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The reported impact of public involvement in biobanks: A scoping review

Abstract Background Biobanks increasingly employ public involvement and engagement strategies, though few studies have explored their impact. This review aims to (a) investigate how the impact of public involvement in biobanks is reported and conceptualized by study authors; in order to (b) suggest how the research community might re‐conceptualize the impact of public involvement in biobanks. Methods A systematic literature search of three electronic databases and the INVOLVE Evidence Library in January 2019. Studies commenting on the impact of public involvement in a biobank were included, and a narrative review was conducted. Results and discussion Forty‐one studies covering thirty‐one biobanks were included, with varying degrees of public involvement. Impact was categorized according to where it was seen: ‘the biobank’, ‘people involved’ and ‘the wider research community’. Most studies reported involvement in a ‘functional’ way, in relation to improved rates of participation in the biobank. Broader forms of impact were reported but were vaguely defined and measured. This review highlights a lack of clarity of purpose and varied researcher conceptualizations of involvement. We pose three areas for further research and consideration by biobank researchers and public involvement practitioners. Conclusions Functional approaches to public involvement in biobanking limit impact. This conceptualization of involvement emerges from an entrenched technical understanding that ignores its political nature, complicated by long‐standing disagreement about the values of public involvement. This study urges a re‐imagination of impact, re‐conceptualized as a two‐way learning process. More support will help researchers and members of the public to undergo such reflective exercises.


| Biobanks
Biobanks are large collections of samples linked to data which today combine genetic, medical and other personal data. 1 They entail the collection and storage of tissue and/or blood samples, and often require additional personal data, such as genealogical and lifestyle information. 2 Biobanks vary according to tissue type, purpose of use and ownership. 3  donors, the logistics of data disclosure to participants, the right to ownership of intellectual property, and the privacy and security of donors who participate'. 5

| Public involvement in biobanks
Biobanks are increasingly employing public involvement and engagement strategies. Public involvement aims to have the public, patients or research participants actively contributing to the research process. 6 Public involvement is seen as a means to produce and maintain public trust and legitimacy, which are essential for the functioning of biobanks. 6 This increase in efforts to involve the public in processes of decision making has occurred across the health-care sector. In the UK, 'public involvement' is mandated by the National Institute for Health Research and other research funders. 7 In other national contexts, terms such as involvement and engagement are used interchangeably, but the aims of these initiatives are similar despite the linguistic variation. The Canadian Institutes of Health Research advocate 'proactive mechanisms for dialogue and shared agenda-setting in decisions that affect Canadians as health consumers and citizens'. 8 In the USA, deliberative engagement strategies are commonplace, and, since 2012, the Patient-Centered Outcomes Research Institute funds health studies that cover research questions critical to the public. 9

| The impact of public involvement in biobanks
Investigating the impact of public involvement in biobanking is an important research question. There is a growing literature on the role of public involvement in the ethical, legal and policy implications of biobanking. [10][11][12][13][14][15] In 2019, Nunn et al 6 conducted a global review of involvement in genomic research, finding that only one third of studies involved the public and concluding that more involvement would have intrinsic value for future studies. Yet, as Nunn et al note, there are few published accounts of the impact that public involvement has had on the governance, design and conduct of biobanks, 16 or on the public who are involved. The existing evidence on the effects, if any, of public involvement practices on biobanking, or indeed health research in general, is contested and varied. 6,[17][18][19][20] There are cases where public involvement is reported to have improved the accountability or transparency of the biobank or the recruitment and retention of participants. 21 Others have claimed that public involvement makes no difference to research or harms it, providing legitimacy for pre-conceived conclusions. Involvement is also criticized for 'placating the public and speeding product development, as mechanisms for engineering consent, and as framed by narrow questions'. 22(p453) This review investigates the impact of public involvement on biobank studies. Due to the limited evidence in this field, we aimed to 1. Describe the impact of public involvement in biobanks, including how it is conceptualized by the study authors; in order to 2. Suggest how the research community might re-conceptualize the impact of public involvement in biobanks.

