowledge on similarities and differences in “national human research ethics”, that is, national ethical guidelines, Institutional Review Boards, and research stakeholder’ ethical attitudes and behaviors. We begin to address this situation by reporting upon our experiences in conducting a multinational study into the mental health of children who had a parent/carer in prison. The study was conducted in 4 countries: Germany, Great Britain, Romania, and Sweden. Data (...)
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  • Defining Financial Conflicts and Managing Research Relationships: An Analysis of University Conflict of Interest Committee Decisions.Elizabeth A. Boyd & Lisa A. Bero - 2007 - Science and Engineering Ethics 13 (4):415-435.
    Despite a decade of federal regulation and debate over the appropriateness of financial ties in research and their management, little is known about the actual decision-making processes of university conflict of interest (COI) committees. This paper analyzes in detail the discussions and decisions of three COI committees at three public universities in California. University committee members struggle to understand complex financial relationships and reconcile institutional, state, and federal policies and at the same time work to protect the integrity of the (...)
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  • Empirical Assessments of Clinical Ethics Services: Implications for Clinical Ethics Committees.Laura Williamson - 2007 - Clinical Ethics 2 (4):187-192.
    The need to evaluate the performance of clinical ethics services is widely acknowledged although work in this area is more developed in the United States. In the USA many studies that assess clinical ethics services have utilized empirical methods and assessment criteria. The value of these approaches is thought to rest on their ability to measure the value of services in a demonstrable fashion. However, empirical measures tend to lack ethical content, making their contribution to developments in ethical governance unclear. (...)
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  • Is Ethical Expertise Possible?Jukka Varelius - 2008 - Medicine, Health Care and Philosophy 11 (2):127-132.
    Services of ethics committees are nowadays commonly used in such various spheres of life as health care, public administration, business, law, engineering, and scientific research. It is taken that as their members have expertise in ethics, these committees can have valuable contributions to make in solving practical moral problems. It has, however, also been maintained that it is simply absurd to claim that one has some special knowledge and skills in moral matters; in connection with moral questions there is no (...)
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