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A scoping review of considerations and practices for benefit sharing in biobanking

Abstract

Background

Despite the rapid global growth of biobanking over the last few decades, and their potential for the advancement of health research, considerations specific to the sharing of benefits that accrue from biobanks have received little attention. Questions such as the types and range of benefits that can arise in biobanking, who should be entitled to those benefits, when they should be provided, by whom and in what form remain mostly unanswered. We conducted a scoping review to describe benefit sharing considerations and practices in biobanking in order to inform current and future policy and practice.

Methods

Drawing on the Arksey and O’Malley framework, we conducted a scoping review of the literature in three online databases (PubMed, Cochrane library, and Google Scholar). We extracted and charted data to capture general characteristics, definitions and examples of benefits and benefit sharing, justification for benefit sharing, challenges in benefit sharing, governance mechanisms as well as proposed benefit sharing mechanisms.

Results

29 articles published between 1999 and 2020 met the inclusion criteria for the study. The articles included 5 empirical and 24 non-empirical studies. Only 12 articles discussed benefit sharing as a stand-alone subject, while the remaining 17 integrated a discussion of benefits as one issue amongst others. Major benefit sharing challenges in biobanking were found to be those associated with uncertainties around the future use of samples and in resultant benefits.

Conclusion

Most of the benefit sharing definitions and approaches currently in use for biobanking are similar to those used in health research. These approaches may not recognise the distinct features of biobanking, specifically relating to uncertainties associated with the sharing and re-use of samples. We therefore support approaches that allow decisions about benefit sharing to be made progressively once it is apparent who samples are to be shared with, the intended purpose and expected benefits. We also highlight gaps in key areas informing benefit sharing in biobanking and draw attention to the need for further empirical research.

Peer Review reports

Introduction

Biobanking refers to the storage, active sharing and re-use of biological specimens and associated data for research purposes [1, 2]. These specimens, collected specifically for biobanking or leftover from primary research or healthcare, support a wide range of research activities including basic, experimental and clinical research, as well as research applied in the development of tools for prevention, diagnosis and treatment of diseases; including personalized medicine [2, 3]. With increasing research activity and demand for biospecimens for research, the number of biobanks worldwide has increased significantly between 1980 and 1999 [4] with close to 70% of the world’s biobanks located in Europe [4]. Widely discussed ethical issues in literature include: nature of consent (broad, restricted, tiered); who can give informed consent; information to be contained in consent forms [3, 5,6,7]; privacy and confidentiality issues [3, 8]; ownership of samples [7]; the role of regulation in biobanking [9, 10] among others. An existing specific gap is in the understanding of the types of benefits and benefit sharing frameworks that should guide biobanking.

Schroeder (2007) notes that the concept of benefit sharing has not been well defined and provides a general definition for use with genetic resources; “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” [11]. In this definition, the terms ‘advantages/profits’’ are used deliberately to capture the notion that benefit sharing relates to both monetary and non-monetary benefits. Although several studies have explored benefit sharing in health research [11,12,13,14,15,16,17] and described benefit sharing frameworks [12, 18, 19], there is little consideration for benefit sharing in biobanking. There are significant debates in health research literature on benefit-sharing including in relation to the different forms of benefits (monetary, health care, infrastructure development, gifts etc.); who should receive the benefits (participants, communities, researchers, the ‘public’); who is responsible for their provision (researchers, sponsors, relevant government bodies, industry) and when the benefits should be provided (framed on a continuum of time of during and after the research) [17]. There are also important questions about how decisions about benefit sharing are made at institutional, national and supra-national levels. Yet these discourses, on nature of benefits and benefit-sharing mechanisms, have rarely been applied to the context of biobanking, leaving important questions about how benefit sharing should – and could – be considered in the context of biobanking. Thus, we undertook a scoping review of existing literature in order to explore further some of these issues, particularly the types and forms of benefits and benefit sharing considerations for biobanking.

Methods

The scoping review team comprised 3 authors who have varied experience in bioethics, biobanking and genomic research as proposed by Levac and colleagues [20]. The team discussed and agreed on the design of the scoping review including the research question, the search criteria, the databases to use and analytical approach. This scoping review was carried out according to the Arksey and O’Malley framework [21] improved upon by Levac et al. [20]. The review included the following five key phases: (1) identifying the research question, (2) identifying relevant literature, (3) literature selection, (4) charting the data, and (5) collating, summarizing, and reporting the results. The optional ‘consultation exercise’ recommended in the framework was not carried out.

