Results for 'Ethics Committees, Research'

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  1.  65
    Health Research Ethics Committees in South Africa 12 Years Into Democracy.Myer Landon & Moodley Keymanthri - 2007 - BMC Medical Ethics 8 (1):1-8.
    Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. (...)
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  2. The Views of Members of Local Research Ethics Committees, Researchers and Members of the Public Towards the Roles and Functions of LRECs.G. Kent - 1997 - Journal of Medical Ethics 23 (3):186-190.
    BACKGROUND: It can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties-potential research participants, society, and researchers. Local Research Ethics Committees (LRECs) have a number of roles and functions in the research enterprise, but there have been some indications that LREC members, researchers and the public can have different views about these responsibilities. Any such differences are potential sources of disagreement and misunderstanding. OBJECTIVES: To (...)
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  3.  41
    Delays and Diversity in the Practice of Local Research Ethics Committees.A. H. Ahmed & K. G. Nicholson - 1996 - Journal of Medical Ethics 22 (5):263-266.
    OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received (...)
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  4.  73
    Performance of Research Ethics Committees in Spain. A Prospective Study of 100 Applications for Clinical Trial Protocols on Medicines.R. Dal-Re, J. Espada & R. Ortega - 1999 - Journal of Medical Ethics 25 (3):268-273.
    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a (...)
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  5.  49
    Responses by Four Local Research Ethics Committees to Submitted Proposals.G. Kent - 1999 - Journal of Medical Ethics 25 (3):274-277.
    BACKGROUND: There is relatively little research concerning the processes whereby Local Research Ethics Committees discharge their responsibilities towards society, potential participants and investigators. OBJECTIVES: To examine the criteria used by LRECs in arriving at their decisions concerning approval of research protocols through an analysis of letters sent to investigators. DESIGN: Four LRECs each provided copies of 50 letters sent to investigators after their submitted proposals had been considered by the committees. These letters were subjected to a (...)
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  6.  12
    Can UK NHS Research Ethics Committees Effectively Monitor Publication and Outcome Reporting Bias?Rasheda Begum & Simon Kolstoe - 2015 - BMC Medical Ethics 16 (1):1-5.
    BackgroundPublication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service research ethics committee to monitor both types of reporting bias.MethodsAs part of an internal audit we accessed research ethics database records for studies submitting (...)
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  7.  25
    Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments.Marek Czarkowski & Krzysztof Różanowski - 2009 - Science and Engineering Ethics 15 (2):201-212.
    The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (range: (...)
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  8.  19
    Views of the Process and Content of Ethical Reviews of Hiv Vaccine Trials Among Members of Us Institutional Review Boards and South African Research Ethics Committees.Robert Klitzman - 2008 - Developing World Bioethics 8 (3):207-218.
    ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to (...)
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  9.  15
    Shortcomings of Protocols of Drug Trials in Relation to Sponsorship as Identified by Research Ethics Committees: Analysis of Comments Raised During Ethical Review.Marlies van Lent, Gerard A. Rongen & Henk J. Out - 2014 - BMC Medical Ethics 15 (1):83.
    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 (...)
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  10.  19
    Impact of Three Years Training on Operations Capacities of Research Ethics Committees in Nigeria.Morenike Oluwatoyin Folayan, Aisha Adaranijo, Florita Durueke, Ademola Ajuwon, Adebayo Adejumo, Oliver Ezechi, Kola Oyedeji & Olayide Akanni - 2012 - Developing World Bioethics 12 (3):1-14.
    This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement (...)
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  11.  8
    Mapping Research Ethics Committees in Africa: Evidence of the Growth of Ethics Review of Health Research in Africa.Boitumelo Mokgatla, Carel IJsselmuiden, Doug Wassenaar & Mary Kasule - 2018 - Developing World Bioethics 18 (4):341-348.
    Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees. The urgent need for continued capacity development in Africa has necessitated research initiatives to identify existing capacity. This discussion paper describes the mapping of RECs in (...)
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  12.  11
    A Role for Research Ethics Committees in Exchanges of Human Biospecimens Through Material Transfer Agreements.Donald Chalmers, Dianne Nicol, Pilar Nicolás & Nikolajs Zeps - 2014 - Journal of Bioethical Inquiry 11 (3):301-306.
