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      The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines

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          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 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 use, there is considerable disagreement in the scholarly literature about 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 as it is employed in major national and international research ethics 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, application, 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 we propose that a process of stakeholder engagement would well-support this effort.

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          Most cited references 18

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          Vulnerability in research and health care; describing the elephant in the room?

          Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions may be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner.
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            The limitations of "vulnerability" as a protection for human research participants.

            Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.
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              Elucidating the concept of vulnerability: Layers not labels

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                Author and article information

                Contributors
                dearbhail.bracken-roche@ircm.qc.ca
                emily.bell@mcgill.ca
                mary.macdonald@mcgill.ca
                (514) 987-5723 , eric.racine@ircm.qc.ca
                Journal
                Health Res Policy Syst
                Health Res Policy Syst
                Health Research Policy and Systems
                BioMed Central (London )
                1478-4505
                7 February 2017
                7 February 2017
                2017
                : 15
                Affiliations
                [1 ]ISNI 0000 0001 2292 3357, GRID grid.14848.31, Neuroethics Research Unit, , Institut de recherches cliniques de Montréal, ; 110 Avenue des Pins Ouest, Montréal, QC H2W 1R7 Canada
                [2 ]ISNI 0000 0004 1936 8649, GRID grid.14709.3b, Biomedical Ethics Unit and Division of Experimental Medicine, , McGill University, ; Montréal, QC Canada
                [3 ]ISNI 0000 0004 1936 8649, GRID grid.14709.3b, Faculty of Dentistry, Oral Health and Society Research Unit, , McGill University, ; 2001 McGill College, Suite 500, Montréal, QC H3A 1G1 Canada
                [4 ]ISNI 0000 0001 2292 3357, GRID grid.14848.31, Department of Medicine and Department of Social and Preventive Medicine, , Université de Montréal, ; Montréal, QC Canada
                [5 ]ISNI 0000 0004 1936 8649, GRID grid.14709.3b, Department of Neurology and Neurosurgery, , McGill University, ; Montréal, QC Canada
                Article
                164
                10.1186/s12961-016-0164-6
                5297186
                28173859
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000024, Canadian Institutes of Health Research;
                Award ID: 97982
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100000156, Fonds de Recherche du Québec - Santé;
                Award ID: 30998
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100008644, Faculty of Medicine, McGill University;
                Award ID: Internal Studentship 2015-16
                Award Recipient :
                Categories
                Research
                Custom metadata
                © The Author(s) 2017

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