| Definition of terms and scope
We based the review on INVOLVE's definitions of the public and public involvement in research, conceptualized as, 'doing research with or by the public, rather than to, about or for the public'. 23 We What is already known on this topic Accordingly, the impact centres around functional domains such as enhancement of consent forms, processes and recruitment • There are significant epistemological and methodological challenges to capturing impact, suggesting that the impact of public involvement needs to be re-imagined, both in biobanking and wider health and social care research understand involvement to mean 'mechanisms whereby there can be meaningful and legitimate public input into policy that involves dialogue between relevant publics with scientists, policy makers, and other stakeholders… [We are] not referring to unidirectional attempts to increase public awareness of certain aspects of science and technology; nor […] to the measurement of "public opinion" on certain controversial issues'. 24(p3) As a scoping review, we relied on the understanding and reporting of impact from study authors, rather than imposing a pre-established definition. We thus included a wide variety of perspectives on impact, both empirical and normative.
Biobanks can be situated within a wider number of data-intensive health research initiatives. 15 Although the term biobank might not always be used to refer to such collections of bioresources, 25 this term is favoured in our review since large nation-wide projects have chosen this term before. 26

| Inclusion and exclusion
We included papers where the impact of public involvement in a biobank was either the primary outcome or implicitly addressed. We put no limits on publication date and excluded studies not in English, French or Spanish. We excluded viewpoints and general discussion papers, and articles with insufficient detail of the contribution of the public to the biobank. We also excluded studies of educational or awareness campaigns on biobanks; public attitudes towards biobanks and public involvement; representation and diversity of biobank participants; and ethical models of individual consent without public involvement.

| Identifying relevant evidence
On completion of the search, titles of papers and (where available) abstracts were scrutinized for possible inclusion in the review by LLP and WK independently. Disagreements and uncertainty about eligibility were resolved through discussion until consensus was reached.
Evaluation of the impact of public involvement on biobank studies did not have to be the study authors' primary research question.
We put no limits on publication date, but only studies in English, French or Spanish would be included.

| Extracting relevant data from studies included
A data extraction table was developed. Data were extracted relating to country where the biobank operates; type and size of biobank; method and stage of public involvement; tasks addressed by involvement; description of the public actively involved; the impact of public involvement; factors that influence the impact of involvement; challenges encountered; and facilitating strategies and recommendations. While there may appear to be similarity in the categories of involvement reported, such as between 'community engagement' and 'community-based participatory research', we recorded the methods reported by study authors.
We adapted common categories of impact found in the literature 17 when extracting data pertaining to the impact of involvement, so as to provide a holistic definition of impact that concerned the biobank, its context and its stakeholders (eg impact on research design and delivery, and impact on researchers). Indeed, although we had initially planned to use categories already identified, 17 after data extraction we noticed that some categories specific to the biobank, not limited to research, were needed. Consequently, we included new categories such as 'establishment of the biobank', 'governance' and 'operations' and we changed the name of others, for example 'impact on the research' became 'impact on the biobank'. This demonstrates the importance of working iteratively when conducting scoping reviews.
LLP and WK extracted data from the papers and created categories for methods of involvement and types of impact independently, including a working definition for each category. Their tables and lists were compared: if the same category appeared in both, the category remained. If not, the authors decided through discussion whether a new category was needed, or whether the data could be included in an existing category.

| Expanding data on studies included
For the included studies, additional grey information was sought through official websites and online searching to provide more detailed information on the context, process and impact of involvement. Such grey literature, 'that which is produced on all levels of government, academics, business and industry in print and electronic formats, but which is not controlled by commercial publishers', [27][28][29] 60 Olson et al, 36 Kimball et al, 16

| Characteristics of studies included in the scoping review
Our search yielded 1143 records. After excluding duplicates, we Fourteen were population biobanks, 13 were disease-specific, three were hypothetical, and one was a network of four biobanks.
Also, three papers did not refer to a specific biobank, and the public involved gave input on hypothetical studies that would become actual biobanks in the future. [31][32][33] More details (including the method of involvement, the tasks addressed by involvement and a short description of the public involved) of the biobanks covered in the studies included can be found in Table 1. Additionally, a Supplementary Table in Appendix 3 provides details on each biobank. This was completed with data retrieved from the grey literature.

