{"doi":"10.1111/bioe.13427","title":"Vulnerability: On a Welcome Paradigm Shift in the 2024 Declaration of Helsinki","abstract":"The 2024 version of the Declaration of Helsinki [1] provoked a flurry of commentaries from the international research community on a host of different issues [2-6]. These included the broadened scope of the revised Declaration, its emphasis on integrity, the inclusion of the notion of meaningful engagement, the importance of ethical research in public health emergencies, research ethics committees’ (RECs) independence and the importance of providing them with adequate resources. It should also be noted that, with regard to some very controversial issues such as placebo control and post-trial benefits, the Declaration is not vastly different from its 2013 version [4]. However, some significant changes have arguably not been sufficiently considered in the published commentaries. Here, I will focus on paragraphs 19 and 20 of DoH 2024 that refer to vulnerability and suggest that these changes usher in a welcome paradigm shift regarding the concept of vulnerability. The importance of certain changes to language in the revised version of the DoH has been noted. For example, the term “research subject” was replaced by “participant” [3, 6]. Thus far, no scholarship has addressed the linguistic dimension surrounding the Declaration's revision of the notion of vulnerability. Yet in paragraph 19, there is indeed a crucial change in language related to this concept. A new description of vulnerabilities is introduced: individuals, groups, and communities are in a “situation of more vulnerability.” In other words, the 2024 DoH leaves behind the essentialist conception of vulnerability–that individuals and groups are particularly vulnerable (Paragraph 19 (DoH 2013)). Note that the term “vulnerable populations” has been avoided, as now different situations may render these groups or communities more vulnerable. Furthermore, this is dynamic and contextual and may change. This addition of a more dynamic conception of vulnerability has important consequences for research ethics. Perhaps most significantly, it means not labeling a priori with a categorical or essential property or following a predetermined list of people already considered vulnerable. However, some commentators fail to appreciate this difference and still use the previous terminology from 2013 [5, 7] as the 2024 version still maintains that factors may be fixed. But the 2024 DoH expands and refers to “a situation of more vulnerability as research participants, due to factors that may be fixed or contextual and dynamic,”1 thus introducing a different way of thinking about the concept that captures the various ways in which vulnerabilities are expressed. This non-essentialist vision avoids stereotyping and labeling individuals, groups, and communities as vulnerable. As when a label is applied, it fixes the content and is quite difficult to remove; but if we think there are circumstances or characteristics that are dynamic, they may change. The context can also be modified. The essentialist approach makes two assumptions. On one hand, it assumes a baseline standard for a default paradigmatic participant: a mature, reasonably educated, literate, self-supporting person. This is an overly idealized vision of research participants. Second, it assumes that identifying vulnerabilities in populations means identifying populations failing to meet the characteristics of this paradigm. (In addition, it may also include subpopulations or persons that may not be vulnerable.) The alternative concept of vulnerability instead allows for a complex description of vulnerabilities. That is, there might be several vulnerabilities that may overlap, compounding a participant's vulnerability. They might be multiple and different, some related to the lack of informed consent, to socio-economic conditions, age, gender, and other characteristics. Vulnerabilities may co-exist, and they can be minimized or eradicated (when possible) one by one. I have discussed this extensively elsewhere [8, 9].2 The idea of m","journal":"Bioethics","year":2025,"id":534183,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9478,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":737664,"name":"Florencia Luna","orcid":"0000-0001-8865-2756","position":0,"is_corresponding":true}],"reference_count":16,"raw_metadata":null,"created_at":"2026-07-19T02:51:47.434742Z","pmid":"40667693","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}