The research question guiding this review was: what are the benefit sharing considerations and practices in biobanking described in literature? More specific questions were: (1) How are benefits and benefit sharing defined with relation to biobanking?; (2) Who are the stakeholders involved in biobanking and how are decisions on benefit sharing made?; (3) what are the motivators, barriers and enablers to benefit sharing in biobanking; and (4) what benefit sharing mechanisms have been proposed?

Data sources and search strategy

We conducted the initial literature search in September 2020 in three electronic databases, PubMed, Cochrane Library and Google Scholar. The databases were chosen due to their free access, comprehensiveness and were known to cover health-related matters. Google Scholar was included to cater for forms of literature that could not be obtained in the other databases. The search query consisted of terms that covered the two key areas of “benefit sharing” and “biobanking” and was expanded by use of Medical Subject Headings (MeSH) and relevant synonyms. The search was limited to the titles and abstracts of the articles within the databases. In keeping with the suggestion by Bramer et al. to include opposites of key search terms to avoid bias, we also included ‘risk sharing’ within the search criteria [22]. Table 1 describes the search terms used for the PubMed database, with the search query tailored to the specific requirements of each database. For Google Scholar, slightly different search strings were used because of the lack of MeSH terms within the database (see Additional file 2: Appendix 2). In addition to the search strategy described above, we also used the “cited by” function in Google Scholar and examined the reference lists of all the selected articles to identify additional articles that met our inclusion criteria. No date limits were placed on the database search and only articles in English were considered.

Table 1 PubMed search criteria

Citation management

All the citations from the different databases were exported to EndNote X9 and duplicates removed. This was followed by screening for relevant papers guided by a title and abstract screening tool (Additional file 1: Appendix 1).

Eligibility criteria

Any articles that described any aspect of biobanking and benefit sharing, allocation or distribution was included. Articles were not limited to geographical location and included peer reviewed journal publications, commentaries, editorials and reports. Any articles about benefit sharing not directly related to human health research were removed. Articles about financial banking, banking of animal tissue, banking of microorganisms (e.g. virus or microbiome archives), temporary banking of amputated parts, banking of tissue/organs for care and milk banks for dietary supplementation were excluded because they were out of the scope of the current review.

Title and abstract relevance screening

Only the titles and abstracts of citations identified in the database search were reviewed during the first stage of screening. Articles of which titles seemed to meet the inclusion criteria but where abstracts were missing were included for full article review in the data characterization phase. AS screened all the articles and the final list of selected articles was then reviewed by JDV and DK. Throughout the screening process AS, JDV and DK met to discuss and resolve any uncertainties related to study selection [20].

Data characterization

The full articles for all the citations deemed relevant via title and abstract screening and those missing abstracts were obtained for subsequent full text review. For articles that were not openly available, or those that could not be obtained through institutional library access, attempts were made to contact the author for assistance in obtaining them. Any articles that could not be obtained through these processes were excluded. Two separate templates were developed for data abstraction and characterization. The first was a Microsoft Excel sheet that captured study characteristics such as author name(s), publication year, publication type, geographic setting, and area of focus (see Table 2 below). The second was a coding framework developed in NVivo to capture the actual study content that related to the study questions. Both data charting forms (Excel and NVivo) were discussed extensively during analysis by the study team. The characteristics of each full-text article were extracted by AS and any additional studies that did not to meet the inclusion criteria were excluded at this phase. Frequencies were utilized to describe nominal data while narrative analysis was carried out on the qualitative content to draw out the themes.

Table 2 General characteristics of included articles

Results

Articles included in the scoping reviews

The search yielded 1174 potentially relevant citations. Eight duplicates were discarded after which the remaining citations were subjected to title and abstract relevance screening. At this stage a further 1098 citation were excluded. A total of 68 articles were lined up for retrieval of which 66 were eventually retrieved. Upon reading the full text, 21 articles met the inclusion criteria. An additional 8 articles were identified by going through the reference lists of the selected articles making the total number of articles included in the analysis 29 (see Fig. 1 below).