    International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs (...)
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  13.  23
    Research Ethics Committee Audit: Differences Between Committees.M. E. Redshaw, A. Harris & J. D. Baum - 1996 - Journal of Medical Ethics 22 (2):78-82.
    The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, (...)
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  14.  10
    Resource and Needs of Research Ethics Committees in Africa: Preparations for HIV Vaccine Trials.C. Milford, D. Wassenaar & C. Slack - 2005 - IRB: Ethics & Human Research 28 (2):1-9.
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  15.  78
    The Role of Research Ethics Committees in Making Decisions About Risk.Allison Ross & Nafsika Athanassoulis - 2014 - HEC Forum 26 (3):203-224.
    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 (...)
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  16. Human Research Ethics Committees in Technical Universities.David Koepsell, Willem-Paul Brinkman & Sylvia Pont - 2014 - Journal of Empirical Research on Human Research Ethics 9 (3):67-73.
    Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey (...)
     
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  17.  14
    Composition and Operation of Selected Research Ethics Review Committees in Latin America.R. Rivera & E. Ezcurra - 2000 - IRB: Ethics & Human Research 23 (5):9-12.
  18.  17
    Research Ethics Committees: Differences and Moral Judgement.Sarah J. L. Edwards, Richard Ashcroft & Simon Kirchin - 2004 - Bioethics 18 (5):408–427.
  19.  17
    Twenty Years of Human Research Ethics Committees in the Baltic States.Vilius Dranseika, Eugenijus Gefenas, Asta Cekanauskaite, Kristina Hug, Signe Mezinska, Eimantas Peicius, Vents Silis, Andres Soosaar & Martin Strosberg - 2011 - Developing World Bioethics 11 (1):48-54.
    Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries. Problems connected to (a) public availability of information, (b) management of conflicts of interest, (c) (...)
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  20.  37
    Twenty Years of Human Research Ethics Committees in the Baltic States.Vilius Dranseika, Eugenijus Gefenas, Asta Cekanauskaite, H. U. G. Kristina, Signe Mezinska, Eimantas Peicius, Vents Silis, Andres Soosaar & Martin Strosberg - 2011 - Developing World Bioethics 11 (1):48-54.
    Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries. Problems connected to (a) public availability of information, (b) management of conflicts of interest, (c) (...)
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  21.  15
    Co-Design and Implementation Research: Challenges and Solutions for Ethics Committees.Felicity Goodyear-Smith, Claire Jackson & Trisha Greenhalgh - 2015 - BMC Medical Ethics 16 (1):1-5.
    BackgroundImplementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials.DiscussionImplementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question (...)
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  22.  42
    Descriptive Ethics: A Qualitative Study of Local Research Ethics Committees in Mexico.Edith Valdez-Martinez, Bernardo Turnbull, Juan Garduno-Espinosa & John D. H. Porter - 2006 - Developing World Bioethics 6 (2):95–105.
  23.  30
    Challenges Faced by Research Ethics Committees in El Salvador: Results From a Focus Group Study.Jonathan W. Camp, Raymond C. Barfield, Virginia Rodriguez, Amanda J. Young, Ruthbeth Finerman & Miguela A. Caniza - 2009 - Developing World Bioethics 9 (1):11-17.
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  24.  40
    Regulating Human Participants Protection in Medical Research and the Accreditation of Medical Research Ethics Committees in the Netherlands.Marcel J. H. Kenter - 2009 - Journal of Academic Ethics 7 (1-2):33-43.
    The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised (...)
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  25.  42
    Research Ethics Committees: A Regional Approach.Cheryl Cox Macpherson - 1999 - Theoretical Medicine and Bioethics 20 (2):161-179.
    Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs (...)
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  26.  12
    Response to Schrag: What Are Ethics Committees for Anyway? A Defence of Social Science Research Ethics Review.Sean Jennings - 2012 - Research Ethics 8 (2):87-96.
