Research ethics principles and regulations typically have been applied to the protection of individual human subjects. Yet, new paradigms of research that include the place-based community and cultural groups as partners or participants of environmental research interventions, in particular, require attention to place-based identities and geographical contexts. This paper argues the importance of respecting “place” within human subjects protections applied to communities and cultural groups as part of a critical need for research ethics and cultural competence training for graduate research (...) students. These protections and benefits are extensions of the Belmont Principles and have been included in recent recommendations from research regulatory committees. (shrink)

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources.

Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research (...) on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. (shrink)

The use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study at research (...) sites in the Western Cape and Gauteng, South Africa. (shrink)

Biological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples.

Rapid advances in high throughput genomic technologies and next generation sequencing are making medical genomic research more readily accessible and affordable, including the sequencing of patient and control whole genomes and exomes in order to elucidate genetic factors underlying disease. Over the next five years, the Human Heredity and Health in Africa (H3Africa) Initiative, funded by the Wellcome Trust (United Kingdom) and the National Institutes of Health (United States of America), will contribute greatly towards sequencing of numerous African samples for (...) biomedical research. (shrink)

BackgroundGenetic testing presents unique ethical challenges for research and clinical practice, particularly in low-resource settings. To address such challenges, context-specific understanding of ethical, legal and social issues is essential. Return of genetics and genomics research (GGR) results remains an unresolved yet topical issue particularly in African settings that lack appropriate regulation and guidelines. Despite the need to understand what is contextually acceptable, there is a paucity of empirical research and literature on what constitutes appropriate practice with respect to GGR.The study (...) assessed patients’ awareness, experiences and perceptions regarding genetic testing and the return of GGR results in a hypothetical context.MethodsThis cross-sectional study employed a qualitative exploratory approach. Respondents were patients attending the medical outpatient unit of Mulago National Hospital. Three deliberative focus group discussions involving 18 respondents were conducted. Data were analysed through thematic analysis.ResultsThree main themes and several subthemes were identified. Most respondents were aware of genetic testing, supportive of GGR and receiving results. However, only a few had undergone genetic testing due to cost constraints. They articulated the need for adequate information and genetic counselling to inform decision-making. Privacy of results was important to respondents while others were willing to share results.ConclusionThere was general awareness and support for GGR and the return of results. Stigmatisation emerged as a barrier to disclosure of results for some. Global health inequity impacts access and affordability of genetic testing and counselling in Africa and should be addressed as a matter of social justice. (shrink)

BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA (...) tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.ResultsOut of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.ConclusionOur review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process. (shrink)

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the (...) review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned. (shrink)

Genomic biobanking research is undergoing exponential growth in Africa raising a host of legal, ethical and social issues. Given the scientific complexity associated with genomics, there is a growing recognition globally of the importance of science translation and community engagement for this type of research, as it creates the potential to build relationships, increase trust, improve consent processes and empower local communities. Despite this level of recognition, there is a lack of empirical evidence of the practise and processes for effective (...) CE in genomic biobanking in Africa. To begin to address this vacuum, 17 in-depth face to face interviews were conducted with South African experts in genomic biobanking research and CE to provide insight into the process, benefits and challenges of CE in South Africa. Emerging themes were analysed using a contextualised thematic approach. Several themes emerged concerning the conduct of CE in genomic biobanking research in Africa. Although the literature tends to focus on the local community in CE, respondents in this study described three different layers of stakeholder engagement: community level, peer level and high level. Community level engagement includes potential participants, community advisory boards and field workers; peer level engagement includes researchers, biobankers and scientists, while high level engagement includes government officials, funders and policy makers. Although education of each stakeholder layer is important, education of the community layer can be most challenging, due to the complexity of the research and educational levels of stakeholders in this layer. CE is time-consuming and often requires an interdisciplinary research team approach. However careful planning of the engagement strategy, including an understanding of the differing layers of stakeholder engagement, and the specific educational needs at each layer, can help in the development of a relationship based on trust between the research team and various stakeholder groups. Since the community layer often comprises vulnerable populations in low and middle income countries, co-development of innovative educational tools on genomic biobanking is essential. CE is clearly a component of a broader process best described as stakeholder engagement. (shrink)

For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and research ethics (...) committees. This paper examines stakeholders’ perspectives of and responses to the ethical issues arising from these research practices. (shrink)

