Search results for 'Ethics committees' (try it on Scholar)

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  1.  57
    Keymanthri Moodley & Landon Myer (2007). Health Research Ethics Committees in South Africa 12 Years Into Democracy. 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.  86
    G. Kent (1997). The Views of Members of Local Research Ethics Committees, Researchers and Members of the Public Towards the Roles and Functions of LRECs. 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 compare the views (...)
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  3.  11
    Marek Czarkowski & Krzysztof Różanowski (2009). Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments. 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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  4.  3
    J. Simek, L. Zamykalova & M. Mesanyova (2010). Ethics Committee or Community? Examining the Identity of Czech Ethics Committees in the Period of Transition. 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 (...)
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  5.  36
    G. Kent (1999). Responses by Four Local Research Ethics Committees to Submitted Proposals. 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 content (...)
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  6.  59
    R. Dal-Re, J. Espada & R. Ortega (1999). Performance of Research Ethics Committees in Spain. A Prospective Study of 100 Applications for Clinical Trial Protocols on Medicines. 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 (...)
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  7.  26
    A. H. Ahmed & K. G. Nicholson (1996). Delays and Diversity in the Practice of Local Research Ethics Committees. 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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  8.  13
    M. Hayry (1998). Ethics Committees, Principles and Consequences. Journal of Medical Ethics 24 (2):81-85.
    When ethics committees evaluate the research proposals submitted to them by biomedical scientists, they can seek guidance from laws and regulations, their own beliefs, values and experiences, and from the theories of philosophers. The starting point of this paper is that philosophers can only be helpful to the members of ethics committees if they take into account in their models both the basic moral intuitions that most of us share and the consequences of people's choices. A (...)
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  9.  5
    Anna C. Zielinska (2015). Moral Principles and Ethics Committees: A Case Against Bioethical Theories. Ethics and Social Welfare 9 (3):269-279.
    This paper argues that the function of moral education in the biomedical context should be exactly the same as in a general, philosophical framework: it should not provide ready-to-use kits of moral principles; rather, it must show the history, epistemology and conceptual structure of moral theories that would enable those who have to make decisions to be as informed and as responsible as possible. If this complexity cannot be attained, an incomplete product—i.e. bioethics or bioethical principles—should not be seen as (...)
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  10.  7
    Svitlana V. Pustovit (2006). Some Methodological Aspects of Ethics Committees' Expertise: The Ukrainian Example. Science and Engineering Ethics 12 (1):85-94.
    Today local, national and international ethics committees have become an effective means of social regulation in many European countries. Science itself is an important precondition for the development of bioethical knowledge and ethics expertise. Cultural, social, historical and religious preconditions can facilitate different forms and methods of ethics expertise in each country. Ukrainian ethics expertise has some methodological problems connected with its socio-cultural, historical, science and philosophy development particularities. In this context, clarification of some common (...)
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  11.  4
    Rasheda Begum & Simon Kolstoe (2015). Can UK NHS Research Ethics Committees Effectively Monitor Publication and Outcome Reporting Bias? 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 an end (...)
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  12.  4
    Marek Czarkowski, Katarzyna Kaczmarczyk & Beata Szymańska (2015). Hospital Ethics Committees in Poland. Science and Engineering Ethics 21 (6):1525-1535.
    According to UNESCO guidelines, one of the four forms of bioethics committees in medicine are the Hospital Ethics Committees. The purpose of this study was to evaluate how the above guidelines are implemented in real practice. There were 111 hospitals selected out of 176 Polish clinical hospitals and hospitals accredited by Center of Monitoring Quality in Health System. The study was conducted by the survey method. There were 56 hospitals that responded to the survey. The number of (...)
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  13.  1
    Marlies van Lent, Gerard A. Rongen & Henk J. Out (2014). Shortcomings of Protocols of Drug Trials in Relation to Sponsorship as Identified by Research Ethics Committees: Analysis of Comments Raised During Ethical Review. 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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  14.  14
    Reidar Pedersen, Victoria Akre & Reidun Førde (2009). Barriers and Challenges in Clinical Ethics Consultations: The Experiences of Nine Clinical Ethics Committees. Bioethics 23 (8):460-469.
    Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also (...)
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  15.  8
    Robert Klitzman (2008). 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. 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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  16.  23
    Linda Farber Post (2007). Handbook for Health Care Ethics Committees. Johns Hopkins University Press.
    The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the (...)
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  17.  8
    Morenike Oluwatoyin Folayan, Aisha Adaranijo, Florita Durueke, Ademola Ajuwon, Adebayo Adejumo, Oliver Ezechi, Kola Oyedeji & Olayide Akanni (2012). Impact of Three Years Training on Operations Capacities of Research Ethics Committees in Nigeria. 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 in the (...)
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  18.  13
    Guy Lebeer (ed.) (2002). Ethical Function in Hospital Ethics Committees. Ios Press.
    IOS Prexs, 2002 Introduction This book is the final project report of the BIOMED II project Ethical Function in Hospital Ethics Committees Commission,-2001 ...
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  19.  12
    Alice Gaudine, Marianne Lamb, Sandra LeFort & Linda Thorne (2011). The Functioning of Hospital Ethics Committees: A Multiple-Case Study of Four Canadian Committees. [REVIEW] HEC Forum 23 (3):225-238.
    A multiple-case study of four hospital ethics committees in Canada was conducted and data collected included interviews with key informants, observation of committee meetings and ethics-related hospital documents, such as policies and committee minutes. We compared the hospital committees in terms of their structure, functioning and perceptions of key informants and found variation in the dimensions of empowerment, organizational culture of ethics, breadth of ethics mandate, achievements, dynamism, and expertise.
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  20.  7
    Brian S. Marcus, Gary Shank, Jestin N. Carlson & Arvind Venkat (2015). Qualitative Analysis of Healthcare Professionals’ Viewpoints on the Role of Ethics Committees and Hospitals in the Resolution of Clinical Ethical Dilemmas. HEC Forum 27 (1):11-34.
    Ethics consultation is a commonly applied mechanism to address clinical ethical dilemmas. However, there is little information on the viewpoints of health care providers towards the relevance of ethics committees and appropriate application of ethics consultation in clinical practice. We sought to use qualitative methodology to evaluate free-text responses to a case-based survey to identify thematically the views of health care professionals towards the role of ethics committees in resolving clinical ethical dilemmas. Using an (...)
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  21.  23
    Jean-Claude Chevrolet & Bara Ricou (2009). Hospital Clinical Ethics Committees. The Geneva Experience - Switzerland. Diametros 22:21-38.
    Hospital ethics committees were created in the United States of America in the 1970s. Their aims were the education of the hospital personnel in the field of ethics, the development of policies and the publication of guidelines concerning ethical issues, as well as consultations and case reviews of hospitalized patients when an ethical concern was present. During the last thirty years, these committees disseminated, particularly in Western Europe. In this manuscript, we describe the benefit, but also (...)
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  22.  20
    Leah McClimans, Anne-Marie Slowther & Michael Parker (2012). Can UK Clinical Ethics Committees Improve Quality of Care? HEC Forum 24 (2):139-147.
    Failings in patient care and quality in NHS Trusts have become a recurring theme over the past few years. In this paper, we examine the Care Quality Commission’s Guidance about Compliance : Essential Standards of Quality and Safety and ask how NHS Trusts might be better supported in fulfilling the regulations specified therein. We argue that clinical ethics committees (CECs) have a role to play in this regard. We make this argument by attending to the many ethical elements (...)
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  23.  20
    Caterina Caminiti, Francesca Diodati, Arianna Gatti, Saverio Santachiara & Sandro Spinsanti (2011). Current Functions of Italian Ethics Committees: A Cross-Sectional Study. Bioethics 25 (4):220-227.
    Background: The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of Ethics Committees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross-sectional study aims to give an overview of the different types of activities of Italian ECs and favour discussion (...)
