Ethical Concept That Can Be Used With Vulnerable Populations
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The concept of 'vulnerability' in enquiry ethics: an in-depth assay of policies and guidelines
Health Research Policy and Systems volume 15, Article number:8 (2017) Cite this article
An Erratum to this article was published on 03 Apr 2017
Abstract
Background
The concept of vulnerability has held a key place in research ethics guidance since its introduction in the United States Belmont Written report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread utilise, in that location is considerable disagreement in the scholarly literature most the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability equally it is employed in major national and international research ideals policies and guidelines.
Methods
We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, awarding, normative justification and implications of vulnerability.
Results
Few policies and guidelines explicitly defined vulnerability, instead relying on implicit assumptions and the delineation of vulnerable groups and sources of vulnerability. On the whole, we found considerable richness in the content on vulnerability across policies, but note that this relies heavily on the structure imposed on the data through our analysis.
Conclusions
Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and nosotros advise that a process of stakeholder date would well-support this attempt.
Peer Review reports
Groundwork: the function of vulnerability in research ideals guidance and policy
Research on human subjects is idea to be fundamentally ethically challenging, requiring ideals standards to guide researchers as well as blessing and oversight of research proposals from independent committees. Society allows researchers to invite individuals to participate in research one time sure weather are met, including a research ethics board's (REB, as well known equally Institutional Review Boards, or IRBs, or Enquiry Ethics Committees, or RECs) determination that risks and benefits are accordingly balanced, that the proposed strategy for subject recruitment is fair, and that voluntary, informed consent volition be sought from each potential subject [1]. The concept of vulnerability, which finds it origins in the United States Belmont Report of 1979 [2], plays a primal role in research ideals thinking, drawing attention to situations where these conditions may not be met [ane]. Since 1979, the number of legal and non-legal research ideals policies and guidelines has increased tremendously and, with them, the apply and scope of the concept of vulnerability or vulnerable populations [2, iii]. However, in that location is much scholarly disagreement over the appropriate meaning and application of this concept in research ethics, and policymakers are charged with the challenge of navigating this contentious landscape in the evolution and refinement of research guidelines and policies [4]. A growing body of literature critiques and aims to advance the way vulnerability is conceptualised and employed in research ethics, with major debates regarding foundational elements of this important ethical concept [5–ten].
Major debates surrounding the concept of vulnerability in research ethics
In that location is widespread understanding that some research participants may be particularly vulnerable and in need of special protections, yet the concept of vulnerability itself has been described equally 'vague' [11], with a lack of consensus in the scholarly literature regarding the concept'southward fundamental features. Contrasting accounts take been proposed regarding the justification of vulnerability and which ethical principles interpret into obligations for the special protection of vulnerable research participants. Some accounts propose a justice-based reason for protection, concerned with the fairness of participant recruitment and of the distribution of research burdens and benefits [12, xiii]. Others ground vulnerability in a principle of autonomy or respect for persons, suggesting that persons who cannot provide informed and voluntary consent are susceptible to harm because they are not able to protect their interests [5, 13]. These approaches are non mutually sectional, but we must at to the lowest degree be able to identify which ethical principles define to whom we owe special consideration. In enquiry, there are often gaps between the rules intended to govern and the practices at hand, requiring those tasked with the implementation of these rules to interpret and employ them in their specific context [3]. An ethical foundation is needed for these interpretations; otherwise, it is hard to sympathise the intentions of the authoring parties or apply the dominion to the situation at hand [3]. In this context, a amend agreement of the justifications of vulnerability becomes a crucial goal of scholarly piece of work in this area.
The application of vulnerability and its scope in research has also been a subject of much debate. In particular, vulnerability has been charged with being both too broad and besides narrow. An overly broad concept captures all inquiry participants, creating conceptual confusion over the meaning of 'special protections', while an overly narrow concept may get out some vulnerable participants at take chances and without the needed protection [5, 11, 12, fourteen]. Practically, a definition of vulnerability must exist comprehensive enough to capture those in need of additional protections without overburdening participants for whom protection across the norm is unnecessary. Farther, it must provide researchers and research ethics boards with the information necessary to identify those who are vulnerable, every bit well as what they might be vulnerable to. There are compelling arguments confronting narrow definitions of vulnerable groups that support the identification of specific factors within the enquiry context and the participants' personal situation that create possible vulnerabilities [half-dozen].
