Included Studies
A total of 1521 studies were identified from the systematic searches. From these, 25 studies were included in the review. The research was conducted primarily in the UK (five studies in Scotland, four in England, one in Wales and two across the UK) and in North America (seven studies in the USA and three in Canada) with one study set in Japan, another in Sweden and one worldwide. Data was collected from 1999 to 2013, though eight studies did not report data collection dates. The research participants included patients, service users, carers, surrogate decision-makers, lay persons and the general public ranging from 18 years of age to over 75 years. Six studies reported expert opinions from healthcare professionals, managers, health service staff and diabetes specialists in addition to the views of members of the wider public or patient groups. The qualitative methods of data collection included focus groups, interviews, deliberative events, dialogue workshops and asynchronous online interviews. Six studies included mixed methods using surveys or structured questionnaires. Additionally, three studies reported both primary and secondary research including a literature or policy review or systematic review.
Seven key themes were identified across the included studies: Widespread Conditional Support; Conditions for Support; Benefits; Control and Consent; Uses and Abuses of Data; Private Sector Involvement; and Trust and Transparency.
Key Themes
Widespread Conditional Support
The included studies point to a clear trend that there was generally widespread—albeit conditional—support for uses of data in health research.Footnote 1 This is typically expressed in relation to a view that health research—or research more broadly—is “in the public interest” or is expected to bring about benefits for “the greater good”.Footnote 2 For example, one participant in study number 25 stated:
“I think the medical research is going to be of general benefit to the general population and if my records can help; I think personally I would be quite willing to participate in any medical study that is of general benefit to the population. I just feel it is worthwhile to participate in these studies” (Patient 4, Willison et al. 2003: 2)
Uses of data for health or medical research were often conceptualised in relation to the potential for discovery of new cures or treatments, or the improvement of healthcare services.
In several studies participants were reported as being surprised that data are not already more widely used, with questions being asked such as: “Doesn’t this happen already?!”.Footnote 3 Many studies reported that participants considered research uses of data to be in the public interest and conversely that not using data was against the public interest since this was a resource which should be used, not wasted.Footnote 4
Despite broad agreement that using health data for medical research is generally a good thing, across the studies it is evident that support for these data uses was never unconditional. A number of factors were identified as being important conditions for public support or acceptance.
Conditions for Support
In a large number of studies assurances of individuals’ confidentiality were reported as crucial for public support.Footnote 5 Whilst confidentiality may be assured through various mechanisms, in the included studies this was largely associated with anonymisation of data. Public preferences for data to be anonymous were widely reported,Footnote 6 for example in one studyFootnote 7 a participant stated:
“[The public need] reassurance about anonymity because that’s what people worry about”
Some individuals expressed a view that if the data are anonymous “what does it matter?!”.Footnote 8 However, others noted that anonymisation is not an absolute guarantee of confidentiality Footnote 9 and in a number of studies participants recognised that the anonymisation process is imperfect and therefore did not fully or adequately protect individuals’ confidentiality.Footnote 10 For example, it was said:
“I think you’re right enough, it’s anonymised. But then if you’re dealing with particular areas, that again kind of cuts in to the anonymous factor, because if you’re looking at maybe, let’s say, a housing estate, so there’s only so many people, so it’s not…I don’t think there’s anything that’s truly anonymous; I think everything can be found out if you’ve got the wherewithal and the curiosity to find things out.”
Footnote 11
In a number of studies participants made a distinction between “plain stats” and more detailed qualitative information, with the former largely considered not to be concerning while the latter raised greater issues relating to confidentiality and privacy.Footnote 12
Assurances of safeguards to protect against misuse or abuse of data were also widely considered important for ensuring public support/acceptability.Footnote 13 Similarly, members of the public often expressed a preference for strong accountability mechanisms to be in place.Footnote 14 However, there was generally found to be low public awareness of current research practicesFootnote 15 and in particular, of current governance or ethics processes.Footnote 16 As such, in a number of studies it was reported that public acceptance increased after participants were informed about existing safeguards and governance mechanisms.
