The governance of genomic biobank research in Africa: reframing the regulatory tilt

Abstract

Genomic biobank research has experienced exponential growth in recent years. It represents a real opportunity to remedy global health inequity that has seen limited investment in diseases affecting populations from low- and middle-income countries. Previous research in Africa was limited to so-called parachute research, whereby samples were taken from local populations for use in high-income countries with no local oversight or use of the sample. These exploitative practices must be guarded against, but the current regulation of genomic research in Africa adopts a precautionary approach that at times is restrictive in nature. We argue that the regulation and oversight of genomic biobank research should guard against exploitative research, but in a manner that promotes reciprocal benefit and not restrictive research practices. To achieve this, there must be a rebalancing of the regulatory tilt.

I. Introduction

Genomic biobank research, that is biobanking with the aim of fostering genomic research, has brought about a change in our approach to medical research. In such research, biological samples and biological data (collectively here referred to as biological materials) are collected, stored, and potentially re-used to advance genomic research. These biological materials can easily be shared and moved across borders to be re-used by researchers who were not originally involved in their collection. The rise of genomic biobank research has been accompanied by a broader science policy shift toward ‘open science’ that advocates the wide sharing of samples and data.

The ease with which biological materials can now be stored, transported across borders, used and re-used has required a re-examination of long-held ethical principles. In particular, the ‘one-study, one informed consent’ paradigm is unsuitable in a realm, where the sharing or reuse of biological material is not only encouraged but also may be a condition of funding.¹ Requiring that every participant is re-contacted and re-consented each time the materials are to be re-used is burdensome and could potentially lead to the waste of a valuable resource. In response to this, there has been a growing acceptance internationally of broad consent, a consenting model through which a participant donates their biological materials for future research use, subject to further oversight by a research ethics committee (REC) or data access committee.² Furthermore, there is growing recognition that the anonymization of biological materials may not be possible and the confidentially and privacy of the participant can no longer be guaranteed.³

Genomic biobank research is often transnational research that involves international collaborations and as a result, regulation of this research is increasingly complex. The regulation of genomic biobank research is polycentric in nature and often involves national and international actors and instruments, and rules and policies, which have been developed in an uncoordinated manner.⁴ At the national level, this can include legislation, regulations, codes of conduct, and local REC policies. Added to this may be requirements set by international funders, legally enforceable international regulations and treaties, professional codes of conduct, and consortia policies.⁵ These policies are often in conflict, challenging collaboration, and the regulatory oversight of genomic biobank research.

These issues have come to the fore in Africa in recent years where genomic research has seen considerable development, fuelled in part through international collaborative projects such as HapMap,⁶ MalariaGEN,⁷ H3Africa⁸, and B3Africa.⁹ The hope is that the expansion of genomic research to the African continent could begin to remedy the underrepresentation of Africans in international genomics research databases.¹⁰ This expansion has led to increased personnel and infrastructural capacity for the research on the continent. Yet there are challenges in governing the collection, storage, use, and re-use of biological materials.¹¹ The experiences in developing regulations for genomic biobank research in high-income countries (HICs) can guide policy development in Africa, but regulations developed elsewhere cannot simply be adopted and applied in the African context. To do so would ignore the inequitable and sometimes exploitative character of research collaborations with African countries in the past. It would also fail to consider the different values that permeate African societies and that underpin genomic biobank research on the continent. Thus, while in many HICs the challenge for genomic biobank governance is to promote open science while respecting and protecting research participants, in Africa there is a need to develop and revise regulations, so that they guard against exploitation, while fostering science that has the potential to help remedy health inequity.¹²

The purpose of this paper is to identify key benchmarks, which are particularly important in the regulation of genomic biobank research in Africa. It will begin by critically reflecting on the current regulations before arguing that the regulations must be re-framed in light of historical exploitative research. Drawing on our collective experience in the ethico-legal oversight of genomic biobank research in Africa and on published empirical work on this topic, we will outline what procedural and substantive norms should guide the development of regulations in this context, before outlining additional benchmarks for good governance of genomic biobank research in Africa.