The foundational argue near the concept of vulnerability revolves around its definition, with diverse proposals made for its delineation in the literature. Arguing that vulnerability lacks an organising principle, Hurst [five] suggests that vulnerable persons are properly conceived of as those who accept "an identifiably increased likelihood of incurring boosted or greater wrong". This account emphasises that both private and situational factors must be evaluated in defining vulnerability considering being overly focused on individual characteristics tin obscure features of the research protocol or environment that may impairment participants. Luna [6] argues that vulnerability must be conceived of as 'relational', in that vulnerabilities can only be discovered by examining an individual in context, and 'dynamic', since one's vulnerability depends on ane's context. Luna and Vanderpoel [14] describe layers of vulnerability which ascend from interactions between an individual's characteristics and their environment, and which interact with one another to create an inextricably context-dependent vulnerability.
To our knowledge, an in-depth analysis of the concept of vulnerability every bit it exists in the policies and guidelines that govern research on man subjects has not been conducted. This is an important gap because, at present, the scholarly literature seeks to advance the concept without an understanding of the full telescopic of the regulatory context. Without a clear understanding of the conceptualisation and operationalisation of vulnerability in current research ethics, recommendations for its refinement take a chance existence disconnected from the range of policy options. To explore the multifariousness of options with respect to the enshrinement and application of the concept of vulnerability in research ethics guidelines, nosotros conducted an in-depth analysis of major national and international inquiry ethics policies and guidelines.
Methods
Sampling
Inspired by previous research ideals policy analyses [3, xv], we compiled a sample of internationally- and nationally-adopted research ethics guidelines and policies, focusing on Canada (the authors' own regulatory context) and regions with like demographic and legal structures to Canada, including Australia, the European Wedlock, the United Kingdom, and the U.s. [15]. We began our search using a compilation of international human research standards produced by the Office for Human Research Protections of the Us Department of Health and Human Services [sixteen]. Additionally, we performed secondary searches of the references of any included guidelines and policies for relevant, not-duplicated documents.
Our primary goal was to build a sample of guidelines and policies that discussed or referenced vulnerability in general health enquiry. As such, we excluded those in which vulnerability was not explicitly discussed (east.g. the Nuremberg lawmaking) also as those focused on specific areas of or issues within research (e.g. paediatric inquiry, genetic research), put frontward past professional organisations, or published as working papers, drafts, commentaries, or otherwise less broadly adopted documents. Our last sample included 11 guidelines and policies, half-dozen of which are internationally-adopted (i.e. across multiple countries) [17–22] and five of which are nationally-adopted (i.e. within individual countries) [23–27]. All documents were downloaded and saved for data extraction. Encounter Table 1 for an overview of our sample and the key characteristics of included policies.
Inter-policy component analysis
This stage of analysis consisted of an inter-policy analysis, allowing united states to capture and explore patterns in the data across our sample. Given our specific interest in understanding how guidelines and policies employ the concept of vulnerability, each document was give-and-take-searched for the term 'vulnerab'. Using this truncated keyword allowed united states to identify all uses of the terms 'vulnerability' or 'vulnerable'. We read the broader sections of text surrounding the key terms to facilitate a contextual understanding of how the notion of vulnerability was used.
We employed a content analysis strategy, developing an initial coding guide deductively and refining information technology inductively. We hypothesised, based on the literature (every bit described in the Background section), that inquiry ideals guidance on vulnerability should include at least the following basic content: (1) a definition of vulnerability, (2) a word of the sources or circumstances from which vulnerability tin can arise and/or identification of groups probable to be in those circumstances, (3) an explanation of the ethical justification of the concept to aid in its application. A preliminary coding guide was created to capture these content areas. This preliminary guide was applied to a subset of the sample (n = 3). Through this 'piloting' stage, the coding scheme was refined inductively by 3 authors (DBR, EB, ER) to ensure other major areas of content were captured. This resulted in the add-on of a fourth content category, 'implications of vulnerability', which captures responses to vulnerable participants laid out within the guidelines and policies. Definitions and rules for the awarding of each code were developed to ensure rigor and thoroughness. Throughout the coding procedure, 3 authors (DBR, EB, ER) engaged in open discussions in order to account for whatsoever biases of the primary coder (DBR) and to ensure the total depth of the data would exist represented through this analytic strategy. Once final coding was complete, it was reviewed by other authors (EB, ER, MEM) and consensus was accomplished through team discussions.
