Pub Date : 2023-01-03DOI: 10.7196/sajbl.2022.v15i3.822
S. Mahomed, M. Labuschaigne
While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking.
{"title":"The evolving role of research ethics committees in the era of open data","authors":"S. Mahomed, M. Labuschaigne","doi":"10.7196/sajbl.2022.v15i3.822","DOIUrl":"https://doi.org/10.7196/sajbl.2022.v15i3.822","url":null,"abstract":"While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across South African borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42081199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Contexte : Dans la majeure partie de l'Afrique, la maladie mentale est considérée comme une épidémie silencieuse en raison d'obstacles structurels et systémiques tels qu'une infrastructure de soins de santé inadéquate, un nombre insuffisant de spécialistes de la santé mentale, la stigmatisation et la discrimination liées à la maladie mentale et le manque d'accès à tous les niveaux de soins. La souffrance et l'invalidité continues dues à la maladie mentale nécessitent de nouveaux traitements et une recherche continue dans le domaine du traitement et de la thérapie de la santé mentale. Les comités d'éthique de la recherche sont conscients de l'importance de cet aspect, mais la route vers cet avenir innovant est semée de dilemmes éthiques ainsi que de questions éthiques, juridiques et des implications sociales. Il y a un besoin urgent d'avoir des lignes directrices qui guident l'éthique de la recherche impliquant des participants en santé mentale. Méthodes : : Des lignes directrices ont été élaborées pour l'examen éthique des protocoles de recherche en santé mentale dans le but d'accroître l'équité et l'accès à la santé en Afrique et dans d'autres pays à faible revenu. Nous avons analysé systématiquement 13 outils d'évaluation de programmes, de recherche et de politiques à la lumière de la santé mentale et des attributs culturels. Résultats: Un outil d'évaluation de 54 items a été créé pour guider le processus d'évaluation du protocole de recherche en santé mentale en tenant compte des facteurs éthiques, de genre et socioculturels en Afrique. Conclusions: Les thèmes émergents, à savoir la gouvernance de la recherche, le contexte et la justification, la méthodologie et l'impact éthique de la recherche qui constituent la base de l'outil d'évaluation, sont liés aux principes bioéthiques de respect de l'autonomie, de bienfaisance, de non-malfaisance et de justice. Lorsqu'ils sont appliqués à l'évaluation d'une étude, ils ne font pas que souligner ces principes, ils améliorent leur application et augmentent l'accès à une santé équitable en Afrique et dans d'autres milieux à faibles ressources, quels que soient les contextes variés. Mots-clés : Bioéthique, Santé mentale, Éthique de la recherche, Examen éthique ; genre
{"title":"Lignes directrices pour l'examen éthique des protocoles de recherche en santé mentale dans une perspective culturellement sensible","authors":"Mercury Shitindo, Farah Nabil","doi":"10.58177/ajb240523","DOIUrl":"https://doi.org/10.58177/ajb240523","url":null,"abstract":"Contexte : Dans la majeure partie de l'Afrique, la maladie mentale est considérée comme une épidémie silencieuse en raison d'obstacles structurels et systémiques tels qu'une infrastructure de soins de santé inadéquate, un nombre insuffisant de spécialistes de la santé mentale, la stigmatisation et la discrimination liées à la maladie mentale et le manque d'accès à tous les niveaux de soins. La souffrance et l'invalidité continues dues à la maladie mentale nécessitent de nouveaux traitements et une recherche continue dans le domaine du traitement et de la thérapie de la santé mentale. Les comités d'éthique de la recherche sont conscients de l'importance de cet aspect, mais la route vers cet avenir innovant est semée de dilemmes éthiques ainsi que de questions éthiques, juridiques et des implications sociales. Il y a un besoin urgent d'avoir des lignes directrices qui guident l'éthique de la recherche impliquant des participants en santé mentale. Méthodes : : Des lignes directrices ont été élaborées pour l'examen éthique des protocoles de recherche en santé mentale dans le but d'accroître l'équité et l'accès à la santé en Afrique et dans d'autres pays à faible revenu. Nous avons analysé systématiquement 13 outils d'évaluation de programmes, de recherche et de politiques à la lumière de la santé mentale et des attributs culturels. Résultats: Un outil d'évaluation de 54 items a été créé pour guider le processus d'évaluation du protocole de recherche en santé mentale en tenant compte des facteurs éthiques, de genre et socioculturels en Afrique. Conclusions: Les thèmes émergents, à savoir la gouvernance de la recherche, le contexte et la justification, la méthodologie et l'impact éthique de la recherche qui constituent la base de l'outil d'évaluation, sont liés aux principes bioéthiques de respect de l'autonomie, de bienfaisance, de non-malfaisance et de justice. Lorsqu'ils sont appliqués à l'évaluation d'une étude, ils ne font pas que souligner ces principes, ils améliorent leur application et augmentent l'accès à une santé équitable en Afrique et dans d'autres milieux à faibles ressources, quels que soient les contextes variés. Mots-clés : Bioéthique, Santé mentale, Éthique de la recherche, Examen éthique ; genre","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":"21 1","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77987836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rose Mwangi, Maseke Mgabo, Blandina Mmbaga, Rachel Manongi
