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  1. Introduction: The Fogarty International Research Ethics Education and Curriculum Development Program in Historical Context.Joseph Millum, Christine Grady, Gerald Keusch & Barbara Sina - 2013 - Journal of Empirical Research on Human Research Ethics: An International Journal 8 (5):3-16.
    In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research (...)
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  • What changes are there in decisions by the Wits Human Research Ethics Committee and in process errors by research applicants between 2003 and 2015? [REVIEW]Peter Cleaton-Jones - 2016 - South African Journal of Bioethics and Law 9 (2):66-68.
    Objective. A retrospective examination of numbers of applications, decision rates, and process errors in 2015 was done for comparison with earlier studies to understand current ethics secretariat workload. Methods. In December 2015 information from committee minutes of all the meetings in 2015 was collected to quantify change in application numbers and process errors. Statistical analysis used SAS for Windows. Statistical significance was set at p<0.05. Results. There were 809 new general research applications considered in 2015. Monthly approvals at first evaluation (...)
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  • Status of national research bioethics committees in the WHO African region.Joses Kirigia, Charles Wambebe & Amido Baba-Moussa - 2005 - BMC Medical Ethics 6 (1):1-7.
    Background The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. Methods This is a descriptive study. The (...)
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  • Do research ethics committees identify process errors in applications for ethical approval?E. Angell & M. Dixon-Woods - 2009 - Journal of Medical Ethics 35 (2):130-132.
    We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.
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  • Evaluating institutional capacity for research ethics in Africa: a case study from Botswana. [REVIEW]Adnan A. Hyder, Waleed Zafar, Joseph Ali, Robert Ssekubugu, Paul Ndebele & Nancy Kass - 2013 - BMC Medical Ethics 14 (1):31.
    The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this approach in the form (...)
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  • Ethical Oversight of Research in Developing Countries.Nancy Kass, Liza Dawson & Nilsa I. Loyo-Berrios - 2003 - IRB: Ethics & Human Research 25 (2):1.
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  • Opening Closed Doors: Promoting IRB Transparency.Holly Fernandez Lynch - 2018 - Journal of Law, Medicine and Ethics 46 (1):145-158.
    Institutional Review Boards have substantial power and authority over research with human subjects, and in turn, their decisions have substantial implications for those subjects, investigators, and the public at large. However, there is little transparency about IRB processes and decisions. This article provides the first comprehensive taxonomy of what transparency means for IRBs — answering the questions “to whom, about what, and by what mechanisms?” It also explains why the status quo of nontransparency is problematic, and presents arguments for greater (...)
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  • Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?A. Nyika, W. Kilama, R. Chilengi, G. Tangwa, P. Tindana, P. Ndebele & J. Ikingura - 2009 - 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 (ERCs) across sub-Saharan Africa (...)
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  • Ethical review of health research: a perspective from developing country researchers.A. A. Hyder - 2004 - Journal of Medical Ethics 30 (1):68-72.
    Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. (...)
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  • Things may not be as expected: surprising findings when updating work load at the Wits Human Research Ethics Committee.Peter Cleaton-Jones & E. S. Grossman - 2015 - South African Journal of Bioethics and Law 8 (1):14.
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  • 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. Results Health RECs (...)
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  • 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 the REC, membership (...)
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  • Auditing the process of ethics approval for Master’s degrees at a South African university.Damian Luiz Clarke - 2014 - South African Journal of Bioethics and Law 7 (1):23.
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  • Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka.Athula Sumathipala, Sisira Siribaddana, Suwin Hewege, Manura Lekamwattage, Manjula Athukorale, Chesmal Siriwardhana, Joanna Murray & Martin Prince - 2008 - BMC Medical Ethics 9 (1):3-.
    BackgroundInternational guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.MethodsWe obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 (...)
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  • Ethical dilemmas in research in relation to ethical review: An empirical study.Gunnel Colnerud - 2014 - Research Ethics 10 (4):238-253.
    The aim of the present article is to contribute empirically derived knowledge about Swedish researchers’ experience of ethical problems, conflicts and dilemmas in their research practice in relation to the ethical vetting legislation and procedure. The study has been carried out using the critical incident technique, with researchers from various disciplines providing examples from their own research practice of problems relating to research ethics. The analysis of the researchers’ responses indicates three phenomena, partly in line with similar studies in other (...)
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  • Under-representation of developing countries in the research literature: ethical issues arising from a survey of five leading medical journals.Athula Sumathipala, Sisira Siribaddana & Vikram Patel - 2004 - BMC Medical Ethics 5 (1):1-6.
    Background It is widely acknowledged that there is a global divide on health care and health research known as the 10/90 divide. Methods A retrospective survey of articles published in the BMJ, Lancet, NEJM, Annals of Internal Medicine & JAMA in a calendar year to examine the contribution of the developing world to medical literature. We categorized countries into four regions: UK, USA, Other Euro-American countries (OEAC) and (RoW). OEAC were European countries other than the UK but including Australia, New (...)
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  • (1 other version)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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  • Research Integrity in the Context of Social Science Research in Africa.Nico Nortjé & Willem A. Hoffmann - 2019 - In Nico Nortjé, Retha Visagie & J. S. Wessels (eds.), Social Science Research Ethics in Africa. Springer Verlag. pp. 117-123.
    This chapter will provide an outline of the concept of integrity pertaining to social science research. An inclusive definition is proposed where integrity is seen as both a value as well as a virtue. Developments on the continent of Africa are listed which support the notion of research ethics and integrity, but the question is also asked, against the backdrop of well-known cases of misconduct, on how integrity can be developed. An approach is described where integrity should be internalised by (...)
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  • Mapping African ethical review committee activity onto capacity needs: The Marc initiative and hrweb's interactive database of recs in Africa.Carel Ijsselmuiden, Debbie Marais, Douglas Wassenaar & Boitumelo Mokgatla-Moipolai - 2012 - Developing World Bioethics 12 (2):74-86.
    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 (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent (...)
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  • (1 other version)Assessment of the ethical review process in sudan.Dya Eldin M. Elsayed & Nancy E. Kass - 2007 - Developing World Bioethics 7 (3):143–148.
    ABSTRACT The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the country; these committees have no institutional regulations to govern (...)
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  • Justice and medical research: A global perspective.Soloman R. Benatar - 2001 - Bioethics 15 (4):333–340.
    Economic globalization has profound implications for health. The scale of injustice at a global level, reflected in inexorably widening disparities in wealth and health, also has critical implications for health related research – in particular when the opportunities for exploiting research subjects are carefully considered. The challenge of developing universal guidelines for international clinical research is addressed against the background of a polarizing, yet interdependent, world in which all are ultimately threatened by lack of social justice. It is proposed that (...)
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  • Views of South African biomedical research ethics committee members on their own ethics review outcomes.B. Silaigwana & D. Wassenaar - 2019 - South African Journal of Bioethics and Law 12 (1):8.
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