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Cited by 283Ethics in Clinical ResearchEthics and bioethics in healthcareQualitative Research Methods and Ethics

The DOI matches its Crossref record; 35 of the 36 references it cites were found in a registry or an index.

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

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Bracken-Roche, Dearbhail, Bell, Emily, Macdonald, Mary Ellen, Racine, Eric·2017·Health Research Policy and Systems
DOI 10.1186/s12961-016-0164-6PMC PMC5297186
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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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Metadata

Authors
Bracken-Roche, D., Bell, E., Macdonald, M. E., & Racine, E.
Affiliations
  • Montreal Clinical Research Institute (CA)
  • McGill University (CA)
ORCID
Macdonald, Mary Ellen
Venue
Health Research Policy and Systems
Publisher
Springer Science and Business Media LLC
Published
2017-02-07
Volume
15
Issue
1
Pages
8-8
ISSN
1478-4505 (ISSN-L)
DOI
10.1186/s12961-016-0164-6
PMC
PMC5297186
OpenAlex
W2587319655
Cited by
283
References
36
Citations by year
2026: 23 · 2025: 29 · 2024: 29 · 2023: 47 · 2022: 42 · 2021: 38 · 2020: 28 · 2019: 24 · 2018: 9 · 2017: 10
FWCI
18.23
Type
journal article
Language
en
Update notices
correction (2017-04-03)
Open access
Licence
cc-by
Locations
  • Health Research Policy and Systems (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • eScholarship@McGill (McGill) (submittedVersion, cc-by)
Funders
  • Canadian Institutes of Health Research (97982)
  • Fonds de Recherche du Québec - Santé (30998)
  • Faculty of Medicine, McGill University (Internal Studentship 2015-16)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
  • Social Sciences › Sociology and Political Science › Qualitative Research Methods and Ethics
Keywords
research participant vulnerability, research ethics guidelines, Belmont Report, vulnerable populations, research ethics policy, research ethics committees, stakeholder engagement
MeSH terms
Clinical Trials as Topic, Health Policy, Humans, Informed Consent, International Cooperation, Practice Guidelines as Topic, Personal Autonomy, Ethics, Research, Biomedical Research, Vulnerable Populations

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