A Review of Regulatory Frameworks Governing Biobanking in the Low and Middle Income Member Countries of BCNet

Abstract

Biomedical research based on the sharing and use of ever larger volumes of samples and data is increasingly becoming an essential component of scientific discovery. The success of biobanking and genomic research is dependent on the broad sharing of resources for use by investigators. However, important ethical challenges need to be addressed for the sample and data sharing to be successful. Despite low- and middle-income countries (LMICs) carrying a higher burden of disease, biomedical research conducted to date has mainly focused on high-income countries. In order for LMICs to benefit from the advances in such research, normative documents (such as laws and guidelines) play a significant role in allowing LMIC projects to partake and be represented in global biomedical research. The administration and management of the ethical aspects of biobanking, including informed consent, are key components in ensuring that samples and data can legally and ethically be used and shared.

As part of its support to the LMIC biobanks, the International Agency for Research on Cancer (IARC) established a biobank and population cohort building network (BCNet) in 2013 with the aims of providing support (including education and training) and facilitating the development and improvement of biobanking infrastructure in LMICs. A comparative analysis of the laws and guidelines in BCNet countries was completed to highlight some of the ethical and legal issues related to biobanking in LMICs and to identify examples of effective systems of governance already in operation.

Introduction

Starting in 1947, the free and informed consent of the research participant was enacted as a fundamental ethical principle by the Nuremberg Code, which requires that “the nature, the purpose, and the risk” of research must be explained to the participant to ascertain the full understanding of the research purpose.¹

Since then, research using human samples has greatly expanded, especially with the latest developments in biomedical research, which carry an enormous potential to improve the understanding and treatment of many diseases.² The samples and associated data, often used by investigators not involved in their original collection, have yet unknown applications for future research that may challenge long-standing informed consent concepts and positions.^3,4 The question of whether individuals can consent to the future use of their samples and data without knowing the exact details of these future research studies (broad consent) or whether participants must consent to each individual use of their samples and data in research (specific consent) is still very much debated in low- and middle-income countries (LMICs).

While the growing population density of LMICs carries a higher burden of disease, biomedical research has overwhelmingly been focused on high-income countries.^5–7 There is a risk that if more LMICs are not represented in such research initiatives, they might miss research opportunities on conditions or diseases that impact heavily on their communities, and as such lose the opportunity to benefit from this research.^2,8,9 As part of its support to the LMIC biobanks, the International Agency for Research on Cancer (IARC) established a biobank and population cohort building network (BCNet)^10,11 in 2013 with the aims of providing support (including education and training) and facilitating the development and improvement of biobanking infrastructure in LMICs, as a foundational step toward greater participation in global biomedical research. The ongoing discussions on consent represent a current priority area in BCNet member countries.

The shift to broader consent could perhaps facilitate greater participation in biomedical research, which is generally a consent option preferred by researchers.^12–14 However, there is resistance to broad consent in countries where there has been a history of exploitation of research participants coupled with little attempt to build local research capacity.¹⁵ For example, in certain African countries, concerns about broad consent have centered on the question of whether it “sufficiently protects the interests of vulnerable communities and participants.”¹⁵

This article will first give a succinct overview of the different models of informed consent described in the literature and then turn to a brief overview of stakeholder views on broad consent. It will then look in more detail at the different regulatory approaches within BCNet member countries and the extent to which they address concerns about broad consent and facilitate research on human samples and data from their communities.

Members of BCNet come from 32 research institutions in 23 countries, mainly from Africa but also Asia, the Middle-East, South America, and Eastern Europe (Table 1). BCNet members are recruited on a voluntary basis through an application form on the IARC website, to be considered for membership. Future members must be part of LMICs, have an infrastructure with routine biobanking activities, adhere to the principles and practices supported by BCNet, and a commitment to sharing and collaboration.¹¹ For the purposes of this research only countries which have legal research material, readily available in English through national online resources, were included. This article is therefore a narrative review based on those documents, identified as of May 2020 and summarized in Table 2.

Table 1.