The results of our comparative data analysis are presented in tables, with direct excerpts from the guidelines and policies provided where possible. Two codes (groups and sources of vulnerability, and implications) included more information than others and thus the text has been condensed (i.e. directly citations are not provided). To ensure allegiance to the data, one author (DBR) condensed this text and some other (ER) reviewed it to ensure accurate representation of the guidelines and policies.
Intra-policy holistic analysis
Subsequently the inter-policy comparative assay, we examined the conceptualisation and operationalisation of vulnerability within each policy. Building on the structure adult in our comparative analysis, nosotros assessed the logical consistency between the 4 content areas of vulnerability. More specifically, nosotros analyzed each policy and guideline in isolation to examine (one) which major content areas are lacking, (2) whether the four content areas (definitions, justifications, groups and sources, and implications) are consequent (e.grand. in their pregnant) with one another, and (iii) what overall impression a guideline or policy user might have about the concept of vulnerability within the certificate.
Results
Inter-policy comparative analysis
Defining vulnerability
All policies in our sample reference vulnerability and/or vulnerable subjects, but simply three out of 11 explicitly ascertain these terms (Table ii). Of these, the Council for International Organizations of Medical Sciences (CIOMS) and the Tri-Quango Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) guidelines define vulnerability itself, while the International Conference on Harmonisation, Good Clinical Practice (ICH GCP) instead provides a definition of vulnerable subjects. These definitions share similar structures, all defining vulnerability or vulnerable subjects and identifying paradigmatic sources (or causes) of vulnerability. The ICH GCP definition focuses on issues of consent, where a lack of voluntariness in a field of study'due south decision to participate establishes their vulnerability. The CIOMS and TCPS2 guidelines employ broader language, both stating that vulnerability arises from a discipline's lack of ability to protect their own interests. Both identify sources of vulnerability located within the subject (east.yard. a lack of decision-making chapters) and in their environment (e.g. a lack of access to medical care). Merely the definition provided by the TCPS2 makes explicit reference to another central upstanding concept – that of autonomy. This reference suggests an of import link between vulnerability and autonomy, though this connection is not further explained.
The definition provided past the TCPS2 is distinct from the others because it explicitly states that vulnerability is context-dependent, and is experienced "to unlike degrees and at different times, depending on [an individual's or group's] circumstances" ([24], p. 210) . Nevertheless, qualifying linguistic communication employed in other policies implicitly suggests a like view that vulnerability exists on a spectrum or as a matter of degree (Table 2). The Announcement of Helsinki, Australian National Statement, and Belmont Written report, for example, discuss participants who are "particularly vulnerable" [17], "more-than-usually vulnerable" [23], or "especially vulnerable" [26], respectively. Unlike the TCPS2, no other guidelines in our sample state explicitly that vulnerability should be thought of as existing on a spectrum, or as a feature that can vary betwixt circumstances.
Ethical justifications for the concept of vulnerability
Many guidelines and policies (CIOMS, UNESCO Declaration, Declaration of Helsinki, Australian National Argument, TCPS2, Belmont Report) provide explicit ethical argumentation relating to vulnerability and/or vulnerable subjects. There is significant overlap across the sample between the principles from which obligations or considerations relating to vulnerability arise (encounter Table 3 for an overview). In all cases where guiding ethical principles are provided by a policy or guideline, vulnerability-related concerns are discussed in the application of each principle.
The normative condition of the concept of vulnerability is inconsistent across policies and guidelines. In certain cases (CIOMS, Australian National Statement, TCPS2, Belmont Written report), obligations towards vulnerable research participants arise from the awarding of other primal principles. For example, in the TCPS2, obligations towards those in circumstances of vulnerability are entailed by the policy's core principles of Respect for Persons, Concern for Welfare, and Justice. In others, concerns or obligations related to vulnerability are themselves characterised as fundamental principles. Specifically, principles 19 and 20 of the Declaration of Helsinki focus on vulnerability, with 19 stating that "[due south]ome groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm" [17]. Similarly, Commodity 8 of the UNESCO Declaration promotes "[r]espect for human being vulnerability and personal integrity" [19] as a principle in and of itself.
The CIOMS guidelines are a unique example in our sample because they characterise vulnerability as both a principle and every bit a consideration derived from other principles. In the introduction to the CIOMS guidelines, issues of human rights are described as relating to two principles, one of which is the "protection of dependent or vulnerable persons and populations" ([18], p. eleven), while the principle of Respect for Persons is described every bit entailing "at least two fundamental ethical considerations", including "protection of persons with dumb or diminished autonomy, which requires that those who are dependent or vulnerable be afforded security against harm or abuse" ([xviii], p. 17).
