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  1. The Challenges of Vulnerability
  2. Stop Trying to Be “Vulnerable.” Do This Instead.
  3. Water scarcity
  4. How showing vulnerability helps build a stronger team |

This paper explores the different dimensions of consumer vulnerability and considers what the CMA can do to help. These discussions have been lively and impassioned and have contributed greatly to improving our understanding. We are grateful to all those who have taken part. And we need to take particular account of this experience in designing remedies, so that when we intervene in a market, we do so in a way that will can benefit everyone. At the end of last year, the CMA published our response to the loyalty penalty super-complaint.

The topics of consumer vulnerability and exploitation of loyal customers are closely linked, and speak to wider public concerns about the role of markets and the balance between competition and regulation. There has been a widespread erosion of trust in markets, and the CMA and other regulators can and should be playing an important role in arresting and reversing that loss of trust. We recognise, however, that we need to do more.

In particular, we need to improve our understanding of the different dimensions of consumer vulnerability across markets and to ensure that we are in a better position to help those members of our society who are at greatest risk of suffering from poor market outcomes. To help achieve these aims, in we established a programme of work on vulnerable consumers. This has comprised of wide-ranging engagement with different groups , analysis and externally-commissioned research, providing a rich insight into the different forms that consumer vulnerability can take and what can be done to help.

We considered the experience of vulnerable consumers throughout our response and set out a package of cross-cutting reforms and market-specific recommendations to tackle the loyalty penalty, including consideration of additional protections for vulnerable consumers.

This paper sets out some of the lessons that we have learned from our vulnerable consumers programme of work. It is structured as follows:. In this paper we use the term consumer vulnerability in a broad sense, to refer to any situation in which an individual may be unable to engage effectively in a market and as a result, is at a particularly high risk of getting a poor deal. Such vulnerability may arise for a variety of reasons. Many of us can be vulnerable in certain market contexts, such as when we have to choose between complex alternatives or make decisions on the basis of imperfect information.

Some of us may experience vulnerability during difficult periods of our lives, such as when we go through a bereavement, a divorce or a period of ill health. Vulnerability can also derive from more enduring personal circumstances, such as a long term physical disability. Consumer vulnerability is not, therefore, a binary concept: it is multidimensional and often highly context-specific. There has been comparatively little focus on vulnerability associated with personal characteristics, or the challenges faced by certain groups of vulnerable consumers across different markets.

We expand upon these two definitions below, giving some examples from recent CMA work. There are certain market contexts in which all of us can experience a degree of vulnerability - for example, when we need to make a purchase at a stressful time. Vulnerability can also arise if assessing the value of a product involves complex estimations of risk or probability as is the case with many financial services products or if we are required to make a choice when we do not fully understand the options available to us. Our market study into care homes, for example, showed to what extent an emotionally stressful situation such as choosing care arrangements for a loved one, can inhibit our ability and willingness to exercise consumer choice.

This is also a key issue we are looking at in our ongoing market study into funeral services , as explained in Box 1. The death of a loved one is one of the most difficult events that any of us will face in our lives and it falls upon those who are most affected by the loss to organise the funeral. People are often poorly prepared, grieving, emotional and under pressure to arrange a funeral quickly.

In addition, we purchase a funeral relatively infrequently, and therefore have little knowledge of what is required or what options are open to us. In our research, a large group of respondents reported emotional distress as one of the factors for not shopping around. When probed about reasons for not considering different funeral directors, many explained that they had been struggling to handle their grief and deal with practical arrangements at the same time. Our research shows that people who organise a funeral do not use some of the most basic ways of seeking value for money eg getting more than one quote that consumers typically display in other circumstances.

Behavioural economics seeks to categorise some of the ways in which consumer vulnerabilities can manifest themselves in specific market contexts. A leading practitioner in this field, Nobel Laureate Professor Richard Thaler, addressed us on this topic at our symposium on vulnerable consumers. More recently, we investigated this practice of charging higher prices to longstanding customers - sometimes called the loyalty penalty - in response to a super-complaint, as explained in Box 2.

Our investigation found that in markets which are subscription-based, or have auto-renewal or roll over contracts, longstanding customers can end up paying more than other customers a loyalty penalty. We identified two main reasons for this. First, some people are less likely or able to negotiate or switch provider to get a better deal. Second, businesses are able to charge higher prices to such customers and choose to do so. Loyalty penalty pricing might also arise in other auto-renewal, roll over or subscription-based markets, such as other insurance markets, pay-TV, credit checking services, or software.

While digital markets can create opportunities for helping consumers overcome vulnerability, business practices in digital markets can also exacerbate existing vulnerabilities and create new forms of vulnerability. We jointly hosted a roundtable on vulnerability in digital markets with Citizens Advice to explore some of these issues. We have taken action where we have found evidence of business practices that seek to exploit consumer vulnerability in digital markets.

Last year we took enforcement action against online gambling firms which were making it difficult for customers to access their winnings, which made it harder for customers to stop gambling. We secured undertakings from six firms to commit to stop these unfair practices. We also recently took action against a number of online travel agents, following concerns about practices including: pressure selling; misleading discount claims; the effect that commission has on how hotels are ordered on sites; and hidden charges.

As a result, these businesses have voluntarily agreed to make changes to their practices to address these concerns. To date, the CMA has placed less emphasis on understanding to what extent groups of consumers with certain characteristics face enduring problems across markets. If individuals with mental health problems, or on low incomes, for example, face a consistent set of problems across markets, this has potentially important implications for the best way to intervene to help such consumers.

