With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (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)

BackgroundCurrent advances in biomedical research have introduced new ethical challenges in obtaining informed consent in low and middle-income settings. For example, there are controversies about the use of broad consent in the collection of biological samples for use in future biomedical research. However, few studies have explored preferred informed consent models for future use of biological samples in Malawi and South Africa. Therefore, we conducted an empirical study to understand preferred consent models among key stakeholders in biomedical studies that involve (...) collection of biological samples in Malawi and South Africa. The main objective of the study was to explore views of key stakeholders on current policies on informed consent in Malawi and South Africa. MethodsThis was a qualitative study involving in-depth interviews and focus group discussions. Thirty-four in-depth interviews and 6 focus group discussions were conducted with REC members, Funders, Policymakers, CAB members and Research Participants in Malawi and South Africa to gather their views on models of informed consent. The study was conducted in Cape Town, South Africa, and Blantyre and Lilongwe in Malawi.ResultsMost key stakeholders preferred broad consent and tiered consent to specific consent. Some participants expressed a strong preference for specific consent to other models of informed consent in biomedical research. Few participants did not have any preference for a consent model, opting for any consent model which provides adequate information about the proposed research and what their national consent regulations require. Finally, very few participants preferred blanket consent to other informed consent models.ConclusionsThis study aimed to help fill the gap in the scientific literature on key stakeholder views on consent models for future use of biological samples in Malawi and South Africa. The findings of the study have provided some evidence that may support policies on permissible consent models for future use of biological samples in sub-Saharan Africa considering the differences in informed consent regulations and guidelines. Finally, the findings can inform ongoing discussions on permissible consent models to be used for future use of biological samples. (shrink)

A multitude of legislation impacts the use of samples and data for research in South Africa. With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must also be considered (...) and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders. (shrink)

Background A biobank is a structure which collects and manages biological samples and their associated data. The collected samples will then be made available for various uses. The sharing of those samples raised ethical questions which have been answered through specific rules. Thus, a Biobank functioning under tight ethical rules would be immensely valuable from a scientific and an economic view point. In 2009, Côte d’Ivoire established a biobank, which has been chosen to house the regional biobank of Economic Community (...) of West African States countries in 2018. To ensure optimal and efficient use of this biobank, the scientific community must be aware of its existence and its role. It was therefore necessary to evaluate the knowledge of laboratories staff on the role and activities of a biobank. Methods This descriptive study was done by questioning staff from laboratories working on human’s health, animals or plants. The laboratories were located in southern Côte d’Ivoire. Results A total of 205 people completed the questionnaire. Of these 205 people, 34.63% were biologists, 7.32% engineers, 48.78% technicians and 9.27% PhD students. The average length of work experience was 10.11 ± 7.83 years. In this study, 43.41% of the participants had never heard of biobanking. Only 48.78% of participants had a good understanding of the role of a biobank. Technicians and PhD students were less educated on the notion of biobank. Conclusion The level of knowledge of laboratory staff about biobanking needs to be improved. Training on the role, activities and interests of the biobank is important. (shrink)

Biobanks and biospecimen collections are becoming a primary means of delivering personalized diagnostics and tailoring individualized therapeutics. This shift towards precision medicine requires interactions among a variety of stakeholders, including the public, patients, healthcare providers, government, and donors. Very few studies have investigated the role of healthcare students in biobanking and biospecimen donations. The main aims of this study were to evaluate the knowledge of senior healthcare students about biobanks and to assess the students’ willingness to donate biospecimens and the (...) factors influencing their attitudes. A cross-sectional study was conducted among senior healthcare students at King Abdulaziz University, Saudi Arabia. The data were obtained using a self-administered questionnaire in English. In addition to the respondents’ biographical data section, the questionnaire assessed the respondents’ general knowledge about biobanking, the factors influencing their willingness to donate biospecimens to biobanks and their general attitudes towards biomedical research. A total of 597 senior healthcare students were included in the study. The general knowledge score was 3.2 out of 7. Only approximately 44% and 27% of students were aware of the terms “Human Genome Project” and “biobank,” respectively. The majority of the students were willing to donate biospecimens to biobanks. Multiple factors were significantly associated with their willingness to donate, including their perceived general health, past experience with both tissue testing and tissue donation, biobanking knowledge score and biomedical research attitude score. The main reasons for students’ willingness to donate were advancement of medical research and societal benefits, whereas misuse of biospecimens and confidentiality breaches were the main reasons for a reluctance to donate. Despite their strong willingness to donate biospecimens, students exhibited a notable lack of knowledge about biobanking and the HGP. To expedite the transition towards PM, it is highly recommended to enhance healthcare curricula by including more educational and awareness programmes to familiarize students with OMICs technologies in addition to the scope of research and clinical applications. (shrink)