    Zachary Schrag would like to put the burden of proof for continuation of research ethics review in the Social Sciences on those who advocate for research ethics committees (RECs), and asks that we take the concerns that he raises seriously. I separate his concerns into a principled issue and a number of pragmatic issues. The principled issue concerns the justification for having research ethics committees; the pragmatic issues concern questions such as the effectiveness of (...)
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  27.  7
    Science Review in Research Ethics Committees: Double Jeopardy?S. Humphreys, H. Thomas & R. Martin - 2014 - Research Ethics 10 (4):227-237.
    Research ethics committees ‘ members’ perceptions of their role in regard to the science of research proposals are discussed. Our study, which involved the interviewing of 20 participants from amongst the UK’s independent ethics committees, revealed that the members consider that it is the role of the REC to examine and approve the scientific adequacy of the research – and this notwithstanding the fact that a more competent body will already have done this and even (...)
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  28.  18
    The Contribution and Attitudes of Research Ethics Committees to Complete Registration and Non-Selective Reporting of Clinical Trials: A European Survey.Daniel Strech, Jasper Littmann & on Behalf of the Open Consortium - 2016 - Research Ethics 12 (3):123-136.
    Background: For many years, studies have shown that the results of clinical trials are often published or reported selectively with a statistically significant bias in favour of positive trial results. Trial registration as a precondition for publication had only limited effects on current practice. Results of trials which were approved by research ethics committees are often published only partially, with a substantial time lag or not at all. This study examined existing procedures of RECs in the European Union (...)
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  29.  46
    Ethical Review of Action Research: The Challenges for Researchers and Research Ethics Committees.Leslie Gelling & Carol Munn-Giddings - 2011 - Research Ethics 7 (3):100-106.
    Action research has repeatedly demonstrated how it can facilitate problem solving and change in many settings through a process of collaboration which is driven by the community at the heart of the research. The ethical review of action research can be challenging for action researchers and research ethics committees. This paper explores how seven ethical principles can be used by action researchers and research ethics committees as the basis for ethical review. This paper (...)
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  30.  52
    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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  31.  6
    The Value of Sharing Genomic Findings with Research Ethics Committees.Angeliki Kerasidou - 2017 - Research Ethics 13 (2):59-64.
    The role of ethics committees is to protect and safeguard the rights and welfare of participants, and promote good research by providing ethical guidance to researchers. In order for ethics committees to fulfil their role and obligations, they need to have adequate understanding of the science and scientific methods used in research. Genomics is a novel and rapidly evolving research field, and identifying the ethical issues raised by it is not straightforward. Limited understanding of, and (...)
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  32.  8
    Lay Members of New Zealand Research Ethics Committees: Who and What Do They Represent?Helen Gremillion, Martin Tolich & Ralph Bathurst - 2015 - Research Ethics 11 (2):82-97.
    Since the 1988 Cartwright Inquiry, lay members of ethics committees have been tasked with ensuring that ordinary New Zealanders are not forgotten in ethical deliberations. Unlike Institutional Review Boards in North America, where lay members constitute a fraction of ethics committee membership, 50% of most New Zealand ethics committees are comprised of lay members. Lay roles are usually defined in very broad terms, which can vary considerably from committee to committee. This research queries who lay representatives (...)
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  33.  4
    Rethinking Research Ethics Committees in Low- and Medium-Income Countries.Luchuo Engelbert Bain, Ikenna Desmond Ebuenyi, Nkoke Clovis Ekukwe & Paschal Kum Awah - 2018 - Research Ethics 14 (1):1-7.
    Key historical landmark research malpractice scandals that shocked the international community were the origin of the institution of ethics review prior to carrying out research involving humans. Nonetheless, it is plausible that unethical research is ongoing or may have been conducted in recent times that has escaped public notice, especially in the vulnerable low- and middle-income country contexts. The basic constitution of these committees at some point has not been clearly defined, with most scientists declaring political (...)
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  34.  19
    The Risk-Benefit Task of Research Ethics Committees: An Evaluation of Current Approaches and the Need to Incorporate Decision Studies Methods. [REVIEW]Johannes J. M. Van Delden Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers - 2012 - BMC Medical Ethics 13 (1):6.
    BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; (...)