Introduction: The field of bioethics lacks empirical evidence to support the debates surrounding human involvement in clinical investigations. We focused on HIV clinical trials to explore participants’ perceptions and experiences towards clinical trial endpoints. Methods: This qualitative multiple case study used in-depth interviews (IDIs), and case narratives to collect data. IDIs were conducted with HIV study participants at the Care and Treatment Centers (CTC) and the Child Centred Family Care Clinic (CCFCC) until data saturation was achieved. The interviews covered motivations for participation, perceived risks and benefits, and trial endpoint expectations. Additionally, participants were also encouraged to provide relevant recommendations. Results: A total of 18 in-depth interviews were conducted with individuals visiting CTC and CCFCC for various reasons including routine medication, voluntary counselling and testing, for visits as mandated by clinical trials, or as caretakers/guardians accompanying their children to HIV clinic for prevention of mother to child (PMTCT) programs. Participants reported different reasons for their motivation to participate in clinical trials. They perceived no risks involved in participating in clinical trials and highlighted financial benefits and high-quality healthcare received from health workers during the clinical trial at the period of participation. However, at the exit of the study, all participants expressed uncertainties about their fate and their children after the trials. Participants wished to continue accessing post-trial medical services similar to the one provided during the clinical trials even after being linked to other health facilities for standard care. They appreciated friendly service, regular professional advice, and follow-up of their health during the clinical trials. Conclusion: Our findings show that although at the end of the trial, patients are linked to standard care, continuation of supportive measures after the trial is also essential. Our findings highlight the importance of providing post-trial benefits for participants in HIV studies as a basic ethical practice such as intervention treatment, professional advice, and devices found beneficial to participants. Further research should focus on participants’ transition to standard care and their post-trial coping strategies.
{"title":"‘Please do not leave us’ Qualitative excerpts of HIV-infected participants’ perspectives towards a clinical trial endpoint in Tanzania","authors":"Rose Mwangi, Maseke Mgabo, Blandina Mmbaga, Rachel Manongi","doi":"10.58177/ajb230007","DOIUrl":"https://doi.org/10.58177/ajb230007","url":null,"abstract":"Introduction: The field of bioethics lacks empirical evidence to support the debates surrounding human involvement in clinical investigations. We focused on HIV clinical trials to explore participants’ perceptions and experiences towards clinical trial endpoints. Methods: This qualitative multiple case study used in-depth interviews (IDIs), and case narratives to collect data. IDIs were conducted with HIV study participants at the Care and Treatment Centers (CTC) and the Child Centred Family Care Clinic (CCFCC) until data saturation was achieved. The interviews covered motivations for participation, perceived risks and benefits, and trial endpoint expectations. Additionally, participants were also encouraged to provide relevant recommendations. Results: A total of 18 in-depth interviews were conducted with individuals visiting CTC and CCFCC for various reasons including routine medication, voluntary counselling and testing, for visits as mandated by clinical trials, or as caretakers/guardians accompanying their children to HIV clinic for prevention of mother to child (PMTCT) programs. Participants reported different reasons for their motivation to participate in clinical trials. They perceived no risks involved in participating in clinical trials and highlighted financial benefits and high-quality healthcare received from health workers during the clinical trial at the period of participation. However, at the exit of the study, all participants expressed uncertainties about their fate and their children after the trials. Participants wished to continue accessing post-trial medical services similar to the one provided during the clinical trials even after being linked to other health facilities for standard care. They appreciated friendly service, regular professional advice, and follow-up of their health during the clinical trials. Conclusion: Our findings show that although at the end of the trial, patients are linked to standard care, continuation of supportive measures after the trial is also essential. Our findings highlight the importance of providing post-trial benefits for participants in HIV studies as a basic ethical practice such as intervention treatment, professional advice, and devices found beneficial to participants. Further research should focus on participants’ transition to standard care and their post-trial coping strategies.