Countries Represented Among BCNet Members

BCNet member countries included in this article	BCNet member countries not included in this article
Cameroon	Indonesia
Brazil	Jordan
Egypt	Lithuania
Ghana	Poland
Kenya	Côte d'Ivoire
Nigeria	Mexico
South Africa	Iran
Sudan	Colombia
Tanzania
Ethiopia
Thailand
The Gambia
Uganda
Zambia
Zimbabwe

BCNet, biobank and population cohort building network.

Source: International Agency for Research on Cancer, World Health Organization.¹⁶

Table 2.

List of the Documents Used in This Narrative Review, Arranged by Country

Country	Title	Year	Refs.
Ethiopia	National Research Ethics Review Guidelines	2014	⁵¹
Ghana	Public Health Act	2012	⁴⁵
Ghana	Data Protection Act	2012	⁷⁹
Kenya	Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects	2004	⁴⁶
Kenya	The Health Laws (Amendment) Act	2019	⁴⁷
Nigeria	Policy Statement on Storage of Human Samples in Biobanks and Biorepositories	2013	⁵³
Nigeria	National Health Act	2014	⁴⁹
Sudan	National Guidelines for Ethical Conduct of Research Involving Human Subjects	2008	⁵⁰
South Africa	The National Health Act	2003	⁵⁵
	Regulations Relating to the Use of Human Biological Material	2012	⁵⁶
	Protection of Personal Information Act	2013	⁷⁸
	Ethics in Health Research: Principles, Processes, and Structures	2015	⁵⁷
Tanzania	The Human DNA Regulation Act	2009	⁴³
Tanzania	Guidelines of Ethics for Health Research in Tanzania.	2009	⁴⁴
Thailand	Ethical Guidelines for Research on Human Subjects	2007	⁵²
The Gambia	Guidelines of the National DNA Bank	2001	⁶³
Uganda	National Guidelines Involving Humans as Research Participants	2014	⁶¹
Uganda	Data Protection and Privacy Act	2019	⁸⁰
Zambia	National Health Research Act	2013	⁴¹
Zimbabwe	Medical Research Council of Zimbabwe. Adult Consent Form.	2013	⁶⁵

Context on Informed Consent in LMICs

The question of how specific informed consent must be, when future research is anticipated, has been a contested one. The models of consent can be seen along a spectrum moving from specific consent, through to broad consent, and at the other end open or blanket consent.

Models of informed consent

Specific consent involves a participant consenting to the use of their samples and data for a specific, well-defined research project or projects. If further research is to be conducted, the participant would need to provide a new consent, specific to the new question(s) being asked.^17,18 Broad consent allows a research participant to consent to future research, where the details of such research are not yet known. While there have been different definitions of broad consent, consensus is forming that broad consent involves consenting to a framework for future use of samples and data in research, essentially “consent for governance.”¹⁵ The definition of broad consent recently agreed to by a group of subject-matter leaders was “consent for an unspecified range of future research subject to a few content and/or process restrictions.”¹⁴ Broad consent also requires ethics approval and ongoing communication for it to be considered ethical.¹⁹ Open or blanket consent is an unrestricted right to use the sample and data in all future research without any limitations.¹⁹ No international guidelines however recommend such an approach, and it is thus not widely supported.²⁰

Stakeholder views

At the international level, consensus seems to be forming that broad consent is appropriate only with safeguards in place to protect sample donors, local researchers, and communities. Most international guidelines have adopted this position, and as major guidelines are revised, a model of broad consent with appropriate governance is increasingly being included. For example, updated guidelines from the Council for International Organizations of Medical Sciences were approved in November 2016 that allow for either specific consent or broad consent. The guidelines make it clear that the “ethical acceptability of broad consent relies on proper governance.”²¹

While broad consent is increasingly accepted in the scientific community as a research tool, in some LMICs there has been reluctance to use it. One of the first steps in setting up the BCNet network was a questionnaire survey that was conducted by IARC to gather information on biobanking activities and facilities in LMICs.²² The results showed that specific consent was favored over broad consent in the majority of the institutions, raising the question whether the lack of broad consent permitting extended use of samples meant that the “utility of these valuable resources is limited.”²² More specifically, it was highlighted in the survey that ethics review committees in some LMICs can be hesitant to approve broad consent forms.