II. The regulation of genomic biobank research in Africa: Current perspectives

In governing genomic biobank research in Africa, a key factor that needs to be considered is that historically much research on the continent has been more or less exploitative in nature. The starkest example of exploitation is so-called parachute or helicopter research, whereby biological samples were collected in Africa and sent back to laboratories in other HICs for use in research,¹³ precluding the possibility of local oversight of the use of the samples. As a result researchers in Africa lost a valuable resource that could be used to develop local scientific capacity and for research on diseases, which are relevant to the local population. Furthermore, any intellectual property rights from resultant technologies or patents were lost to the local community and the local economy. This practice has stemmed from inequitable ‘collaborative’ research that exploited both research participants and scientists in Africa. Unsurprisingly, African researchers can at times mistrust their international collaborators.¹⁴

This history of research on the continent makes it essential that the regulation of genomic research in Africa guards against such practices and fosters a sense of trustworthiness. Empirical research and engagement with stakeholders on this topic demonstrates that participants do want to contribute to genomic biobank research in Africa. Participants have expressed an appreciation of possible research benefits and a desire that their contribution to science will benefit others.¹⁵ The regulation of genomic biobank research in Africa should respect these motivations and enable the research while also ensuring that they benefit African research participants and research. Thus, we argue that genomic biobank regulations in Africa should enable beneficial (non-exploitative research) in Africa.

There has been increasing attention on the governance issues affecting genomic biobank research in Africa. In recent years, a number of studies have analyzed the national ethics frameworks and regulations on genomic biobank research on the African continent.¹⁶ The current national regulatory approaches can broadly be divided into three categories: jurisdictions where no regulations exist; jurisdictions that have regulations that are so specific that they quickly become outdated as the technology develops; and jurisdictions that have some regulations, but they are lacking certain key components.

In the first category where no regulations exist, De Vries et al. identified national regulatory frameworks for only 22 countries, despite the study attempting to source the regulations in all African jurisdictions. It is quite possible that the other countries—which would be more than 30—have no official national or local ethics guidance for health research. A national governance system should provide certainty and accountability in the legal and ethical conduct of research, and a lack of national guidelines or regulations is problematic as it is unclear what rules and procedures govern the research. Arbitrary decisions will be made on an ad hoc basis by a local REC and it is unlikely there will be consistency of approach. It also makes it unclear what procedures, if any, are put in place to guard against exploitative research and research practices.

Juxtaposed with these jurisdictions are the second category of African countries that have specific and detailed provisions on genomic and biobank research. This includes Malawi, Zambia, Ethiopia, Nigerian, Rwanda, and South Africa.¹⁷ While regulating genomic biobank research is important, in these cases, the regulations are often unsatisfactory, and at times are so specific that they are quickly outdated as technology develops. This has occurred in Malawi and Zambia, where the regulations are particularly restrictive for genomic research. While there have been calls for specific regulations pertaining to genomic biobank research,¹⁸ there must be some flexibility and reflexivity of approach, so that the regulations can adapt to changes and developments in the science.¹⁹

The majority of African jurisdictions fall into the third category, whereby genomic biobank research is regulated within the general health research frameworks, although only implicitly in some cases and more explicitly in others. Gaps identified in the De Vries study were a lack of provisions on consent, ownership, reuse of samples, data sharing, exportation/importation, and transfer of samples.²⁰ Considering these are issues that have an important bearing on genomics research, the absence in specificity in the regulations on these topics is concerning. This suggests that, at the least, the regulations fail to sufficiently prevent exploitative research.

A second important feature of these regulations is that they tend to adopt a precautionary approach, which prescribes that in a state of scientific uncertainty, we should avoid acting, or if we do act, we should act with extreme caution. Because in the case of genomic biobanking, this principle most clearly manifests in the context of ethical concerns, we will use the term the ethical precautionary approach.

In the African context, while it is imperative that regulations prevent exploitative research and collaborations, this ethical precautionary approach at times has the net effect of resulting in restrictive legislation. For example, in Zambia, the 2013 Health Research Act specifically prohibits broad consent for future unspecified research as section 47(2) states that biological materials cannot be withdrawn and used for ‘any unspecified future health research activity or unspecified storage.’ Similarly in South Africa, there have been concerns expressed that the use of broad consent for the sharing of genomic data is not permissible under the Protection of Personal Information Act 2013.²¹

Precautionary measures in and of themselves are not a problem and ‘the State is authorized to act in a precautionary way for the sake of the integrity of the Community’.²² However, currently there is concern and some anecdotal evidence that overly precautionary measures adopted to protect against exploitative research collaborations is hampering research and efforts to develop capacity.²³ In seeking to guard against exploitative research and collaborations, the ethical precautionary approach could have a considerable negative impact on the research generally.