In the remaining guidelines (ICH GCP, EU Clinical Trials Directive, European union Clinical Trials Regulation, United Kingdom Research Governance Framework, Mutual Rule), vulnerability is not explicitly discussed in relation to any ethical principles, nor is information technology described as a guiding principle itself. In these cases, concerns relating to vulnerable persons seem to serve the role of consideration for ethics review or ethical research with no explicit upstanding status.
Identifying vulnerable groups and individuals
All guidelines and policies in the sample provide means through which vulnerability can be identified. The majority identify subject field groups who are likely to exist vulnerable. Vulnerable groups identified in our sample are captured in Table 4, along with the corresponding explanations of why a subject field group is considered vulnerable or what they are vulnerable to, when these details are bachelor. Notably, while the European union Clinical Trials Directive and Clinical Trials Regulation, also equally the United kingdom of great britain and northern ireland Inquiry Governance Framework, all identify vulnerable subject groups, none of these policies provide whatever supporting caption. Further, only four policies (CIOMS, Australian National Statement, TCPS2, and the Common Dominion) provide whatever explanations of what sure identified groups are vulnerable to.
Across the sample, a smashing number of groups are identified as vulnerable. Counting just those wide groups identified in our table (i.e. excluding the examples of subgroups discussed in the footnote to Table 4), 32 groups were identified; when these subgroups are included, the total number of groups identified as vulnerable expands to 51. Groups near oftentimes identified are children, minors or young people (discussed in vii policies), prisoners (discussed in v policies), as well as persons with mental wellness bug, patients in emergency settings, and sure ethnocultural, racial or ethnic minority groups (each discussed in four policies). Concerns for the vulnerability of children centre around consent, with both the CIOMS and TCPS2 guidelines positing a vulnerability arising from their express freedom or capacity to consent and the Mutual Rule emphasising children's vulnerability to compulsion or undue influence. The Australian National Argument similarly positions the vulnerability of immature people relative to capacity and consent, though it is unclear how this policy conceives of the relationship betwixt these concepts. It outlines various scenarios regarding the vulnerability of young people: in some cases, young people may exist able to understand information but their "relative immaturity means they remain vulnerable" ([23], p. fifty); in other cases they may be "mature plenty to understand and consent [though] not vulnerable through immaturity in ways that warrant additional consent" ([23], p. 50); and in yet other cases, young people may be "mature enough to empathize the relevant information and to give consent, although vulnerable considering of immaturity in other respects" ([23], p. 50). The 'other respects' in which immaturity can return young people vulnerable are not made explicit, leaving the designation of vulnerability open to estimation in this instance. Other policies employ similarly open up-ended strategies, the CIOMS guidelines most explicitly by listing vulnerable groups and sources of vulnerability, and calculation that "[t]o the extent that these and other classes of people have attributes resembling those of classes identified equally vulnerable, the need for special protection of their rights and welfare should be reviewed and practical, where relevant" ([18], p. 65).
There is picayune 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 caption of their vulnerability was unclear or defective entirely. The European union Clinical Trials Directive and Clinical Trials Regulation and United Kingdom Research Governance Framework provide no caption or justification for any of the groups they designate as vulnerable, and while the Mutual Rule specifies that information technology is concerned with vulnerability to coercion or undue influence, it does not address 'handicapped persons' in this caption despite too identifying them as a vulnerable subject grouping. The CIOMS and ICH GCP guidelines, on the other hand, provide definitions of vulnerable subjects and explanations for some vulnerable groups. However, both of these policies include categories of 'other vulnerable groups' and neglect to provide any connection between these other groups and their overarching definition of vulnerability. As such, information technology 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.due east. without any relation or clan to a specific vulnerable group. For case, neither the Declaration of Helsinki nor the UNESCO Declaration identifies whatever detail field of study groups as vulnerable. Instead, they identify characteristics of vulnerable participants or key sources of vulnerability (Table 5). Information technology is important to note that, while the TCPS2 does place certain groups as likely to be in vulnerable circumstances, it qualifies whatever such labels, emphasising that "[i]ndividuals should non automatically be considered vulnerable but because of assumptions made most the vulnerability of the group to which they belong" ([24], p. 54).