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":"40 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135561117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In public health emergencies that warrant mass vaccination, vaccine mandates are sometimes imposed. There is historical evidence of the effectiveness of vaccination mandates, but varying strategies in policy implementation. The COVID-19 vaccine mandate presents an ethical imbroglio that poses these bioethical questions, “Is there ethical justification for a vaccine mandate?”, and “Whose responsibility is it to ensure the equitability of a vaccine mandate in a pandemic?” Using ethical principles and theories, this paper focuses on the health equity of vaccine mandates, considering both the global and local implications. Vaccination mandate, in a pandemic, is driven by the need to accelerate the achievement of public health goals of herd immunity, protecting the most vulnerable in terms of case fatality and hospitalization rates, protecting the capacity of the acute health care system, as well as circumventing the economic impact. These mandates must still be guided by appropriate stakeholder involvement and bioethical considerations, to assess their validity and equitability, as vaccine mandates may impose restrictions on the freedoms and rights of an individual. Using COVID-19 as a case study, we argued the equitability of vaccine mandates based on the WHO framework of ethical considerations and caveats for mandatory vaccination. Necessity and proportionality of the vaccine, sufficient evidence of safety, efficacy, and effectiveness, sufficient supply, and public trust are key during ethical processes of decision-making. We conclude that vaccine mandates are more equitable as population-specific mandates, as opposed to global or universal mandates, even in pandemics. This is due to varying geographic, socio-cultural, and economic characteristics. Bioethicists should be actively engaged in discussions on the vaccine mandate, as its equitability is a function of critically analyzing the proposed mandate based on ethical recommendations prior to being issued. Retrospective bioethical analysis is warranted to identify shortfalls and make recommendations for future decision-making.
{"title":"The Equitability of Universal Vaccine Mandates – A Bioethical Analysis of COVID-19 Vaccine","authors":"Florence Akumiah, Joseph Yaria","doi":"10.58177/ajb230004","DOIUrl":"https://doi.org/10.58177/ajb230004","url":null,"abstract":"In public health emergencies that warrant mass vaccination, vaccine mandates are sometimes imposed. There is historical evidence of the effectiveness of vaccination mandates, but varying strategies in policy implementation. The COVID-19 vaccine mandate presents an ethical imbroglio that poses these bioethical questions, “Is there ethical justification for a vaccine mandate?”, and “Whose responsibility is it to ensure the equitability of a vaccine mandate in a pandemic?” Using ethical principles and theories, this paper focuses on the health equity of vaccine mandates, considering both the global and local implications. Vaccination mandate, in a pandemic, is driven by the need to accelerate the achievement of public health goals of herd immunity, protecting the most vulnerable in terms of case fatality and hospitalization rates, protecting the capacity of the acute health care system, as well as circumventing the economic impact. These mandates must still be guided by appropriate stakeholder involvement and bioethical considerations, to assess their validity and equitability, as vaccine mandates may impose restrictions on the freedoms and rights of an individual. Using COVID-19 as a case study, we argued the equitability of vaccine mandates based on the WHO framework of ethical considerations and caveats for mandatory vaccination. Necessity and proportionality of the vaccine, sufficient evidence of safety, efficacy, and effectiveness, sufficient supply, and public trust are key during ethical processes of decision-making. We conclude that vaccine mandates are more equitable as population-specific mandates, as opposed to global or universal mandates, even in pandemics. This is due to varying geographic, socio-cultural, and economic characteristics. Bioethicists should be actively engaged in discussions on the vaccine mandate, as its equitability is a function of critically analyzing the proposed mandate based on ethical recommendations prior to being issued. Retrospective bioethical analysis is warranted to identify shortfalls and make recommendations for future decision-making.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":"14 1","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83016897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David Machaku, Mwanaidi Y. Kafuye, R. Joseph, Paul E Kazyoba, Muhsin Aboud