Our programme of work on vulnerable consumers was created in part to fill this gap, and this is the main focus of the rest of this paper. In our discussions with different organisations and our commissioned qualitative research 9 , we have focussed on four characteristics associated with consumer vulnerability: mental health problems; physical disabilities; age; and low income.

These were chosen on the basis that our own experience and previous research suggests that consumers with these characteristics may face additional, specific challenges in engaging across a range of markets. That is not to say that all individuals with such characteristics are necessarily vulnerable.

Publicly available statistics suggest that there are significant numbers of people with at least one of these four characteristics:. What these official statistics do not tell us, however, is the extent to which these characteristics overlap in the population and how many individuals have one or more of these characteristics.

To explore this question, we analysed data in our survey of 7, domestic energy customers in Great Britain, conducted as part of our energy market investigation. In developing our views on the challenges faced by vulnerable consumers, we have drawn on a number of roundtables that we have held jointly with a range of organisations representing different groups of people. With the Joseph Rowntree Foundation we organised a session on the challenges facing people on low incomes, and with the Money and Mental Health Policy Institute MMHPI , we discussed the issues faced by people suffering from mental health problems.

These were followed by sessions with Age UK on elderly consumers and with Scope on consumers with physical disabilities. We also visited the devolved nations to understand specific issues facing vulnerable consumers in Scotland, Wales and Northern Ireland. Finally, we held a symposium that brought together insights from a wide spectrum of contributors on the challenges facing vulnerable consumers and the potential solutions to these challenges.

All of these sessions have been well attended, they have invariably led to lively debate and we have found them invaluable in developing our thinking. This research has provided us with rich and detailed insights into the experiences of vulnerable consumers in engaging with markets, and we refer to our findings throughout this paper.

Consumers with poor mental health can struggle to engage with markets for a number of reasons. Around a third of participants in our commissioned research had mental health problems in addition to being on a low income. We draw on their experiences here, as well as our roundtable discussion with MMHPI and other research. In order to understand the challenges that consumers with mental health problems face when engaging with markets, it is important to consider the nature of their condition and how it may affect their ability to participate.

There is a wide range of mental health conditions, from depression to affective psychosis to schizophrenia and many in-between. Some participants in our qualitative research self-identified as having mental health problems including anxiety, depression, post-traumatic stress disorder and personality disorder. A key overarching point that was raised in the roundtable discussion regards the often transient nature of mental health. People can go through periods of good and poor mental health, for varying lengths of time. When they are experiencing good mental health, they may be able to cope with certain tasks and activities that become extremely difficult for the same individual when experiencing poor mental health.

This means that during bouts of poor mental health, individuals can struggle to pay bills on time, or go through periods of disengagement from their supplier.

The Challenges of Vulnerability

This theme also came out of our research. In our roundtable discussion and qualitative research we identified a number of reasons why people with mental health problems may be more likely to have difficulty engaging with markets. An important insight is that the specific mental health problem an individual has, can be fundamental to understanding the difficulty they face in engaging with markets. This is reflected in the examples set out below. Many people suffering from poor mental health have difficulties with certain types of communication. This can mean that they are unable to engage with suppliers through the channels available to them, for example to ask a question about their billing or account services.

The nature of the difficulty can vary by mental health condition - people with anxiety may avoid interactions or communication with others as a coping mechanism, to prevent themselves getting overwhelmed, which may be easier to do with letters or emails, whereas people who suffer from paranoia or delusion may struggle to communicate by phone because, for example, they may think their phone line has been bugged. Participants in our qualitative research with mental health problems often described having low levels of confidence in engaging with others, which was reflected in the difficulties they faced when communicating with suppliers.

I just want to shut everything out and be alone in my room. Our qualitative research found that participants with mental health problems were likely to fall into the segment of participants who stayed with their provider and did not switch, shop around or negotiate. This group were often aware that they could be overpaying for services and aware that switching and negotiating are possible but were not taking action because they felt that it would be too overwhelming and difficult. Understanding which individuals exhibit these sorts of characteristics can be relevant to remedy design, as we discuss later.

Other research has found that consumers with mental health problems such as stress, anxiety and depression, may avoid switching suppliers or services because they require stability and routine to help maintain their mental wellbeing. For such individuals, change can be highly disruptive. This can affect their ability to manage their supplier or service accounts if there are changes in for example, what these look like or how they operate, or to deal with any unanticipated problems in their service provision. Compulsive behaviour and addiction can make it difficult for consumers to engage safely and effectively in a market.

The investigation found that in promotions, consumers are often prevented from accessing winnings from their deposit funds until they meet wagering requirements. The requirement for consumers to commit to an extended period of gambling before winnings can be withdrawn, and preventing them from stopping gambling whenever they choose, was considered a particular risk to consumers vulnerable to problem gambling.

This in turn can cause problems down the line, such as a reliance on high-cost credit, and indebtedness. While many participants in our qualitative research reported finding the credit market problematic, this was particularly the case for participants with mental health problems. For example, an individual with memory impairment from conditions like ADHD, bipolar disorder or obsessive compulsive disorder, may struggle to track their spending and to budget their finances. Someone with depression or borderline personality disorder can experience attention problems, preventing them from being able to concentrate for the time needed to pay or check a bill.

People with mental health problems may therefore need additional help or support to engage with markets. However, our discussions and qualitative research identified a key challenge in providing such support, which is that those who do engage with suppliers often do not disclose their condition.