Assurances of data security were also found to be important for public acceptance of the use of health data in researchFootnote 17 and across the studies concerns about data security were widely identified.Footnote 18 Such concerns related to the fallibility of IT systems to protect against breachesFootnote 19 as well as to human error. Media reports of “laptops left on trains” or misplaced data were widely called upon to illustrate this latter point.Footnote 20 However, in a number of studies it was reported that participants regarded breaches of security as always being possible, yet security risks were sometimes regarded as tolerable or acceptable where individuals valued the purpose and potential benefits of research.Footnote 21
A further condition for public support was that data would only be used for legitimate purposes. Whilst the term “legitimate” was not always referred to explicitly, the included studies often suggested or concluded that the extent to which members of the public perceived uses of data to be legitimate influenced their responses or preferences.Footnote 22 However, there were varying views on how, or by whom, legitimacy was to be defined.
Public Benefits
Another key condition for public support for research using individuals’ data was that such research must have public benefits.Footnote 23 Whilst in some cases perceived personal benefits, or personal relevance of research was reported to motivate participation in research,Footnote 24 benefits of research were largely conceptualised in terms of benefits to wider society, or “the greater good”. For example, study participants said:
“…We wouldn’t have the national health service, we wouldn’t have drugs, we wouldn’t have anything, if it hadn’t have been for people being allowed to try things out in the past. So, I suppose, when you look at it like that, it is almost as if you have a moral duty to say, we have benefited, so why shouldn’t we contribute for [future generations?]”Footnote 25
In many cases it was reported that concerns relating to personal privacy were balanced with recognition of the importance of societal benefits anticipated to come from research.Footnote 26 Moreover, in two studies it was reported that some participants prioritised societal benefits over personal privacy.Footnote 27
Assurances that research would bring about public benefits—or at least that it had the potential to bring about such benefits—were widely reported to be fundamental for ensuring public support or acceptance. If research is perceived to be focussed primarily at benefitting individual researchers (e.g. through advancing their careers or raising their profile), as having no clear practical application or “real-world” value, or as being conducted solely for profit this leads to concerns and opposition (or at least less support) for research uses of data.Footnote 28
Control and Consent
Perceived autonomy, or individual control over how data is used, was found to be a key factor shaping public responses in a number of studies.Footnote 29 It was reported that members of the public valued having control over their own data.Footnote 30 Such control relates to what data are collected, who has access to this, how and with whom data is shared and for what purposes the data are used. In a number of studies participants explicitly referred to this control in terms of individual or human rights.Footnote 31
Whilst perceived individual control clearly emerged as a key factor shaping public attitudes or acceptance of research uses of data, there was no clear consensus (across or within) the studies regarding what this control implied or necessitated. In some studies there was a clear link between levels of trust in research organisations or data controllers and desired level of individual control.Footnote 32 This suggests that where individuals trust organisations handling their data they are less likely to favour more stringent forms of control. Conversely, when this trust is lacking individuals want to have greater control over their own data.
Preferences for control are also influenced by wider attitudes towards the value of research. In a number of studies it was found that, whilst individual control was highly valued, participants did not want this control to come at the cost of creating barriers to research. Thus it was often found that participants felt that individual control needs to be balanced with efficiency of research.Footnote 33
Across the included studies control is largely discussed in relation to consent. There is evidence that members of the public also made this association and recognised consent as a mechanism for facilitating individual control.Footnote 34 However, both between and within studies there were varied views on consent and what form this should take.Footnote 35 Some studies indicated public preferences for explicit opt-in consent models,Footnote 36 whilst an acceptance of opt-out models was also reported due to recognition of the challenges or practical limitations of opt-in.Footnote 37 In a significant number of studies there was a clear preference for varied or flexible consent models which would enable individuals to set limits on their consent or to indicate particular preferences or objections.Footnote 38 Similarly, some studies reported that participants objected to one-time consent models which would not allow individuals to review or change their consent preferences.Footnote 39 This relates to the fact that public opinions or preferences are not fixed but change and adapt in response to information, deliberation, events or circumstances.Footnote 40
Whilst consent was widely valued as a mechanism for facilitating individual control in many studies, it was also recognised to be problematic.Footnote 41 In particular participants in the studies acknowledged the potential for selection bias or low participation rates if explicit opt-in consent is required. Such recognition led to some individuals becoming more inclined to support opt-out consent models or non-consented uses of data, however this trend was certainly not universal and others maintained that consent was always important.