III. Shifting the regulatory tilt

The regulation of genomic biobank research should not overly restrict the research or prevent collaborations. Rather the focus should be on guarding against exploitative research and exploitative collaborations. By shifting our focus in this manner, we can view genomic biobank research as something that is to be welcomed and important in strengthening research capacity in Africa.²⁴ Regulations thus should serve the goal of supporting non-exploitative research and an important part of this is addressing many of the gaps in the regulations that have been identified above. As such, we argue that there should be a shift in the regulatory tilt.

The regulatory tilt refers to the extent to which regulations are permitting or prohibiting research, and cases of ambiguity will be decided in favor of however the law is tilting.²⁵ Regulations that fall into the second category can be described as tilting toward restriction. In other words, they tend to prohibit or restrict the research. Jurisdictions falling into category one or three described above lack a clear tilt due to the gaps or non-existence of regulatory structures.

It is submitted that a restrictive regulatory tilt is both a disservice to science in Africa and to efforts to rebalance global health inequity as it prevents the development of the research. The regulatory tilt for genomic biobank research in Africa should be re-framed in favor of permitting non-exploitative genomic biobank research and collaborations. Such a nuanced approach encourages the research and its allied benefits, but considers mechanisms other than restrictive policies to prevent exploitative research and collaborations. To achieve this there must be a shift in the values underpinning the research and this conversation has already begun.

The legacy of exploitative research is not unique to the African continent, and has occurred in many resource-limited settings. In response, there has been a growth in guidelines and codes to promote research in these settings, while guarding against exploitative behavior. The Global Code of Conduct for Research in Resource Poor Settings,²⁶ developed by the EU funded TRUST project and now applies to all EU funded research,²⁷ puts the values of fairness, respect, care, and honesty at the heart of any collaborative research between HICs and low- and middle-income countries (LMICs). These values are echoed in guidelines developed by indigenous researchers in the United States. The Guiding Principles for Engaging in Research with Native American Communities focus on the following principles: research should be native-centered²⁸; respect; self-reflection and critical humility; authentic relationships; honor community time frames; build on strengths; co-learning and ownership; continual dialog; transparency and accountability; integrity; community relevance.²⁹ The Guidelines for Ethical Research in Australian Indigenous Studies have 14 principles that are grouped under the broad categories of rights, respect, and recognition; negotiation, consultation, agreement, and mutual understanding; participation, collaboration, and partnership; benefits, outcomes, and giving back; managing research: use, storage, and access; and reporting and compliance.³⁰

In the context of biobank research, a call for the global governance of biobanks by Chen and Pang seeks to remedy the disparity in capacity and governance between LMICs and HICs through the following key elements: respecting participants and donors of biological samples, and protecting their privacy and confidentiality; informing participants and donors of potential risks through initial consultations; sharing samples, data and benefits in a fair, transparent and equitable manner; ensuring quality and interoperability of samples and their associated data; improving public awareness, trust and participation in biobanks; and defining the role of the private sector in the use of knowledge derived from biobank operations.³¹

In the African context, two pertinent documents reflect these changes in values. The San Code of Research Ethics³² was developed in response to exploitative and discriminatory research published in Nature involving members of the San Community.³³ The Code focuses on respect, honesty, justice, and fairness, care and due process as key values to be considered when engaging with the San community for research. More specifically for genomic biobank research, theH3Africa Consortium embarked on a 3-year stakeholder engagement and developed the Ethics and Governance Framework for Best Practice in Genomic Research and Biobanking in Africa.³⁴ The Framework is guided by the principles of solidarity or communal-based worldviews, fairness, equity, and reciprocity.

Although other guidelines and codes of practices do exist for genomic biobank research, these new guidelines and codes of conduct are informed by past injustices and inequitable collaborations. They do not seek to limit collaborations, but to foster equitable research for the benefit of the local populations. As such they align and help to inform our regulatory tilt and the principles of solidarity, reciprocity, justice, and trust that are so important in these documents can inform the development or revision of regulations that are reflective of this proposed new regulatory tilt. In particular, they can help to identify some procedural and substantive norms that should underpin the regulation of genomic biobank research in Africa. We will now briefly consider each in turn.