| Methods of involvement
We identified eleven methods of involvement (listed in Table 2); many individual biobanks combined multiple methods. The most common forms were the creation of lay advisory panels (13), focus groups (13) and deliberative exercises (9). Ad-hoc consultation and support, community-based participatory research, public representatives in biobank governance structure and surveys were each used by four biobanks. Three were patient-led biobanks, two used community engagement. Finally, a formal partnership with a patient organization or a public representative in an ethics panel was each reported in one biobank.

| Aspects of biobank involvement
Biobanks invited public input into varied aspects of the organization. Most commonly, the public had a role in governance (18), and in working with researchers to determine models of consent and the design of consent forms (14). Thirteen biobanks involved the public in discussion of promotional measures and recruitment strategies.
Members of the public were involved in aspects pertaining to sam-

| Types of impact reported
The impact of involvement reported in the studies included could be classified into three main categories (a detailed classification is shown in Figure 1) based on where the impact is seen. These were Of the forty-one studies included, less than one-third (n = 12) included members of the public as authors, or in the reporting of impact (eg through quotes).
Twenty-one biobanks also made normative claims (ie value judgements about impact, as opposed to descriptive claims) about the impact of public involvement. In these cases, authors reported that involving the public led to increased transparency, accountability, trust and lasting research partnerships, but they did not provide evidence.

Impact on model of consent (n = 14)
Biobanks that had their models of consent shaped by the public ei- involved also produced a list of topics to be communicated to potential biobanking participants as part of an informed consent process.

Impact on participant recruitment and consent materials (n = 12)
Studies reporting the impact of public involvement on the production of participant materials and consent forms typically involved simplifying the language and shortening recruitment materials. Kimball et al 16

| Impact on people
We identified four main groups to which the studies referenced  Very few biobanks reported any negative impact on the members of the public involved, despite studies outside of this review arguing that the complexity of topics discussed and lack of clarity of process can lead to dissatisfaction and frustration with the process of public involvement. 38

| Summary
This review included forty-one studies covering thirty-one biobanks from eleven different countries. Three main findings can be highlighted. Secondly, most studies focused on functional involvement that worked to improve the efficiency of existing biobank activities. This can be characterized as using participation to achieve predetermined project goals and objectives. The wider literature on public participation has recognized this dynamic in other projects, where 'such involvement may be interactive… but tends to arise only after major decisions have already been made by external agents'. 44 Based on the studies included in this review, we suggest that the extent of the reported impact involvement in biobanks can be conceptualized in four broad types ( Figure 2). The most cited form of involvement is the public performing a functional task, mostly with the purpose of improving participation rates. Accordingly, the impact centres around the enhancement of consent forms, processes and recruitment. In other instances, the public were involved in exercises of idea generation but within a pre-defined aim or procedure. Also, more than a third of the studies included made normative claims about the impact of involvement but did not include evidence to support these.
Thirdly, only in a few cases did the public's influence go beyond the aims pre-defined by the biobank. Although there were cases where a broader form of 'impact' was seen through involvement, this type of impact was only vaguely defined and reported. This supports the first and second findings-that there is a lack of clarity over purpose in conducting involvement beyond improving participation rates. It also suggests either a lack of consideration of impact or a lack of understanding of how to conceptualize it.

| Strengths and limitations of our review
To our knowledge, this is the first attempt to review the impact of public involvement in biobanking. This review provides a narrative summary of how impact has been captured and conceptualized, before discussing some of the difficulties encountered. Our results are consistent with previous studies exploring methods of involvement in biobanks which suggest the dominance of functional approaches.
Unlike previous studies, our review departs from attempts to quantify 'outcomes' of public involvement and turns to issues associated with the conceptualization of impact by researchers.
Our study had several limitations. The level of detail when report- Moreover, since evaluation does not include long-term follow up, we could not explore some of the impacts to the wider research community, such as national policies emerging from the public's recommendations or greater trust of the community towards biobanks.
Finally, our study can only account for forms of impact that are reported in the literature, limited in most cases to the perspective of experts.
We pose three areas for further research and consideration by biobank researchers and public involvement practitioners.