The included studies highlight a number of areas where consent was regarded as particularly important, for example in relation to named or identifying data,Footnote 42 qualitative information rather than “plain stats”,Footnote 43 research using genetic dataFootnote 44 or where a commercial entity is involved in research.Footnote 45
Where consent was acknowledged to be problematic and/or where individuals reported that they were largely unconcerned about research uses of data, consent was nevertheless widely viewed to be important. In a number of studies consent was in this regard represented as an act of courtesy with participants suggesting that they would be happy to allow their data to be used for research but that this should nonetheless not be used without their permission.Footnote 46
Uses and Abuses of Data
A key area of concern regarding research uses of data related to the potential for data to be misused or abused.Footnote 47 In some cases this related to concerns that individuals with access to data would use it maliciously or inappropriately, for example it was stated that:
“there are some people, [that] regardless of the consequences will defy rules and regulations to justify their existence or to prove they can do it…” (Damschroder et al. 2007: 231)
In other instances these concerns related to data being sold or passed on to third partiesFootnote 48 and used for commercial purposes, e.g.:
“What I don’t like is any information being passed on to a third party, for promotion purposes. Say you’ve got a particular problem then it goes to a drugs supplier or something like that, that I would object to.” (Participant 4, group 1, Hill et al. 2013: 6)
There was also concern about data being used for political purposes,Footnote 49 e.g.:
“If the Government are using the details for the benefit of society, I think that’s okay. But if the Government are using that data to then look at their next election campaign, or look at the independence campaign by looking at the demographics of a particular area, then I don’t know if that’s as acceptable. They’[d] simply be using our data for their own goals” (Female, aged 18–34, Glasgow, Davidson et al. 2013).
Some participants in the studies expressed concerns about potential future uses of data.Footnote 50 While current uses or research objectives may be regarded as acceptable participants expressed scepticism that such uses would remain clearly defined and limited. Some study participants were worried about potential “slippery slopes” with more and more information becoming accessibleFootnote 51 or with data being used for purposes other than those which were originally described.Footnote 52
There were also concerns about the proliferation of data within modern societies and increasing surveillance through data collection. For some these concerns were expressed in relation to the creation of a “Big Brother Society”,Footnote 53 e.g.:
“You can’t move. You can’t do anything without somebody, somewhere knowing exactly what you’re up to” (Female, depth interview, MRC & Ipsos-MORI 2007: 25)
A significant area of concern related to the potential outcomes or implications of research. In particular, study participants were concerned about the potential for stigma or discriminatory treatment to result from research which would label or categorise groups within society,Footnote 54 e.g.:
“I think research maybe tends to lump everybody together, and there must be individuals that would be totally different […] so it could lump everybody together and maybe that’s not what we want.” (Tayside—Female4, Aitken 2011: 12)
“Some universities might feel: ‘we don’t want to involve people from areas of deprivation, because we know they are less likely to finish their course and that’s bad for us, for our figures’” (Male, oldest age group, Edinburgh) (Davidson et al. 2013: 70)
There were also concerns relating to potential indirect negative impacts on individuals from participating in research.Footnote 55 For example, a frequent concern related to potential for insurance premiums to increase or be denied as a result of information being accessible from medical records. Additionally there was concern that employers may gain access to information which could be used to the detriment of individual employees. Participants were concerned that data which was shared could be accessed and used in ways which could be harmful for individuals, e.g.:
“Money’s money but health is how you feel as well and if you’re being persecuted in a way because of that, it’s just going to make you worse” (Female, depth interview, MRC & Ipsos-MORI 2007: 29).
“People can judge them, so if they find out something about you because of your health you could be picked on” (Female, depth interview, MRC & Ipsos-MORI 2007: 29).
Such concerns were particularly salient in relation to more sensitive forms of data. Across the studies it was reported that participants differentiated between types of data and regarded some as more sensitive—and concerning—than others.Footnote 56 Examples of particularly sensitive forms of data include data relating to mental health, sexual health, sexuality and religion.
