Applying Research Ethics Guidelines: The View from a Sub-Saharan Research Ethics Committee

Henderson, Gail E.; Corneli, Amy; Mahoney, David B.; Nelson, Daniel K.; Mwansambo, Charles

doi:10.1525/jer.2007.2.2.41

Cited by 13 publications

(15 citation statements)

References 27 publications

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“…There was substantial methodological heterogeneity as most studies did not measure the same variables, thus precluding rigorous comparison of outcomes of most studies. The sample of RECs described in each article reviewed varied from 1 (Henderson, Corneli, Mahoney, Nelson, & Mwansambo, 2007) to 31 in 18 countries (Nyika, Kilama, Chilengi, et al, 2009; Nyika, Kilama, Tangwa, et al, 2009).…”

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%

“…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).…”

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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“…The interpretation and application of ethical principles may differ from one society to another. This is not limited to the situation in the Middle East, but also to other areas in the developing world, such as Africa [29]. Issues such as research on women, informed consent, and breaches of confidentiality require more attention in the guidelines and applications of research in the Middle East [25,28].…”

Section: Discussionmentioning

confidence: 99%

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

2012

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BackgroundResearch ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents.MethodsThirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others.ResultsThis study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics.ConclusionsRecently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines.

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“…Publication authorship, the named principal investigators and grant holders for funding applications, staff remuneration policies, tax exemption for foreign researchers and the ownership of samples and data have all been presented as areas where current inequalities undermine equal partnerships and collaborations [ 14 , 15 , 16 ]. It has been argued, that the term ‘collaboration’ can sometimes mask or exacerbate such problems [ 17 , 18 ]. For instance, a recent examination of publications, resulting from global health research collaborations between American and European scientists and those in Central Africa, found that the most frequent role for African scientists was in providing samples and conducting fieldwork not research design [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

Good and Bad Research Collaborations: Researchers’ Views on Science and Ethics in Global Health Research

2016

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There has been a dramatic rise in the scale and scope of collaborative global health research. A number of structural and scientific factors explain this growth and there has been much discussion of these in the literature. Little, if any, attention has been paid, however, to the factors identified by scientists and other research actors as important to successful research collaboration. This is surprising given that their decisions are likely to play a key role in the sustainability and effectiveness of global health research initiatives. In this paper, we report on qualitative research with leading scientists involved in major international research collaborations about their views on good and bad collaborations and the factors that inform their decision-making about joining and participating actively in research networks. We identify and discuss eight factors that researchers see as essential in judging the merits of active participation in global health research collaborations: opportunities for active involvement in cutting-edge, interesting science; effective leadership; competence of potential partners in and commitment to good scientific practice; capacity building; respect for the needs, interests and agendas of partners; opportunities for discussion and disagreement; trust and confidence; and, justice and fairness in collaboration. Our findings suggest that the sustainability and effectiveness of global health research collaborations has an important ethical or moral dimension for the research actors involved.

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Applying Research Ethics Guidelines: The View from a Sub-Saharan Research Ethics Committee

Cited by 13 publications

References 27 publications

Biomedical Research Ethics Committees in Sub-Saharan Africa

Biomedical Research Ethics Committees in Sub-Saharan Africa

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

Good and Bad Research Collaborations: Researchers’ Views on Science and Ethics in Global Health Research

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