This study aimed to explore stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV. A qualitative approach to investigation involved five focus group discussions with 30 Community representatives, 12 key informant interviews with researchers, and 12 in-depth interviews with research ethics committee members. In total, 54 stakeholders who were involved in pharmacogenomics research and HIV treatment and care contributed to the data collection between September 2021 and February 2022. The study explored five (...) prominent themes: (i) defining the nature of research results to return to participants; (ii) preparing research participants to receive their results; (iii) obtaining informed consent for the return of results; (iv) opinions on health personnel to return the results to participants; and (v) opinions on how research results should be communicated to participants. Respondents identified various strategies for the return of individual results with minimal ethical risks including the setting up of a diverse and independent committee to undertake a risk-benefit assessment based on local context; ongoing discussions about the possible kinds of results and their implications throughout the study; and employing genetic counsellors to communicate results to participants. The strategies identified in this study should be further studied and independently verified. (shrink)

BackgroundLow literacy of study participants in Sub - Saharan Africa has been associated with poor comprehension during the consenting process in research participation. The concerns in comprehension are far greater when consenting to participate in genomic studies due to the complexity of the science involved. While efforts are made to explore possibilities of applying genomic technologies in diseases prevalent in Sub Saharan Africa, we ought to develop methods to improve participants’ comprehension for genomic studies. The purpose of this study was (...) to understand different approaches that can be used to seek consent from individuals with low literacy in Sub-Saharan African countries in genomic research to improve comprehension.MethodsUsing qualitative study design, we conducted focus-group discussions, in-depth interviews and participant observations as data collection methods. This study was embedded in a hospital based genomic study on Sickle Cell Disease at Muhimbili National Hospital in Tanzania. Thematic content analysis was used to analyse the transcripts and field notes.ResultsFindings from this study show that literacy level has little influence on understanding the research details. According to the participants of this study, the methods used to provide information, the language, and time spent with the study participants were the key factors influencing understanding. The availability of group sessions held before individual consent to allow for a detailed questions and answers format was agreed to be the best method to facilitate the comprehension.ConclusionThe quality of the consenting process of participants will be influence by a number of factors. The type of research consented for, where the research will be implemented and who are the potential study participants are amongst the factors that need to be assessed during the consenting. Measures to improve participants’ comprehension need to be developed when consenting participants with low literacy level in genomic studies. (shrink)

In biomedical research lack of trust is seen as a great threat that can severely jeopardise the whole biomedical research enterprise. Practices, such as informed consent, and also the administrative and regulatory oversight of research in the form of research ethics committees and Institutional Review Boards, are established to ensure the protection of future research subjects and, at the same time, restore public trust in biomedical research. Empirical research also testifies to the role of trust as one of the decisive (...) factors in research participation and lack of trust as a barrier for consenting to research. However, what is often missing is a clear definition of trust. This paper seeks to address this gap. It starts with a conceptual analysis of the term trust. It compares trust with two other related terms, those of reliance and trustworthiness, and offers a defence of Baier’s attribute of ‘good will’ a basic characteristic of trust. It, then, proceeds to consider trust in the context of biomedical research by examining two questions: First, is trust necessary in biomedical research?; and second, do increases in regulatory oversight of biomedical research also increase trust in the field? This paper argues that regulatory oversight is important for increasing reliance in biomedical research, but it does not improve trust, which remains important for biomedical research. It finishes by pointing at professional integrity as a way of promoting trust and trustworthiness in this field. (shrink)

Community engagement has been recognised as an important aspect of the ethical conduct of biomedical research, especially when research is focused on ethnically or culturally distinct populations. While this is a generally accepted tenet of biomedical research, it is unclear what components are necessary for effective community engagement, particularly in the context of genomic research in Africa.

Key to discussions around feedback of individual results from genomics research are practical questions on how such results should be fed back, by who and when. However, there has been virtually no work investigating these practical considerations for feedback of individual genetic results in the context of low-and middle-income countries (LMICs), especially in Africa. Consequently, we conducted deliberative focus group discussions with 6 groups of adolescents (n = 44) who previously participated in a genomics study in Botswana as well as (...) 6 groups of parents and caregivers (n = 49) of children who participated in the same study. We also conducted in-depth interviews with 6 adolescents and 6 parents or caregivers. Our findings revealed that both adolescents and parents would prefer to receive their individual genetic results in person, with adolescents preferring researchers to provide feedback, while parents preferred doctors who are associated with the study. Both adolescents and parents further expressed that feedback should be supported by counselling but differed on the timing of feedback, with preferences ranging from feedback as quickly as possible to feedback at project end. In conclusion, decisions on practicalities for feedback of results should be done in account of participants’ context and considerations of participants’ preferences. (shrink)