Background Protecting the privacy of research participants is widely recognized as one of the standard ethical requirements for clinical research. It is unknown, however, how research professionals regard concepts of privacy as well as the situations in the research setting that require privacy protections. The aim of this study was to explore the views of research professionals from Arab countries regarding concepts and scope of privacy that occur in clinical research. Methods We adopted an exploratory qualitative approach by the use (...) of focus group discussions. We recruited individuals involved in research from Egypt and Morocco. We analyzed focus group data via a constant comparison approach, which consisted of close reading of the transcribed interviews followed by coding and then determining themes and subthemes. Results Between August 2016 and July 2018, we conducted nine focus group discussions. Respondents discussed several privacy issues that occurred before the research began ; during research, and after the research. Respondents revealed their perspectives of patients towards privacy in the clinical and research settings and mentioned that patients are more likely to permit access to their privacy in the clinical setting compared with research setting due to the existence of benefits and trust in clinical care. Respondents also recommended training regarding data protections for individuals involved in research. Conclusions Our study shows that research professionals discussed a range of privacy issues that are present during the different stages of research. We recommend 1) development of standards regarding privacy protections during recruitment efforts; 2) additional training for individuals involved in research regarding best practices with data security in secondary research; 3) a quantitative study involving investigators and REC members to determine their knowledge, attitudes and practices regarding privacy issues that occur in research; and 4) a quantitative study involving patients to elicit their views regarding their privacy concerns in research. (shrink)

Biobanking has become a global activity of growing relevance to research. The African continent is part of this global effort to collect, store and re-use samples and data. International research and capacity development efforts such as the Human Health and Heredity Africa project seek to empower African researchers and research participants alike. Given that African genetic diversity is a unique global resource, retaining samples and data on the continent is critical to building trust in communities who have been historically exploited (...) in the name of research. Diverse and multiple stakeholders are involved in biobanking. Engaging authentically with these various stakeholder groups is a pre-requisite to building trust. Likewise, establishing legitimacy of biobanks also contributes to development of trust in communities. This paper reflects on the concepts of trust, legitimacy and stakeholder engagement. Empirical research conducted on researchers in South Africa as well as on research participants and Community Advisory Board members is briefly presented. The development of educational pamphlets on genetics, genomics and biobanking and an educational video on biobanking in conjunction with CAB members is described. These tools were used to engage research participants and CAB members in discussions around biobanking. Establishing biobanks in African settings is challenging. However, efforts must be made to engage with relevant stakeholders on the basis of mutual respect and trust. (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)

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these (...) ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research. (shrink)

BackgroundThere is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A qualitative (...) study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research.MethodsThis study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed.ResultsOn the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted.Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns.ConclusionsStudy findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants. (shrink)

Information is clearly vital to public health, but the acquisition and use of public health data elicit serious privacy concerns. One strategy for navigating this dilemma is to build 'trust' in institutions responsible for health information, thereby reducing privacy concerns and increasing willingness to contribute personal data. This strategy, as currently presented in public health literature, has serious shortcomings. But it can be augmented by appealing to the philosophical analysis of the concept of trust. Philosophers distinguish trust and trustworthiness from (...) cognate attitudes, such as confident reliance. Central to this is value congruence: trust is grounded in the perception of shared values. So, the way to build trust in institutions responsible for health data is for those institutions to develop and display values shared by the public. We defend this approach from objections, such as that trust is an interpersonal attitude inappropriate to the way people relate to organisations. The paper then moves on to the practical application of our strategy. Trust and trustworthiness can reduce privacy concerns and increase willingness to share health data, notably, in the context of internal and external threats to data privacy. We end by appealing for the sort of empirical work our proposal requires. (shrink)

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature (...) of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa’s current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template. (shrink)