Research-Related Stakeholders' Perspectives on Sociocultural Considerations in Biobanking Practice in South Africa

Abstract

Background:

Biobanking practice continues to proliferate in South Africa, yet little is known about how stakeholders engage with social, cultural, and religious considerations in this area of research. This study was undertaken to establish the perspectives of South African stakeholders (researchers, biobankers, clinicians, and research committee members) on sociocultural considerations in biobanking research.

Methods:

This in-depth exploratory study used semistructured face-to-face or Skype interviews with 25 purposively selected stakeholders involved in the biobanking-related practice. The study sample comprised biobankers, clinicians, researchers, postgraduate students in biobanking research, and research ethics committee members in South Africa. The interview focused on social and cultural challenges facing the biobanking practice in the country. Further probes included stakeholder perspectives on ownership and custodianship of stored biosamples. Thematic analysis was used to analyze the collected data.

Results and Discussion:

Several themes arose from the data analysis. These included respondents' perceptions of poor understanding of biobanking among research participants and communities; inconsistency in defining ownership and custodianship of biosamples; variability in respondents' understanding of cultural, religious, and social implications of biobanking; the notion of distrust; and building trust in biobanking. There were also inconsistencies in respondents' recognition of social, cultural, and/or religious influences on participant decision-making in biobanking research. Respondents highlighted that a general climate of distrust existed in the biobanking practice in South Africa.

Conclusion:

There is a need for greater stakeholder awareness of sociocultural considerations in biobanking practice in South Africa. One possible way to achieve this could be through the availability of training programs aimed at improving stakeholder understanding of the sociocultural context for biobanking practice in addition to greater efforts at community engagement with respect to all biobanking activities and research.

Introduction

Biobanking in Africa provides a fertile landscape for exploitative practices due to several historical and cultural factors. First, the continent boasts of a rich genetic history and diversity in populations.^1,2 Second, the global north-south divide in biobanking research has seen more samples leaving the continent on the pretext of poor resource capacity and inadequate researcher expertise within Africa.²

Africa has also been plagued by centuries of colonial exploitation, underdevelopment, and disregard for the beliefs and practices of local populations. One of the hallmarks of colonialism was a Eurocentric monotheistic approach to religion and cultural beliefs, where indigenous practices were considered un-Christian.³ Yet, many African cultures have different cultural interpretations of the human body and the continuum between life and the after-life. Blood is considered sacred and is believed to be capable of sustaining a life force outside of the human body.⁴ These diverse cultural interpretations of the human body have important implications for the collection, storage, and sharing of biospecimens in biobanking practice. For example, the distinction between a Eurocentric and African interpretation of life and the after-life becomes more pronounced when one considers the storage of blood samples in a biobank.

Biobanking research brings these issues back into focus, specifically in light of an increasing global need to recognize and protect the rights and interests of participating individuals and communities.⁵

Much of the research on the ethical, legal, and social implications of biobanking has focused on issues related to consent, sample storage and sharing, participant privacy, return of research results, benefit sharing, custodianship, governance, commercialization, and regulatory issues.^6,7 Few studies have investigated how participants' and communities' beliefs, customs, and cultural and religious practices fit into existing biobanking research efforts.⁸ Similarly, much of ethics guidance on biobanking research has focused on a Western autonomous approach to informed consent, through which consent is considered valid when an individual makes an independent decision on whether to participate in research.⁹ Relational autonomy, however, argues that decision-making cannot be entirely independent because an individual's relationship with others could influence his/her decision-making.¹⁰

From a shared African perspective, a person is defined through the community. Thus, decision-making could be influenced by members of the family, community or spiritual leaders, and possibly even ancestral spirits.¹¹ The notion of communitarianism in African as well as in other indigenous belief systems brings the shortcomings of autonomous decision-making back into focus. This dislocation between indigenous cultural practices and imported Western belief systems could contribute to the overall community distrust in research. Therefore, risk assessment in biobanking should occur at both the individual and community levels.¹²

