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  1. 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.
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  • Legislative regulation and ethical governance of medical research in different European Union countries.Piret Veerus, Joel Lexchin & Elina Hemminki - 2014 - Journal of Medical Ethics 40 (6):409-413.
    Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states (...)
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  • Ethics Committee or Community? examining the identity of Czech Ethics Committees in the period of transition.J. Simek, L. Zamykalova & M. Mesanyova - 2010 - Journal of Medical Ethics 36 (9):548-552.
    Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research team took part at six regular voluntary meetings (...)
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  • Research ethics committees: the role of ethics in a regulatory authority.S. McGuinness - 2008 - Journal of Medical Ethics 34 (9):695-700.
    This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.
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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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  • Clinical Ethics Consultation in the Transition Countries of Central and Eastern Europe.Marcin Orzechowski, Maximilian Schochow & Florian Steger - 2020 - Science and Engineering Ethics 26 (2):833-850.
    Since 1989, clinical ethics consultation in form of hospital ethics committees was established in most of the transition countries of Central and Eastern Europe. Up to now, the similarities and differences between HECs in Central and Eastern Europe and their counterparts in the U.S. and Western Europe have not been determined. Through search in literature databases, we have identified studies that document the implementation of clinical ethics consultation in Central and Eastern Europe. These studies have been analyzed under the following (...)
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  • How local IRBs view central IRBs in the US.Robert Klitzman - 2011 - BMC Medical Ethics 12 (1):13.
    Background: Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear. Methods: I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. Results: These interviewees had often interacted with (...)
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  • Scandals, Ethics, and Regulatory Change in Biomedical Research.Adam Hedgecoe - 2017 - Science, Technology, and Human Values 42 (4):577-599.
    This paper explores how a particular form of regulation—prior ethical review of research—developed over time in a specific context, testing the claims of standard explanations for such change against more recent theoretical approaches to institutional changes, which emphasize the role of gradual change. To makes its case, this paper draws on archival and interview material focusing on the research ethics review system in the UK National Health Service. Key insights center on the minimal role scandals play in shaping changes in (...)
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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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