Fig. 1
figure1

PRISMA Flow chart of study selection process

General characteristics of included articles

Of all the articles included in the review, only one was published in 1999 [23] while the rest were published between 2000 and 2020. Journal articles formed majority of documents included in the review (22/29; 75.8%), followed by book chapters/sections (5/29; 17.2%). There were also 2 reports specific to benefit sharing that were included in the review [23, 24]. Five of the 29 documents were findings from empirical studies [25,26,27,28,29] while the rest were either reports, commentaries, opinions or debates. In terms of geographic settings for the empirical studies, there was one study each from India [25], Australia [27], South Africa [26] and UK/Germany [28]. One study was done across 27 different countries classified as 18 High, 6 Medium, and 3 Low-income [29]. Some of the non-empirical articles were also country-specific, and included one each from China [30], Australia [31], Ireland [32], India [33] and two from South Africa [34, 35]. The two reports included in the review were from the United States [23] and Iceland [24]. Majority of the articles discussed benefit sharing from a global perspective, often comparing high-income and low-income countries. Less than half of the documents reviewed (12/29; 41.4%) addressed benefit sharing as a stand-alone subject [30, 32, 33, 36,37,38,39,40,41,42,43,44] while the rest discussed it as one of several ethical issues in biobanking. While most of the articles looked at biobanking in general, 11 documents (37.9%) discussed biobanking within genetics/genomics research.

Reported definition of benefits and benefit sharing

There were broad variation in definitions of the terms ‘benefit’ and ‘benefit sharing’ in the articles included in the review. Only three of the 29 articles specifically defined the term benefit [36, 40, 45]; all three made reference to the 2000 statement on benefit-sharing by the Human Genome Organization (HUGO) ethics committee that defined benefit as “a good that contributes to the wellbeing of an individual and/or a given community” [38]. A larger number of articles (n = 12) provided some form of definition or description of benefit sharing. Of those, 7 articles adopted, with slight variations, Schroeder et al.’s definition [11] earlier described [33, 37, 41, 43,44,45,46]. A further two articles listed the elements of the HUGO ethics committee statement on benefit sharing in providing their definitions [36, 40]. Three papers gave independent definitions of benefit sharing as “an equitable exchange in return for genetic resources” [47]; as a “process or action of sharing in the benefits that derive from the research in a manner that is fair and equitable” [35]; or as”mechanisms that might be put in place to ensure that benefits stemming from biobanking and use of biobank resources in biomedical research are not perceived to be the exclusive domain of the commercial sector” [27].

Reported benefits

The reviewed articles describe a wide range of benefits in biobanking spanning those that can be enjoyed at individual level, at community level and at a global scale. Table 3 below highlights the types of benefits mentioned within the articles and provides some specific examples.

Table 3 Benefits and potential beneficiaries

Justification for benefit sharing

In the papers reviewed, a significant amount (18/29; 62.1%) justify the importance of benefit sharing in biobanking, with the majority (13/18; 72.2%) indicating that benefit sharing is important as a matter of justice and as a means of redressing existing inequalities, promoting fairness and equality and addressing potential for exploitation [25, 32, 33, 35,36,37, 39, 42, 43, 47,48,49,50]. Other reasons stated included sharing benefits as a moral duty/ethical obligation [25, 33, 39, 44, 45, 49]; in order to comply with existing regulation/ethical principles on benefit sharing [27, 39, 42, 43]; that we share a common heritage and therefore benefits should be shared in solidarity/or as a common good [27, 39, 40]; to respond to participant needs/requests [39, 48]; and that investments by private enterprises currently exceed contributions by governments and that the enterprises need to share the benefits [36, 38, 41].

Governance mechanisms for benefit sharing

Of the documents we reviewed majority (22/29; 75.9%) mention ways in which benefit sharing can be governed in biobanking. The governance mechanisms range from institutional level policies to international level guidelines and frameworks. A summary of the mechanisms, relevant clauses and articles that make reference to governance is presented in Table 4 below.

Table 4 Governance mechanisms for benefit sharing

Challenges to benefit sharing

A wide variety of conceptual and practical challenges to benefit sharing in biobanking were highlighted in 24 of the articles reviewed (see Table 5 for a summary). These range from the long periods associated with the development of any meaningful interventions from biobanking, the difficulties in determining who is to benefit and the proportions of those benefits, and the often large numbers of stakeholders involved (from specimen donors to researchers in multiple countries) and the power dynamics between them [24, 25, 28, 32, 33, 35, 37, 39,40,41, 44,45,46,47, 50]. Apart from benefit sharing in biobanking often being described as impracticable, articles also described challenges relating to cost with concerns that implementing benefit sharing would inflate the cost of research thereby discouraging investment especially in research that may not have big or immediate returns [28, 29, 31, 32, 37, 39, 50]. Another barrier mentioned in 12 articles is the lack of regulatory support/infrastructure for benefit sharing, specifically the lack of details in international and national ethics and guidance documents to guide implementation of benefit-sharing agreements. Institutions involved in biobanking are therefore left to interpret and implement benefit sharing as they deem best [24, 32, 33, 35, 37, 39, 42, 43, 45, 46, 48, 50]. Other issues identified included tensions between benefit sharing and other ethical principles such as coercion, undermining altruism and concerns about the commodification of human tissues.

