“It’s all about trust”: reflections of researchers on the complexity and controversy surrounding biobanking in South Africa

Some of the concerns raised in this study of researchers echo findings in other studies from resource rich environments. However, many concerns deviate significantly.

The most striking sub-theme underlying the major themes that emerged in this study was the importance of building trust with communities. In some countries biobanks are being established in a “context of heightened concerns” about a “decline in trust” in scientists, authorities and experts in the regulatory systems governing biotechnology innovations [22]. Recently the tension has been exacerbated by participants exercising individual and group autonomy and demanding return of their blood specimens [23]. Several authors cite trust as a central component of the research participant-researcher relationship [2, 24–26]. In developing countries, failure to engage with communities has been identified as a reason for erosion of trust in researchers [27]. Similarly, Barchi et al., in their study on REC members in Botswana, identified lack of trust as a significant challenge and also cite failure to engage with communities as a cause of the erosion of trust [11]. Dilution of trust in the researcher – donor relationship may occur when samples are exported for unknown future use in foreign countries [28]. Respondents in this study concurred that trust underscores all biobanking endeavours and is critically predictive of success.

Governance of biobanks will require understanding of the “immense diversity found in organizational features” [29]. Considerable heterogeneity exists in the field and biobanks may range from small collections of disease specific blood and tissue samples to large scale general population based collections of blood and other tissue. Respondents in this study identified the dissonance between the type of biobank, the nature of proposed research and the ability of REC members to appreciate the risk. This was perceived as a major obstacle to obtaining approval.

A standardized approach in reviewing all protocols involving biobanks in the same way has the potential to lead to generalization of risks and over-regulation of research. They argued that it is important for RECs to be able to stratify risk according to type of biobank being proposed or used. Small, local, non-communicable disease specific biobanks (such as exist for hypertension or diabetes) within institutions tend to use stored samples for specific research limited to that disease area in the future. If patients have consented to such specific future use, such research carries lower risk than a project involving the collection of large volumes of specimens from healthy participants for undefined broad future use including export to other countries.

Similarly, specimens collected in the context of highly infectious disease outbreaks such as Ebola carry higher risk in terms of risk to biobank personnel, transportation, export and security risks. Often small collections of samples are over-regulated while large-scale biorepositories and sample collections that are potentially infectious are under-regulated. Thousands of specimens left West Africa during the recent Ebola outbreak and the fate of these specimens is still unclear and unregulated [30].

Many respondents in this study expressed frustration about the decisions made by RECs based on a lack of understanding of biobanks and the potential future use of biospecimens in research. Similar frustration was expressed by researchers in the United Kingdom who participated in 4 focus group discussions (FGDs) in 2011. In fact, in that study, the challenges experienced by researchers with regulatory bodies was the most striking finding that emerged from the FGDs. These challenges were exacerbated in international studies where sharing of samples and data across borders was involved. In such studies the REC approval process was considerably lengthened [16]. Such concerns have been raised in previous publications examining governance in Africa [8, 9]. Likewise, in our study, the lack of a national MTA in South Africa and in other African countries was regarded as holding the potential to seriously delay biobanking and biobanking research on the continent and to undermine trust in international studies.

At a national level in South Africa, governance was cited as an obstacle due to regulations that are not sufficiently comprehensive and even absent in the arena of biobanking for research. This concern echoes findings in previous publications [8, 9]. The South African research ethics regulatory structure comprising a National Health Research Ethics Council (NHREC) with an oversight and accreditation function over the 33 RECs registered with it, requires that the national body establish guidance on biobanking review and capacity development of REC members in this field. It is also the obligation of the NHREC to strongly motivate, via the Department of Health, for the development of legislation on biobanking in South Africa. Likewise, selection of REC members in South Africa must be reviewed with attention devoted to expertise, research experience and commitment to research ethics review. Training opportunities for REC members have been repeatedly emphasized yet this often remains a neglected issue at an institutional level.

Given the low levels of science literacy in South Africa and the challenges posed in consent processes for a wide range of research, consent for biobanking was prominently discussed by respondents in this study. In keeping with published studies on researcher perspectives which reflect a preference for broad consent with open-ended future use [19], the respondents in this study strongly supported broad consent. This finding was echoed by Whitley et al. where broad consent was preferred due to the challenges posed by predicting future research use [16]. However, many respondents reflected a deep concern for the principle of respect for persons by suggesting flexibility in consent options, engaging with communities and respecting cultural contexts and norms, especially of indigenous populations. There was a sensitivity to previous exploitation of research participants in Southern Africa and the consequent enforcement of rules in specific indigenous communities as a protective measure. The approach of community consultation for research required by the San Council in Southern Africa is unique in the context of research ethics review systems in the country that are based on a more individualized approach to personhood. It is however important to note that community consent will not replace individual consent. The San Council views the two levels of the consent process as complementary.

Few previous studies have explored dynamic consent where participants are able to liase with a biobank on a long-term basis using a mobile application and give input on future use of their donated biospecimens [16]. However, researchers proposed this as a strategy to build trust in South Africa given our large mobile phone network and the possibility of using mobile applications to engage biobank donors in discussions around future use of donated biospecimens. It could be argued that dynamic consent carries the potential to erode privacy. However, engaging with biobank donors in this manner will involve the creation of secure platforms to ensure confidentiality to the extent possible and privacy will also respected. Donors will be contacted discretely and only when absolutely necessary. Despite the convenience of broad consent to researchers and biobanking custodians, a significant proportion of research participants surveyed in South Africa have articulated a desire to be consulted on future use of their samples [10]. Tiered consent affords research participants the opportunity to make this choice while dynamic consent allows for implementation of this choice.

This expressed need to involve biobank donors in decision-making could be a response to the claim that the traditional science-society relationship premised upon a “clear separation between expert and lay knowledge” has been exposed in biobanking [22]. Respondents in this study were acutely aware of the need to bridge this gap by engaging with communities to facilitate consent processes in biobanking. Various suggestions were made to ensure science translation and some of these community engagement tools have been described elsewhere [31]. However, involving patients as active partners in biobanking, deliberative democracy activities with communities [31] and patient led biobanks [12] were not mentioned. Even though such measures have been implemented in the United States and Europe, the authors caution that it was not without challenges including financial and human resources [12, 30]. Implementing such a “cultural revolution in health research” [12] in South Africa is to be encouraged. However, significant education of educationally disadvantaged communities is a precursor to this intense level of public engagement. It is unclear if new models of public engagement will change the asymmetrical power relations between researchers/scientists and civil society [22] in South Africa.

Finally an important and repeated comment in this study was the “myth of anonymization”. While RECs viewed anonymization as protective of participant rights to privacy, technological advances in genetics and genomics may make anonymization impossible. Biobanking is widely cited as having the potential to create ethical concerns. Privacy is a prominent concern voiced by donors. It is imperative that the question of coding and anonymization be addressed so that consent processes are not perceived as misleading and hence a barrier to the development of mutual trust between researchers/scientists and civil society.

Although this is the first study in South Africa to reflect the perspectives of researchers, it has surveyed respondents in 3 regions only. Future research that casts the net more widely in a geographic sense has the potential to increase generalisability of the study. Surveys in other African countries will also yield interesting comparative data. Given that this is the first survey of researchers in South Africa, a wide range of concerns was raised in this study. Future research could narrow the focus to examine some of these issues in greater depth. In particular, benefit sharing was briefly mentioned with respect to indigenous communities. However this represents a study in its own right and could potentially be explored especially in resource poor settings. Likewise the myth of anonymity should be further explored.