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  35.  25
    How Do We Know That Research Ethics Committees Are Really Working? The Neglected Role of Outcomes Assessment in Research Ethics Review.Carl H. Coleman & Marie-Charlotte Bouësseau - 2008 - BMC Medical Ethics 9 (1):6-.
    BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts (...)
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  36.  41
    Manual for Research Ethics Committees.Sue Eckstein (ed.) - 2003 - Cambridge University Press.
    The sixth edition of the Manual for Research Ethics Committees is a unique compilation of legal and ethical guidance which will prove invaluable for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic (...)
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  37.  10
    The Structure of Ethics Review: Expert Ethics Committees and the Challenge of Voluntary Research Euthanasia.Julian Savulescu - 2018 - Journal of Medical Ethics 44 (7):491-493.
    In 2002, I wrote an editorial in this Journal arguing that it was time to review the structure and function of ethics committees in the USA, Australia and the UK.1 This followed the deaths of Ellen Roche and Jesse Gelsinger, which were at least in significant part due to the poor functioning of research ethics committees in the USA.2 In the case of Ellen Roche, it was the failure to require a systematic review of the existing literature (...)
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  38.  37
    Protecting Vulnerable Research Participants: A Foucault-Inspired Analysis of Ethics Committees.T. I. Juritzen, H. Grimen & K. Heggen - 2011 - Nursing Ethics 18 (5):640-650.
    History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and (...)
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  39.  18
    Research Ethics Committees and Paternalism.S. J. L. Edwards - 2004 - Journal of Medical Ethics 30 (1):88-91.
    In this paper the authors argue that research ethics committees should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: competent (...)
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  40.  20
    Factors Influencing the Effectiveness of Research Ethics Committees.C. A. Schuppli & D. Fraser - 2007 - Journal of Medical Ethics 33 (5):294-301.
    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 (...)
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  41.  19
    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 (...)
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  42.  8
    Ethics Committees. Research Ethics: Beyond the Guidelines.C. C. Cc Macpherson - 2001 - Developing World Bioethics 1 (1):57.
    There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects.
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  43. Standards for Research Ethics Committees: Purpose, Problems and the Possibilities of Other Approaches.H. Davies, F. Wells & M. Czarkowski - 2009 - Journal of Medical Ethics 35 (6):382-383.
    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, (...)
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  44.  13
    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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  45.  15
    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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  46.  13
    Research Involving Adults Who Lack Capacity: How Have Research Ethics Committees Interpreted the Requirements?M. Dixon-Woods & E. L. Angell - 2009 - Journal of Medical Ethics 35 (6):377-381.
    Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Regulations”). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental (...)
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  47.  20
    Identifying Structures, Processes, Resources and Needs of Research Ethics Committees in Egypt.Hany Sleem, Samer S. El-Kamary & Henry J. Silverman - 2010 - BMC Medical Ethics 11 (1):12-.
    Background: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of (...)
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  48.  8
    Reviewing Code Consistency is Important, but Research Ethics Committees Must Also Make a Judgement on Scientific Justification, Methodological Approach and Competency of the Research Team.Samantha Trace & Simon Kolstoe - 2018 - Journal of Medical Ethics 44 (12):874-875.
    We have followed with interest the commentaries arising from Moore and Donnellys1 argument that authorities in charge of research ethics committees should focus primarily on establishing code-consistent reviews.1 We broadly agree with Savulescu’s2 argument that ethics committees should become more expert, but in a different way and for a different reason. We have recently been working with the UK Health Research Authority analysing the outcomes of their ‘Shared Ethical Debate’ exercises.3 Each ShED exercise involves the circulation (...)
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  49.  6
    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 (...)
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  50.  24
    Non-Therapeutic Research with Minors: How Do Chairpersons of German Research Ethics Committees Decide?C. Lenk - 2004 - Journal of Medical Ethics 30 (1):85-87.
    Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by local research ethics committees . The current study has been designed to document and evaluate decisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. The authors’ purpose was to examine whether non-therapeutic research was acceptable for chairpersons at all, and whether there was certainty on how to decide in research trials involving more than minimal risk.Design: In (...)
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