Table 5 Benefit sharing challenges in biobanking

Mechanisms for benefit sharing

A total of 11 articles we reviewed propose mechanisms for benefit sharing. Benefit sharing agreements—described as formal engagements between two or more parties involved in biobanking in which decisions about how benefits that arise in biobanking would be shared—were described in 5 articles [25, 29, 32, 41, 49]. However, they did not provide information on what such agreements should contain, and how they could be negotiated including who would be involved. Some of the articles proposed consultations with stakeholders at different stages of the biobanking process [38, 41, 47, 49]. However, apart from participants/ specimen donors and their communities, the articles do not describe which other parties should be consulted, the specific issues to be discussed, at what stage of the biobanking process nor the context under which the consultations should be undertaken.

The role of ethics/regulatory review in supporting benefit sharing was highlighted in 3 articles which discussed this role as limited to checking for specific benefit sharing provisions prior to approving primary research [33, 46, 50]. One of the articles proposed a tissue trust in which tissues are held in trust for the donors by a trustee who oversees uses in accordance with the wishes of the donors. The tissue trust is then capable of returning long term benefits to the source community that extend beyond the benefits of primary research, such as improvement of healthcare facilities and capacity building of local personnel [49].

Discussion

In this paper, we set out to explore the considerations and practices for benefit sharing in biobanking. To guide our discussions, we began by describing the definitions of ‘benefits’ and ‘benefit sharing’ in the context of biobanking. The articles we reviewed characterised ‘benefits’ in biobanking very broadly to include anything that contributes to the wellbeing of an individual or community at local, national or global level. This broad definition allows for the inclusion of a wide variety of benefits ranging from provision of basic, tangible household supplies such as soap, to more complex and less tangible items such as building research skills within the community [14, 17]. Although this non-specificity in the description of benefits expands the breadth of what could be considered as a benefit in biobanking, it also further complicates considerations for benefit-sharing in biobanking due to its broad nature.

Similarly, among the reviewed articles, benefit sharing in biobanking was broadly described to encompass the fair and equitable distribution of any benefits that accrue from biobanking. Although it was considered an ethical obligation and discussed alongside other ethical issues in research such as consent, privacy and confidentiality, it did not receive specific attention as a stand-alone ethical issue within the reviewed articles. Whilst biobanking is a supportive function of research rather than research, benefit sharing in biobanking has mostly been framed in a similar manner to benefit sharing in health research.

The challenges to benefit sharing outlined in the reviewed papers are not unique to biobanking but are magnified by the nature of biobanking. Biobanking typically tends to blend primary research, which is organised around specific research questions and methods, with more open-ended secondary research which is often unknown at the time of sample collection. It is not always clear at the time of sample collection exactly what kind of secondary research will be done in the future with the samples, when, by whom, and what product/intervention might be realised, if any. This lack of clarity coupled with the fact that there may be long intervening periods between sample collection and intervention development, means that biobanking benefits are often not immediately known or apparent and raises important unresolved questions such as whether benefit sharing ought to be contingent on intervention development. The pooling of samples from different studies, communities or even biobanks as well as requirements for de-identification mean that it might be difficult to attribute inventions to particular communities thereby further complicating return of benefits to sample donors or their communities.

Majority of the challenges plaguing benefit sharing in biobanking seem to be those stemming from the uncertainties about if, when, by whom and for what purposes stored samples will be used and the attendant difficulty in predicting benefits. Additionally, benefit sharing in biobanking is still poorly understood with some stakeholders perceiving it as idealistic or unworkable and further confounded by weak governance mechanisms.

Benefit sharing ideally involves various stakeholders who have different roles as providers, producers, and recipients of benefits. Various stakeholders are described as important in benefits sharing arrangements in biobanking. These stakeholders include sample donors, their families/communities, researchers, regulatory bodies, biobanks, research institutions, countries and the global community. However, a number of areas remain unclear including which stakeholders play what role- if any, extent to which they are involved in benefit sharing discourse/negotiations, when and how benefit sharing decisions would be made and the regulatory environment within which such stakeholder interactions should take place.

The reviewed articles refer to a wide variety of governance mechanisms that can be drawn upon to guide benefit sharing in biobanking. However, most of the stated mechanisms are from related fields such as genomics, health research, human rights and other benefit sharing conventions. The lack of specificity to biobanking underscores the need to develop governance mechanisms that are not only targeted at biobanking, but also context-specific and have the potential for international application especially when samples and data are shared across borders.