At the same time, public distrust in biobanking research has been linked to poor community engagement on the African continent.^13,14 Such distrust is linked to the transfer of thousands of Ebola samples off the African continent and the recent publicized dispute over the unauthorized sharing and possible commercialization of biosamples. These claims were made by a South African university against a research team based in the United Kingdom.^5,15 This institution had research collaborations with a university in the United States, and biological material (blood samples) and associated data were shared with the U.S.-based university through this collaborative process. The samples were transferred from South Africa to the U.S.-based university with the necessary export permits for the cross-border transfer of samples and with consent obtained from the affected research participants.

These shared samples were subsequently transferred to the Wellcome Sanger Institute for research-related genome analysis, as part of the agreed material transfer agreement (MTA) between the South African institution and the university in the United States. The dispute arose when the samples were allegedly further shared by the Wellcome Sanger Institute with a commercial company for the creation of gene chips (also known as “microarrays” for rapid genetic testing), but without the South African university's knowledge nor with consent from the research participants. The South African university further claimed that no data sharing agreement was in place with this third party and hence demanded the return of shared samples from the Wellcome Sanger Institute.^15–17 The outcome of this case is not publicly known.

Other examples further outline distrust in biobanking research. From 1982 to 1985, Dr. Richard Ward collected 833 vials of blood from members of the Nuu-chah-nulth tribe, with their consent, to screen for arthritis biomarkers, but at the end of that study, he continued using those samples for other genetic anthropology studies without the participants' knowledge or consent.¹⁸ Similarly, members of the Havasupai Tribe in Arizona, USA, learned that researchers at the Arizona State University collected their blood samples between 1990 and 1994 to search for a link to diabetes but instead continued using the samples to look for other diseases such as schizophrenia, as well as for other genetic markers.¹⁹

Thus, building public trust in biobanking, through transparency and communication, is critical. While recognition of sociocultural considerations in nonemergency biobanking research is vital for building public trust, the COVID-19 pandemic has inadvertently brought into focus the need to consider other factors when dealing with the collection and handling of samples during a public health emergency.

The following example illustrates how existing sociocultural practices could not be followed due to public health concerns related to these practices. During the Ebola virus outbreak in West Africa, common funeral rituals such as “washing and cleaning of the dead body,” “relatives washing their hands in a common bowl after which they touch the face of the deceased,” and people laying over the corpse of a prominent deceased person were disallowed by authorities in the affected countries to prevent “human-to-human transfer of the Ebola virus.”²⁰ Likewise, collection of samples for research purposes during the COVID-19 pandemic should follow the country-specific national legislations that regulate such practices.

These highlighted issues have relevance to the South African context of biobanking practice given the prevailing diversity in linguistic, cultural, and ethnic belief systems in the country, coupled with the historical inequities in socioeconomic status. There is limited published empirical evidence in South Africa to create a clear picture on how researchers, biobankers, and research ethics committees (RECs) consider sociocultural considerations in nonemergency biobanking research. A study conducted by Moodley et al. suggested that research participants preferred more engagement with researchers on issues related to sample collection, storage, and reuse.²¹ However, little is known about researchers' understanding of diverse cultural and social practices, as well as their willingness to engage with research participants and communities on issues related to these practices.

The purpose of this study was to elicit stakeholder (researchers, biobankers, clinicians, and research committee members) perspectives on the sociocultural considerations in biobanking practice in South Africa. This study forms part of a larger research project that explores the development of an online course on ethical, legal, and social issues related to the biobanking practice in South Africa.

Methods

This in-depth exploratory study used a qualitative approach to engage with stakeholders involved in biobanking practice to understand whether and how biobanking practices attend to sociocultural issues.