BackgroundObtaining consent has become a standard way of respecting the patient’s rights and autonomy in clinical research. Ethical guidelines recommend that the child’s parent/s or authorised legal guardian provides informed consent for their child’s participation. However, obtaining informed consent in paediatric research is challenging. Parents become vulnerable because of stress related to their child’s illness. Understanding the views held by guardians and researchers about the consent process in Malawi, where there are limitations in health care access and research literacy will (...) assist in developing appropriate consent guidelines.MethodsWe conducted 20 in-depth interviews with guardians of children and research staff who had participated in paediatric clinical trial and observational studies in acute and non-acute settings in the Southern Region of Malawi. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Interviews were compared across studies and settings to identify differences and similarities in participants’ views about informed consent processes. Data analysis was facilitated by NVIVO 11 software.ResultsAll participants across study types and settings reported that they associated participating in research with therapeutic benefits. Substantial differences were noted in the decision-making process across study settings. Guardians from acute studies felt that the role of their spouses was neglected during consenting, while staff reported that they had problems obtaining consent from guardians when their partners were not present. Across all study types and settings, research staff reported that they emphasised the benefits more than the risks of the study to participants, due to pressure to recruit. Participants from non-acute settings were more likely to recall information shared during the consent process than participants in the acute setting.ConclusionThe health care context, culture and research process influenced participants’ understanding of study information across study types and settings. We advise research managers or principal investigators to define minimum requirements that would not compromise the consent process and conduct study specific training for staff. The use of one size fits all consent process may not be ideal. More guidance is needed on how these differences can be incorporated during the consent process to improve understanding and delivery of consent.Trial registration Not applicable. (shrink)

Research Ethics, Volume 18, Issue 4, Page 265-280, October 2022. Concerns around comprehension and recall of consent information by research participants have typically been associated with low health and research literacy levels. In genomics research, this concern is heightened as the scientific and ethical complexities of genetics research, such as biobanking, genetic susceptibility, data sharing, and incidental findings may be more difficult for potential research participants to understand. However, challenges to research participants’ comprehension of consent information may be compounded by (...) factors beyond health and research literacy levels. To identify factors that may impact research participants’ understanding and recall of consent information, we designed a qualitative study to explore whether participants enrolled in a tuberculosis genetics study in Cameroon understood the objectives of the study, the risks and benefits and certain key aspects of the study such as biobanking and data sharing. The results showed that research participants had limited understanding and/or recall of the TBGEN-Africa study goals and methods. Some participants were of the opinion that TBGEN-Africa was not a genetics study because tuberculosis is not an inheritable condition. Factors that may have hindered understanding and/or recall of study information are diagnostic misconception, and information overload and situational vulnerability. There is a need for improved practices to support research participants’ understanding of consent information in genetics studies including designing the consent process in ways that minimize psychological distress and diagnostic/therapeutic misconception. (shrink)

Advances in genetic and genomic research have introduced 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 an H3Africa genomic study on Rheumatic Heart Disease at the University of Cape Town in South (...) Africa. The main aim of the study was to understand ethical challenges in obtaining informed consent in the RHDGen study. We used a qualitative study methodology involving in-depth interviews and participant observations. Our study participants were RHDGen cases, healthy controls and research staff involved in the recruitment of RHDGen cases and controls. In total, we conducted 32 in-depth interviews with RHDGen cases and controls, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen cases and controls. The interviews were conducted in English, audio-recorded and transcribed verbatim. Data were analyzed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa. Most healthy controls joined the RHDGen study in order to be screened for rheumatic heart disease. A majority of RHDGen cases decided to join the RHDGen study because of therapeutic misconception. The ethical challenges that impacted on obtaining informed consent in the RHDGen study were complex. In this study, the main challenges were diagnostic misconception among RHDGen controls and therapeutic misconception among RHDGen cases. (shrink)

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not (...) allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi. (shrink)