At the same time, members of the H3Africa Consortium conducted a workshop with ethics review committee members from five African countries (including Kenya, Ghana, South Africa, and Tanzania, who are also represented in BCNet) to gain a better understanding of ethical issues relating to the consortium's research agenda.²³ Workshop participants expressed concerns about using broad consent.²³ A further workshop with chairs from 40 research ethics committees (RECs) in 18 African countries identified that there was considerable diversity in the experience of the different countries represented and that “within particular countries there may be legal limits to the permissibility of broad consent.”²⁴ The authors identified a need to outline the criteria under which broad consent could or could not be used in research in Africa to inform practices and the development of policy in this area.²⁴ A more recent H3Africa consultation meeting targeting members of REC identified a shift in approaches to broad consent and “a greater willingness to explore whether and how broad consent could be adopted as a viable, ethical consent model for genomics research and biobanking.”²⁵

From a research participant perspective, broad consent is likely to be supported if it is clear that there are safeguards in place regarding storage of samples and data, as well as decisions about future use. The literature suggests that there is support from stakeholders for consent that will allow for some future use of samples and data.^26–28 Safeguards are key elements for ensuring the protection of individuals and compliance of the research to the guidelines and law. There is however concern about consent to future use with no safeguards in place.²⁶ In a number of studies potential donors/research participants expressed a desire to have some control over the use of their samples,²⁹ to know prospectively the kinds of research for which the samples could be used^27,30 or for the reuse of samples to be for a “good cause.”²⁵ Participants also expressed a desire to be kept informed about the research that samples were being used for.^27,30

This brief overview of international guidelines and the views of some of the key stakeholders provides a LMIC-specific context for reviewing the regulatory approaches adopted in BCNet countries on the future use of samples and data. This article seeks to address whether there are limits to the legal permissibility of broad consent in a select group of LMICs and to look at the governance frameworks required in those countries that allow it.

Regulatory Approaches to Biobanking and Future Use of Samples in BCNet Countries

There are a number of different approaches to the regulation of biobanking activities within BCNet countries that are reviewed descriptively in this section. These activities range from an absence of regulation to comprehensive legislative schemes. Between these two operational boundaries there are many countries where guidelines play the primary role in governing how biobanks should operate and define the parameters of consent for future use.

Despite stakeholder concerns about broad consent, very few countries represented in the BCNet have targeted provisions that restrict its use. A few countries require specific consent, but most either have no provisions or directly authorize the use of broad consent, as Table 3 shows. While a few countries have legislation addressing the issue of broad consent, it is usually “soft law,” such as guidelines, that set the parameters for future use. Soft law is a collective term, characterizing legally nonbinding recommendations, which nevertheless often carry the weight of a wide consensus of stakeholders and/or field experts. For example, soft law includes the International Declaration on Human Genetic Data (2003) and the Universal Declaration on Bioethics and Human Rights (2005), as well as European Union Guidelines.³¹

Table 3.

Consent Provisions Among Countries in the BCNet

Specific consent only	No provision mentioning directly or indirectly whether broad consent is permitted	Broad consent allowed
Zambia^h	Cameroon^s	Nigeria^h
Tanzania^s,h	Egypt^s	South Africa^h,^*
	Ghana^h	Sudan^s
	Kenya^s,h	The Gambia^s
	Ethiopia^s	Thailand^s
		Uganda^s
		Zimbabwe^s
		Brazil^s,h

The specific provision mentioning consent as a general subject may be in hard law^h or for soft law^s as indicated.

South Africa moved closer toward the specific consent model in 2019.

There are a number of reasons why soft law might be adopted versus hard law in medical sciences, including biobanking activities. In the case of rapid technological development, often soft laws (guidelines) precede national legislation (laws) to allow for the flexibility of updating guidelines as technology proceeds and thus incorporate measures to address emerging concerns. In some cases the absence of hard law might be due to the lack of a competent legislator being immediately available, which may therefore necessitate the drafting of soft law measures by the research community itself.³² Soft law tools can also be seen as a by-product of the harmonizing and standardizing activities, for example, of collaborating biobanks across borders.³³ However it has to be noted that it is not possible to rely entirely on such soft law mechanisms, as they are often most effective when intertwined or aligned with national laws.