This can be due to a fear of stigmatisation that they will be treated differently or offered poor value deals, uncertainty about how the information might be used, or because they do not think it will make a difference to their experience. In addition, a few participants in our research felt that there was no suitable time or point in their engagement with suppliers to disclose their mental health problem.

If suppliers are not aware that a customer has mental health problems, they cannot provide the additional support customers may need. Our research found that in a few cases, participants had disclosed their vulnerability to suppliers and received no offer for additional help or consideration.

These types of challenges can mean that consumers with poor mental health are at an increased risk of experiencing poor outcomes in markets. They are less likely to get a good deal from a supplier, for example through switching or shopping around, because of the challenges they experience in these forms of engagement. This can mean they may be paying more than they need to for services. Consumers with mental health problems can also feel the consequences of experiencing poor outcomes in markets more acutely.

For example, they are more likely to experience financial harm. One in four people experiencing a mental health problem is also in problem debt, and people with mental health problems are three times more likely to be in financial difficulty and more than twice as likely to be behind with some or all of their bills. The UK population is ageing, with the number of people over 85 predicted to double to 3.

The CMA, its predecessor bodies and regulators have been active across a range of markets to tackle challenges and deliver better outcomes for older customers. Key markets for older people include regulated services such as energy, financial services, telecoms and water and a range of services relevant to later life such as care homes, assistive products, funerals and retirement income products. Our roundtable on vulnerability in later life with Age UK and our qualitative research provided insight on the range of challenges facing older consumers when engaging with markets.

It highlighted the need for caution in using age as an indicator of vulnerability, since being older does not necessarily make you vulnerable. Older people face the same challenges as consumers of all ages, although there are conditions associated with ageing that may lead to some older people becoming more vulnerable. Older people can become vulnerable due to the interaction of personal characteristics, situational circumstances and environmental factors which include business and market interactions.

Some older people will face challenges when navigating markets due to personal characteristics arising from multiple health conditions, sensory impairment, disability and cognitive impairment. Digital exclusion and limited digital capabilities are also factors in vulnerability and can constrain the ability of older people to engage in modern markets. Recent research into cognitive ageing has highlighted the complex nature of the ageing process and how this can affect the ability of older people to make decisions. Normal cognitive ageing entails older people often having greater knowledge but being slower at processing information.

However, a subset of individuals will experience greater degrees of age-related decline and severe forms of cognitive impairment such as dementia. In , an estimated , people were living with dementia in the UK, with the vast majority being older people. People with dementia are likely to be particularly vulnerable and at risk when navigating markets.

The condition will affect a large and growing part of the population in future, with the number of people with dementia forecast to increase to over one million by While technology has the potential to alleviate some challenges, digital developments can also create new barriers for older people. First there is the problem of digital exclusion: a higher proportion of older people either do not have access to the internet or do not feel confident using it.

For those who do have access to the internet, our roundtable highlighted that some older people may have limited capabilities when online and are less likely to keep software up to date, with implications including missing out on services, security risks and possible product obsolescence. There are likely to be particular risks associated with groups experiencing more severely impaired judgement going online.

In particular, security protections for online and telephone services may make it difficult to engage and there is also potential for older people to be more vulnerable to mistakes. Digital innovations may also be used in more negative ways to target older consumers, whose lack of confidence online may mean they are more susceptible to fraud and scams. For example, those aged 65 and over are least likely to check if an internet site is secure before giving their bank or credit card details as well as being less likely to use the internet overall.

Some older participants in our qualitative research perceived that older people were more likely to be taken advantage of, while for others, the threat of being scammed itself acted as a deterrent to going online. People take advantage of old age people … I think probably they think they are too vulnerable, maybe, to understand, or they cannot do much.

That is the reason. Age-related vulnerability is often linked to particularly stressful life events. We found that once in a care home, it is often difficult for older people to move, complain and obtain redress — with people being vulnerable to unfair consumer law practices. We recommended that industry provide better information - for example on costs, that government and local authorities improve support for people seeking care, and that regulators play a greater role in protecting older people from unfair contracts.

Line rental prices were found to have risen significantly between and , despite wholesale costs falling. In some markets it may have never occurred to older people to switch supplier for a better price or deal, particularly if they are comfortable in using a former monopoly supplier or do not think there is an issue or need to switch. Some older participants in our qualitative research noted that they had no desire to change supplier. There are challenges in defining and measuring disability, given the overlapping nature of some disabilities and the potential for certain conditions to fluctuate over time and affect people differently at different times.

Twenty-two per cent around 14 million of people in the UK report having some form of disability — defined as a longstanding illness, disability or impairment which causes substantial difficulty with day to day activities. The prevalence of disability rises with age. Commonly-reported impairments are those that affect mobility. It highlighted that users of mobility aids may be more likely to be vulnerable when making purchasing decisions, due to their limited mobility and age-related conditions.

In addition, the OFT found that complaints about unfair sales practices in the sector were high — particularly for doorstep sales. The OFT subsequently also used its competition powers to investigate concerns in the sector — taking action against two mobility scooter manufacturers for entering into arrangements with retailers that breached competition law.

Our roundtable considered the challenges experienced by disabled people across many aspects of their lives. Scope told us about the challenges faced by physically disabled people when accessing essential goods and services, which include extra costs due to their impairment or condition. After housing costs, Scope estimated that disabled people on average spend almost half of their remaining income on disability-related costs.

This is an example of how one aspect of vulnerability eg physical disability can lead to others, such as stress and money worries. Depending on the source of physical disability, people may find it harder to access the best deals, or to find out about them. If a physical disability affects cognitive capability for instance, through being tired or in pain then people might find it harder to assess alternatives.