Implications of vulnerability in research
All policies in our sample place practical implications of vulnerability in research, i.e. responses to vulnerability in the blueprint and review of research and to vulnerable participants themselves. A wide range of implications were identified, some directed explicitly towards REBs and/or investigators but the majority formulated more broadly with no specific group targeted. Further, these implications span the research process, from considerations important in the design of research to actions that must be taken when vulnerable persons are participating in research (Table 6).
A majority of policies and guidelines identify implications relating to restrictions for enquiry with vulnerable groups or individuals, simply these entail both negative and positive duties. Overall, these policies and guidelines advise that the involvement of vulnerable groups in research ought to be restricted to some extent; vulnerable persons ought to be involved only when the enquiry cannot be carried out with persons who are less vulnerable and special justification is required for their interest. Yet, when these persons are involved in inquiry, boosted actions are required, such every bit the design of inquiry that is responsive to their needs or priorities and the provision of benefits relevant to their group/discipline population. Across our sample, a common underlying assumption seems to exist that vulnerable groups can and should be involved in research, but that additional measures are required to ensure this involvement occurs in an ethical style. In fact, several policies (CIOMS, European union 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 and so far every bit 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. Withal, at that place 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 bureau of those in vulnerable circumstances. For example, it is suggested that they should be afforded opportunities to influence enquiry and that research ought to enhance vulnerable persons' capacity for participation. Furthermore, the TCPS2 guidance states more broadly that vulnerable groups may demand or desire special measures to ensure their rubber, suggesting a part for participants in the design and implementation of their protections.
In addition to conditions and restrictions for enquiry involvement, the process of informed consent is a major expanse 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 offering a fully informed consent to inquiry. Mechanisms of support include ensuring adequate fourth dimension and an appropriate environment (CIOMS), as well equally ensuring that data is fully explained and understood (United Kingdom Inquiry Governance Framework). Additionally, the Australian National Argument uniquely suggested that participants be given the choice of using a participant abet within the consent process.
Holistic policy analysis
Of the 11 policies and guidelines in our sample, merely two, the CIOMS guidelines and TCPS2, meet our criteria for a full conceptualisation of vulnerability, addressing all content areas (Table 7). In this section, we nowadays the results of our intra-policy analysis of vulnerability with a narrative nearly each policy argument, addressing (1) which major content areas are lacking, (ii) whether the content areas are consistent (i.eastward. in their significant) with one some other, and (3) what overall impression a guideline or policy user might have about the concept of vulnerability inside the certificate.
International policies and guidelines
Proclamation of Helsinki
The Proclamation conveys a impairment/wrong-based conceptualisation of vulnerability that is internally coherent due to its broad language. Information technology does not identify what these wrongs or harms might consist of and, because business for vulnerability is presented as a fundamental principle, interpretation cannot exist guided past other ethical principles. Implications of vulnerability focus on the need for responsive inquiry, special justification for involving vulnerable persons, and to-group benefits, suggesting these harms include the unfair distribution of the risks and benefits of research.
CIOMS
These guidelines nowadays an autonomy-based conceptualisation of vulnerability that is comprehensive in telescopic but lacks internal clarity in its discussion of vulnerable groups. While the provided definition focuses on vulnerability as stemming from an incapacity to protect one's ain interests attributable to both private and ecology features, vulnerability is also explicitly linked to justice-based concerns well-nigh the distribution of the risks and benefits of research. The identified implications of vulnerability thus correspond to concerns relating to participants' ability to provide free and informed consent and relating to the ceremoniousness of involving vulnerable participants in research. At that place is a lack of clarity and consistency, however, in the discussion of vulnerable groups. The CIOMS guidelines distinguishes between three types of vulnerable groups – those who are "conventionally considered vulnerable", those who are vulnerable due to social pressures (i.e. persons in dependent human relationship with researchers, such as students or pharmaceutical employees), and "other groups or classes" ([xviii], p. 64) for whom no caption is provided and who do not, on their confront, conduct a significant resemblance to these other groups.
UNESCO Declaration
The Declaration is concerned with both a general "human vulnerability" and a more than item "special vulnerability" ([19], Fine art. eight), neither of which are defined. Its identification of personal, societal and environmental conditions every bit sources of vulnerability suggests a concept with broad-ranging concerns. The Declaration identifies respecting the personal integrity of vulnerable groups as a key implication, suggesting that vulnerability may consist, at to the lowest degree in office, of risks to one's personal integrity. Since concerns relating to vulnerability are presented as fundamental principles, their estimation cannot be guided by other ethical principles.