In this study, stakeholders were defined as individuals involved in the operationalization and/or management of stored biological material (biobankers, researchers, or clinicians), or in the ethics review of such related research (REC members). The study did not include stakeholders such as policymakers, funders, and research participants. Individuals involved in biobanking in South Africa form a relatively small community. We used online searches and literature reviews to identify representatives from various biobanks in locations across the country, as well as representatives from RECs involved in the review of biobanking research. We contacted these representatives to confirm they were indeed associated with the biobank or REC of interest, and to ask them to refer us to others involved in biobanking and research ethics review.

Thus, we used a combination of purposive and snowball sampling to ensure a wide representation of stakeholders to recruit. Letters of invitation for participation in the research were sent to all the identified individuals. Those who were interested in participating were asked to contact the researchers. Respondents ultimately came from four universities located in different provinces in South Africa. One of the responding universities is classified as a historically disadvantaged university. Twenty-five semistructured interviews were conducted between January and August 2019. Twenty-four of these were conducted face-to-face, while one was conducted via Skype (Table 1).

Table 1.

List of Respondents

Interviewee	Position/experience
1	Researcher in biobanking, biobanker, REC member University A.
2	Researcher in biobanking, biobanker, University B.
3	Clinical care/nurse in biobanking research, University B.
4	REC member, ethics teaching, University B.
5	Clinician, researcher in biobanking, biobanker, University B.
6	Researcher in biobanking, biobanker, University B.
7	Retired, former REC member. University D.
8	Clinician, researcher in biobanking, biobanker, University B.
9	Researcher in bioethics, REC member, University B.
10	Researcher in pharmacology, REC member, University A.
11	Retired, researcher in bioethics, REC member. University A.
12	Clinician, researcher in biobanking, biobanker, University B.
13	Clinician, researcher in emergency medicine, REC member, University A.
14	Researcher in genetics, REC member, University A.
15	REC member, researcher in bioethics, University A.
16	Researcher in community-based and clinical trials, REC member, University A.
17	Researcher in clinical and biobanking research, postgraduate student, University A.
18	Researcher in biobanking, biobanker, University A.
19	Researcher in clinical and biobanking research, postgraduate student, University C.
20	Researcher in clinical and biobanking research, postgraduate student, University A.
21	Researcher in bioethics, University D.
22	REC member, University D.
23	Researcher in bioethics, University D.
24	REC member, researcher in bioethics, University D.
25	Researcher in biobanking, biobanker, University C.

REC, research ethics committee.

Ethical clearance was obtained from Stellenbosch University Health REC Reference: S18/05/091. All ethical considerations such as written informed consent, participant privacy, and confidentiality were adhered to. Interviews lasted 30–60 minutes and were digitally recorded. The interview was conducted in English as most academics and scientists are fluent in English in South Africa, and participants had multiple prior engagements with the researcher in setting up the appointments.²²

The interview focused on respondents' perceptions of the social and cultural challenges facing biobanking practice, and respondents were asked to provide examples of such challenges. They were also asked about their understanding of ownership and custodianship of stored biosamples.

Before data analysis, respondents were offered transcripts of their interviews to verify that they represented a true reflection of their statements on biobanking practice.²² For analysis, transcripts were read in their entirety, descriptive narratives were created to summarize each participant's perspectives, and the narratives were used to identify and refine emergent themes using thematic analysis techniques.²³

Results

Five themes arose emerged from data analysis, which we explore in detail below. These themes are respondents' perceptions of poor understanding of biobanking among research participants and communities; respondents' inconsistency in defining ownership and custodianship of biosamples; variability in respondents' understanding of cultural, religious, and social implications of biobanking; the notion of distrust in biobanking; and building trust in biobanking.

Perceptions of poor understanding of biobanking among communities

Respondents believed that biobanking practice was poorly understood by individuals and communities involved in providing biosamples for storage and reuse. Some of the reported barriers to community understanding of biobanking were attributed to low health literacy and educational levels. The decision to participate in biobanking could be influenced by possible pressure from the leadership within a community or the perception that research facilitates access to health care (also called therapeutic misconception). One respondent noted:

Most of these research participants come from very socially challenged backgrounds and they simply become part of research because either their chief or the tribal leader tells them to or because they have easy access to treatment (11).

