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Beyond fixed categories: dynamic vulnerability and context-sensitive inclusion in the revised Declaration of Helsinki

jmepb · 2026-07-08 · canonical JSON source

2 visible annotations · policy: published · automated confidence ≥ 75.00%

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This response analyses the discussion by Parsa-Parsi et al on the 2024 revision of the Declaration of Helsinki (DoH). While their narrative reflections on some of the internal processes behind the revision are, for the most part, appropriately nuanced and illuminating, I argue that they underestimate the conceptual and practical significance of the new approach to the concept of vulnerability and how this approach connects to the Council for International Organizations of Medical Sciences (CIOMS) 2016 Guidelines. Drawing on the idea of ‘layers of vulnerability’, I highlight how vulnerability is often contextual, dynamic and cumulative, and how this view avoids essentialising entire groups (such as pregnant persons) while clarifying when and how people facing multiple vulnerabilities can be ethically included in research with appropriate protections. I further argue that there are similarities between DoH and CIOMS and that a closer alignment with CIOMS in the interpretation of the DoH offers a more coherent and practically useful framework for research ethics committees and researchers.