| Biobanks' functional approach to public involvement limits impact
This review demonstrates that many biobanks pursue public involvement with a functional objective of increasing participation. A functional approach to involvement leads to largely functional outcomes.
Biobanks that choose such an approach to public involvement encounter two major risks.
Firstly, this approach can mislead the public about their potential influence. Clarity when inviting involvement 20,46 will prevent the obfuscation of goals and subsequent public frustration. This recommendation echoes Lemke's suggestion that 'biobank community engagement efforts need to have clearly defined goals'. 33 If involvement is perceived by the public simply as another tool for researchers to achieve participation in their studies, biobanks face a 'risk that the public will mistrust researchers and will simply not participate in sufficient numbers'. 47 Secondly, a narrow scope for the public limits involvement to ex-

| Disagreement in public involvement is valuable and should be captured
Public involvement is often presented as a process that is neutral and technical. But it has too an essentially political nature 49 and, particularly under the form of public deliberation, often results in persistent disagreement, 50 which creates an inherent tension in trying to achieve involvement that is meaningful to all stakeholders. While some studies included in this review referred to certain tensions and moments of disagreement, 35

| The impact of public involvement needs to be re-imagined
This study has demonstrated the inherent difficulties in capturing the impact of public involvement. Firstly, the lack of clarity over impact arises because of the challenges of defining 'impact' [17][18][19]54 and competing rationales for its investigation. To some, public involvement should be able to produce a demonstrable change in the research to justify its existence, much like an intervention. To others, impact is better conceived as a process of reflective learning between researchers and the public. Some outcomes are more readily quantifiable, such as improved participation rates, while others are highly subjective or unpredictable, such as changing researcher attitudes. Consequently, it is difficult to expect a uniform standard for conducting and evaluating public involvement activity. Thirdly, beyond the largely functional aspects of public involvement, many biobanks made normative claims that public involvement led to increased transparency, accountability and lasting, trusting research partnerships. These claims appear to be more difficult to evidence than the impact of task-based involvement, because they require different methods of design and analysis over a longer period.
This study supports a growing call in the literature for an approach that conceptualizes involvement as conversations that support two-way learning 52 (see also Ref.55). This is an approach for both biobanking and wider health and social care research. Less focus on mandating the reporting of quantifiable outcomes will enable greater focus on the process of reflective learning for researchers and the public in partnership. Organizing and facilitating involvement in biobanks consumes time and resources, and consideration of best practices and guidance is important. Researchers might currently find it difficult to evidence 'non-functionalist' forms of impact or might lack awareness of its relevance. Alongside an approach focused on reciprocity, funders should also support longer-term, social science research to understand varieties of 'public involvement'. Methods to capture more subjective forms of impact need to be developed to improve reflective two-way learning.

| CON CLUS IONS
The functional approach to public involvement reported from most biobanks limits likely impact. Reporting of involvement by study authors is often limited to outcomes from the agenda of researchers defined prior to involvement. This conceptualization of involvement emerges from long-standing disagreement about why public involvement is valuable, and an entrenched neutral and technical understanding that ignores the political nature of involvement.
There are several inherent difficulties in trying to capture impact, both epistemological and methodological, not least the competing rationales for why impact should be investigated. Ultimately, this study urges a re-imagination of impact, re-conceptualized as a two-way learning process. More support must be provided to researchers and the public to undergo such reflective exercises.

ACK N OWLED G EM ENT
The authors thank Will Viney for helpful review of the manuscript.

CO N FLI C T O F I NTE R E S T
There were no financial support or other benefits from commercial sources for the work reported on in the manuscript, or any other financial interests that any of the authors may have, which could create a potential conflict of interest or the appearance of a conflict of interest with regard to the work.

DATA AVA I L A B I L I T Y S TAT E M E N T
The data that support the findings of this study are available from the corresponding author upon reasonable request. Public involvement ((consumer* or citizen* or client* or carer* or communit* or lay or patient* or public* or service user* or user* or survivor* or stakeholder* or family or families or relative* or parent*) and (involv* or collaborat* or engage* or partner* or consult* or advis* or emancipat* or empower* or advocat* or embed* or represent* or particip* or led)).ti.