Respondents also pointed out that while international collaborative research was necessary, the global north-south divide becomes more apparent in how different communities understand and engage in biobanking research. Terminologies such as RNA or DNA extraction from blood, genetics, and gene sequencing are generally difficult for the layperson to understand. This challenge is compounded in communities with low health literacy levels. Thus, issues such as storage of biosamples for future use or transfer of such material can be difficult to comprehend. In addition, lengthy consent documents that do not consider the local context or community level of understanding could act more as an impediment to biobanking research. A respondent added that:

Low literacy rates among communities is a challenge. Although the people explaining the consent form are from the community it remains difficult… Americans will insist on certain things which might be appropriate for the US study participant but clearly not appropriate for our study. I am not saying our participants need less information but the type of information, the type of language is not appropriate (8).

Local researchers and research participants could have less bargaining power in studies that involve foreign researchers. Thus, both researchers and the affected study participants may not have the necessary influence regarding decisions related to how the study is operationalized and what information is provided to the research participants.

On the contrary, the power dynamics between researchers, clinicians, and the communities at large must also be taken into consideration. One respondent pointed out that:

The other thing that people [research participants] have to get used to is that the specimens will be taken away. Another challenge is getting people to understand that [the specimens] might even go overseas, so the specimens can be shipped overseas for analysis or for testing (16).

Inconsistency in defining ownership and custodianship of biosamples

There were inconsistency and confusion among respondents with regard to the ownership of stored biospecimens. Some respondents believed that the biosamples belonged to the researcher or to the institution that housed the biorepository, and others believed that biosamples belonged to the research participants. One respondent highlighted the need for dual ownership (researcher and participant) with contractual agreements. This lack of clarity in ownership of the biological material has ethico-social implications, specifically in terms of respecting and upholding the rights of individuals and communities to shared benefits that might accrue from the study. Respondents provided the following comments:

In my personal opinion the sample belongs to the person who designed that study, who developed that concept and who actually went out and did the research to get that sample. So, the public having ownership of that sample to me that's just incorrect unless there were data sharing agreements (1).

I just prefer the notion of custodianship. I am aware of some documents; I think that there are some Americans who have suggested that the donor does not own a sample, if I am not mistaken. I do not have well developed ideas about that, but I think the universe owns the samples. The researcher is the custodian of the samples (15).

The nuances on the ownership of stored biospecimens were further articulated by one respondent who believed that perhaps too much emphasis was placed on individual ownership of biological material but that this needs to be balanced in terms of the participants' access to care and other direct benefits that could arise from participation in research.

Variability in respondents' understanding of cultural, religious, and social implications of biobanking

There was variability in respondents' understanding on whether cultural and/or religious practices influenced participant decision-making in biobanking research.

One respondent reported that community participation in biobanking was unaffected by the prevailing cultural beliefs and practices, noting:

In the five years that we have been collecting specimens, people or participants have actually surprised us in that they are very willing to assist, and cultural beliefs or practices do not even come into play (2).

A possible explanation could be the assumption that this willingness on the part of research participants was attributed to the research team's relationship with the affected community.

On the contrary, some participants believed that culture definitely does influence participation in biobanking as reflected in the following quote:

There were community concerns that the [collected] blood was being sold and that the blood was used to disadvantage the community in some spiritual way. There were quite deep cultural beliefs about the ownership of blood and about not being able to give blood from your clan to somebody else. There was a deep layered cultural significance given to blood. I think it has sensitised me to that kind of issue and I became aware that different communities really do have quite strong communal beliefs about human tissue and samples. I think researchers and ethics committees and people writing guidelines need to be sensitive to that (15).