Looking first at solidarity, solidarity-based approaches to genomic biobank research have gained prominence in some HICs. Prainsack and Buyx have argued that biobank governance should be guided by solidarity alongside autonomy³⁵ as such an approach would more appropriately reflect altruistic motivations to participate. Prainsack and Buyx argue that solidarity overlaps with other concepts such as charity, reciprocity, altruism, or empathy, but for them, their definition of solidarity (in its simplest form) is ‘manifestations of people’s willingness to carry costs (financial, social, emotional, or otherwise) to assist others.’³⁶

As discussed in the H3Africa Framework, solidarity is reflective of the communitarian worldview prevalent in African societies. Such a worldview focuses on the interconnectedness of society, recognizing that individuals are shaped by their relations to people around them, and emphasizes respectful and harmonious relationships between individuals, and between individuals and their environment. However, this view of solidarity places importance on ‘reciprocity, consultation, and accountability’ and is in part informed by abuses of research in the past. There is some expectation that ‘the community also contributes to the individual’s sustainable wellbeing.’³⁷

This formulation of solidarity differs from that as outlined by Prainsack and Buyx. It signifies that an individual is willing to be involved and donate a sample for some communal benefit. This manifestation of solidarity would be supportive of broad consent, but there must be accountability to ensure benefit. If we understand broad consent as ‘consent for governance,’³⁸ researchers must be accountable within this governance framework. Indeed this is not unique to the African context and in other resource limited settings, the importance of accountability in the relationship between the research team and the community involved in genomic biobank research has been highlighted.³⁹ We thus consider accountability to be an essential component of the governance of broad consent in Africa and this brings us to our first procedural norm: procedural accountability.

As part of solidarity, the H3Africa Framework places emphasis on the importance of consultation. Community engagement is increasingly recognized as a critical component in the ethical conduct of health research, and this is particularly pertinent in communitarian societies. However, it is not just the research itself that must be informed by community engagement, but the regulations themselves. If we are to truly foster non-exploitative research, we must be adequately informed about the different ways in which participants have been exploited. As noted by James et al., ‘researchers who have not been grounded in, or are dismissive of, the historical context that shape values and beliefs…cannot adequately assess “risk” related to cultural harms as perceived by…groups.’⁴⁰ Equally, if research is to be for some communal benefit, there must be an understanding of this benefit. Thus, the development of genomic biobank regulations and the implementation of the research must be supported by community engagement. We consider community engagement to be both a procedural and substantive norm.

Now turning to reciprocity, as discussed, the conceptualization of solidarity in H3Africa puts emphasis on the importance of reciprocity and recognizes that ‘as much as the individual contributes to the community, the community also contributes to the individual’s sustainable wellbeing.’ Once again this is not unique to the African context and there is evidence that some indigenous groups expect reciprocity as a guiding value in genomic and biobanking research, which should be built into the process of donation and sharing of biological materials.⁴¹ Reciprocal benefits can take the form of capacity building, improvements to health, or employment opportunities for community members. Reciprocity is important at both a national and local level. Nationally, the regulations should be informed by reciprocity as a mechanism through which exploitative research is avoided. Locally, reciprocity and possible reciprocal benefits should be discussed as part of community engagement. As such, it informs both procedural and substantive law. With regards to justice, there has been a historical lack of fairness in the access and use of biological samples obtained in Africa. Past research practices often saw the uni-directional flow of samples for use in other HICs, thereby preventing their use by local researchers, but it also prevented local oversight of the sample. To remedy this, the fair use of biological materials must be supported by procedural and distributive justice throughout the research process. Procedural justice is concerned with the fairness and transparency of decision-making processes and an integral part of that is establishing local and national policies on the use of biological materials that are informed by community engagement. Local and national oversight can help to prevent or at least limit exploitative research practices and ensure that there are transparent processes in decisions on the use of the materials. Having policies in place can also promote certainty and transparency and legitimize decisions on the use of the biological materials. As such procedural justice should be a procedural norm. However, it must be recognized that these biological materials are a valuable resource and there may be justified reasons (such as capacity building) to warrant putting some limits on its access. In the context of data sharing, controlling data access is seen as important in protecting the rights and interests of the parties involved in genomic data sharing⁴² and the same would apply to biological samples themselves. Thus in the development of substantive legislation and policies on genomic biobank research, distributive justice should be a guiding norm.

Finally, empirical evidence has highlighted the importance of trust in the governance and success of genomic biobank research. Participants must trust the biobank, they must trust the researchers, and the work must be conducted in such a way that participation is seen as a ‘trustworthy activity.’⁴³ There has been the suggestion in many LMICs that participants’ trust in research has been eroded and by implication, trust in researchers, but there has also been a loss of trust experienced between researchers in LMICs vis a vis researchers in HICs.⁴⁴ Trust is important on different levels and each must be addressed in the governance framework for genomic biobanking in Africa: trust between the participant and the researcher to whom they are donating their sample and data; trust between the participant and the institution in which the materials are stored; participant trust in the governance framework; trust between the regulators and those implementing the research; and trust between researchers in Africa and other international collaborators. A governance system that is built upon regulations, which are legitimate, reflective of local values, and ensure accountability supports the development of trustworthy relationships. Trust reinforces the importance of procedural accountability, but to fully understand and address these differing layers of trust, there should be wide stakeholder engagement on these matters. As such we consider stakeholder engagement to be our final procedural norm.