EU Clinical Trials Directive
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, merely also on the need to avoid financial inducements for participation, suggesting a business organisation for a risk of exploitation. Other implications include a need to perform research with children in which group benefits volition exist obtained and ensuring the interests of the patient prevail over those of social club. As such, in improver 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 exist guided by ethical principles.
Eu Clinical Trials Regulation
The Clinical Trials Regulation conveys a mixed concept of vulnerability, concerned both with issues of consent and increased health risks. While vulnerability is not defined and no caption for the vulnerability of listed groups is provided, they tin be grouped by those assumed to confront bug of consent in enquiry (people affected by mental health disorders, minors, and incapacitated subjects) and those who may be at greater physical (i.e. wellness) risks in inquiry (frail or older people, people suffering from chronic conditions, and significant or breastfeeding women). The implications identified do not fall along this consent/health risk distinction, even so, with a need for enquiry to better treatments a key implication for delicate or older people, people with chronic weather condition, and people afflicted by mental health disorders, and the need for special expertise in research ethics review identified as a specific consideration for minors, incapacitated subjects, and pregnant or breastfeeding women. No ethical framework is provided in the Regulation to facilitate interpretation of this guidance.
ICH GCP
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 equally those whose ability to provide voluntary consent may be compromised past social pressures, and the showtime category of groups listed is conspicuously linked to this definition. However, it is non clear how the broad 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.
National policies and guidelines
Australian National Statement
The National Statement suggests a comprehensive conceptualisation of vulnerability relating to concerns nigh consent, fair interest in research, and a balance of risks and benefits to participants. It favours a grouping-specific approach to vulnerability, where this concept is discussed largely in reference to specific groups. Full general statements well-nigh vulnerability suggest that information technology is an of import factor when considering the advisable method of consent. While vulnerability is not defined, explanations for the vulnerability of all identified groups are provided and are discussed with reference to the Statement'southward guiding ethical principles. 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 articulate; 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 intendance originates in the risks of long-term harms and is linked to beneficence. However, while persons in pre-existing/dependent relationships with researchers are said to face issues providing voluntary consent, the key implication relating to this group is grounded in the principle of justice (i.e. ensuring they are not over-researched). Similarly, while persons with terminal illness are said to be vulnerable to unrealistic expectations of do good (i.e. may have a compromised ability to consent), the key response to this is to balance the benefits and burdens of research and is grounded in beneficence.
TCPS2
The TCPS2 presents an autonomy-based conceptualisation of vulnerability that is comprehensive in scope. The provided definition of vulnerability states that it stems from a diminished ability to protect one's own interests acquired by both individual (e.g. lack of decision-making capacity) and ecology (east.g. lack of access to social appurtenances) factors. Importantly, vulnerability is said to be context-specific and dynamic, discouraging assumptions of vulnerability based on group membership. All the same, the policy still relies on the identification of groups likely to exist vulnerable, every bit 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.
Uk Research Governance Framework
The framework conveys a consent-based conceptualisation of vulnerability that is narrow in scope, labelling adults who may take bug with understanding and decision-making every bit vulnerable. Consistent with this, the implications of vulnerability focus on providing participants with the necessary support in the informed consent process. Since no upstanding framework or principles are discussed relative to vulnerability, these cannot be used to facilitate interpretation of the guidance.
Belmont Report
The Report conveys a consent-based conceptualisation of vulnerability that lacks clarity in the features of vulnerability it aims to target. Information technology is assumed that vulnerable subjects have a "dependent condition and frequently compromised capacity for free consent" ([26], Part C. iii), which seems to form the basis of their vulnerability. Special considerations about vulnerable subjects are discussed in reference to respect for persons (ordinary inducements may exist come up 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 inquiry).
Common Rule
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, just 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 choice and the provision of additional safeguards, merely 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.