Another respondent further illustrated the extent to which cultural practices influenced participation in biobanking such as a person not wanting to donate her placenta for research purposes due to her cultural beliefs. Certain indigenous cultures believe that the placenta from childbirth needs to be buried to ensure a healthy life for the infant.²⁴ Respondents who appeared to share an ethnically similar background or cultural and belief system to those involved in providing samples for biobanking seemed better able to express understanding of sociocultural considerations in biobanking, however, it should be noted that the researcher did not ask specific questions regarding interviewees' sociocultural beliefs.

A further ethical complication can occur when the research participant who provided the biosample dies. The surviving family might request the return of the stored biosamples, because, according to certain African cultural beliefs, all bodily or biological parts of the deceased person must be buried with the affected person. This is to ensure that there is a proper transition from the world of the living to the spiritual realm. As explained earlier, all extracted biosamples, including blood, are still connected to the host, and therefore, any residual bodily part could hinder the transition of the departed soul.^25,26 While the deceased person has no property rights,²⁷ sensitivity and respect for the surviving families' and relatives' beliefs should be considered.

Similarly, some respondents reported that certain cultures believe that collected biosamples could be used for satanic purposes or witchcraft. Hence, storing blood in a biobank or biorepository becomes particularly problematic in this context. This illustrates that the role of culture and belief systems is multifaceted, and stakeholders in biobanking need to consider the diversity in cultural and religious beliefs both within a community and across different countries. One respondent postulated that:

The western model is enforced everywhere and that is not the only model that should count. So, we have African perspectives too and Asian perspectives and regional perspectives. For instance, it is very different in South Africa, Malawi and Uganda, what people can collect and for what people will give consent I am just talking about blood now. In Malawi you can't get away with more than ten millilitres for instance it is just not socially acceptable. In Uganda it is a bit more than that but also much less than in South Africa and in some countries up north in Africa you can't get away with anything… And then of course the understanding of the consent form is really important. We kid [delude] ourselves if we think that the patients understand a third of what we say. Although it is written in layman terms, people just don't understand (8).

Likewise, from a social perspective, respondents indicated that researchers need to be aware that in some cultures, women are not allowed to make independent decisions regarding participation in research.

The wife cannot give any consent and then you need the husband to come in. Like someone coming from Rwanda or Somalia or Nigeria those women can't just say yes to anything [such as donating to a biobank leftover human biological material from clinical procedures] (3).

This brings into question the role that women occupy in a patriarchal society and how this influences their participation in biobanking research, however, it should be noted that these study participants did not indicate that they had expertise in understanding sociocultural practices in these highlighted countries. Researchers need to be aware of these nuances and address this accordingly through community engagement efforts.

Setting up a biobank, should include an intimate understanding of the prevailing social, cultural and religious beliefs that could have a profound influence on the nature and sustainability of the biobank.

The notion of distrust in biobanking

Respondents pointed out that a general climate of distrust exists in biobanking. This level of distrust was seen as more than simply community attitudes and refusal to participate in research. There were expressions of antagonism by respondents toward internationally driven research and the term “helicopter research” was used. The central purpose of “helicopter research” was seen as extraction of biosamples for export out of the country. In the absence of any benefit sharing processes, these activities were seen as a means to enrich researchers in wealthier countries with very little consideration for capacity development in the country providing the biosamples. One respondent added:

So social challenges I think can mean different things. I would say there is general distrust because essentially… samples are collected and then they benefit the West. And they benefit wealthy helicopter scientists who fly [in] and help themselves. The NIH [National Institute of Health] is demanding broad consent on samples that are biobanked and there are no options for participants to disagree with that in most cases. So, it just pushes home this message that researchers are there for the purpose of collecting samples for their own benefit (21).

An interesting perspective is that while South African researchers and communities on the African continent were generally distrustful of Western countries, distrust could also exist within these high-income countries. Marginalized and socially or politically excluded communities within wealthier nations could also be skeptical of the intentions of biobanking research. Distrust was also extended to researchers who are reluctant to share biosamples.