Ethics review of health research protocols is paramount for the protection of the rights, safety, and welfare of research participants. The review of protocols is done by designated committees called Research Ethics Committees (RECs). In Tanzania, the National Research Ethics Committee (NatHREC) processes a large volume of protocols every year. Although the turnaround time of ethics review has been identified as a concern for stakeholders involved in the review process, there is a lack of comprehensive research on the specific factors that influence the duration of the review process by examining the research protocols themselves. While the long review timelines have significant implications for the timely commencement of research activities, as well as questions regarding the capacity of research ethics committees (RECs), the existing literature does not adequately address this aspect. The study aimed to assess the factors that influenced the turnaround time of ethics review at the National Health Research Ethics Committee (NatHREC) for research protocols submitted between January 2018 and August 2019. This specific time frame was chosen to capture a substantial sample of protocols and provide a comprehensive understanding of the factors affecting the review process during that period and also because during this period the REC employed two different review systems for protocol review. Several factors were identified as influencing the turnaround time of the ethics review process. Firstly, the review systems played a significant role as during the study period, the REC employed two different review systems; Precursor Protocol Review System (PPRs) and Improved Protocol Review System (IPRs) which proved to be more time-efficient. Secondly, the type of study being reviewed also had an influence on turnaround time as clinical trials had a longer review turnaround time than non-clinical trials. Additionally, the time taken for researchers to resubmit their protocols for review affected the overall turnaround time. If researchers took longer to make necessary revisions, it would naturally extend the review process. By focusing on the NatHREC, which is a prominent and nationally recognized research ethics committee, the study aimed to explore the factors that are influential within a well-established and reputable review system. Understanding the specific factors that contribute to the turnaround time at this committee would provide valuable insights for other similar committees and research ethics bodies across the country. Overall, the study highlighted the importance of addressing factors that influence the turnaround time of the review process to improve the efficiency of the process. The findings suggest that implementing the IPRS can significantly reduce the time taken for ethics review, benefiting both researchers and research participants.
{"title":"FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW IN TANZANIA: ASSESSMENT OF PROTOCOL REVIEW SYSTEMS","authors":"David Machaku, Mwanaidi Y. Kafuye, R. Joseph, Paul E Kazyoba, Muhsin Aboud","doi":"10.58177/ajb230003","DOIUrl":"https://doi.org/10.58177/ajb230003","url":null,"abstract":"Ethics review of health research protocols is paramount for the protection of the rights, safety, and welfare of research participants. The review of protocols is done by designated committees called Research Ethics Committees (RECs). In Tanzania, the National Research Ethics Committee (NatHREC) processes a large volume of protocols every year. Although the turnaround time of ethics review has been identified as a concern for stakeholders involved in the review process, there is a lack of comprehensive research on the specific factors that influence the duration of the review process by examining the research protocols themselves. While the long review timelines have significant implications for the timely commencement of research activities, as well as questions regarding the capacity of research ethics committees (RECs), the existing literature does not adequately address this aspect. The study aimed to assess the factors that influenced the turnaround time of ethics review at the National Health Research Ethics Committee (NatHREC) for research protocols submitted between January 2018 and August 2019. This specific time frame was chosen to capture a substantial sample of protocols and provide a comprehensive understanding of the factors affecting the review process during that period and also because during this period the REC employed two different review systems for protocol review. Several factors were identified as influencing the turnaround time of the ethics review process. Firstly, the review systems played a significant role as during the study period, the REC employed two different review systems; Precursor Protocol Review System (PPRs) and Improved Protocol Review System (IPRs) which proved to be more time-efficient. Secondly, the type of study being reviewed also had an influence on turnaround time as clinical trials had a longer review turnaround time than non-clinical trials. Additionally, the time taken for researchers to resubmit their protocols for review affected the overall turnaround time. If researchers took longer to make necessary revisions, it would naturally extend the review process. By focusing on the NatHREC, which is a prominent and nationally recognized research ethics committee, the study aimed to explore the factors that are influential within a well-established and reputable review system. Understanding the specific factors that contribute to the turnaround time at this committee would provide valuable insights for other similar committees and research ethics bodies across the country. Overall, the study highlighted the importance of addressing factors that influence the turnaround time of the review process to improve the efficiency of the process. The findings suggest that implementing the IPRS can significantly reduce the time taken for ethics review, benefiting both researchers and research participants.","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":"72 