Limitations

Despite attempts to be as comprehensive as possible, this review only utilised free online databases to perform literature searches and may not have identified all relevant articles in the published and grey literature. Searching other bibliographic databases may have yielded additional literature. Similarly, our inclusion of articles published in English only constitutes a limitation to our analysis.

Conclusions

Biobanking is expanding rapidly globally whilst benefit sharing in biobanking is still at its infancy. This is reflected in the limited number of dedicated articles and empirical studies in the review. Based on the literature reviewed, we highlight the main gaps in key areas informing benefit sharing in biobanking and draw attention to the need for empirical research involving various categories of stakeholders in both LMICs and HICs in order to: support how stakeholders define what counts as appropriate benefits for them; demonstrate the need for benefit sharing; clarify contentious issues such as under what circumstances benefits should be shared, in what form, with which stakeholders; and how decisions about benefit sharing should made.

Traditional benefit sharing mechanisms such as material transfer agreements and ethics or regulatory review may be insufficient in addressing the complex nature of benefit sharing in biobanking; due to their focus on discrete research protocols. Alternative, novel mechanisms such as benefit sharing agreements, that can be developed and used concurrently, at micro-level (between specimen donors/communities and researchers), meso-level (between researchers and biobanks or between biobanks) and macro levels (between countries) have been proposed. Such approaches may provide the latitude to account for the different benefit sharing levels, the needs of the stakeholders within particular settings and can include clauses for amendments, allowing for progressive decision making as more information becomes available during the biobanking cycle. However, there is paucity of empiric information on these and other benefit sharing mechanisms. Further research could help inform the development, adoption, implementation and testing of benefit sharing mechanisms appropriate for biobanking within different contexts.

Availability of data and materials

All data generated or analysed during this study are included in this published article and its supplementary information files.

Abbreviations

CBD:

Convention on Biological Diversity

CIOMS:

Council for International Organizations of Medical Sciences

ECs:

Ethics Committees

ELSI:

Ethical Legal and Social Issues

HGRDs:

Human genetic research databases

HUGO:

Human Genome Organizations

IP:

Intellectual property

IRBs:

Institutional Review Boards

KEMRI:

Kenya Medical Research Institute

MeSH:

Medical subject headings

N/A:

Not applicable

OECD:

Organisation for Economic Co-operation and Development

PRISMA:

Preferred Reporting Items for Systematic Reviews and Meta-Analysis

UK:

United Kingdom

UN:

United Nations

UNESCO:

United Nations Educational, Scientific and Cultural Organization

USA:

United States of America

WHO:

World Health Organization

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Acknowledgements

The authors appreciate colleagues at the KEMRI-Wellcome Trust Research Programme for their useful comments and suggestions during the development of this manuscript. The corresponding author would also like to acknowledge IDEAL (Initiative to Develop African Leaders) for the opportunity to conduct this research as part of his PhD studentship. We also acknowledge the Centre for Geographic Medicine (Coast), Kenya Medical Research Institute/Wellcome Trust Research Programme for providing an enabling environment to conduct this work.

Funding

This work was supported through the DELTAS Africa Initiative [DEL-15-003]. The DELTAS Africa Initiative is an independent funding scheme of the African Academy of Sciences (AAS)'s Alliance for Accelerating Excellence in Science in Africa (AESA) and supported by the New Partnership for Africa's Development Planning and Coordinating Agency (NEPAD Agency) with funding from the Wellcome Trust [107769/Z/10/Z] and the UK government. The views expressed in this publication are those of the author(s) and not necessarily those of AAS, NEPAD Agency, Wellcome Trust or the UK government.

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AS conceived and designed the study with the input of JDV and DK. AS carried out the study selection and data extraction. JDV & DK supported AS in analysis and writing of the draft manuscript. AS, JDV and DK reviewed the manuscript.

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Correspondence to Allan Sudoi.

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As this study involved an analysis of publicly available documents only, this is not human subjects research and does not require ethics approval.

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This manuscript was written with the permission of Director KEMRI CGMRC. All authors read and approved the final manuscript for publication.

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The authors declare that they have no competing interests.

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Supplementary Information

Additional file 1. Appendix 1

: Title and Abstract screening tool.

Additional file 2. Appendix 2

: Google Scholar and Cochrane Library search strings.

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Sudoi, A., De Vries, J. & Kamuya, D. A scoping review of considerations and practices for benefit sharing in biobanking. BMC Med Ethics 22, 102 (2021). https://doi.org/10.1186/s12910-021-00671-x

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Keywords

  • Benefits
  • Benefit sharing
  • Biobanking
  • Biobanks
  • Ethics
  • Sample sharing