The abundance of South African clinical and public health research data has the potential to unlock important and valuable future advances in biomedical science. Amid increasing calls for more effective sharing of individual-level data, commitment to promote access to research data is evident within South Africa’s public research sector, but national guidance and regulation are absent. This qualitative study examined the perceptions, experiences and concerns of 32 research stakeholders about data-sharing practices. There was consensus about the utility of data sharing in publicly funded health research. However, disparate views emerged about the possible harms and benefits of sharing data and how these should be weighed. The relative dearth of policies governing data-sharing practices needs to be addressed and a framework of support developed that incentivizes data-sharing practices for researchers that are both ethical and effective.
In South Africa, biomedical research cannot commence until it has been reviewed and approved by a local research ethics committee (REC). There remains a dearth of empirical data on the nature and frequency of ethical issues raised by such committees. This study sought to identify ethical concerns typically raised by two South African RECs. Meeting minutes for 180 protocols reviewed between 2009 and 2014 were coded and analyzed using a preexisting framework. Results showed that the most frequent queries involved informed consent, respect for participants, and scientific validity. Interestingly, administrative issues (non-ethical) such as missing researchers’ CVs and financial contracts emerged more frequently than ethical questions such as favorable risk/benefit ratio and fair participant selection. Although not generalizable to all RECs, our data provide insights into two South African RECs’ review concerns. More education and awareness of the actual ethical issues typically raised by such committees might help improve review outcomes and relationships between researchers and RECs.
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.
Mycobacterium tuberculosis complex (MTBC) causes tuberculosis (TB) in humans and animals. We investigated the presence of MTBC in cattle milk and its drug resistance using polymerase chain reaction (PCR). Two hundred samples (100 mL each) were obtained from a dairy farm in the Nkonkobe region of South Africa. The samples were processed using the modified Petroff method. DNA was isolated using a Zymo Bacterial DNA kit and amplified using Seeplex® MTB Nested ACE assay. The Genotype® Mycobacterium tuberculosis-multidrug resistantplus (MTBDRplus) assay was used to perform drug susceptibility and detection of mutations conferring resistance to isoniazid (INH) and rifampicin (RIF). Eleven samples tested positive for MTBC DNA using the Seeplex® MTB Nested ACE assay. The Genotype® MTBDRplus assay showed that 10/11 samples were resistant to both INH and RIF i.e., multi-drug resistant (MDR). The most and least frequent rpoB mutations detected in RIF resistant samples were H526Y (9/10) and D516V (2/10) respectively. None of the INH resistant samples harbored mutations in the katG gene. However, all of them harbored the T8A mutation in the inhA gene. These results have clinical and epidemiological significance and calls for further studies and necessary actions to delineate the situation.
Research ethics committees (RECs; known as institutional review boards (IRBs) in the USA) are an integral part of the human research participants' protection system. [1] They have the authority to approve, conditionally approve or reject research proposals, depending on the committee's determination of a study's ethical acceptability, as judged in terms of local and international guidance. [1] Unfortunately, RECs generally operate behind closed doors, meaning that there is little understanding of REC reviews in practice. Two books, Behind Closed Doors: IRBs and the Making of Ethical Research [2] and Ethics Police: The Struggle to Make Human Research Safe, [3] provide important insights into the work of IRBs in the USA. However, research into the operation of RECs is still relatively limited in developing countries such as South Africa (SA). While RECs play an important role in ensuring the protection of research participants, they are often heavily criticised for overstepping their scope, being too bureaucratic, delaying important research and spending too much time rewording informed consent forms. [3,4] Some social science commentators have even called for the abolition of REC reviews, arguing that mandatory ethics review is itself unethical because RECs do not respect researchers or each other, lack merit and integrity and are neither just nor beneficent. [5] Despite such criticism, there have been relatively few empirical studies exploring the work of RECs, although some studies [6-9] have examined REC minutes and decision letters retrospectively to identify the ethical issues raised, both internationally and in SA. These studies This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.
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