IV. Benchmarks for good governance for genomic biobank research in Africa

In an effort to reduce bureaucracy and improve the regulatory process, discussion often focuses on good governance and key features that should support governance to improve regulation. Within the European Union, the 2001 Mandelkern Report on Better Regulation, which forms the basis of better regulation within the EU, set out seven key principles for better regulation: necessity, proportionality, subsidiarity, transparency, accountability, accessibility, and simplicity.⁴⁵ In the UK, the Better Regulation Task Force identified proportionality, accountability, consistency, transparency, and targeting as its principles of ‘Better Regulation.’⁴⁶ Good governance and better regulation is also a feature of many international organizations, including the OECD which sees improved regulatory policy as one of the key tools that governments can use to improve societal welfare.⁴⁷ Good governance is also seen as one of the principles and objectives of the African Union (AU)⁴⁸ and transparency, accountability and participatory democracy are seen as important features of good governance within the AU.⁴⁹ In the context of genomic biobank research, O’Doherty et al. have identified respresentativeness, accountability, transparency, reflective, and sustainability as necessary conditions for biobank governance.⁵⁰ Shabani et al. have identified objectivity, fairness, transparency, and accountability as important in improving the governance of accessing genomic data.⁵¹

In developing and revising its governance of genomic biobank research, African law makers should consider each of these principles. The Better Regulation principles have also been used as the basis on which to analyze biobank regulations in the UK.⁵² However, so as to ensure that regulations support our proposed reframing of the regulatory tilt, we consider that law makers in Africa should be particularly guided by the procedural norms (procedural accountability, community engagement, reciprocity, and stakeholder engagement) and substantive norms (community engagement, reciprocity) that we have outlined. In the final section of this paper, we will outline how these norms should be reflected in a governance framework through an identification of certain benchmarks for good governance for genomic biobank research in Africa. These benchmarks are to be considered to be in addition to the above principles of good governance and Better Regulation and are what we propose are particularly pertinent in achieving this re-framed regulatory tilt.

A. Legislative framework

As discussed previously, it is thought that many jurisdictions in Africa do not have any national regulations for genomic biobank research. Regulations can clearly outline the rules and policies that govern the use and re-use of biological materials and importantly, specify the conditions under which non-exploitative research and collaborations can take place. The purpose of our re-framed regulatory tilt is to protect the participant from exploitative research and equally protect the research from exploitative research and collaborations. These regulations can thus limit the use and re-use of the materials, particularly if they are to achieve either of those stated aims. Regulations however cannot only prevent exploitative research, but also encourage non-exploitative research by putting some limits on the research, provided this is in the interests of capacity building. For example, national regulations can mandate that the use of samples and data require a local principal investigator, or that samples will only be used overseas if accompanied by an African student.

It is less important whether jurisdictions enact specific regulations for genomic biobank research or regulate it within existing regulations for health research. What is essential is that there is a national legislative scheme in place and that it aligns with the regulatory tilt. However, in developing general data protection regulations that seek to regulate the use of all types of personal data, law makers in Africa must be mindful that the use of data for health research and for genomic biobank research require sector-level responses to fill the regulatory gaps left by general data protection regulations.⁵³

Stakeholder engagement will be key in informing the development of the content and substantive elements of these regulations. At a minimum they should regulate for consent for future use of samples and data; use, re-use, and exportation of samples and data; oversight of the use and regulatory approval; capacity building; benefit sharing; community engagement; sample ownership and custodianship; and data sharing. It is of particular concern that it appears that many jurisdictions in Africa lack regulations on data sharing and protection for genomic biobank research, and there are concerns that institutions in Africa do not have robust frameworks in place to oversee the use of genomic data.⁵⁴ This could also make adhering to the strict provisions of international regulations such as the EU General Data Protection Regulation (GDPR) that can at times apply to researchers in Africa challenging, and may compromise the ability of researchers in Africa to collaborate with European institutions as well as access EU funding. Where data protection regulations do exist, they are quite similar to the GDPR and may not be reflective of the context in which they operate.⁵⁵ For example, restrictions on access to data, or preferential treatment to local researchers for a certain period to enable them to maximize the use of the materials, can develop capacity in this area.⁵⁶ Although this is contrary to international best practice and some funding requirements, which puts emphasis on rapid release of data, the interests of science in Africa may require putting short-term restrictions on the sharing of data.⁵⁷