3
Public involvement outcomes (impact* or effect* or adapt* or modif* or change* or develop* or design* or improve* or worse* or increase* or boost* or decreas* or reduc* or differ* or edit* or suggest*).ab,ti   41 Filocamo et al, 40 Terry et al, 43 Rabeharisoa 42 'interest on the part of Patient Organisations in the biobanking service, which has led to 13 written agreements designed to formalise this process.  41 Dry et al, 69 Filocamo et al, 40 Flowers et al, 66 Molster et al, 35 O'Doherty and Hawkins, 24 O'Doherty et al, 57 Olson et al, 36 Parkinson et al, 39 Secko, 2008, Terry et al, 37 Wilcox et al, 21 O'Doherty and Burgess,59 McWhirter et al, 50 Lemke et al, 61 Terry et al, 43 Rabeharisoa 42 during a deliberative exercise 16 41 Bossert et al, 31 Dry et al, 69 Filocamo et al, 40 Forrest et al, 34 Kimball et al, 16 McCarty et al, 12 Mitchell et al, 3 Molster et al, 35 O'Doherty et al, 57 Olson et al 36 ; Wilcox et al, 21 McWhirter et al, 50 Jenner et al, 53 Lemke et al, 61 Watson Mitchell et al, 3 Olson et al, 36 Wilcox et al, 21 McWhirter et al, 50 Lemke et al 61 ' Godard et al, 47 Kimball et al, 16 Lemke et al, 33 Levitt, 56 Levitt and Weldon, 70 Marsh et al, 63 McCarty et al, 12 Molster et al, 35 O'Doherty et al, 56 Rotimi et al, 62 Secko, 2008, Terry et al, 37 Walmsley, 51 O'Doherty and Burgess, 59 Jenner et al, 53 Haddow et al, 38 Lemke et al 61 'The participants in our project wanted fair and equitable access, and wanted a voice in the process. 4 main areas of concern after first dialogue session: (1) 69 Marsh et al, 62 Mitchell et al, 3 Rotimi et al, 61 Terry et al, 37 Wilcox et al, 21 Jenner et al, 52 Lemke et al, 60  41 Olaitan et al, 67 Terry et al, 43 Rabeharisoa  41 Chalmers et al, 4 Rabeharisoa 42 'Deliberative democracy brings to medical research and health care policy a method by which the community can gain standing in the development of policy on a range of issues previously dominated by researchers, lawyers and ethicists.
The advantage of this method over previous ones is that it is a two-way, iterative process of information exchange' leading to 'significant shifts in participants' thinking associated with access to information and dialogue with researchers' (

O'Doherty and
Hawkins, 24 Terry et al, 43 Wilcox et al, 21 Lemke et al, 61 Rabeharisoa 42 'A steering group [38 steering group members] was convened when the biobank was founded to ensure all relevant stakeholders were able to input into the formation and initiation of the WCB [...] Three lay members were patients, and one was a caregiver for a cancer patient. These four lay members went on to form the core of the patient and ethics committee' ( O'Doherty et al, 57 Wilcox et al, 21 Jenner et al, 53 Lemke et al, 61 Rabeharisoa 42 'Deliberative democracy brings to medical research and health care policy a method by which the community can gain standing in the development of policy on a range of issues previously dominated by researchers, lawyers and ethicists. […] Another advantage of this deliberative democracy methodology is that it permits effective consultation with cohorts of people who are traditionally difficult to engage, including people who live in remote locations, who are from lower socio-economic strata and who have lower literacy  37 Terry et al, 43 Lemke et al, 61 Watson, 64 Rabeharisoa 42 'providing access to actual patients and their stories through CAG patient networks ensured media uptake of press releases, driving public interest in the Alliance' (Watson 63 ) Dissemination and further adoption of involvement methods in STPs AFM; PXE Terry et al, 43 Rabeharisoa 42 'creation of the Genetic Alliance Biobank (a coalition of over 600 disease advocacy organizations, using its infrastructure as a repository for their model and methods)' (Terry et al 43 )