Another respondent pointed out:

If someone wants to pull out a whole blood sample for example from the freezer to do a paternity test, [this has] social harm ramifications for the individual from whom that sample came. We don't know exactly what that sample is going to be used for. In some research it may be an ethical violation. They may state I am just using the whole blood to extract DNA to identify particular genetic markers (1).

The theme of distrust in biobanking highlighted that the general culture of biobanking appeared to be riddled with distrust that occurred at multiple layers.

Building trust in biobanking

Respondents generally agreed that trust building efforts were necessary to establish trust between the researchers, individuals, and communities involved in biobanking research. However, the notion of trust building needs to be wider and more inclusive. Building community trust meant acting in the best interests of participants, which required elements of honesty, transparency, veracity, and truthfulness, as illustrated by the following quote.

We trained our nursing sisters. They are responsible for most of the informed consent to approach research participants with sensitivity to cultural differences and religion and gender and other important related issues. We don't push people if they have strong personal feelings not to [participate], we accept that (5).

While building of public trust and support for biobanking is essential for the core functioning of biobanks, the conduct of researchers also plays an important role in building trust in the biobanking practice. A respondent indicated that:

You first must have compassion. Then you must have the knowledge of why we are doing [this]. You should know the when, where and how so that you can really answer the patient, because the patient is not at the hospital for nothing. They are sick with something or the other and then you come and collect a biobank sample. You can't put extra stress on them so you really need to know your facts (3).

Discussion

This study demonstrated variations in the identified stakeholders' perceptions and understandings of sociocultural considerations in biobanking practice. Some respondents detailed the importance of recognizing how blood and human tissues are viewed in certain cultural settings in South Africa and other parts of the continent. A number of other studies have highlighted the complexities of demonstrating respect for diverse cultural beliefs regarding the use of specimens for research. Dive et al. noted that “the persisting personal and cultural identity that attaches to human tissue even when it is disembodied” should be an important consideration in genomic research.⁷ Beliefs regarding the triad of mind, body, and soul in relation to a person's lived experience are not uniquely African. Similar views on the interconnectedness of “land, ancestors, culture, and bodily substances” have been documented in indigenous communities around the globe, and thus, how individual human biological material is handled takes on additional importance.²⁸

Aramoana et al. pointed out that “samples like placenta, fingernails, hair, and urine may be viewed as waste in European society but have significance and importance in indigenous communities.”²⁸

In addition, this study highlighted the need to recognize that individual health is embedded in population health. Studies further illustrate that respect should be shown to all cultures irrespective of the variation in belief systems and that the preservation of these values and practices should be ensured.^28,29 Such values could include the need for respect, honesty, justice, and fairness (such as benefit sharing efforts with the community) as articulated in the San Code of Research Ethics.³⁰ Other similar codes for research ethics have been developed by the Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS)³¹; the Tkarihwaié:ri Code of Ethical Conduct on Respect for the Cultural and Intellectual Heritage of Indigenous and Local Communities Relevant for the Conservation and Sustainable Use of Biological Diversity³²; and the First Nations Code of Conduct,³³ to name a few.

This reiterates the need for a well thought-out community and stakeholder engagement process.^34–39 Respondents' understanding and expression of sociocultural considerations in biobanking appeared to be influenced by their belief systems and cultural practices, however, as explained earlier, the researcher did not ask specific questions regarding interviewees' sociocultural beliefs. This variation could also be influenced by differences in the experiences of the respondents with studies involving different sample types and study populations that may have differences in sociocultural beliefs and perspectives. This observation is not unique. For example, Aramoana et al. note that “Western researchers” might struggle to “comprehend” the link between human biological material and cultural practices.²⁸ Applied to biobanking research, this means that although researchers and other stakeholders are seen as caring and acting in the best interests of individuals and communities, the deeper impact of personal beliefs should not be ignored.