Background: Genetic research involving racial/ethnic populations has novel ethical implications for various stakeholders, but ethical acceptability among stakeholders regarding such research is not clear. Methods: As part of a multifaceted National Institute of Mental Health (NIMH)/National Human Genome Research Institute (NHGRI) funded survey, we used repeated-measures factorial multivariate analysis of variance (MANOVA) to compare the perspectives of institutional review board (IRB) chairs (n = 203), investigators (n = 183), and community members (n = 192) on the ethical acceptability of participating (...) in and reporting of psychiatric genetic research focused on racial/ethnic minority groups. Stakeholder views were assessed with two sets of three questions. Results: All stakeholder groups perceived participation in genetic studies focused on racial/ethnic groups as ethically acceptable and endorsed as ethical any decisions by racial/ethnic minorities to decline to participate in such studies if concerned about possible discrimination/stigmatization based on the study findings. Stakeholders disagreed considerably on the ethical acceptability of researchers or journal editors choosing not to publish genetic study results focused on racial/ethnic minority groups based on potential harm of the study findings. Conclusion: Findings show community and professional stakeholders support participation in genetic research focused on specific racial/ethnic groups but recognize that the results of such studies may contribute to discrimination or stigmatization. Stakeholders differed in their perspectives of investigators and editors in balancing ethical issues intrinsic to advancing science versus minimizing harm to potentially vulnerable populations. (shrink)

Background Biobanking and genomic research requires collection and storage of human tissue from study participants. From participants’ perspectives within the African context, this can be associated with fears and misgivings due to a myriad of factors including myths and mistrust of researchers. From the researchers angle ethical dilemmas may arise especially with consenting and sample reuse during storage. The aim of this paper was to explore these ethical considerations in the establishment and conduct of biobanking and genomic studies in Africa. (...) Methods We conducted a narrative synthesis following a comprehensive search of nine (9) databases and grey literature. All primary research study designs were eligible for inclusion as well as both quantitative and qualitative evidence from peer reviewed journals, spanning a maximum of 20 years (2000–2020). It focused on research work conducted in Africa, even if data was stored or analysed outside the region. Results Of 2,663 title and abstracts screened, 94 full texts were retrieved and reviewed for eligibility. We included 12 studies (7 qualitative; 4 quantitative and one mixed methods). Ethical issues described in these papers related to community knowledge and understanding of biobanking and genomic research, regulation, and governance of same by research ethics committees, enrolment of participants, types of informed consents, data collection, storage, usage and sharing as well as material transfer, returning results and benefit sharing. ca. Biospecimen collection and storage is given in trust and participants expect confidentially of data and results generated. Most participants are comfortable with broad consent due to trust in researchers, though a few would like to be contacted for reconsenting in future studies, and this would depend on whether the new research is for good cause. Sharing data with external partners is welcome in some contexts but some research participants did not trust foreign researchers. Conclusion Biobanking and genomic studies are a real need in Africa. Linked to this are ethical considerations related to setting up and participation in biobanks as well as data storage, export, use and sharing. There is emerging or pre-existing consensus around the acceptability of broad consent as a suitable model of consent, the need for Africans to take the lead in international collaborative studies, with deliberate efforts to build capacity in local storage and analysis of samples and employ processes of sample collection and use that build trust of communities and potential study participants. Research ethics committees, researchers and communities need to work together to work together to adapt and use clearly defined ethical frameworks, guidelines, and policy documents to harmonize the establishment and running of biobanking and genomic research in Africa. (shrink)

This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK’s National Health Service. We explore two aspects of consent: first, (...) how healthcare professionals consider the act of ‘consenting’ patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients’ understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients’ decision-making. Rather, decision-making is socially contextualised – also based on factors outside of information provision. A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed. (shrink)

Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups.

This article provides empirical evidence of the social context and moral reasoning embedded within a parents’ decision to participate in autism genetics research. Based on in-depth interviews of parents who donated their family’s blood and medical information to an autism genetic database, three narratives of participation are analyzed, including the altruistic parent, the obligated parent, and the diagnostic parent. Although parents in this study were not generally concerned with bioethical principles such as autonomy and the issues of informed consent and/or (...) privacy and confidentiality of genetic information, a critical analysis reveals contextual bioethics embedded within these different narratives. These include the negotiations of responsibility that parents confront in biomedical research, the misguided hope and expectations parents place in genomic science, and the structural barriers of obtaining an autism diagnosis and educational services. Based on these findings, this article demonstrates the limits of a principle-based approach to bioethics and the emergent forms of biological citizenship that takes into account the social situations of people’s lives and the moral reasoning they negotiate when participating in autism genetic research. (shrink)