Discussion
The objective of this assay 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 near frequently discussed in terms of vulnerable groups, with some attending given to the sources of vulnerability, and the implications of conducting inquiry with vulnerable participants. In many respects the policies come up out, on the whole, equally richer and more complex than some scholarly analyses of the concept of vulnerability suggest [6, 28, 29]. For example, the policies and guidelines identify sources of vulnerability that are both individual and situational [29]; vulnerability can stem from a lack of chapters or from one's health status, but also from social pressures that may impact one'due south power to make a gratis and informed conclusion, consequent with some scholarly perspectives [30]. Responding to vulnerability requires caution and special consideration on the part of researchers and REBs only, ultimately, the implications identified in our written report propose that participant vulnerability demand not indicate a need for exclusion from research. The few explicit definitions in our sample define vulnerability equally a deficiency of the participant, every bit an inability to protect one's interests in research. The bulk of other guidelines and policies implicitly convey a similar conceptualisation of vulnerability every bit a deficiency in a participant's ability to provide voluntary informed consent. Appropriately, 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 chronicle to (one) previous critiques found in the scholarly literature and (2) the office of stakeholder engagement in the process of refining the concept of vulnerability in research ethics policies and guidance.
Previous critiques from the scholarly literature
Within the scholarly literature several critiques of vulnerability in inquiry ethics guidelines have been voiced. First, concerns have been raised that the manner in which vulnerability is defined and operationalised in research ethics governance stereotypes and reinforces stigma almost whole categories of individuals [9, 12, 31]. Our results reinforce these concerns, every bit the reliance on listing groups of vulnerable persons is rampant. This labelling [6] or sub-population [30] approach does niggling to bring attention to the importance of context and of assessing the characteristics of individual research participants across their membership in a group [five, 6, 9]. It is important to note that research protocols create groups through sampling "regardless of whether the sample is fatigued from a naturally occurring community" ([9], p. 2221). Understanding this betoken underscores the fact that group membership in this context may non well capture the various relevant aspects (and potential vulnerabilities) in an individual participant'southward situation. This may result in inappropriate and ineffective protections being practical in some protocols. Group listings may besides crusade confusion due to the broadness of some labels (due east.thousand. persons with mental disease or mental health issues). Furthermore, information technology seems that the designation of some groups every bit vulnerable may be based on assumptions not supported by evidence (east.1000. the designation of significant women as vulnerable to coercion or undue influence in the Common Dominion).
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 bulk of policies and guidelines convey implicitly that vulnerability is fundamentally an inability to provide free and informed consent. However, the implications of vulnerability ofttimes move beyond consent, addressing issues of fair subject selection and favourable chance benefit assessments. In addition to providing explicit definitions for what, exactly, is meant when the term 'vulnerability' is used, the clarity and usability of policies and guidelines could be improved by ensuring that these definitions clearly relate to the concerns with which vulnerability is associated.
Though they recognise both individual and contextual sources of vulnerability, all policies and guidelines conveyed that vulnerability is a personal characteristic. Fifty-fifty the TCPS2, with its notable emphasis on vulnerability as a context-dependent characteristic, ultimately defines it equally a person's inability to protect their own interests in research. In dissimilarity, a growing body of scholarly literature converges around the notion that vulnerability is a relational feature, borne of power asymmetries betwixt participants and research staff, investigators and institutions [10, 31, 34]. Adopting such a view in inquiry ethics guidelines may ameliorate serve participants, encouraging measures that would empower and promote their bureau in the enquiry context [34]. Furthermore, the focus on enquiry participants neglects how research environments (e.one thousand. the existence of conflicts of interest) can actively contribute to disempowering research participants/research subjects and thus create the need for remediation that does not necessarily concern the research participant per se [half dozen, ten].
A need for evidence and stakeholder engagement to refine enquiry ethics policies and guidance on vulnerability
Enquiry ideals 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 simply as a marker of other research ethics concerns already captured by existing concepts such every bit damage or consent [35]. This is certainly an important conceptual concern, only 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, six]. It may be the case that vulnerability just serves to signal concerns relating to other pre-existing upstanding concepts, but if these concerns would be otherwise missed, the concept would then be proven to have a vital practical function in inquiry ethics. A few authors take made explicit claims to that consequence. For example, Kipnis argues that vulnerability stems from impairments to ane's ability to provide voluntary informed consent. He identifies vi types of vulnerability which all indicate potential problems with a participant's ability to consent: cognitive, deferential and medical vulnerability, all of which relate to characteristics of the participant themselves, and juridic, allocational and infrastructural vulnerability, all of which relate to factors in the participant's environment [30]. These categories help bring attending to more specific aspects that generate vulnerability. Luna argues that vulnerability, when conceived of as dynamic, flexible and inessential, can serve as "a fine grain tool to analyze, interpret, and evaluate the enquiry situation" ([6], p. 130). She proposes that vulnerability exist conceived of through the metaphor of layers, in which different layers of vulnerability can operate and collaborate within a given participant's circumstances. Luna's business relationship of vulnerability thus provides researchers and REBs with a conceptual tool with which to examine a enquiry participant's circumstances, identify potential vulnerabilities (e.g. relating to capacity or social pressure in the consent process), and develop targeted strategies for their remediation.