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  24.  5
    Donald Chalmers, Dianne Nicol, Pilar Nicolás & Nikolajs Zeps (2014). A Role for Research Ethics Committees in Exchanges of Human Biospecimens Through Material Transfer Agreements. 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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  25.  10
    Andrea Dörries, Pierre Boitte, Ana Borovecki, Jean-Philippe Cobbaut, Stella Reiter-Theil & Anne-Marie Slowther (2011). Institutional Challenges for Clinical Ethics Committees. HEC Forum 23 (3):193-205.
    Clinical ethics committees (CECs) have been developing in many countries since the 1980s, more recently in the transitional countries in Eastern Europe. With their increasing profile they are now faced with a range of questions and challenges regarding their position within the health care organizations in which they are situated: Should CECs be independent bodies with a critical role towards institutional management, or should they be an integral part of the hospital organization? In this paper, we discuss the (...)
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  26.  4
    Dr Martin Tolich & Kate Mary Baldwin (2005). Unequal Protection for Patient Rights: The Divide Between University and Health Ethics Committees. [REVIEW] Journal of Bioethical Inquiry 2 (1):34-40.
    Despite recommendations from the Cartwright Report ethical review by health ethics committees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health researchers (...)
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  27.  10
    Simon Clarke (2005). Two Models of Ethics Committees. Journal of Bioethical Inquiry 2 (1):41-47.
    A distinction is made between two models of ethics committees. According to the Mirror Model, ethics committees ought to reflect the values of society. The Critical Model says committees are to critically examine these standards rather than merely reflect them. It is argued that the Critical Model should be accepted because a society's ethical standards can be mistaken and a society that has Critical rather than merely Mirror ethics committees is more likely to (...)
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  28.  8
    D. Micah Hester & Toby Schonfeld (eds.) (2012). Guidance for Healthcare Ethics Committees. Cambridge University Press.
    Introduction to healthcare ethics committees / D. Micah Hester and Toby Schonfeld -- Brief introduction to ethics and ethical theory / D. Micah Hester and Toby Schonfeld -- Ethics committees and the law / Stephen Latham -- Cultural and ...
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  29.  31
    Eleanor Updale (2009). The Role of Clinical Ethics Committees. Diametros 22:116-123.
    Over the past 15 years or so, Clinical Ethics Committees (CECs) have been established in many healthcare settings in the UK. How do they work, who sits on them, and what do they discuss? How formal should they be? Should their decisions be binding on clinicians, or purely advisory? Should they offer their services to patients and their families too? Are they valuable additions to clinical support, or simply intellectual talking-shops for their members? Should other countries set up (...)
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  30.  20
    A. Nyika, W. Kilama, R. Chilengi, G. Tangwa, P. Tindana, P. Ndebele & J. Ikingura (2009). Composition, Training Needs and Independence of Ethics Review Committees Across Africa: Are the Gate-Keepers Rising to the Emerging Challenges? Journal of Medical Ethics 35 (3):189-193.
    Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (...)
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  31.  5
    C. Milford, D. Wassenaar & C. Slack (2005). Resource and Needs of Research Ethics Committees in Africa: Preparations for HIV Vaccine Trials. IRB: Ethics & Human Research 28 (2):1-9.
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  32.  10
    M. E. Redshaw, A. Harris & J. D. Baum (1996). Research Ethics Committee Audit: Differences Between Committees. 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, timing and (...)
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  33.  7
    Allison Ross & Nafsika Athanassoulis (2014). The Role of Research Ethics Committees in Making Decisions About Risk. 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 which the role of (...)
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  34. Ronald E. Cranford & A. Edward Doudera (eds.) (1984). Institutional Ethics Committees and Health Care Decision Making. Health Administration Press.
     
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  35.  11
    Vilius Dranseika, Eugenijus Gefenas, Asta Cekanauskaite, H. U. G. Kristina, Signe Mezinska, Eimantas Peicius, Vents Silis, Andres Soosaar & Martin Strosberg (2011). Twenty Years of Human Research Ethics Committees in the Baltic States. 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) REC composition and (...)