Physical constraints may also make it harder to act on decisions. Not having access to the internet will further reduce the ability of these people to access assess and act to secure good deals. We also heard about the experience of a parent caring for their child with multiple disabilities. In particular, we heard about how extra costs can be experienced across a range of every day goods and services — from costs associated with regular hospital appointments, financial challenges incurred from the regular purchase of bespoke wheelchair equipment to difficulties of accessing common gateway products, such as insurance for holiday travel.

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Day to day priority caring activities also take time and energy, as well as placing a strain on finances. The challenges of caring for children with multiple disabilities were illustrated by one participant in our qualitative research who was disabled. The question of whether consumer on low incomes secure poor market outcomes has attracted a high level of political and public attention.

However, of the four dimensions of consumer vulnerability that we have considered in our research, this relationship is perhaps the most complex to understand. Part of the challenge lies in the fact that it is not always clear whether low income consumers are likely to secure better or worse outcomes than higher income consumers in specific markets. On the one hand, consumers on low incomes stand to gain proportionally more from engagement in a market, relative to their income, than other consumers. If an individual is living hand-to-mouth, the ability to save a few hundred pounds a year from switching supplier can make a huge difference to their lives — much more so than for someone who is comfortably off.

Consumers on low incomes therefore have a greater incentive to engage, which might encourage them to seek better market outcomes than people on higher incomes. For example, participants were able to recite the exact amounts of their bills and when these were due to be paid. In contrast, the control group of higher earners were far less likely to be able to recount financial outgoings in as much detail.

However, as discussed at the roundtable on low income consumers that we co-hosted with the Joseph Rowntree Foundation, and explored further in our qualitative research, there are a range of factors that push in the other direction, suggesting that low income consumers can face additional barriers to engagement and hence may secure worse outcomes in some markets.

Key among the factors that may inhibit engagement among consumers on low incomes are: constrained finances and higher risk of indebtedness; limited access to enabling products; and correlation with other dimensions of vulnerability. Being on a low income often leads to constrained finances, which are likely to make consumers less willing to take risks because they have fewer or no savings to meet an unexpected cost.

This focus on getting by from day to day may in turn lead such individuals to prioritise cash flow control and flexibility of expenditure over the total longer term costs of a product or service. This is illustrated by a preference among a number of participants in our research to use pay-as-you-go services rather than long fixed term contracts. Constrained finances may also lead some low income consumers to seek to defer expenditure even if this implies paying more over the long term eg by purchasing a good through a hire purchase scheme.

You have to take each day as it comes. You focus on your bills. For some of the consumers on low incomes in our research, the aversion to risks arising from constrained finances sometimes meant that they were unwilling to switch for fear that something would go wrong or that contractual arrangements would result in them being penalised. Not a clue. Low income consumers are also at a higher risk of indebtedness, which can reduce the options available to them to get better deals. This is illustrated very starkly in the case of prepayment meters, onto which energy consumers are moved if they have an outstanding debt.

A number of participants in our qualitative research described similar experiences. That was the only way I could do it. High levels of debt can also reduce creditworthiness, reducing the options for, and increasing the cost of, debt — as shown in the CC market investigation into payday lending. The challenges posed by a lack of options were also highlighted by participants in our qualitative research.

You use your demons like X doorstep lender, and you know, all your doorstop knockers who give you money. Consumers on low incomes are also less likely to have access to important enabling products, such as the internet, a car or a bank account, which can be essential for obtaining the best deals in many markets.

Our qualitative research highlighted how this challenge area could be reinforced or made worse by the presence of other vulnerabilities, such as having a physical disability. These include the other factors discussed in this paper - poor mental health, physical disability and old age — and many others, including low levels of education, digital exclusion or being time poor, among others.

We analysed data from our survey of 7, energy customers undertaken for our energy market investigation to assess the extent of this relationship, as shown in Table 1. The results are striking: low income individuals are substantially more likely than people on higher incomes to exhibit each of the above dimensions of vulnerability.

In particular, they are five times more likely to have a disability and more than six times more likely to have no qualifications. This suggests that these other dimensions of vulnerability are likely to be highly significant factors in shaping the experience of low income consumers in engaging with markets, and that low income consumers who do not have these characteristics may not be vulnerable to the same extent. For example, for participants with physical disabilities, reliability and consistency of service was often important where they were dependent on the service as a result of their disability.

Low income consumers with physical conditions were therefore particularly unwilling to tolerate any uncertainty or disruption in certain markets, such as energy.

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As a result, they were unlikely to want to switch suppliers, even if this could get them a better deal. For participants on low incomes with mental health problems, barriers to engagement with suppliers were often related to difficulties with communication. Having mental health problems also led participants to feel overwhelmed at the thought of managing their finances or engaging with a supplier, which often meant they avoided doing so.

Further, where being on a low income is correlated with other dimensions of vulnerability, specifying the precise nature of the causal relationship between them can sometimes be challenging — as MMHPI has highlighted regarding the relationship between low income and poor mental health. We also found evidence of this in our qualitative research. Researcher: What about your mental health though? Is it more the low income or is it your mental health on top of that I suppose? The patterns of vulnerability affecting low income consumers are, therefore, complex, and sometimes pull in different directions.

Degrees of vulnerability differ quite markedly both between low income consumers and across different markets. This is borne out in our research, which found that consumers on low incomes generally felt more confident engaging with the grocery market compared to the other markets explored telecoms, energy, credit, insurance.