1","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86081545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The establishment of a National Bioethics Committee is a requirement for member states of UNESCO who are signatories to the UNESCO 2005 Universal Declaration on Bioethics and Human Rights. The Universal Declaration on Bioethics and Human Rights advocates for an independent, multidisciplinary, and pluralist National Bioethics Committee at the national, regional, local or institutional level. Therefore, the National Bioethics Committee is expected to conform to the guidelines of the Declaration. According to UNESCO’s Assisting Bioethics Committee project document, the National Bioethics Committee is to provide advice on ethical issues member states may encounter in research development, application of scientific knowledge, formulating recommendations regarding guidelines and legislation, develop tools for standard setting, strengthening coordination and contacts among experts and institutions, foster debates, education and public awareness and engagements in bioethics. The National Bioethics Committee is to reinforce the role of UNESCO as an international clearing house for ethical issues, as well as act as an intermediary body for the implementation of the normative instruments adopted by member states. As a member state of UNESCO and a signatory to the 2005 Universal Declaration on Bioethics and Human Rights, Nigeria is expected to establish a National Bioethics Committee that is independent, multidisciplinary, and pluralist. This paper highlights the several meetings and steps taken to establish the Nigerian National Bioethics Committee, as well as the challenges. Keywords: Bioethics, Committee, Establish, National, Nigeria, UNESCO
{"title":"Establishing National Bioethics Committee: The case of Nigeria","authors":"Chitu Womehoma Princewill","doi":"10.58177/ajb230006","DOIUrl":"https://doi.org/10.58177/ajb230006","url":null,"abstract":"The establishment of a National Bioethics Committee is a requirement for member states of UNESCO who are signatories to the UNESCO 2005 Universal Declaration on Bioethics and Human Rights. The Universal Declaration on Bioethics and Human Rights advocates for an independent, multidisciplinary, and pluralist National Bioethics Committee at the national, regional, local or institutional level. Therefore, the National Bioethics Committee is expected to conform to the guidelines of the Declaration. According to UNESCO’s Assisting Bioethics Committee project document, the National Bioethics Committee is to provide advice on ethical issues member states may encounter in research development, application of scientific knowledge, formulating recommendations regarding guidelines and legislation, develop tools for standard setting, strengthening coordination and contacts among experts and institutions, foster debates, education and public awareness and engagements in bioethics. The National Bioethics Committee is to reinforce the role of UNESCO as an international clearing house for ethical issues, as well as act as an intermediary body for the implementation of the normative instruments adopted by member states. As a member state of UNESCO and a signatory to the 2005 Universal Declaration on Bioethics and Human Rights, Nigeria is expected to establish a National Bioethics Committee that is independent, multidisciplinary, and pluralist. This paper highlights the several meetings and steps taken to establish the Nigerian National Bioethics Committee, as well as the challenges. Keywords: Bioethics, Committee, Establish, National, Nigeria, UNESCO","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":"137 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135550270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
V. Naanyu, E. Kamaara, Alfred Kirui, H. Koros, Daniel K. Lagat, Singh Ilina, E. Kwobah, L. Atwoli
Abstract Context: The use of biological materials raises diverse ethical concerns and there is insufficient research into the views of stakeholders on these concerns. Aims: This study investigated healthcare providers’ (HCPs) and clients’ perspectives on giving feedback about biological samples that are used in research and sharing of subsequent benefits. Settings and Design: Using a qualitative in-depth interviewing approach, this study investigated perspectives on feedback and benefit sharing in studies using biological materials. We engaged HCPs (doctors, clinical officers, nurses, and laboratory technicians) and clients from the Moi Teaching and Referral Hospital, Kenya. Methods and Material: Vignettes and open-ended questions were used, and all sessions were audio recorded, transcribed, then coded and summarized thematically. Results: We found no substantive differences between the perspectives of HCPs and clients. Participants desired that sample donors were provided with feedback and support for their healthcare. Community-level feedback and initiation of health development projects were viewed as valuable. Participants lauded the global dissemination of findings and sharing of benefits ensuing from the research. Conclusions: Healthcare providers and clients in Eldoret Kenya appreciate the use of biological materials in research. They believe in feedback and benefit sharing at individual and community levels, and in broad dissemination of the research findings. All research stakeholders should be encouraged to plan and implement contextualized dissemination of research findings. In addition, feedback on research findings and equitable benefit sharing should be strengthened. Key-words: Biological material, research ethics, research benefits, in-depth interviews, Kenya