B. Stakeholder engagement

Internationally, there is growing recognition of the importance of stakeholder engagement not only in research but also in the development of regulations. The OECD’s 2012 recommendations require engagement with stakeholders at all levels, both in developing and reviewing regulations. Guidance on how this can be done is currently being developed in its Best Practice Principles on Stakeholder Engagement.⁵⁸ Central also to the European Commission’s Better Regulation Agenda is the involvement of stakeholders, and in particular EU citizens, in the design and evaluation of regulations. Good governance is also partly determined by the extent to which the functions of the State reflect the values of the stakeholders.⁵⁹ Seen in this way, effective governance is a partnership between the State and the relevant stakeholders, with stakeholders having an important role in both development and implementation of regulations.

In the context of biobanks, it has also been recommended that stakeholder engagement be one of the benchmarks for good governance.⁶⁰ Such engagement is necessary as internationally very few jurisdictions have introduced regulations in response to biobanks, leaving it to other stakeholders such as RECs, advisory boards, funders, and consortia to develop norms and procedures for biobanks.⁶¹

In Africa, there are similarly a multitude of stakeholders involved in the governance of genomic biobank research including RECs, national regulator bodies, international consortia, and individual biobanks.⁶² In particular, the H3Africa Consortium directly engaged with REC members and national regulators in the development of its Governance Framework, and indirectly with other groups through dissemination of the draft Framework through meetings, networks and informal discussions.⁶³ Although it is intended that this document be used to guide the development of governance frameworks across the continent, national engagement is of particular importance for two reasons.

First, there are regional and cultural differences across the continent. Notably in early drafts of this framework, Ubuntu, which is a philosophy that focuses on the interrelatedness of humans, was selected as its normative basis. It soon became apparent that there was resistance as the term is seen as South African that has strong links to the apartheid struggle in South Africa, and is thus not reflective of developments elsewhere on the continent.⁶⁴ Regulations must thus be contextualized to the particular jurisdiction and this can be achieved in part through stakeholder engagement.

Second, those implementing the regulations should broadly support them, otherwise there will be a considerable disconnect between the law in the books and the law in action. It is irrelevant if the regulatory tilt is reframed if the implementation of the law shifts back to a more precautionary approach. This is perhaps best exemplified by the perception of broad consent in Africa. Globally, there has been a move toward recognition of broad consent as an ethically acceptable model of consent for genomic biobank research. The ease with which samples and data can be shared with relatively minimal risk to participants required a rethink of specific informed consent for this research. Broad consent has faced some resistance at a national level (such as Zambia where the use of broad consent is prohibited). However, where regulations do exists, the majority of jurisdictions explicitly or implicitly permit broad consent.⁶⁵

Despite this, our engagement with RECs on the continent as part of the H3Africa Ethics and Regulatory Issues Working Group informed us that irrespective of the existence of regulations permitting broad consent, they were often hesitant to approve studies that sought to adopt broad consent as the consent model for genomic biobank research.⁶⁶ Similarly, engagement with research participants in Zambia has demonstrated support for broad consent but specific consent is mandated by the Health Research Act 2013.⁶⁷ This points to a disconnect between the law in statute and law in action and demonstrates the crucial importance of stakeholder engagement in developing regulations for genomic biobank research in Africa.

Stakeholder engagement can reveal any concerns with draft regulations as well as regulations that are in force, and help to ensure that the implementation of regulations is in line with the intent of law makers. In this way, it can also legitimize the regulations. Part of stakeholder engagement will involve engaging with communities, and this will be considered in further detail below.

C. Institutional responsibility

Aligned with the development and reformulation of regulations, we must identify a process for ensuring accountability. Similar to stakeholder engagement, accountability and lines of accountability are key features of good governance.⁶⁸ The challenge is who should be the appropriate body that has responsibility for oversight of the research and hold the relevant parties to account.