As set out in the previous section, there is a range of evidence to suggest that certain groups of consumers can experience significant challenges when engaging with markets and, as a result, are likely to be at a higher risk of getting a poor deal. In this section, we review the available evidence on the outcomes that vulnerable consumers achieve in markets. In our energy market investigation, we found strong evidence that vulnerable consumers were less likely to have switched energy provider than other consumers. Figure 1: Proportion of supplier switching in the last three years by demographic and household characteristics.

We also considered engagement and switching among vulnerable consumers as part of our response to the Citizens Advice super-complaint.

Stop Trying to Be “Vulnerable.” Do This Instead.

Drawing on the existing evidence base, we looked at whether particular groups of consumers were more likely to pay a loyalty penalty in the five markets we investigated mobile, broadband, cash savings, home insurance and mortgages. As a result, they may be more likely to pay a loyalty penalty. Evidence from other sources broadly supports these findings. As we set out in our super-complaint response, they therefore may be at risk of paying a loyalty penalty:. Evidence on switching for other groups of vulnerable consumers - such as those on low incomes - is not currently available.

Ofcom is currently conducting further work to understand whether or not potentially vulnerable consumers including those who are elderly pay higher prices than other consumers, and to explore the link between price paid and length of time spent with a provider. This should help to address some of the evidence gaps. Overall, while there are gaps in the evidence base, particularly in relation to mental health, the available evidence suggests that vulnerable consumers are less likely to engage and switch than other consumers across a range of regulated or essential services markets such as energy and financial services.

As a result, they are more at risk of paying a loyalty penalty in these markets. There is less evidence available on the extent to which vulnerable consumers pay higher prices than other consumers. In , the University of Bristol identified six areas where the poverty premium arises : household fuel, telecoms, insurance, grocery shopping, access to money and use of higher-cost credit see also Davies, Finney and Hartfree, Paying to be poor, In others, concerns or obligations related to vulnerability are themselves characterised as fundamental principles. The CIOMS guidelines are a unique case in our sample because they characterise vulnerability as both a principle and as a consideration derived from other principles.

In these cases, concerns relating to vulnerable persons seem to serve the role of consideration for ethics review or ethical research with no explicit ethical status. All guidelines and policies in the sample provide means through which vulnerability can be identified. The majority identify subject groups who are likely to be vulnerable.

Notably, while the EU Clinical Trials Directive and Clinical Trials Regulation, as well as the United Kingdom Research Governance Framework, all identify vulnerable subject groups, none of these policies provide any supporting explanation. Vulnerable groups identified in our sample, as well as explanations for this designation, where available. Given that this is mentioned but not negated, we included these groups in our table. It is unclear whether certain groups were intended to be linked to certain explanations, so all have been included.

The table is grouped by category, and organized by the number of times a group is mentioned in the policies and guidelines. Across the sample, a great number of groups are identified as vulnerable. Counting only those broad groups identified in our table i. Groups most frequently identified are children, minors or young people discussed in seven policies , prisoners discussed in five policies , as well as persons with mental health issues, patients in emergency settings, and certain ethnocultural, racial or ethnic minority groups each discussed in four policies.

The Australian National Statement similarly positions the vulnerability of young people relative to capacity and consent, though it is unclear how this policy conceives of the relationship between these concepts. There is little overlap between the explanations provided by policies and guidelines for other frequently-identified vulnerable groups, and there was a lack of explanation from at least two of them for prisoners, patients in emergency settings, and ethnocultural and racial minorities. For over half of the groups identified across our sample, an explanation of their vulnerability was unclear or lacking entirely.

Water scarcity

The EU Clinical Trials Directive and Clinical Trials Regulation and United Kingdom Research Governance Framework provide no explanation or justification for any of the groups they designate as vulnerable, and while the Common Rule specifies that it is concerned with vulnerability to coercion or undue influence, it does not address 'handicapped persons' in this explanation despite also identifying them as a vulnerable subject group. However, both of these policies include categories of 'other vulnerable groups' and fail to provide any connection between these other groups and their overarching definition of vulnerability.

As such, it is unclear whether they are designated as vulnerable on some other unstated grounds. Some policies and guidelines identify sources or circumstances of vulnerability independently, i. All policies in our sample identify practical implications of vulnerability in research, i.

A majority of policies and guidelines identify implications relating to restrictions for research with vulnerable groups or individuals, but these entail both negative and positive duties. Overall, these policies and guidelines propose that the involvement of vulnerable groups in research ought to be restricted to some extent; vulnerable persons ought to be involved only when the research cannot be carried out with persons who are less vulnerable and special justification is required for their involvement.

Across our sample, a common underlying assumption seems to be that vulnerable groups can and should be involved in research, but that additional measures are required to ensure this involvement occurs in an ethical manner. In fact, several policies CIOMS, EU Clinical Trials Directive, Australian National Statement, and TCPS2 assert that vulnerable groups have a right to participate in research and access its benefits, and while the others do not identify such an entitlement, none go so far as to state that the outright exclusion of vulnerable groups from research best serves to protect them.

The implications of vulnerability all tend towards careful inclusion rather than outright exclusion of vulnerable groups from research. However, there is more variability regarding the extent to which these protections afford agency to vulnerable subjects. The majority specify considerations and actions for researchers and REBs, with few explicitly identifying the desires of these individuals as relevant in the application of these measures.

The TCPS2 in particular puts forth numerous measures intended to promote the agency of those in vulnerable circumstances. Furthermore, the TCPS2 guidance states more broadly that vulnerable groups may need or desire special measures to ensure their safety, suggesting a role for participants in the design and implementation of their protections. In addition to conditions and restrictions for research involvement, the process of informed consent is a major area of focus in the policies and guidelines.