Respondents expressed differing views on the ownership and custodianship of biosamples despite the existence of a clearly illustrated national MTA in South Africa. Other studies have also highlighted biobankers' and researchers' confusion and inconsistencies regarding ownership and custodianship of stored biosamples.^40,41 Moodley et al. illustrated how participants in South Africa believed that the blood they donated for research belongs to them.²¹ A clearly defined MTA could lay to rest some of these challenges. Moodley, however, cautioned that the potential for exploitative practices in biobanking could still occur despite the existence of MTAs, as illustrated by the Sanger case described earlier.⁵ The Material Transfer Agreement of Human Biological Materials (SA MTA), gazetted in July 2018,⁴² specifies that the participant remains the owner of the biospecimens. Custodianship lies with the institution/facility that stores the biospecimen.

Nevertheless, the literature further shows that the debate around ownership and custodianship of biospecimens remains contentious as this may be determined differently in other countries. For example, in the United States, despite recent revisions to the regulations governing the protection of human research subjects, including new provisions that require disclosure in consent forms of possible commercialization of samples, the ownership of samples remains unclear.⁴³ However, a small set of relevant U.S. case laws point to research participants no longer having property rights to donated samples.⁴⁴ Consequently, the discrepancies in defining ownership of biosamples in the United States and South Africa could be problematic when sharing across borders. Moreover, respondents in this study made multiple references to the U.S. context of research collaboration, suggesting that the country has a strong influence on biobanking research initiatives in South Africa.

This study highlighted other challenges that can occur within research collaborations between foreign and South African researchers. For example, study protocols and consent documents are often developed in the United States or in Europe and are circulated globally to various Low-and-Middle-Income Countries when pharmaceutical companies are involved as sponsors. This also occurs with big network studies such as HIV studies. REC interview respondents in our study noted that they could detect this foreign influence when specific terminology is present in consent documents, such as the United States' use of the term “shot” for injection. In addition to examining basic ethical questions such as who gets to decide what language is included in consent forms, future research should investigate how the power dynamics between South African and foreign researchers is negotiated, particularly when South African researchers are dependent on foreign researchers and funding agencies. Thus, the complexities in cross-border research collaborations need further investigation.

The reported culture of distrust among researchers would be an important ethical consideration in biobanking practice. Some respondents believed that research participants, researchers, and local communities were distrustful of biobanking because of the potential for exploitative practices, especially on the part of foreign researchers conducting research in South Africa. The pivotal role of trust has also been highlighted in other studies.^45,46 This finding is not unique to the South African biobanking context. Even in countries where high levels of public trust and positive attitudes exist toward biobanking practice, people's willingness to participate in such research might not be uniform.⁴⁷ The reported layers of distrust in biobanking research as identified by this study need further exploration in future research.

The results of this study highlight the need to position biobanking practice within the wider sociocultural and political fabric of society to ensure better community understanding and support of biobanking-related research. This finding is consistent with a report proposing an eight-step “TRUCE Model for Community Engagement” to facilitate a systematic approach for community engagement in biobanking through community consultation.³⁵ The authors contend that the community becomes a stakeholder in biobanking research as opposed to simply being providers of genetic resources or passive participants. The literature further adds that issues such as loss of privacy, discrimination, and possible commercialization of biobanking practice could influence the extent of cooperation with stakeholders and thus impact on public trust building efforts.⁴⁸ It is therefore imperative to identify and foster effective communication with other stakeholders who can influence biobanking research either directly or indirectly.