{"title":"Views of providers and clients on feedback and benefit sharing in studies using biological materials in Eldoret Kenya","authors":"V. Naanyu, E. Kamaara, Alfred Kirui, H. Koros, Daniel K. Lagat, Singh Ilina, E. Kwobah, L. Atwoli","doi":"10.58177/ajb230002","DOIUrl":"https://doi.org/10.58177/ajb230002","url":null,"abstract":"Abstract Context: The use of biological materials raises diverse ethical concerns and there is insufficient research into the views of stakeholders on these concerns. Aims: This study investigated healthcare providers’ (HCPs) and clients’ perspectives on giving feedback about biological samples that are used in research and sharing of subsequent benefits. Settings and Design: Using a qualitative in-depth interviewing approach, this study investigated perspectives on feedback and benefit sharing in studies using biological materials. We engaged HCPs (doctors, clinical officers, nurses, and laboratory technicians) and clients from the Moi Teaching and Referral Hospital, Kenya. Methods and Material: Vignettes and open-ended questions were used, and all sessions were audio recorded, transcribed, then coded and summarized thematically. Results: We found no substantive differences between the perspectives of HCPs and clients. Participants desired that sample donors were provided with feedback and support for their healthcare. Community-level feedback and initiation of health development projects were viewed as valuable. Participants lauded the global dissemination of findings and sharing of benefits ensuing from the research. Conclusions: Healthcare providers and clients in Eldoret Kenya appreciate the use of biological materials in research. They believe in feedback and benefit sharing at individual and community levels, and in broad dissemination of the research findings. All research stakeholders should be encouraged to plan and implement contextualized dissemination of research findings. In addition, feedback on research findings and equitable benefit sharing should be strengthened. Key-words: Biological material, research ethics, research benefits, in-depth interviews, Kenya","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":"1 1","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89099925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-12DOI: 10.7196/sajbl.2022.v15i2.817
T. Alsamara, G. Farouk, M. Hālima
The article examines the issue of public health and medical services in Algeria and analyses the role of the public and private sectors in supporting and promoting public health. Our study is based on an analysis of legal texts that highlight Algeria’s health policies. Some significant aspects of the article are: the Algerian policy of opening health services up to private investment; the lack of contribution of private health institutions in the field of medical education; and issues surrounding the organisation of blood donation. The article also notes the absence of foreign investment in Algerian hospitals.
{"title":"Public health and the legal regulation of medical services in Algeria: Between the public and private sectors","authors":"T. Alsamara, G. Farouk, M. Hālima","doi":"10.7196/sajbl.2022.v15i2.817","DOIUrl":"https://doi.org/10.7196/sajbl.2022.v15i2.817","url":null,"abstract":"\u0000 \u0000 \u0000 \u0000The article examines the issue of public health and medical services in Algeria and analyses the role of the public and private sectors in supporting and promoting public health. Our study is based on an analysis of legal texts that highlight Algeria’s health policies. Some significant aspects of the article are: the Algerian policy of opening health services up to private investment; the lack of contribution of private health institutions in the field of medical education; and issues surrounding the organisation of blood donation. The article also notes the absence of foreign investment in Algerian hospitals. \u0000 \u0000 \u0000 \u0000","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48024678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-12DOI: 10.7196/sajbl.2022.v15i2.813
A. Furtak
Ethical research behaviour plays an essential role in ensuring the integrity of knowledge. Consequently, ethical transgressions during the research process negatively influence the knowledge produced, and have wider social consequences for various stakeholders in society. To honour the value and role of ethical research for individuals and society, researchers are required to display ethical judgement and ethically responsible research behaviour. Doctoral students, who are considered to be significant contributors to knowledge creation, can improve the quality of their research through their ethical research behaviour. Owing to the implicit and explicit ethical practices and conflicts that can arise during the research process, the supervision process is an opportune moment for developing ethical research behaviour and ethical capabilities in doctoral students. This article focuses on developing ethical research behaviour in doctoral students, and offers pragmatic guidelines for ways in which this behaviour can be developed during the supervision process.