Here in particular there is an emphasis on the provision of meaningful support to enable vulnerable persons to offer a fully informed consent to research. Mechanisms of support include ensuring adequate time and an appropriate environment CIOMS , as well as ensuring that information is fully explained and understood United Kingdom Research Governance Framework.

Additionally, the Australian National Statement uniquely suggested that participants be given the option of using a participant advocate within the consent process. In this section, we present the results of our intra-policy analysis of vulnerability with a narrative about each policy statement, addressing 1 which major content areas are lacking, 2 whether the content areas are consistent i. It does not identify what these wrongs or harms might consist of and, because concern for vulnerability is presented as a fundamental principle, interpretation cannot be guided by other ethical principles.

Implications of vulnerability focus on the need for responsive research, special justification for involving vulnerable persons, and to-group benefits, suggesting these harms include the unfair distribution of the risks and benefits of research. These guidelines present an autonomy-based conceptualisation of vulnerability that is comprehensive in scope but lacks internal clarity in its discussion of vulnerable groups.

There is a lack of clarity and consistency, however, in the discussion of vulnerable groups. Its identification of personal, societal and environmental conditions as sources of vulnerability suggests a concept with wide-ranging concerns. Since concerns relating to vulnerability are presented as fundamental principles, their interpretation cannot be guided by other ethical principles. The Clinical Trials Directive conveys a primarily consent-based vulnerability, with children as the focus of its vulnerability-related regulations.

The implications it identifies focus on obtaining proxy consent and assent, but also on the need to avoid financial inducements for participation, suggesting a concern for a risk of exploitation.

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  • Other implications include a need to perform research with children in which group benefits will be obtained and ensuring the interests of the patient prevail over those of society. As such, in addition to concerns relating to consent, the Directive implicitly relates vulnerability to concerns with the distribution of the benefits and burdens of research.

    The Directive does not provide an ethics framework, so interpretation of this guidance cannot be guided by ethical principles. The Clinical Trials Regulation conveys a mixed concept of vulnerability, concerned both with issues of consent and increased health risks.

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    While vulnerability is not defined and no explanation for the vulnerability of listed groups is provided, they can be grouped by those assumed to face issues of consent in research people affected by mental health disorders, minors, and incapacitated subjects and those who may be at greater physical i. No ethical framework is provided in the Regulation to facilitate interpretation of this guidance.

    These guidelines present a consent-based concept of vulnerability that lacks internal clarity due to its broad scope of vulnerable groups. Vulnerable subjects are defined as those whose ability to provide voluntary consent may be compromised by social pressures, and the first category of groups listed is clearly linked to this definition. However, it is not clear how the wide range of 'other vulnerable groups' relates to this definition or which characteristics are thought to render them vulnerable. The guidelines do not provide an ethical framework to facilitate interpretation of the concept of vulnerability.

    The National Statement suggests a comprehensive conceptualisation of vulnerability relating to concerns about consent, fair involvement in research, and a balance of risks and benefits to participants. It favours a group-specific approach to vulnerability, where this concept is discussed largely in reference to specific groups.

    General statements about vulnerability suggest that it is an important factor when considering the appropriate method of consent. Interestingly, explanations of the vulnerability of identified groups the principles from which obligations to those groups stem do not always line up. In some cases, the relationship is clear; the vulnerability of young persons originates in their lack of ability to provide consent and is linked to respect for persons, and the vulnerability of neonates in intensive care originates in the risks of long-term harms and is linked to beneficence.

    Similarly, while persons with terminal illness are said to be vulnerable to unrealistic expectations of benefit i. The TCPS2 presents an autonomy-based conceptualisation of vulnerability that is comprehensive in scope. Importantly, vulnerability is said to be context-specific and dynamic, discouraging assumptions of vulnerability based on group membership. However, the policy still relies on the identification of groups likely to be vulnerable, as well as the identification of circumstances that can create vulnerability for a participant. While the definition of vulnerability itself is implicitly linked to the principle of autonomy, obligations towards participants in vulnerable circumstances are more comprehensive and are grounded in the principles of respect for persons, concern for welfare and justice.

    The framework conveys a consent-based conceptualisation of vulnerability that is narrow in scope, labelling adults who may have issues with understanding and decision-making as vulnerable. Consistent with this, the implications of vulnerability focus on providing participants with the necessary support in the informed consent process. Since no ethical framework or principles are discussed relative to vulnerability, these cannot be used to facilitate interpretation of the guidance. The Report conveys a consent-based conceptualisation of vulnerability that lacks clarity in the features of vulnerability it aims to target.

    Special considerations about vulnerable subjects are discussed in reference to respect for persons ordinary inducements may be come undue influences for vulnerable populations , beneficence special justification is required for research with vulnerable subjects and justice vulnerable subjects must be protected from over-recruitment to research.

    The Common Rule conveys a consent-based conceptualisation of vulnerability that lacks internal clarity regarding its scope. A number of groups are identified as vulnerable, including handicapped persons, but while the other groups are said to be vulnerable to coercion or undue influence, no explanation is provided for handicapped persons. Similarly, the implications of vulnerability include concern for equitable subject selection and the provision of additional safeguards, but handicapped persons are never associated with these protections.

    Without a definition of vulnerability, it is not clear what special vulnerability handicapped persons may be faced with in research. The objective of this analysis was to describe the concept of vulnerability in research ethics policies and guidelines, and to assess how it is conceptualised and operationalised. All policies and guidelines employed the concept of vulnerability but very few define it. Instead, vulnerability is most frequently discussed in terms of vulnerable groups, with some attention given to the sources of vulnerability, and the implications of conducting research with vulnerable participants.

