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Forschung an und mit Menschen muss sich legitimieren, d. h. sie muss ihre wissenschaftliche Qualität, Rechtmäßigkeit und ethische Vertretbarkeit aufzeigen. Zu den Rechtfertigungsbedingungen zählt ein „günstiges“ Verhältnis von Nutzen- und Schadenpotenzialen des Forschungsvorhabens. Unabhängige Ethikkommissionen sind den Forschenden zur Seite gestellt, um sie bei der Prüfung und Sicherstellung der genannten Erfordernisse zu unterstützen. Eine zum Gebrauch durch Ethikkommissionen und Forschende entwickelte Nutzen- und Schadentaxonomie sowie ein Schema zur Systematisierung von Chancen-Risiken-Bewertungen wurde nachträglich auf alle Ethikanträge des Jahres 2006 an die (...) |
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Submission of study protocols to research ethics committees constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials. |
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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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Background The review of human participant research by Research Ethics Committees or Institutional Review Boards is a complex multi-faceted process that cannot be reduced to an algorithm. However, this does not give RECs/ IRBs permission to be inconsistent in their specific requirements to researchers or in their final opinions. In England the Health Research Authority coordinates 67 committees, and has adopted a consistency improvement plan including a process called “Shared Ethical Debate” where multiple committees review the same project. Committee reviews (...) |
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Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the (...) |
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Aims: The aims of the study were to explore expert opinion on the distinction between “research” and “audit”, and to determine the need for review by a National Health Service (NHS) Research Ethics Committee (REC). Background: Under current guidelines only “research” projects within the NHS require REC approval. Concerns have been expressed over difficulties in distinguishing between research and other types of project, and no existing guidelines appear to have been validated. The implications of this confusion include unnecessary REC applications, (...) |
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Background Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups. Discussion Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness (...) |
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Life sciences research is increasingly international and data-intensive. Researchers work in multi-jurisdictional teams or formally established research consortia to exchange data and conduct research using computation of multiple sources and volumes of data at multiple sites and through multiple pathways. Despite the internationalization and data intensification of research, the same ethics review process as applies to single-site studies in one country tends to apply to multi-site studies in multiple countries. Because of the standard requirement for multi-jurisdictional or multi-site ethics review, (...) |
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This paper reports an initiative from the National Research Ethics Service and research ethics committees in the UK to develop a shared ethical debate between committees and to promote standards of ethical review, exploring the problems and practicalities of such an approach. |
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Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable resources, difficulties of setting (...) |
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Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) |
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Disquiet about the research ethics review process has, historically, been anecdotal and often takes the form of ‘atrocity stories’ from researchers about the bureaucratic nature of the application process or inconsistency and capriciousness in decision-making. However, systematic evidence has often been lacking. We analysed 100 decision letters written by NHS research ethics committees. We found evidence of poor communication in the way in which REC decisions were conveyed to applicants. Typos and grammatical mistakes were found in almost 30% of letters; (...) |
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