Some countries have no laws and guidelines relating specifically to health research or only very basic legislative provisions. As such, they neither authorize nor prohibit the use of broad consent. The regulatory scheme for health research in Cameroon, for example, is very limited. There are provisions relating to ethics review committees,³⁴ but there are no laws or guidelines dealing with obtaining human samples and reusing these samples. Tangwa and Munung identify an urgent need in Cameroon for national regulations to be “put in place to protect research participants, researchers, and the community as a whole.”³⁵ Egypt also has a basic regulatory scheme, and the need for national guidance has been widely recognized.^36,37 Younis reports that relevant stakeholders have worked together to prepare a law regulating the conduct of clinical trials and that “as a result of all these efforts, a draft of the law has been prepared and only needs political will to pass it through.”³⁸ However, he also notes that the political instability in Egypt puts positive initiatives in this area “way beyond the scope of reality for the time being.”³⁵ Renewed efforts from the scientific community in Egypt have provided a unified voice and as such invigorated the dialog in recent months.^39,40

At the other end of the regulatory spectrum are countries that have legislative provisions, which limit the ability of researchers to obtain broad consent. Zambia has legislation that specifically regulates biobanks. The National Health Act 2013 imposes criminal sanctions for failing to comply with many of its provisions. For example, it is an offense to keep biological materials without being a licensed biobank.⁴¹ Materials can only be kept for 10 years unless the National Health Research Authority approves a longer period.⁴¹ Penalties for breaching the Act include large fines and even imprisonment.

The legislation in Zambia requires specific consent for future use of samples. The National Health Research Act 2013 states that a person shall not “withdraw blood; blood products; tissue; or gametes from a living person for any unspecified future health research activity or unspecified storage.”⁴¹ Biological material for health research shall only be collected for the purposes for which it is indicated in the research protocol.⁴¹ While the Zambian model provides a high level of protection of human samples and a clear and enforceable regime for regulating biobanks, it also potentially limits research opportunities as countries with more flexible approaches may be preferred by research partners.⁴²

Tanzania has a legislative scheme that regulates the collection and use of human DNA. The legislation arose out of concerns about the negative consequences of DNA sampling. The legislation is very broad and deals with a number of quite different situations where DNA is used, including research, criminal investigations, and paternity testing. Although the Act concerns samples “for Human DNA,” this is defined very broadly to include any human biological material “from which human DNA can be extracted.”⁴³ The Tanzanian legislation requires certain information to be provided to a person giving a DNA sample (whether for research or another purpose). The person must be informed that their sample will be used exclusively as described in the written authorization,⁴³ while the sample remains the property of the person giving it.⁴³ The Guidelines on Ethics for Health Research in Tanzania deal extensively with informed consent for health research generally, but do not address issues of future use of human samples.⁴⁴ There is legislation relating to research on human subjects in Ghana that addresses informed consent in some detail.⁴⁵ It does not however deal with research on human samples and the question of future use. Kenya has guidelines covering health research, which was updated recently, addressing aspects of clinical trials, but again it does not address the use of human samples.^46,47

In most countries BCNet is involved in guidelines that are the primary means for governing biobanking and research involving human samples.⁴⁸ In some of these countries there is high-level legislation dealing with human research, but it tends to focus more on clinical trials and the establishment of ethics review committees.⁴⁹ This legislation has usually been drafted before the potential for research on human samples was recognized. In three countries in the scope of the review (Sudan, Thailand, and Zimbabwe), guidelines do not directly refer to broad consent but do anticipate the possibility of ongoing storage and future use of samples. The Sudanese guidelines state that when initially seeking informed consent, the permission of prospective research participants should be sought regarding whether there will or could be any secondary use and, if so, whether such secondary use will be limited to a particular type of study.⁵⁰ Similarly in Ethiopia, secondary use of biological samples obtained through informed consent is restricted to anonymized or anonymous samples. This means that the sample cannot be identified or linked to an individual by the “secondary-use-researcher” or any “third party.” However, limited, nonidentifying demographic information may be retained on the sample(s).⁵¹ The provisions on biobanking in Thailand's ethical guidelines require information to be provided regarding the duration of storage and what will happen to materials once this period is over.⁵² As part of the informed consent process, the guidelines assert that participants should be informed about future use of samples, including whether such use is “limited.”⁵²