    In many respects the policies come out, on the whole, as richer and more complex than some scholarly analyses of the concept of vulnerability suggest [ 6 , 28 , 29 ]. Responding to vulnerability requires caution and special consideration on the part of researchers and REBs but, ultimately, the implications identified in our study suggest that participant vulnerability need not signal a need for exclusion from research. Accordingly, even though there is some diversity and richness in policies, it tends to be scattered across multiple policies and relies on implicit assumptions about the definition and nature of vulnerability.

    Indeed, a significant analytic effort was required to bring structure to the data and yield the guidance captured in this paper. We further discuss how our findings relate to 1 previous critiques found in the scholarly literature and 2 the role of stakeholder engagement in the process of refining the concept of vulnerability in research ethics policies and guidance. First, concerns have been raised that the manner in which vulnerability is defined and operationalised in research ethics governance stereotypes and reinforces stigma about whole categories of individuals [ 9 , 12 , 31 ].

    Our results reinforce these concerns, as the reliance on listing groups of vulnerable persons is rampant. This labelling [ 6 ] or sub-population [ 30 ] approach does little to bring attention to the importance of context and of assessing the characteristics of individual research participants beyond their membership in a group [ 5 , 6 , 9 ]. This may result in inappropriate and ineffective protections being applied in some protocols.

    Group listings may also cause confusion due to the broadness of some labels e. Furthermore, it seems that the designation of some groups as vulnerable may be based on assumptions not supported by evidence e. Another major concern has been that vulnerability, as conceived of in the guidelines, focuses overwhelmingly on a lack of ability to consent [ 10 ], blinding researchers and REBs to other relevant types of vulnerability, relating, for example, to an increased risk of exploitation [ 32 ] or a lack of basic rights [ 33 ].

    While vulnerability is rarely defined, the majority of policies and guidelines convey implicitly that vulnerability is fundamentally an inability to provide free and informed consent. However, the implications of vulnerability often move beyond consent, addressing issues of fair subject selection and favourable risk benefit assessments. Though they recognise both individual and contextual sources of vulnerability, all policies and guidelines conveyed that vulnerability is a personal characteristic.

    In contrast, a growing body of scholarly literature converges around the notion that vulnerability is a relational feature, borne of power asymmetries between participants and research staff, investigators and institutions [ 10 , 31 , 34 ]. Adopting such a view in research ethics guidelines may better serve participants, encouraging measures that would empower and promote their agency in the research context [ 34 ]. Furthermore, the focus on research participants neglects how research environments e.

    Research ethics guidelines and policies typically stress the importance of vulnerability. However, it has been argued that vulnerability is not a substantive ethical concept in itself, serving only as a marker of other research ethics concerns already captured by existing concepts such as harm or consent [ 35 ]. This is certainly an important conceptual concern, but what may be of greater relevance in the realm of policy development is the degree to which the concept of vulnerability is a useful, effective tool for those designing, reviewing and conducting research [ 5 , 6 ].

    It may be the case that vulnerability merely serves to signal concerns relating to other pre-existing ethical concepts, but if these concerns would be otherwise missed, the concept would then be proven to have a vital practical function in research ethics. A few authors have made explicit claims to that effect.

    How showing vulnerability helps build a stronger team |

    These categories help bring attention to more specific aspects that generate vulnerability. Empirical evidence has shown that an understanding of vulnerability in the context of research cannot be assumed to be universal — in a study with Russian and Romanian research ethics trainees, Loue and Loff [ 36 ] found that, at the initiation of their training, their existing understanding of vulnerability varied considerably from conceptualisations in the international guidelines.

    A study by Sengupta et al. Taken together, these studies underscore the need for policymakers to clearly delineate and define the concerns vulnerability is intended to encompass, and to assess the alignment of these views with those of research stakeholders. Further, there is a need to assess the outcomes of vulnerability-related guidance and policy and to understand whether protections are actually effective and their impact on vulnerable participants themselves. For example, there are crucial questions about the actual usability and impact of such guidelines as well as the potential need for mid-level guidance between general guidelines and the actual analyses of REBs [ 38 ].

    It has been suggested that more elaborate, on-the-ground guidance on vulnerability would be beneficial to help REBs direct their attention to the most pertinent concerns [ 30 ]. In the process of developing such guidance, the voices of those concerned by the application of what sometimes appears as a label of vulnerability could be instrumental in moving forward and avoiding the perpetuation of stereotyping or stigmatising accounts of vulnerability [ 34 ]. In this endeavour, the perspectives of researchers and REBs, but also of research participants, who seem to have been largely left out of the development of research ethics guidelines, could be investigated.

    Our in-depth analysis of human research ethics guidelines and policies allowed us to analyse different perspectives on the concept of vulnerability, including the definitions, justifications, sources, and implications of vulnerability for researchers and REBs. In some respects, this synthetic account yielded a richer perspective than sometimes admitted in scholarly literature. At the same time, there are conceptual gaps within individual guidelines and policies that require the attention of those charged with their development.

    This lack of clarity could diminish the usability of the guidance put forth in policies and therefore undermine its impact on research practices. Policymakers should revisit the concept of vulnerability to ensure each of its key components is spelled out, and that these components are internally consistent i. Practically-oriented refinement of vulnerability could be facilitated by engaging research stakeholders and examining the concrete impact of guidance and policy related to vulnerability. The authors would like to thank Michael McDonald for his feedback on an earlier version of this manuscript, as well as the members of the Neuroethics Research Unit for their feedback throughout the conduct of this research.