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  36.  1
    Vilius Dranseika, Eugenijus Gefenas, Asta Cekanauskaite, Kristina Hug, Signe Mezinska, Eimantas Peicius, Vents Silis, Andres Soosaar & Martin Strosberg (2011). Twenty Years of Human Research Ethics Committees in the Baltic States. 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) REC composition and (...)
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  37.  6
    Sarah J. L. Edwards, Richard Ashcroft & Simon Kirchin (2004). Research Ethics Committees: Differences and Moral Judgement. Bioethics 18 (5):408–427.
  38.  19
    Edith Valdez-martinez, Bernardo Turnbull, Juan Garduño-espinosa & John D. H. Porter (2006). Descriptive Ethics: A Qualitative Study of Local Research Ethics Committees in Mexico. Developing World Bioethics 6 (2):95–105.
  39.  6
    Pierre Effa, Achille Massougbodji, Francine Ntoumi, François Hirsch, Henri Debois, Marissa Vicari, Assetou Derme, Jacques Ndemanga-kamoune, Joseph Nguembo, Benido Impouma, Jean-paul Akué, Armand Ehouman, Alioune Dieye & Wen Kilama (2007). Ethics Committees in Western and Central Africa: Concrete Foundations. Developing World Bioethics 7 (3):136–142.
    The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines fo.
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  40.  15
    Donna Dickenson (2006). Gender and Ethics Committees: Where's the 'Different Voice'? Bioethics 20 (3):115–124.
  41.  9
    Charlotte McDaniel (2010). Assessing Physicians' Roles on Health Care Ethics Committees. HEC Forum 22 (4):275-286.
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  42.  8
    Jonathan W. Camp, Raymond C. Barfield, Virginia Rodriguez, Amanda J. Young, Ruthbeth Finerman & Miguela A. Caniza (2009). Challenges Faced by Research Ethics Committees in El Salvador: Results From a Focus Group Study. Developing World Bioethics 9 (1):11-17.
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  43. Kenneth M. Boyd (1995). Ethical Review of Research Involving Animals a Role for Instiutional Ethics Committees? Boyd Group.
     
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  44. John O. Christensen (1991). Medical Ethics Committees: A Selective Bibliography of Recent References. Vance Bibliographies.
     
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  45. D. Micah Hester (ed.) (2008). Ethics by Committee: A Textbook on Consultation, Organization, and Education for Hospital Ethics Committees. Rowman & Littlefield Pub..
     
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  46.  3
    Felicity Goodyear-Smith, Claire Jackson & Trisha Greenhalgh (2015). Co-Design and Implementation Research: Challenges and Solutions for Ethics Committees. 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 framing, research design (...)
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  47. David Koepsell, Willem-Paul Brinkman & Sylvia Pont (2014). Human Research Ethics Committees in Technical Universities. 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 of the top 50 (...)
     
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  48.  31
    Marcel J. H. Kenter (2009). Regulating Human Participants Protection in Medical Research and the Accreditation of Medical Research Ethics Committees in the Netherlands. 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 arrangement since most research (...)
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  49.  7
    Hans-Peter Graf (2013). Are the Votes of Ethics Committees in Germany for the Protection of Clinical Study Trial Subjects “Sovereign Acts?”. Science and Engineering Ethics 19 (2):341-354.
    A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethics committees in Germany can perform their task of providing expert opinions for clinical research. The so-called “revaluation” of the Medical Device Law Deutsches Medizinproduktegesetz—MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethics committees are now seen as being sub-organs of the state medical associations or the medical faculties (...)
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  50.  2
    Johannes J. M. Van Delden Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers (2012). The Risk-Benefit Task of Research Ethics Committees: An Evaluation of Current Approaches and the Need to Incorporate Decision Studies Methods. [REVIEW] 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 (...)
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