The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines.
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.
Neuroethics Research Unit, Institut de recherches cliniques de Montréal, 110 Avenue des Pins Ouest, Montréal, QC, H2W 1R7, Canada.|Biomedical Ethics Unit and Division of Experimental Medicine, McGill University, Montréal, QC, Canada.
Dearbhail
D
Bracken-Roche
Neuroethics Research Unit, Institut de recherches cliniques de Montréal, 110 Avenue des Pins Ouest, Montréal, QC, H2W 1R7, Canada.
Emily
E
Bell
Faculty of Dentistry, Oral Health and Society Research Unit, McGill University, 2001 McGill College, Suite 500, Montréal, QC, H3A 1G1, Canada.
Mary Ellen
ME
Macdonald
Neuroethics Research Unit, Institut de recherches cliniques de Montréal, 110 Avenue des Pins Ouest, Montréal, QC, H2W 1R7, Canada. eric.racine@ircm.qc.ca.|Biomedical Ethics Unit and Division of Experimental Medicine, McGill University, Montréal, QC, Canada. eric.racine@ircm.qc.ca.|Department of Medicine and Department of Social and Preventive Medicine, Université de Montréal, Montréal, QC, Canada. eric.racine@ircm.qc.ca.|Department of Neurology and Neurosurgery, McGill University, Montréal, QC, Canada. eric.racine@ircm.qc.ca.
Eric
E
Racine
D035843:Biomedical Research / Q000941:ethics*; D002986:Clinical Trials as Topic / Q000941:ethics; D032984:Ethics, Research; D006291:Health Policy; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007391:International Cooperation; D026684:Personal Autonomy; D017410:Practice Guidelines as Topic; D035862:Vulnerable Populations
Ethics policy; Research ethics; Research oversight; Research policy; Vulnerability; Vulnerable populations