    No funding body played any role in the design of the study or collection, analysis, interpretation of the data, or in the writing of the manuscript. EB and ER developed the idea of conducting a review of research ethics policies and guidelines. DBR developed the search strategy and inclusion and exclusion criteria and gathered the sample with input from EB and ER.

    DBR drafted the final version of the manuscript and all authors agreed on the final version. Dearbhail Bracken-Roche, Email: ac. Emily Bell, Email: ac. Mary Ellen Macdonald, Email: ac. Eric Racine, Phone: , Email: ac. National Center for Biotechnology Information , U. Health Res Policy Syst. Published online Feb 7. Author information Article notes Copyright and License information Disclaimer. Corresponding author.

    Received Oct 26; Accepted Dec This article has been corrected. See Health Res Policy Syst. This article has been cited by other articles in PMC. Abstract Background The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in Conclusions Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and we propose that a process of stakeholder engagement would well-support this effort.

    Background: the function of vulnerability in research ethics guidance and policy Research on human subjects is thought to be fundamentally ethically challenging, requiring ethics standards to guide researchers as well as approval and oversight of research proposals from independent committees. Table 1 Key characteristics of guideline and policy sample. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council , institutions must agree to comply with it; while not required to do so, other organisations and entities are encouraged to adopt this Policy to guide the ethical aspects of the design, review and conduct of research involving humans All those involved in the conduct and review of research funded by the federal research agencies, e.

    Open in a separate window. Inter-policy component analysis This stage of analysis consisted of an inter-policy analysis, allowing us to capture and explore patterns in the data across our sample. Intra-policy holistic analysis After the inter-policy comparative analysis, we examined the conceptualisation and operationalisation of vulnerability within each policy. Table 2 Content regarding definitions of vulnerability and detailing the use of qualifying language.

    This may be caused by limited decision-making capacity or limited access to social goods, such as rights, opportunities and power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on their circumstances. Table 3 Content on the ethical justification of vulnerability and its normative status in each policy. Identifying vulnerable groups and individuals All guidelines and policies in the sample provide means through which vulnerability can be identified. Table 4 Vulnerable groups identified in our sample, as well as explanations for this designation, where available.

    Given that this is mentioned but not negated, we included these groups in our table b The Belmont Report lists a number of vulnerable groups and a series of explanations of their vulnerability. It is unclear whether certain groups were intended to be linked to certain explanations, so all have been included c Within this category, specific subject groups are provided as examples.

    Table 5 Sources of vulnerability identified independently from vulnerable groups. Implications of vulnerability in research All policies in our sample identify practical implications of vulnerability in research, i. Table 6 Implications of vulnerability, grouped by theme. Justifications: What ethical concern s does vulnerability reflect? Implications: How should we respond to vulnerability in research? CIOMS These guidelines present an autonomy-based conceptualisation of vulnerability that is comprehensive in scope but lacks internal clarity in its discussion of vulnerable groups.

    EU Clinical Trials Directive The Clinical Trials Directive conveys a primarily consent-based vulnerability, with children as the focus of its vulnerability-related regulations. EU Clinical Trials Regulation The Clinical Trials Regulation conveys a mixed concept of vulnerability, concerned both with issues of consent and increased health risks. ICH GCP These guidelines present a consent-based concept of vulnerability that lacks internal clarity due to its broad scope of vulnerable groups.

    National policies and guidelines Australian National Statement The National Statement suggests a comprehensive conceptualisation of vulnerability relating to concerns about consent, fair involvement in research, and a balance of risks and benefits to participants. United Kingdom Research Governance Framework The framework conveys a consent-based conceptualisation of vulnerability that is narrow in scope, labelling adults who may have issues with understanding and decision-making as vulnerable.

    Belmont Report The Report conveys a consent-based conceptualisation of vulnerability that lacks clarity in the features of vulnerability it aims to target. Common Rule The Common Rule conveys a consent-based conceptualisation of vulnerability that lacks internal clarity regarding its scope.

    Discussion The objective of this analysis was to describe the concept of vulnerability in research ethics policies and guidelines, and to assess how it is conceptualised and operationalised. A need for evidence and stakeholder engagement to refine research ethics policies and guidance on vulnerability Research ethics guidelines and policies typically stress the importance of vulnerability.

    Conclusion Our in-depth analysis of human research ethics guidelines and policies allowed us to analyse different perspectives on the concept of vulnerability, including the definitions, justifications, sources, and implications of vulnerability for researchers and REBs. Acknowledgements The authors would like to thank Michael McDonald for his feedback on an earlier version of this manuscript, as well as the members of the Neuroethics Research Unit for their feedback throughout the conduct of this research.

    Competing interests The authors have no competing interests to declare. Consent for publication Not applicable. Ethics approval and consent to participate Not applicable. References 1. Coleman CH. Vulnerability as a regulatory category in human subject research. J Law Med Ethics. Respect for human vulnerability: the emergence of a new principle in bioethics. J Bioeth Inq. Do ethical guidelines give guidance? A critical examination of eight ethics regulations. Camb Q Healthc Ethics. Solomon SR. Protecting and respecting the vulnerable: existing regulations or further protections? Theor Med Bioeth.

    Hurst SA. Vulnerability in research and health care; describing the elephant in the room? Luna F. Elucidating the concept of vulnerability: layers not labels. Int J Fem Approaches Bioeth.