In identifying the appropriate body, it may be useful to unpack their responsibilities. First, they will have responsibility for ensuring that the regulations are followed. Second, they will have oversight of the use, re-use, sharing, and possible export of samples. This will include overseeing access arrangements, intellectual property rights and by implication, bearing responsibility for the use of samples and data in research and perhaps the researchers using the sample. It is thus not just the use of the sample and data that the body will have responsibility for, but also holding the users of the resources to account and ensuring that the use and future use of the research is non-exploitative and has reciprocal benefits.

We have discussed the importance of trust in genomic biobank research and the different layers of trust that a governance framework must support. In the African context, Tindana et al. have described an entrustment model that supports broad consent. In this model, participants consent to the use of their sample in research and entrust researchers to use their sample wisely. It is then the institution to which the researcher belongs that has the obligation to ensure that the sample is used responsibly and to ‘reciprocate by providing tangible health benefits.’⁶⁹ For the authors, this model creates a moral responsibility that the sample is used wisely with reciprocal benefits. Thus, the researcher and the institution cannot do whatever they want with the sample. O’Neill notes that we cannot simply take matters on trust, but establish ‘robust systems of accountability’⁷⁰ and Tindana equally notes that such a model is only acceptable where the institution has well-founded relationships of trust with the community and it is supported by governance and accountability.⁷¹ We have already begun to unpack certain benchmarks for this system of governance and note the importance of accountability, but it brings us back to our problem of identifying the body with powers of accountability and the system through which that accountability comes about.

A number of different legal approaches that would be supportive of such accountability have been discussed elsewhere.⁷² Winickoff and Winickoff have proposed the idea of a charitable trust model, whereby an independent body manages the trust and ensures its use in accordance with the wishes of the donors.⁷³ Such an approach does embody elements of the solidarity-based approaches as it embodies this notion of ‘gifting’ (one presumes) for the benefit of others. Through the charitable trust, there will be independent oversight and accountability on the use and re-use of the sample. However, in such a model, the focus tends to be on the wishes of the donor, which is a much more autonomy-based understanding of solidarity that is not necessarily reflective of African values.

A model that may be more closely aligned to that proposed by Tindana et al. is the establishment of a fiduciary relationship between the institution and the participant. A fiduciary relationship arises when one party is entrusted to act on behalf of the best interests of another party, such as the doctor–patient relationship. The doctor has a moral responsibility to act in the interests of the patient, with legal consequences if the doctor does not fulfill their fiduciary duties. In this context, the researcher clearly could not be the trustee, as a trustee or agent cannot act in conflict of interest of the trustor or principal. Their primary obligation is to the research, and the best interests of the participant may at times be in conflict with the best interests of the research itself. Following from the entrustment model, the institution is to have certain moral responsibilities and as a corollary, has fiduciary duties to the participant.

One possible challenge to this fiduciary model is that it protects the duties owed by the trustee (ie the institution) to the trustor (ie the participant). Thus, one could argue that the institution must only protect or guard against any risks to the individual. Viewed through this lens, the institution is responsible for protecting the interests of the participant, which includes the responsible future use of the sample and data. However, the duties must be understood in the broader context of the research and the solidarity basis on which the samples were donated. The institution is thus also responsible for protecting the interests of the community, in which the biological materials are donated. Such a type of fiduciary relationship may work in the African context if the materials are held on trust for the benefit of the community.

A third approach that is perhaps more suitable to the genomic biobank context, is the corporate governance model that involves shareholders, directors, and a company. Under this approach, shareholders invest in the company. They are not involved in the day-to-day running of the company, but have the opportunity during the annual general meeting (AGM) or extraordinary general meetings (EGM) to vote and contribute to the strategic vision of the company. It is the directors who run the business, but they do so on behalf of the shareholders. The directors do not have fiduciary duties to the shareholders (except in specific circumstances), but rather to the company. Their duties include acting in the best interests of the company, ensuring that there is no conflict of interest, acting within the company’s constitution and exercising independent judgment.⁷⁴

Such a model could apply to the genomic biobank context with some adjustments. The shareholders will not be the collective participants, but rather the community from which the participants come. Thus, it is irrelevant if some individuals contributed more samples than others; they do not get extra ‘votes.’ The donation is for the communal benefit and it is thus the community to which the institution must feedback through AGMS or EGMs. The ‘company’ is the genomic biobank. It must act in the interests of that biobank to the extent that it must ensure that it has no conflicts of interest, exercise judgment in the exercise of its functions and also act within the governance framework of the genomic biobank. The best interests of the biobank must not be thought of as meaning ‘the best interests of research.’ Rather, as the institution must act with the shareholders in mind, the best interests of the biobank are to be seen as the use of the biological materials that is for the benefit of the community.