Many of the countries represented in the BCNet do have guidelines in place that directly allow for broad consent. Interestingly, none of the countries surveyed have regulated broad consent through legislation. In Nigeria, the National Health Act provides that research shall only be conducted with the written informed consent of the individual.⁴⁹ Likewise tissue, blood, or blood products cannot be removed from a person's body without them having been informed of the “objects of the research or experimentation.”⁴⁹ The National Health Research Ethics Committee (NHREC) has produced a Policy Statement on Storage of Human Samples in Biobanking and Biorepositories. No organization can operate a biobank in Nigeria without being registered, and biobanks are subject to ongoing oversight by the NHREC.⁵³ It is expected that research that is done with samples from biobanks will be reviewed by a human REC that “has an obligation to ensure that research that incorporates the storage of samples in biobanks or those using samples from biobanks are based on the highest ethical standards that ensure protection for all participants.”⁵³

The policy statement defines and addresses the distinction between different conceptions of broad consent. Broad consent is supported but not blanket consent:

Broad consent for the purposes of this note implies consent in which the type or purpose of research is defined in broad terms and for a work that is not specified by time. A blanket consent on the other hand, is one in which the type or purpose of the research is not defined in any way and does not restrict the use of donated specimen to any type of research.⁵³

The South African Constitution protects the right of individuals to not be subjected to medical experiments without informed consent.⁵⁴ The National Health Act of 2003 also requires research to be conducted with the written consent of the individual after having been given information about the objects of the research and any possible positive or negative consequences of participation.⁵⁵ Regulations under this legislation require the written informed consent of a donor for long-term storage of genetic material, stem cells, or research findings.⁵⁶ The legislation and regulations do not however detail the specificity of the consent required to this storage. New national ethics guidelines were released by the South African Department of Health in March 2015, which have detailed provisions relating to databases, registries, and repositories.⁵⁷ The guidelines recognize that broad consent to future use is possible, as do researchers.⁵⁸ Broad consent is defined as the donor giving permission to use their materials “for a broad range of future studies, subject only to further prior ethics review and approval.”⁵⁷ When obtaining broad consent, “the nature of the further usage should be described as fully as possible” and it should be stipulated that ethics approval will be needed for the future research.⁵⁷

The South African guidelines detail what should be included in informed consent documentation for individuals who are donating material and data to a repository/biobank. This includes information about the purpose and nature of a biobank, the conditions under which data or material will be stored and shared with other researchers, the risks involved, how the participants' privacy and confidentiality will be protected, and how long the consent will last and samples will be stored for.⁵⁷ Participants should also be informed that they are free to withdraw their consent at any time and can request that their data be removed and any unused identifiable material be destroyed. Any limitations on this must be clearly explained. The recent (in 2019) enactment of the Protection of Personal Information Act 4 of 2013 (POPIA) defines new legal requirements for the protection of personal information. This has been driven by the need to protect the privacy rights and individuals in the era of Big Data. However, it is likely that this new South African privacy legislation will affect scientific research and biobanking at least temporarily.^59,60

Uganda also regulates research on human materials through guidelines, which specifically provide for broad consent. A person who collects “identifiable human materials” must ensure that appropriate informed consent has been obtained from participants, including consent for possible future uses. A separate consent form is to be used when it is intended that the collected samples will be stored and used in future research. This separate form must include the following: the purpose of sample storage; the quantities of samples to be stored; the physical location where samples will be stored; a description of the measures in place to protect data and confidentiality; the policies that will govern use of the samples in future research; and the potential risks and benefits of storing samples for future research and any other information deemed necessary by the researcher or REC.⁶¹ All future research studies on stored samples are subject to a subsequent review by a REC.⁶¹ The guidelines seek to maintain some local control over future use of the samples and build in a form of benefit sharing by requiring that a Ugandan scientist be included as coinvestigator in all future studies using human samples collected in Uganda.^61,62

