Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada

Rwabihama, Jean-Paul; Girre, Catherine

doi:10.1136/jme.2009.033142

Cited by 12 publications

(14 citation statements)

References 14 publications

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“…Four studies described the history of African RECs (Henderson et al, 2007; Kass et al, 2007; Oyedeji, 2011; Rwabihama, Girre, & Duguet, 2010). A survey of 20 African RECs reported that 9 countries had established RECs in the 1980s, whereas the other 11 were created during the period 1995 to 2003 (Rwabihama et al, 2010). South Africa, with the oldest REC in Africa, had its first REC established at the University of Witwatersrand in 1967.…”

Section: Resultsmentioning

confidence: 99%

“…South Africa, with the oldest REC in Africa, had its first REC established at the University of Witwatersrand in 1967. The Medical Research Council in Zimbabwe was established soon thereafter in 1974 (Kass et al, 2007; Rwabihama et al, 2010). The National Health Sciences Research Committee of Malawi was established in 1988 (Henderson et al, 2007).…”

Section: Resultsmentioning

confidence: 99%

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Biomedical Research Ethics Committees in Sub-Saharan Africa

Silaigwana

Wassenaar

2015

Journal of Empirical Research on Human Research Ethics

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Research Ethics Committees (RECs) are mandated to protect human participants by conducting ethical reviews of biomedical research. To date, there is a dearth of information on the structure, functioning, and outcomes of RECs in Africa. This article reviews empirical studies investigating African RECs, with the aim of providing an overview of what is known and identifying gaps in our knowledge. We conducted a literature search of the EBSCO, PubMed, and Google Scholar electronic databases. Twenty-three empirical studies reporting on the structure, functions, and outcomes of African RECs were included in our analysis. The review yielded limited systematic data on RECs in Africa. Available empirical evidence suggests that challenges hampering the effective functioning of RECs included lack of membership diversity, scarcity of resources, insufficient training of members, inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation. Relatively little data on the review outcomes of African RECs were described. There is an ongoing need for concerted efforts from various stakeholders to support capacity development and enhancement of African RECs.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Biomedical Research Ethics Committees in Sub-Saharan Africa

Silaigwana

Wassenaar

2015

Journal of Empirical Research on Human Research Ethics

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“…Opponents of CEC and moral expertise may essentially be objecting to the idea of people who profess to have the right answer in moral situations, because: (1) they hold that there is no such objectively verifiable thing, and (2) this society respects and protects autonomous moral decision-making more highly than correct moral decision-making. Rwabihama et al ( 2010 ). Ethics committees for biomedical research in some African emerging countries: Which establishment for which independence?…”

Section: Methodsmentioning

confidence: 99%

Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review

et al. 2017

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This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a “bottom-up” perspective might give healthcare personnel opportunities to think and reflect more than a “top-down” perspective. A “bottom-up” approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a “top-down” approach risks removing such moral responsibility.

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“…Although biomedical research involving human subjects has been conducted in Africa for more than half a century, most ethics committees on the continent were created in the 2000s (Rwabihama et al, 2010). Many committees were initially established with the primary objective of reviewing international research in which both the sponsoring and hosting countries were required to review the research protocol before commencement of the research project (Rwabihama et al, 2010). Furthermore, many IRBs in Africa now have Federal Wide Assurances (FWAs), a contractual assurance with the US federal government, and an indication that institutions have likely received US research funds or have collaborated with US-funded researchers.…”

Section: Introductionmentioning

confidence: 99%

A case study of researchers’ knowledge and opinions about the ethical review process for research in Botswana

et al. 2016

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Most countries, including Botswana, have established Institutional Review Boards (IRBs) to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low-and middle-income country (LMIC) settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana (UB) about the review of research protocols by local IRBs. Data were collected using a web-based survey (SurveyMonkey 1 ). This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced high rates of approval at government ministries and UB, and generally believed that ethics review processes can help researchers themselves better understand and appreciate research ethics in general. Though only about one-quarter of respondents reported a more positive view of research ethics after interacting with the UB IRB, 56.5 percent reported no change. In contexts where IRBs have recently been established, it can be particularly important to document the perspectives of researchers in order to align expectations with capabilities, and identify areas where IRBs can improve operations. Future efforts to advance research ethics and ethical review in Botswana should include establishing research ethics training requirements and courses for researchers, increasing investment in IRBs and their training, further developing institutional and national research ethics policies, and formalizing agreements between IRBs and others involved in research oversight in the country to support coordinated review.

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Ethics committees for biomedical research in some African emerging countries: which establishment for which independence? A comparison with the USA and Canada

Abstract: The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America.

Cited by 12 publications

References 14 publications

Biomedical Research Ethics Committees in Sub-Saharan Africa

Biomedical Research Ethics Committees in Sub-Saharan Africa

Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review

A case study of researchers’ knowledge and opinions about the ethical review process for research in Botswana

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