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, (...) as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

BackgroundLimited research has been conducted on explanations and understandings of biobanking for future genomic research in African contexts with low literacy and limited healthcare access. We report on the findings of a sub-study on participant understanding embedded in a multi-disease community health screening and biobank platform study known as ‘Vukuzazi’ in rural KwaZulu-Natal, South Africa.MethodsSemi-structured interviews were conducted with research participants who had been invited to take part in the Vukuzazi study, including both participants and non-participants, and research staff that (...) worked on the study. The interviews were transcribed, and themes were identified from the interview transcripts, manually coded, and thematically analysed.ResultsThirty-nine individuals were interviewed. We found that the research team explained biobanking and future genomic research by describing how hereditary characteristics create similarities among individuals. However, recollection and understanding of this explanation seven months after participation was variable. The large volume of information about the Vukuzazi study objectives and procedures presented a challenge to participant recall. By the time of interviews, some participants recalled rudimentary facts about the genetic aspects of the study, but many expressed little to no interest in genetics and biobanking.ConclusionParticipant’s understanding of information related to genetics and biobanking provided during the consent process is affected by the volume of information as well as participant’s interest in the subject matter being discussed. We recommend that future studies undertaking biobanking and genomic research treat explanations of this kind of research to participants as an on-going process of communication between researchers, participants and the community and that explanatory imagery and video graphic storytelling should be incorporated into theses explanations as these have previously been found to facilitate understanding among those with low literacy levels. Studies should also avoid having broader research objectives as this can divert participant’s interest and therefore understanding of why their samples are being collected. (shrink)

Returning research results to participants is recognised as an obligation that researchers should always try to fulfil. But can we ascribe the same obligation to researchers who conduct genomics research producing only aggregated findings? And what about genomics research conducted in developing countries? This paper considers Beskow's et al. argument that aggregated findings should also be returned to research participants. This recommendation is examined in the context of genomics research conducted in developing countries. The risks and benefits of attempting such (...) an exercise are identified, and suggestions on ways to avoid some of the challenges are proposed. I argue that disseminating the findings of genomic research to participating communities should be seen as sharing knowledge rather than returning results. Calling the dissemination of aggregate, population level information returning results can be confusing and misleading as participants might expect to receive individual level information. Talking about sharing knowledge is a more appropriate way of expressing and communicating the outcome of population genomic research. Considering the knowledge produced by genomics research a worthwhile output that should be shared with the participants and approaching the exercise as a ‘sharing of knowledge’, could help mitigate the risks of unrealistic expectations and misunderstanding of findings, whilst promoting trusting and long lasting relationships with the participating communities. (shrink)

BackgroundObtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data. This study investigated researchers’ and participants’ parents’ experiences of a consent process and understandings of a genome-wide association study of malaria involving children aged five and under in Mali. (...) It aimed to inform best practices in recruiting participants into genomic research.MethodsA qualitative rapid ethical assessment was undertaken. Fifty-five semi-structured interviews were conducted with the parents of research participants. An additional nine semi-structured interviews were conducted with senior research scientists, research assistants and with a member of an ethics committee. A focus group with five parents of research participants and direct observations of four consent processes were also conducted. French and translated English transcripts were descriptively and thematically coded using OpenCode software.ResultsParticipants’ parents in the MalariaGEN study had differing understandings of the causes of malaria, the rationale for collecting blood samples, the purposes of the study and the kinds of information the study would generate. Genomic aspects of the research, including the gene/environment interaction underlying susceptibility or resistance to severe malaria, proved particularly challenging to explain and understand.ConclusionsThis study identifies a number of areas to be addressed in the design of consent processes for genomic research, some of which require careful ethical analysis. These include determining how much information should be provided about differing aspects of the research and how best to promote understandings of genomic research. We conclude that it is important to build capacity in the design and conduct of effective and appropriate consent processes for genomic research in low and middle-income settings. Additionally, consideration should be given to the role of review committees and community consultation activities in protecting the interests of participants in genomic research. (shrink)