The Gambia has a national DNA bank, and there are detailed guidelines in place for it. The guidelines state that consent can be limited to specific analyses or can be a wider consent that allows for genetic analysis that is described in general terms.⁶¹ Proposals for research utilizing samples and data from the national DNA bank must be evaluated by both the scientific coordinating committee and the ethics committee.⁶³

Zimbabwe does not have formal guidelines dealing with broad consent,⁶⁴ but as mentioned above, the Medical Research Council of Zimbabwe (MRCZ) has sample informed consent forms on its website, which clearly and simply explain the nature of broad consent and the future arrangements for use and storage. The general consent form includes the following paragraph⁶⁵:

At the end of this study, there might be some of your samples left over after all the testing has been completed. These samples may be very useful in the future for other studies. Later, we will ask if you are willing to have your left-over samples saved even after the study is over for future testing on studies that are yet to be designed. These stored samples might be used later on to look for [include a general comment about the possible uses]. The samples will be stored in Zimbabwe. You can still participate in this study whether or not you agree to have your samples stored after the study is completed. We will review the details with you and you will be asked to sign a separate consent form like this one to say if you agree or not to have your samples stored for the future.

There have also been recent examples of detailed research in Zimbabwe to understand current practices and identify potential governance gaps.⁶⁶

In Brazil, guidelines require a comprehensive informed consent process when it is anticipated that samples and data will be stored for possible use in future investigations.⁶⁷ The guidelines differentiate between biorepositories (a collection of samples collected and stored for a specific research project) and biobanks (an organized collection of human biological material and associated information collected and stored in the long term for nonspecific research purposes).⁶⁸ For samples stored in a biorepository, research participants must provide a new consent for each new study. When a participant is giving informed consent to the collection, storage, and use of their biological material in a biobank, they must expressly indicate either that they will provide consent or opt out to each new research activity proposed.⁶⁷ The consent document must also refer to the types of data, which may be obtained in future research on the material.⁶⁷ All new research conducted with stored materials must be submitted for approval from the institutional ethics board and, where appropriate, the National Research Ethical Board.⁶⁷

Discussion

Despite some reluctance to use broad consent among researchers in BCNet countries and uncertainty in some LMICs about whether it is legally permissible, in most of the countries reviewed it is either not prohibited or expressly allowed. This suggests that there is a need for researchers to be able to more easily access information about the regulatory frameworks in which they are operating. Information about laws and guidelines in individual countries can be difficult to find and there is a lack of comprehensive, readily accessible resources that detail the relevant regulatory provisions across countries. In addition, the aspect of institutional leadership in managing complex relationships between researchers, biobanks, and the community has been highlighted as a key enabler.^69,70 The BCNet, with its remit to promote collaboration with and within LMICs, and other international collaborations, potentially offers an opportunity to provide a compilation of laws and guidelines that address issues of relevance to biobanking.

This overview of informed consent provisions in a selection of LMICs that are active in the biomedical research field shows that there are workable regulatory models of broad consent, as mentioned above, already in operation within some countries. These models comply with international guidelines and stakeholder expectations around governance. Nigeria, South Africa, Uganda, The Gambia, and Brazil all have guidelines in place which establish comprehensive governance arrangements that support broad consent. In each country research using stored samples and data must be subject to ethics review, and there are processes in place to protect research participants. Uganda has also built in a form of benefit sharing by requiring the involvement of local scientists in research using stored samples. These approaches can provide guidance to researchers and policy makers in other countries looking to regulate consent in a manner that respects and addresses the concerns that are particularly pertinent in LMICs. One of the limitations of this article is that it does not provide an exhaustive review of the current situation in all LMIC settings, but rather an indicative descriptive review of most of the BCNet members. As such it is likely that there exist nuances not taken into consideration here.

To date, broad consent has not been authorized through legislation in any of the countries considered. In the only countries where legislation has been enacted it has served to limit the use of broad consent. Legislation is less flexible than other normative documents, such as guidelines and statements. Once legislation is passed it often takes many years before it is reviewed and modified. Therefore, guidelines can be more flexible and take less time to develop or review as technology advances and stakeholder expectations shift. Guidelines can also be developed with significant input from those directly involved in research, making them potentially more inclusive of and responsive to the needs of researchers. The limitation of using guidelines is that they may carry less weight than legislation and may therefore be more difficult to enforce.