{"title":"Developing ethical research behaviour in doctoral students","authors":"A. Furtak","doi":"10.7196/sajbl.2022.v15i2.813","DOIUrl":"https://doi.org/10.7196/sajbl.2022.v15i2.813","url":null,"abstract":"\u0000 \u0000 \u0000 \u0000Ethical research behaviour plays an essential role in ensuring the integrity of knowledge. Consequently, ethical transgressions during the research process negatively influence the knowledge produced, and have wider social consequences for various stakeholders in society. To honour the value and role of ethical research for individuals and society, researchers are required to display ethical judgement and ethically responsible research behaviour. Doctoral students, who are considered to be significant contributors to knowledge creation, can improve the quality of their research through their ethical research behaviour. Owing to the implicit and explicit ethical practices and conflicts that can arise during the research process, the supervision process is an opportune moment for developing ethical research behaviour and ethical capabilities in doctoral students. This article focuses on developing ethical research behaviour in doctoral students, and offers pragmatic guidelines for ways in which this behaviour can be developed during the supervision process. \u0000 \u0000 \u0000 \u0000","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47421935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-12DOI: 10.7196/sajbl.2022.v15i2.811
J. Knight, E. Flack-Davison, S. Engelbrecht, R. Visagie, W. Beukes, T. Coetzee, M. Mwale, D. Ralefala
The 2010 Nagoya Protocol is an international framework for access and benefit sharing (ABS) of the use of genetic and biological resources, with particular focus on indigenous communities. This is especially important in Africa, where local communities have a close reliance on environmental resources and ecosystems. However, national legislation and policies commonly lag behind international agreements, and this poses challenges for legal compliance as well as practical applications. This study reviews the academic literature on the Nagoya Protocol and ABS applications, and then considers the implications of this analysis for research in Africa. Results show that there is uneven engagement with the principles of the Nagoya Protocol across different academic disciplines; local communities are sometimes sidelined in these studies; and only 8% of researchers in the literature analysed are located in Africa. Future developments should focus on ensuring national compliance with the Nagoya Protocol, and that researchers and industry work in partnership with local African communities on ABS issues.
{"title":"A literature review analysis of engagement with the Nagoya Protocol, with specific application to Africa","authors":"J. Knight, E. Flack-Davison, S. Engelbrecht, R. Visagie, W. Beukes, T. Coetzee, M. Mwale, D. Ralefala","doi":"10.7196/sajbl.2022.v15i2.811","DOIUrl":"https://doi.org/10.7196/sajbl.2022.v15i2.811","url":null,"abstract":"\u0000 \u0000 \u0000 \u0000The 2010 Nagoya Protocol is an international framework for access and benefit sharing (ABS) of the use of genetic and biological resources, with particular focus on indigenous communities. This is especially important in Africa, where local communities have a close reliance on environmental resources and ecosystems. However, national legislation and policies commonly lag behind international agreements, and this poses challenges for legal compliance as well as practical applications. This study reviews the academic literature on the Nagoya Protocol and ABS applications, and then considers the implications of this analysis for research in Africa. Results show that there is uneven engagement with the principles of the Nagoya Protocol across different academic disciplines; local communities are sometimes sidelined in these studies; and only 8% of researchers in the literature analysed are located in Africa. Future developments should focus on ensuring national compliance with the Nagoya Protocol, and that researchers and industry work in partnership with local African communities on ABS issues. \u0000 \u0000 \u0000 \u0000","PeriodicalId":43498,"journal":{"name":"South African Journal of Bioethics and Law","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2022-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44619366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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