Ogunrin et al. further propose a relative solidarity model for community engagement, which not only promotes common societal good but also recognizes that there could be different voices within such communities and that views expressed by the youth might differ from those expressed by adults in the same community.⁴⁹ Divergent views on identity and community values must be taken into account when engaging with communities.⁴⁹

Going back to biobanking practice, a biobank's purpose and existence are dependent on communities and individuals providing biosamples for storage and future use. Thus, stakeholders involved in the collection, storage, and sharing of biosamples should ensure cultural sensitivity in the management of these processes. As reported in this study, often issues such as informed consent occur at the primary data collection site and researchers, RECs, and biobankers may not be directly involved in biosample collection, but there is still need to have awareness programs in this regard. Thus, greater collaboration and communication with local communities are required along with the creation of community advisory panels.^28,35 There is greater need for biobanking research to be community based with committed community participation. These nuances in understanding health decision-making in different cultures must be built into the training programs for researchers and other stakeholders involved in the research project. Further research into the availability and viability of such training programs would be instructive.

While there is need for these strategies to foster better community engagement efforts, it is equally important to recognize diversity and multiculturalism within communities and that there could be associated potential for disagreements. This is particularly relevant in resource-constrained environments or where there could be differing political and cultural views. Also, existing community advisory boards may not be truly representative of the affected community. Importantly, communities and researchers may not have a shared vision for what is needed in the affected community. It therefore becomes necessary to recognize the potential for conflict to occur and to develop conflict resolution strategies in these settings.⁵⁰ There could be competing interests and possible power dynamics between funders, researchers, and the community at large.

The ultimate goal of biobanking should be societal gains in understanding health and disease, and participants' rights should not be eroded by researcher or organizational interests. The issue of benefit sharing requires more dedicated dialogue to identify possible shared benefits that might accrue either directly or indirectly from the research endeavor.

All of these highlighted issues require a relook at how researchers, biobankers, and RECs engage with or are sensitized to the sociocultural considerations in biobanking. One possible way to increase such stakeholder awareness is through the availability of educational training programs, workshops, and seminars. Such training efforts should include input from communities to highlight their position and understanding of biobanking practice.

While this study was conducted in the pre-COVID-19 era, the complex nature of biobanking research during the COVID-19 pandemic,⁵¹ such as limitations to sociocultural considerations during sample collection in a public health emergency, must be noted (as described earlier in this article). As such, the identified stakeholders need to be updated on the evolving legislative processes during epidemics, pandemics, and public health emergencies.

Limitations of the study

The study has several limitations. The study focused on the perspectives of a small group of specified stakeholders and did not include all stakeholders in the biobanking practice. Stakeholders such as community members, patients, the public at large, policymakers, and funding sponsors were not included. Also, the interview did not document the individual respondent's ethnic and/or religious background, professional training, sex, and age. Such information could have shed more light on the respondents' particular perspectives. The generalizability of the study findings is also limited to the study participants and other similar settings. However, to overcome this possible limitation, the researchers also reviewed the literature on sociocultural considerations in biobanking practice to make associations with the study findings.

Conclusion

More effort is required from a biobanking training perspective to create greater stakeholder awareness of the social, cultural, and religious belief systems that could influence and impact biobanking research. One possible way to achieve this could be through the availability of training programs aimed at improving the identified stakeholders' understanding of the sociocultural context for biobanking, coupled with the need for community engagement as a critical component of related research and practice.

Authors' Contributions

S.S. conceptualized the study, conducted data collection and data analysis, and was responsible for report writing.

R.J.C. and K.M. cosupervised the study and were responsible for reviewing and revising the article. All authors read and approved all versions including the final article.

Ethics Approval and Consent to Participate

Written informed consent was obtained from all participations before commencement of the study. Institutions have been anonymized to preserve confidentiality.

The study was approved by the Stellenbosch University (Health Research Ethics Committee 2, HREC Reference: S18/05/091).

Author Disclosure Statement

No conflicting financial interests exist.

Funding Information

This study was funded by the following: NIH Fogarty grant: D43 TW01511-01—Advancing Research Ethics Training in Southern Africa (ARESA): Leadership Program and National Human Genome Research Institute of National Institutes of Health. Award number UO1HG008222.

U01 HG008222-02—Community Engagement for H3Africa Biobanking Research: The Tygerberg Model.