Private Sector Involvement
Across the studies there was significant concern about private sector involvement in research using individuals’ data.Footnote 57 Such concerns largely related to two key factors: low levels of public trust in the private sectorFootnote 58 and a perception that private sector organisations are primarily—or solely—motivated by profit.Footnote 59 Across the studies participants often made distinctions between research which was perceived to be “for profit” and research perceived to be “for the greater good”.Footnote 60 Similarly, distinctions were made between “research purposes” and “commercial gain”Footnote 61 as if they were opposing motivations. As noted above, the creation of public benefits from research was widely regarded as an essential prerequisite for public support or acceptance. Therefore, where participants regarded research to be conducted for purposes other than creating public benefits this raised concerns.
However, such concerns did not necessarily mean outright opposition to private sector involvement in research. Profit-creation resulting from research was regarded as acceptable under certain conditions. Notably, the included studies indicated that participants wanted assurances that public benefits would be prioritised over profit,Footnote 62 that individuals’ privacy would be prioritised over profitFootnote 63 and that profits would be shared or reinvested so as to create public/societal benefits.Footnote 64 Additionally, while there were concerns about individuals’ data being sold, studies which explored private sector access of public sector data found that participants often felt it was appropriate that private sector organisations pay for access to these dataFootnote 65 and that this would be regarded as acceptable on the condition that revenue generated is appropriately re-invested in the public sector.Footnote 66
While there was widespread concern about private sector involvement in research this was often balanced by a recognition that private sector involvement in research can be important or valuable.Footnote 67 In some cases private sector involvement was represented as a “necessary evil”,Footnote 68 e.g.:
“… the drug companies are just trying to make money, and yes of course they are, it’s all about money in the end of the day but if they don’t find the research for some of these the less interesting or less topical things then they, there will not be research into those things…we need to get funding from drug companies anyway, if they’re the ones with the money.” (Female, patient focus group 3, PPG, Grant et al. 2013: 8).
Thus profit-creation was regarded by some study participants to act as an incentive for private sector organisations to conduct valuable research in the public interest.
Overall, the included studies demonstrate that members of the public hold nuanced and complex views regarding private sector involvement. It is noteworthy that the private sector was not regarded as a homogenous entity, but rather distinctions were made between private sector organisations.Footnote 69 There was also acknowledgement of the different roles that private sector organisations can play in research. For example it was reported in one study that private sector involvement was acceptable as long as commercial actors did not have access to data.Footnote 70 Other studies reported concerns about private sector organisations as funders of research and the implications this may have for the integrity or objectivity of the research.Footnote 71
Whilst low trust in private sector actors is frequently reported, the included studies also demonstrate complex or ambivalent relationships of trust in actors from other sectors. For example, several studies identified ambivalent views on government researchFootnote 72 and concern about government access to data.Footnote 73 Additionally, whilst some studies reported high levels of trust in universities and academic researchersFootnote 74 one reported a lack of trust in university researchers.Footnote 75 Thus relationships of trust are not straightforward and there does not appear to be a clear, or static hierarchy of trusted organisations/sectors.
Trust and Transparency
Trust is a key theme running through all of the included studies (both implicitly and explicitly). A number of studies indicated that the level of trust individuals place in research organisations, oversight bodies or government, informs their level of support for research uses of data.Footnote 76 The included studies indicate that trust is essential for ensuring public acceptance and/or participation in research.Footnote 77
As noted above, relationships of trust are nuanced and complex. However the included studies indicate generally higher levels of trust in the public sector compared with the private sector, largely related to greater confidence in accountability and data protection mechanisms within the public sector.Footnote 78 There is also evidence of particularly high levels of public trust in primary healthcare providers.Footnote 79 This reflects a trend of higher levels of trust in known or familiar individuals or organisations,Footnote 80 which was exemplified in study participants’ confidence in particular healthcare professionals to make good judgements on access to patients’ data:
“I know my physician well enough to have a good feel for the types of things he would be involved with” (Patient 12, Nair et al. 2004: 25).
“If you trust the doctor, I don’t think it would worry me how much [data] you needed, and I do trust the doctor” (Patient 15, Nair et al. 2004: 25).
It also leads to individuals preferring to be contacted only by healthcare professionals, or known individuals:
“I am happy to have personal contact with our hospital, GP or the health professionals who knows me, but I am not happy being contacted by a Pfizer company, or whatever” (MRC & Ipsos-MORI 2007: 19).
