Browsing by Subject "Bioethics"

Now showing 1 - 7 of 7
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    African researchers' perceptions and expectations of the benefits of genomics research in Africa : a qualitative study
    (2016) Munung, Nchangwi Syntia; de Vries, Jantina; Mayosi, Bongani M
    Introduction: Genomics research raises a number of ethical, legal and social issues (ELSI), one of which is the concept of benefit sharing. While benefits and benefit sharing are difficult to discuss because of questions on what needs to be shared, with whom and by whom, it cannot be pushed to the side-lines especially as it is a way of promoting justice in health research and of ensuring that research is of social value to study communities. In this study, we explored the perceptions and expectations of African genomics scientists on the benefits of genomics research to Africa. Method: This was a qualitative study and we adopted a grounded theory approach. I conducted 17 in-depth interviews with genomics researchers in Africa to explore their perceptions of benefits and benefit sharing in genomics research in Africa. Transcripts of interviews were imported into QSR-NVivo 10 for thematic analysis. A thematic analysis of informed consent documents used in 13 genomics studies in Africa was also done to explore how research benefits are documented. Results: Research collaboration, research capacity building and access to genomics medicine were perceived to be the main benefits of African genomics science (AGS). In terms of research collaboration, there were perceived fears of exploitation of African researchers and research participants, and the non-sustainability of AGS. To address the problem of exploitation, African researchers expressed the need for fairness in AGS through transparency and equity in research collaborations, enhancing research oversight, African ownership and leadership of AGS, community engagement and research capacity building. In terms of genomics medicine, African genomics researchers perceived that AGS would have an impact on healthcare in Africa in the area of diagnosis, pharmacogenomics and public health. However, there were concerns around access to genomics medicine by African populations, lack of capacity for genomics medicine in Africa and the need for AGS to focus on Africa's healthcare priorities. There was however limited awareness of the concept of benefit sharing among African genomics researchers though they perceived it is as an important concept for AGS. Interviewees suggested that benefit sharing could be in the form of research capacity building, feedback of study findings, science education, community projects and the sharing of profits.
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    Ethical challenges in obtaining informed consent for the genomic study of rheumatic heart disease: a qualitative study
    (2016) Masiye, Francis; De Vries, Jantina; Mayosi, Bongani
    INTRODUCTION: Advances in genetic and genomic research have introduced new challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for a genomic study on Rheumatic Heart Disease (RHDGen) at the University of Cape Town in South Africa. The main aim of the study was to understand the ethical challenges in obtaining informed consent in the RHDGen study. METHODS: We used a qualitative study methodology involving in-depth interviews and participant observations. Our research participants were RHDGen cases and controls as well as research staff involved in the recruitment of RHDGen research participants. In total, we conducted 32 in-depth interviews with RHDGen research participants, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen research participants. The in-depth interviews were conducted in English, audio-recorded and transcribed verbatim. All the data were analysed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa, and these sites were the Groote Schuur Hospital in Observatory, the Vanguard Community Health Centre in Bonteheuwel and the Heideveld Community in the Cape Flats.
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    Informed consent for voluntary counselling and testing for HIV infection in South African mothers and children: An assessment of burdens and consequences and an argument for a modification in the process of informed consent
    (2001) Roux, Paul; Fleischer, Theodore
    The HIV / AIDS epidemic is devastating Africa. The continent lacks the material resources to treat infected persons or to support those affected by the epidemic. One great resource in Africa is the cohesive strength of families. Because of a fear of stigma, HIV infected persons tend not to disclose their diagnosis to their families. This non-disclosure perpetuates stigma, because ordinary people do not discover that their own family may be affected by the epidemic. Non-disclosure also results in the loss of specific family support to infected individuals and the loss of general family support as a national resource. The standard method of taking informed consent prior to HIV testing of pregnant mothers has the effect of enhancing non-disclosure, because of its inherent focus on the patient as an isolated, autonomous decision maker. This dissertation advances the thesis that an alteration in the process of informed consent, to involve the family in deliberation prior to consent, will facilitate disclosure of an HIV-positive diagnosis to the family. Disclosure will have the positive effects firstly of giving the mother access to the emotional support of her family and secondly of serving to educate the family, and through the family society as a whole, that ordinary, virtuous women can be infected with HIV.