Existing literature highlights the challenges in implementing a broad consent framework while engaging all stakeholders. Recent findings suggest that contextual and relational factors play an important role in the practice of broad consent and illustrate that broad consent relies as much on training and professional intuition as on reasoning and that the return of results can be successful if “conditional trust” has been created between biobanks, physicians, and patients.⁷¹ Especially in the latter case of return of research results or incidental findings, while there exists interest from biobank participants and clinicians for the return of results to become a possibility, questions have been raised on the exact method(s) of implementation, as well as the necessary training to support such an approach within existing legal frameworks and/or guidelines.⁷²

It has to be emphasized that having limited regulation, or no regulation at all, puts research participants and local researchers in a weak position and increases the risk of exploitation.⁷³ There is a pressing need in countries that have no regulatory guidance or whose health research legislation or guidelines do not cover developments in this area to develop a framework that explicitly deals with research on human samples. Further research could be undertaken to consider the impact of different regulatory approaches on the ongoing research activity in different countries. Such research could consider whether more restrictive legislative approaches hinder research or not and to what extent and whether guidelines have appropriate force to ensure that consent is properly implemented, obtained, as well as that appropriate governance arrangements are in place.

This article forms an interlinked part with the earlier BCNet article mentioned previously, where barriers and opportunities were investigated for consent and access procedures in LMIC biobanks.⁹ The previous exploration distilled the views and concerns of individual researchers with regards to the novel legal and policy considerations as arising by the expansion of biobanking practices in LMICs. Thus, the barriers were viewed from the perspective of the individual having to navigate within a complex and changing landscape. Over the last 2 years an additional few publications have enriched our knowledge, always from the individual researcher or operational perspective.^74–77

The current article provides the narrative review of one of the aspects which BCNet researchers must consider, and as such the results of the 2018 work complete the current one and the contextual description of the current operational framework in LMICs. Taken together, both articles concentrate a rich tapestry of experiences within a well-delineated frame. As such they can provide the core knowledge of future work in research aspects in LMICs and the basis for further systematic reviews on the subject. In addition, they can be used as the basis for training workshops addressing ethical, legal, and societal issue aspects in LMIC research, as well as help set targets to help countries achieve what was aspired to in the original workshop.⁹

An important issue that has been beyond the scope of this article is the role that specific data protection regulations play in biobanking. Several LMICs, for example, South Africa, Ghana, and Uganda, have passed or introduced data protection legislation.^78–80 The African Union Convention on Cyber Security and Personal Data Protection has received little attention despite specifically dealing with research activity.⁸¹ The research community will need to actively engage with developments in this area to ensure that laws do not restrict biobanking activities and undermine broad consent provisions.

Conclusion

The growing consensus that broad consent is closely linked to good governance provides an impetus for countries to have regulatory frameworks in place to provide that governance and, thus, facilitate broad consent. International guidelines increasingly support a model of broad consent that includes safeguards and stakeholders expect that appropriate protections will be put in place when providing for future use of samples and data—in some cases even tighter regulations for data.³⁰ A clear regulatory framework allows individual countries to proactively address concerns that exist in some LMICs about exploitation of research participants and misuse of samples. The breadth of approaches taken in the BCNet countries demonstrates the importance of projects like the BCNet to allow for opportunities to share information and collaborate in the development of regulation (through legislation or guidelines) that facilitates biobanking (as foundational infrastructure to local research capacity development) while also protecting local communities and researchers. First and foremost, researchers will need to be familiarized with their jurisdiction's normative standards. This requires a concerted effort by health institutions, policymakers, and funders of research. Furthermore, the trust of the public will need to be maintained through consistent, clear, and accurate information, made easily available. To do so, continuous engagement is key.

Footnotes

Acknowledgments

The authors thank the BCNet members and colleagues across the world for their fruitful discussions during the workshops and meetings, face-to-face or online that have taken place over the last years, highlighting the need for this research.

Disclaimer

Where authors are identified as personnel of the IARC/WHO, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy, or views of the IARC/WHO.

Author Disclosure Statement

No conflicting financial interests exist.

Funding Information

No funding was received for this work.

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