Participants in the included studies often expressed a preference that data-sharing and research uses of data be overseen within, and governed by, the public sector.Footnote 81 In some instances there was a preference for such processes to be overseen and controlled by healthcare professionals (e.g. known/familiar individuals).Footnote 82 However, some study participants acknowledged that this may be overly burdensome and take valuable time and resources away from the provision of healthcare.Footnote 83
The importance of relationships and familiarity to trust is indicative of a broader desire for greater transparency about research practices. The included studies overwhelmingly suggest an appetite among study participants for more information about current research practices and uses of data.Footnote 84 Transparency about how data is used in research is considered crucial for building public trust, and thereby securing public support.Footnote 85 Moreover, many of the included studies point towards the importance of awareness raising for building trust and public support.Footnote 86
However, the included studies highlight that the public should not be conceived of as simply subjects of information provision relating to research uses of data. Rather, several studies indicate public interest and enthusiasm for more meaningful forms of public engagement/involvement.Footnote 87 Such involvement was considered essential for ensuring accountability.Footnote 88
Differences between studies
It is not possible to make clear or consistent comparisons between the findings of the included studies due to different social and cultural contexts. For example, in a Japanese studyFootnote 89 participants were reported to describe “unequal relationships” between patients and doctors with patients belonging to a “lower rank”. This may reflect (actual or perceived) traditional doctor-patient relations in Japan that are more hierarchical and paternalistic [20]. However, discussions of unequal relationships in other studies were not explicitly reported though some study participants may have implicitly referred to them. Diverse study populations also limit the findings from being comparable. These smaller populations include U.S. veterans reporting higher levels of trust and greater support for research by Veteran AffairsFootnote 90; African Americans expressing lower willingness to engage in genetic/genomic research due to past abusesFootnote 91; and LGBT participants in the U.K. concerned for the misuse of data, particularly identifiable data, that could lead to discriminating opinions and behaviour.Footnote 92 These findings build on previous research reporting concerns over the underrepresentation of minority populations in research, such as African Americans [21–23] and LGBTs [24]. While these views may not be comparable to other contexts, they are indeed essential to understanding the needs of different social groups to better inform a wide variety of policies and practices. Despite variations in opinion, the overall views of these study populations were consistent with the general findings of the thematic synthesis.
A further limitation to the review was the underrepresentation of young people across the studies. Of the few studies that compared all age groups, the variations in opinion were detailed. Two studies reported that younger participants expressed greater concerns for privacy and a desire for control over research data.Footnote 93 Another noted that some felt “anxious” about their data being held while others believed they had little control over their own information.Footnote 94 In contrast, older participants were reported to favour less individual controlFootnote 95 or to be less worried about the possible loss of confidentiality.Footnote 96 Previous research by Buckley et al. [25] equally commented on the lack of participation of younger people in their study. The few that responded, were more cautious about the use of their medical information compared to older participants. However, the researchers were wary of these results due to the unrepresentativeness of the sample. Additionally, there are some contradictory findings, for example, King et al. [26] found that younger participants and older respondents over the age of 60 were less concerned about the privacy of their health information compared to participants in the mid age range. King et al. [26] suggested this may be due to the “carefree” nature of younger generations who were perceived to be more willing to share their personal information (e.g. on social-networking sites) and older respondents who are no longer invested in their career and therefore under less scrutiny. More recently the Wellcome Trust [3] found a non-linear relationship between acceptance of commercial access to health data and age and noted that young people are not automatically more supportive/accepting. These varying and, at times, conflicting findings point to the need for greater research to explore the variations in perceptions and opinions across age groups.
Finally, the authors conducted a broad search of public responses to data sharing and data linkage in research that included studies looking at genetic dataFootnote 97 and medical-records data.Footnote 98 These topics were considered together with other papers discussing health, personal or administrative data or information for statistical, health, social or other research purposes. Some studies suggest genetic data is particularly sensitiveFootnote 99 or personal/potentially identifying.Footnote 100 In one study, participants perceived genetic data to be potentially less sensitive than information from medical records (e.g. information relating to reproductive or mental health).Footnote 101 Participants’ from another study reported no real variation in attitudes toward the use of medical records and biological samples.Footnote 102 In some studies, linking medical records data to biological samples raises concerns.Footnote 103 However, overall opinions were largely consistent with the key themes of this review.