Background With growth of genomics research in Africa, concern has arisen about comprehension and adequacy of informed consent given the highly technical terms used in this field. We therefore decided to study whether there are linguistic and cultural concepts used to communicate heritability of characters, traits and diseases in an indigenous African population. Methods We conducted Focus Group Discussions among 115 participants stratified by sex, age and socio-economic status and Key Informant Interviews among 25 stakeholders and Key Opinion Leaders among (...) Yoruba living in Ibadan, Nigeria. We used Atlas-ti v.8.3.17 software to analyze the data, using thematic approach. Results The study participants identified several linguistic and cultural concepts including words, proverbs, and aphorisms that are used to describe heritable characters, traits and diseases in their local dialect. These included words that can be appropriated to describe dominant and recessive traits, variations in penetrance and dilution of strength of heritable characteristics by time and inter-marriage. They also suggested that these traits are transmitted by “blood”, and specific partner’s blood may be stronger than the other regardless of sex. Conclusions Indigenous Yoruba populations have words and linguistic concepts that describe the heritability of characters, traits and diseases which can be appropriated to improve comprehension and adequacy of informed consent in genomics research. Our methods are openly available and can be used by genomic researchers in other African communities. (shrink)

Research Ethics, Volume 18, Issue 3, Page 193-209, July 2022. This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used to (...) convey information and enhance research participants’ understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified. (shrink)

BackgroundHIV molecular epidemiology is increasingly recognized as a vital source of information for understanding HIV transmission dynamics. Despite extensive use of these data-intensive techniques in both research and public health settings, the ethical issues associated with this science have received minimal attention. As the discipline evolves, there is reasonable concern that existing ethical and legal frameworks and standards might lag behind the rapid methodological developments in this field. This is a follow-up on our earlier work that applied a predetermined analytical (...) framework to examine the perspectives of a sample of scientists from the fields of epidemiology, public health, virology and bioethics on key ethical issues associated with HIV molecular epidemiology in HIV network research.MethodsFourteen in-depth interviews were conducted with scientists from the fields of molecular epidemiology, public health, virology and bioethics. Inductive analytical approaches were applied to identify key themes that emerged from the data.ResultsOur interviewees acknowledged the potential positive impact of molecular epidemiology in the fight against HIV. However, they were concerned that HIV phylogenetics research messages may be incorrectly interpreted if not presented at the appropriate level. There was consensus that HIV phylogenetics research presents a potential risk to privacy, but the probability and magnitude of this risk was less obvious. Although participants acknowledged the social value that could be realized from the analysis of HIV genetic sequences, there was a perceived fear that the boundaries for use of HIV sequence data were not clearly defined.ConclusionsOur findings highlight distinct ethical issues arising from HIV molecular epidemiology. As the discipline evolves and HIV sequence data become increasingly available, it is critical to ensure that ethical standards keep pace with biomedical advancements. We argue that the ethical issues raised in this study, whether real or perceived, require further conceptual and empirical examination. (shrink)

BackgroundCommunity engagement in research has gained momentum as an approach to improving research, to helping ensure that community concerns are taken into account, and to informing ethical decision-making when research is conducted in contexts of vulnerability. However, guidelines and scholarship regarding community engagement are arguably unsettled, making it difficult to implement and evaluate.DiscussionWe describe normative guidelines on community engagement that have been offered by national and international bodies in the context of HIV-related research, which set the stage for similar work (...) in other health related research. Next, we review the scholarly literature regarding community engagement, outlining the diverse ethical goals ascribed to it. We then discuss practical guidelines that have been issued regarding community engagement. There is a lack of consensus regarding the ethical goals and approaches for community engagement, and an associated lack of indicators and metrics for evaluating success in achieving stated goals. To address these gaps we outline a framework for developing indicators for evaluating the contribution of community engagement to ethical goals in health research.SummaryThere is a critical need to enhance efforts in evaluating community engagement to ensure that the work on the ground reflects the intentions expressed in the guidelines, and to investigate the contribution of specific community engagement practices for making research responsive to community needs and concerns. Evaluation mechanisms should be built into community engagement practices to guide best practices in community engagement and their replication across diverse health research settings. (shrink)

The practice of making datasets publicly available for use by the wider scientific community has become firmly integrated in genomic science. One significant gap in literature around data sharing concerns how it impacts on scientists’ ability to preserve values and ethical standards that form an essential component of scientific collaborations. We conducted a qualitative sociological study examining the potential for harm to ethnic groups, and implications of such ethical concerns for data sharing. We focused our empirical work on the MalariaGEN (...) Consortium, one of the first international collaborative genomics research projects in Africa. (shrink)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent (...) to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)

Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.