In spite of these more sophisticated proposals, there is a famine of empirical evidence on the functioning of enquiry ethics committees and outcomes of enquiry ideals policies and, to our noesis, few studies have examined the impact or understandings of the concept of vulnerability based on research ethics guidelines and/or more elaborate scholarly accounts. Empirical bear witness has shown that an understanding of vulnerability in the context of enquiry cannot be assumed to be universal – in a written report with Russian and Romanian research ideals trainees, Loue and Loff [36] plant that, at the initiation of their training, their existing understanding of vulnerability varied considerably from conceptualisations in the international guidelines. A written report by Sengupta et al. [37] gathered researchers' perspectives on vulnerability in HIV/AIDS clinical trials and on the Common Rule guidance related to vulnerability and found that researchers assessed vulnerability in relation to situational factors that can return participants vulnerable, and that they emphasised the need to assess vulnerability on a case-past-case basis (i.e. rather than relying on a group-based strategy). Taken together, these studies underscore the demand for policymakers to conspicuously delineate and define the concerns vulnerability is intended to encompass, and to assess the alignment of these views with those of research stakeholders. Farther, at that place is a need to assess the outcomes of vulnerability-related guidance and policy and to sympathize whether protections are really effective and their impact on vulnerable participants themselves. For example, there are crucial questions nearly the actual usability and touch of such guidelines too as the potential demand for mid-level guidance betwixt 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 almost pertinent concerns [30]. In the process of developing such guidance, the voices of those concerned by the application of what sometimes appears every bit a label of vulnerability could be instrumental in moving forward and avoiding the perpetuation of stereotyping or stigmatising accounts of vulnerability [34]. In this attempt, the perspectives of researchers and REBs, only also of inquiry participants, who seem to have been largely left out of the development of research ethics guidelines, could be investigated.
Conclusion
Our in-depth analysis of man 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 constructed account yielded a richer perspective than sometimes admitted in scholarly literature. At the same fourth dimension, at that place 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 bear on 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.e. within individual guidelines). Practically-oriented refinement of vulnerability could exist facilitated by engaging enquiry stakeholders and examining the concrete touch on of guidance and policy related to vulnerability.
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Acknowledgements
The authors would like to thank Michael McDonald for his feedback on an earlier version of this manuscript, equally well as the members of the Neuroethics Research Unit for their feedback throughout the deport of this enquiry.
Funding
Funding for this study was provided past a CIHR grant held by EB, ER and MEM, an FRQ-S career award held by ER, and graduate scholarships from the IRCM and McGill University held by DBR. No funding body played any role in the design of the study or drove, analysis, interpretation of the data, or in the writing of the manuscript.
Availability of information and materials
The datasets used and/or analysed during the electric current written report are bachelor from the corresponding author on reasonable request.
Authors' contributions
EB and ER developed the idea of conducting a review of research ideals policies and guidelines. DBR adult the search strategy and inclusion and exclusion criteria and gathered the sample with input from EB and ER. DBR developed the coding strategy and conducted the data analysis and EB and ER reviewed. DBR drafted the manuscript and ER served as the primary reviewer and editor, with EB and MEM providing feedback. DBR drafted the final version of the manuscript and all authors agreed on the last version.
Competing interests
The authors have no competing interests to declare.
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Additional data
The original version of this commodity was revised. Unfortunately the references inside Table 4 of this article were not corrected during the production process and were therefore incorrect when published.
An erratum to this article is available at http://dx.doi.org/10.1186/s12961-017-0186-eight.
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Bracken-Roche, D., Bell, East., Macdonald, Chiliad.E. et al. The concept of 'vulnerability' in enquiry ethics: an in-depth analysis of policies and guidelines. Health Res Policy Sys 15, 8 (2017). https://doi.org/10.1186/s12961-016-0164-6
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DOI : https://doi.org/10.1186/s12961-016-0164-half dozen
Keywords
- Research ideals
- Vulnerable populations
- Vulnerability
- Research policy
- Ethics policy
- Research oversight
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