The advantage of such a model is that there are clear lines of responsibility and accountability. It describes the continued role that the participant community should have and ensures that the use and re-use of the biological material is not self-regulated by researchers. We propose that it is the institution that is hosting the biobank that must have ultimate oversight. This is supportive of the entrustment model discussed by Tindana, but also mirrors developments in the oversight of data protection. The emerging data protection regulations in Africa do specify clear lines of accountability with the research institution the body with overall responsibility.⁷⁵ Entrusting institutions with responsibility for samples and data ensures a much more coherent approach to the governance of samples and data.

In our view, institutions will serve two key functions. First, they must implement national regulations pertaining to genomic biobank research, and second, they must develop institutional policies. These policies will further guide the implementation of the research and will focus on the substantive rather than procedural elements of the law. It is at the individual project level, where reciprocal benefit sharing arrangements with the local community can be developed.

It is useful to refer to Schroeder who defines benefit sharing as:

“Benefit sharing is the action of giving a portion of advantages/profits derived from the use of human genetic resources to the resource providers to achieve justice in exchange, with a particular emphasis on the clear provision of benefits to those who may lack reasonable access to resulting healthcare products and services without providing unethical inducements”.⁷⁶

Benefit sharing is thus much wider than direct benefit to the participant, but can include other benefits such as capacity building. Indeed it is this conceptualization of benefit that underpins the principles on which H3Africa was developed⁷⁷ and it is reflective of solidarity-based approaches of this research.

The possible content of benefit sharing arrangements is thus considerable and institutions should not adopt a policy on the specifics of such an arrangement. Rather, they should require that any research consider formalized benefit sharing with communities that is supported by community engagement.

D. Community engagement

This brings us to the final benchmark for good governance: community engagement. Community engagement is seen as a requirement for the ethical conduct of research and is a key feature of international codes of conduct for health research.⁷⁸ It is particularly necessary in the context of genomic biobank research as the research has implications for the family and community, as well as the individual. It can help to address the complex ethical and social factors with genomic biobank research.⁷⁹ Controversies surrounding the Havasupai Tribe and research involving members of the San community in genomic research demonstrate the problems that can arise when research is conducted without engaging members of the community.⁸⁰ It is of particular salience in the African context, where a communitarian ethos permeates many societies. Decisions are often taken in consultation with the family and other members of the community. In addition, the traditional political structures give clear authority to the elders, tribal leaders, and chiefs. The approval of these community leaders will often be required prior to the commencement of the research. Thus, as part of the institutional oversight of the research, a community engagement strategy must be required as part of the research protocol. This should be supported by national regulations and should mandate that community engagement is an essential component of research, unless it is deemed to be unnecessary by a REC.

Community engagement should not however simply be seen as important in the design of the research itself. If the governance of genomic biobank research is to be sensitive to the context in which it operates,⁸¹ the development of institutional policies must be informed by community engagement and the institutional oversight of the research should include community representation. By being a part of the design and implementation of governance frameworks, the community can become part of the accountability measures. As part of these accountability measures, there should be feedback of findings to the community, and where possible, the individual.

Ensuring community engagement in national policy and strongly encouraging feedback of findings must also be met with resources to support training and implementation. To do otherwise would only give lip-service to such measures. National training for community engagement will be necessary, but in resource limited settings requirements that a certain percentage of a grant be spent on community engagement (unless waived by a REC), could help to alleviate some resource concerns.

V. Conclusion

The growth of genomic biobank research in Africa represents a real opportunity to help remedy global health disparity and develop scientific research capacity on the continent. Allied with this must be recognition of the exploitative research practices of the past and a commitment to ensuring ethical research practices. Good governance and oversight of the research can help ensure that exploitative research does not occur, but this must not result in precautionary based approaches that result in restrictive regulations. Rather, the focus should be on how best to remedy the problem (ie exploitative research and exploitative collaborations) in a way that can promote genomic research as a means to increase scientific knowledge and improve the health of the population, but in a manner that results in reciprocal benefits.

As a first step in achieving this, there is a need to shift the regulatory tilt to guard against such exploitative research and collaborations. Thus, the regulatory tilt is neither generally permissive nor restrictive, but rather focuses on preventing such research. By following our additional benchmarks of legislative framework, stakeholder engagement, institutional responsibility and community engagement for good governance for genomic biobank research in Africa, this can support law makers in Africa following this re-framed regulatory tilt.