Vulnerability in research ethics: A call for assessing vulnerability and implementing protections

Significance This article examines the standard approach of relying on stated categories for addressing vulnerability and presents a practical approach for improving vulnerability assessment and protections. Original data collected from 355 legal/regulatory documents governing social/behavioral research for 107 countries identifies 68 distinct vulnerability categories that vary regionally, calling attention to possible overreliance on international standards. The data also reveal that some categories, such as displacement and trafficking, where research participants are vulnerable by any reasonable definition, are neglected. The article provides a conceptual framework that shifts the problem away from static, enumerated categories toward differentiation of inherent, situational, and research-induced vulnerability. Based on our conceptualization and coding, we present a framework for assessing vulnerability and implementing appropriate protections.

N otes: All categories reported with number of mentions in columns 2-7.Countries below the midrule line did not appear in the HHS list.Countries above the midrule line but with 0s in columns 2-7 appeared in the HHS list but contained human subjects research documents for medical, stem cell, data protection, or other non-general or non-social-behavioral documents.
Fig. S1.Coding SummaryNotes: Summary of selection of countries/documents for coding.Note that the country counts include the EU as a separate entity.
All categories reported with number of mentions in columns 2-7.Countries below the midrule line did not appear in the HHS list.Countries above the midrule line but with 0s in columns 2-7 appeared in the HHS list but contained human subjects research documents for medical, stem cell, data protection, or other non-general or non-social-behavioral documents.
All categories reported with number of mentions in columns 2-7.Countries below the midrule line did not appear in the HHS list.Countries above the midrule line but with 0s in columns 2-7 appeared in the HHS list but contained human subjects research documents for medical, stem cell, data protection, or other non-general or non-social-behavioral documents.
All categories reported with number of mentions in columns 2-7.Countries below the midrule line did not appear in the HHS list.Countries above the midrule line but with 0s in columns 2-7 appeared in the HHS list but contained human subjects research documents for medical, stem cell, data protection, or other non-general or non-social-behavioral documents.
All categories reported with number of mentions in columns 2-7.Countries below the midrule line did not appear in the HHS list.Countries above the midrule line but with 0s in columns 2-7 appeared in the HHS list but contained human subjects research documents for medical, stem cell, data protection, or other non-general or non-social-behavioral documents.

Table S2 . Consolidated List of Vulnerability Mentions.
N otes: Consolidated categories with number of mentions in second and fourth columns.

Table S3 . Categories Organized by Levels of Aggregation.
Columns 3 and 6 correspond to the original 153 categories before condensing to the list of 68.(See next page for continuation of the table.) N otes: Columns 1 and 4 (Type) correspond to the innermost circle of Manuscript Figure1.Columns 2 and 5 (Broader Category) correspond to the inner ring.

Table S4 . Categories Organized by Levels of Aggregation (cont).
Columns 1 and 4 (Type) correspond to the innermost circle of Manuscript Figure1.Columns 2 and 5 (Broader Category) correspond to the inner ring.Columns 3 and 6 correspond to the original 153 categories before condensing to the list of 68.(See prior page for beginning of the table.)SeeTableS6forcorrespondingoveralland sectoral mentions.See TableS8for corresponding overall and sectoral mentions.
N otes: Fig. S2.Number of Unique Vulnerability Mentions by Country in North America and the Caribbean Notes: See TableS5for corresponding overall and sectoral mentions.Fig.S3.Number of Unique Vulnerability Mentions by Country in South AmericaNotes: See TableS5for corresponding overall and sectoral mentions.Michael G. Findley, Faten Ghosn, and Sara Lowe Fig. S4.Number of Unique Vulnerability Mentions by Country in Europe Notes: Fig. S5.Number of Unique Vulnerability Mentions by Country in Asia/Pacific Notes: See TableS7for corresponding overall and sectoral mentions.Fig.S6.Number of Unique Vulnerability Mentions by Country in the Middle East Notes: Fig. S7.Number of Unique Vulnerability Mentions by Country in Sub-Saharan Africa Notes: See TableS9for corresponding overall and sectoral mentions.