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    Potential use of clinical polygenic risk scores in psychiatry – ethical implications and communicating high polygenic risk
    (BioMed Central, 2019-02-27) Palk, A C; Dalvie, S; de Vries, J; Martin, A R; Stein, D J
    Abstract Psychiatric disorders present distinct clinical challenges which are partly attributable to their multifactorial aetiology and the absence of laboratory tests that can be used to confirm diagnosis or predict risk. Psychiatric disorders are highly heritable, but also polygenic, with genetic risk conferred by interactions between thousands of variants of small effect that can be summarized in a polygenic risk score. We discuss four areas in which the use of polygenic risk scores in psychiatric research and clinical contexts could have ethical implications. First, there is concern that clinical use of polygenic risk scores may exacerbate existing health inequities. Second, research findings regarding polygenic risk could be misinterpreted in stigmatising or discriminatory ways. Third, there are concerns associated with testing minors as well as eugenics concerns elicited by prenatal polygenic risk testing. Fourth, potential challenges that could arise with the feedback and interpretation of high polygenic risk for a psychiatric disorder would require consideration. While there would be extensive overlap with the challenges of feeding back genetic findings in general, the potential clinical use of polygenic risk scoring warrants discussion in its own right, given the recency of this possibility. To this end, we discuss how lay interpretations of risk and genetic information could intersect. Consideration of these factors would be necessary for ensuring effective and constructive communication and interpretation of polygenic risk information which, in turn, could have implications for the uptake of any therapeutic recommendations. Recent advances in polygenic risk scoring have major implications for its clinical potential, however, care should be taken to ensure that communication of polygenic risk does not feed into problematic assumptions regarding mental disorders or support reductive interpretations.
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    Privacy, secrecy and confidentiality : changing paradigms in the face of the HIV pandemic
    (2004) Andrews, Steven; Benatar, Solomon Robert
    This paper stems from discussion of real life problems experienced at a local state hospital, and that have been presented to the University of Cape Town Bioethics Centre. These problems will be outlined from their social, medical and ethical perspectives. The dilemmas relating to confidentiality and disclosure of HIV status will be illustrated by empirical research data conducted in an HIV treatment unit, and with reference to the broad literature on this subject. It will be argued that confidentiality issues are poorly understood by healthcare professionals and their patients. In addition, and related to this lack of understanding, is a failure to construct and implement policies to protect specific confidentiality needs in the healthcare environment The practical problem of patient disclosure of HIV status will be explored using data generated from the author’s own practice. A review of the debate regarding confidentiality in the healthcare context will be provided, with reference to the literature on the subject. Guidelines for drafting a facility specific confidentiality policy will be provided, along with a draft policy for use as a template in this situation.
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    Reporting of ethical requirements in published physiotherapy research
    (2004) Frank, Denise M; Henley, Lesley
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    Small is beautiful: demystifying and simplifying standard operating procedures: a model from the ethics review and consultancy committee of the Cameroon Bioethics Initiative
    (2016) Ouwe Missi Oukem-Boyer, Odile; Munung, Nchangwi Syntia; Tangwa, Godfrey B
    Abstract Background Research ethics review is a critical aspect of the research governance framework for human subjects research. This usually requires that research protocols be submitted to a research ethics committee (REC) for review and approval. This has led to very rapid developments in the domain of research ethics, as RECs proliferate all over the globe in rhyme with the explosion in human subjects research. The work of RECs has increasingly become elaborate, complex, and in many cases urgent, necessitating supporting rules and procedures of operation. Guidelines for elaborating standard operating procedures (SOPs) for the functioning of RECs have also been proposed. The SOPs of well-placed and well-resourced RECs have tended to pay much attention to details, resulting, as a consequence, in generally long, elaborate, intricate and complex SOPs; a model that can hardly be replicated by other committees, equally under ethics review pressures, but working under much more constraining conditions in resource-destitute environments. Methods In this paper, we looked at the content and length of SOPs from African RECs and compared them to the World Health Organization (WHO)’s guidelines as the gold standard. We also looked at the SOPs from the Ethics Review and Consultancy Committee (ERCC) of the Cameroon Bioethics Initiative that we elaborated in a simplified way in 2013, and compared them to the WHO’s guidelines and to the other SOPs. Results Sixteen SOPs from 14 African countries were collected from various sources. Their average length was of 30 pages. By comparison to the guidance of the WHO, only six of them were found acceptable with more than 70 % of the criteria from the gold standard that were fully described. Among those six, two of them were very long and detailed (65 and 102 pages), while the four remaining SOPs ranged from 16 to 24 pages. The ERCC SOPs are seven pages long but maintain all that is of essence for the rigorous, efficient and timely review of protocols. Conclusions We are convinced that, because of their brevity, simplicity, clarity and user-friendliness, the ERCC SOPs recommend themselves as a model template to, at least, committees similarly situated and/or circumstanced as the ERCC of the Cameroon Bioethics Initiative is. In fact, brevity, clarity, simplicity and user-friendliness are recognized values. Whatever is brief and clear is better than what is not and saves time. What is simple and user-friendly is better than what is not even though the two have the same aims because it saves both time and mental energy. And if this be true in general, it is even truer of the context and its peculiar constraints that we are addressing.