{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T08:13:51Z","timestamp":1787904831507,"version":"build-2784847793"},"reference-count":102,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T00:00:00Z","timestamp":1751328000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002803","name":"Fondazione Cariplo","doi-asserted-by":"publisher","award":["2020-1322"],"award-info":[{"award-number":["2020-1322"]}],"id":[{"id":"10.13039\/501100002803","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002803","name":"Fondazione Cariplo","doi-asserted-by":"publisher","award":["2020-1322"],"award-info":[{"award-number":["2020-1322"]}],"id":[{"id":"10.13039\/501100002803","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The history of research involving human subjects has demonstrated the importance of offering everyone an equal opportunity to participate in research, while safeguarding those who require special attention. When it comes to vulnerable individuals, this consideration is relevant. However, disagreement still exists about the meaning of vulnerability, the identification and definition of vulnerable populations, and how these concepts should be operationalised in policy documents in order to implement appropriate, preventive and respectful measures for all those subsumed within this category.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Following the PRISMA-Ethics guidance, we performed a systematic review of policy documents to provide a comprehensive overview of how vulnerability is conceptualised and operationalised in research ethics. The aim is to investigate the meaning and definition of vulnerability in research ethics, its normative justification, the comprehensive set of subjects it refers to, and consequent provisions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Our search centred on three main sources: three overview lists that provide comprehensive coverage of research ethics policy documents and guidelines (the\n                      <jats:italic>International Compilation of Human Research Standards,<\/jats:italic>\n                      the\n                      <jats:italic>Listing of Social-behavioral Research Standards<\/jats:italic>\n                      and the\n                      <jats:italic>Ethics Legislation, Regulation and Conventions<\/jats:italic>\n                      ); search databases (PubMed and Web of Science) and grey literature (Google Scholar), to ensure completeness of included policy documents. Search strings were developed by the last author (VS) in consultation with the co-first author (GB). The whole screening process was performed by the first (AG) and co-first author (GB), separately. The search was originally performed in April 2023, and then re-performed in May 2025 to exclude obsolescent results. English-language policy documents in the field of human research ethics and addressing the subject of vulnerability were included. Eligibility criteria covered both national and international application. For data analysis and synthesis, the authors followed the steps of the QUAGOL methodology: policy documents\u2019 reading (AG), highlighting of relevant parts (AG), development of a summary of each document\u2019s highlighted parts (AG), summary evaluation and verification against previous QUAGOL steps (AG, GB, VS), creation of a comprehensive scheme (AG, GB, VS), and description of results (AG, GB, VS). No automation tools were used at any stage of the review.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Results and discussion<\/jats:title>\n                    <jats:p>Seventy-nine policy documents were included in the review. Research findings were organised in four different subsections, corresponding to four research questions. The analysis of such a significant number and variety of documents allowed us to identify several recurring patterns that characterise the way vulnerability is described and addressed by policy documents. Based on our roles as bioethicists, research ethicists, biotechnologies expert in clinical trials, and study coordinators, we identified some key themes, e.g., a tendency to identify and define vulnerable groups, rather than providing a general definition of vulnerability, and a tendency to define vulnerability in relation to informed consent.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec005\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Only a proper understanding of the meaning of vulnerability, its implications and its normative justifications will make it possible to ensure a fair and ethically legitimate participation in research for all involved subjects. As to the study limitation, only publications written in English, or officially translated in English, were included in the review.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0327086","type":"journal-article","created":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T13:28:01Z","timestamp":1751376481000},"page":"e0327086","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":7,"title":["Vulnerability in research ethics: A systematic review of policy guidelines and documents"],"prefix":"10.1371","volume":"20","author":[{"given":"Asia","family":"Grigis","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giorgia","family":"Beretta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4931-9560","authenticated-orcid":true,"given":"Pascal","family":"Borry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7756-3010","authenticated-orcid":true,"given":"Virginia","family":"Sanchini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,7,1]]},"reference":[{"key":"pone.0327086.ref001","author":"Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral","year":"1979"},{"issue":"4","key":"pone.0327086.ref002","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1080\/08989621.2022.2119136","article-title":"Appropriate inclusion of adult research participants with intellectual disability: an in-depth review of guidelines and policy statements","volume":"31","author":"K Meierer","year":"2024","journal-title":"Account Res"},{"issue":"1","key":"pone.0327086.ref003","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1111\/bioe.12471","article-title":"Enriching the concept of vulnerability in research ethics: An integrative and functional account","volume":"33","author":"E Racine","year":"2019","journal-title":"Bioethics"},{"issue":"1","key":"pone.0327086.ref004","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1007\/s11017-013-9242-8","article-title":"Protecting and respecting the vulnerable: existing regulations or further protections?","volume":"34","author":"SR Solomon","year":"2013","journal-title":"Theor Med Bioeth"},{"issue":"5","key":"pone.0327086.ref005","doi-asserted-by":"crossref","DOI":"10.1002\/pon.70182","article-title":"Exploring Barriers to Inclusivity: Systematic Analysis of Exclusion Criteria and Potential Bias in Clinical Cancer Trials for Psychiatric and Neurological Conditions in European Protocols","volume":"34","author":"M Dah\u00f2","year":"2025","journal-title":"Psychooncology"},{"key":"pone.0327086.ref006","author":"H Kahrass","year":"2021"},{"key":"pone.0327086.ref007","unstructured":"Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), U S D of H and HS (HHS). International Compilation of Human Research Standards. 2024."},{"key":"pone.0327086.ref008","unstructured":"U.S. Department of Health and Human Services (HHS). Listing of social-behavioral research standards. 2018."},{"key":"pone.0327086.ref009","unstructured":"European Commission. Ethics legislation, regulation and conventions. 2020."},{"issue":"7","key":"pone.0327086.ref010","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1000097","article-title":"Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement","volume":"6","author":"D Moher","year":"2009","journal-title":"PLoS Med"},{"issue":"3","key":"pone.0327086.ref011","doi-asserted-by":"crossref","first-page":"360","DOI":"10.1016\/j.ijnurstu.2011.09.012","article-title":"QUAGOL: a guide for qualitative data analysis","volume":"49","author":"B Dierckx de Casterl\u00e9","year":"2012","journal-title":"Int J Nurs Stud"},{"key":"pone.0327086.ref012","volume-title":"Ethics in health research: principles, structures, and processes","author":"SA Department of Health (DH) R of","year":"2015"},{"key":"pone.0327086.ref013","volume-title":"Note for guidance on good clinical practice (CPMP\/ICH\/135\/95)","author":"Therapeutic Goods Administration","year":"2000"},{"key":"pone.0327086.ref014","volume-title":"National ethical guidelines for biomedical and health research involving human participants","author":"Indian Council of Medical Research (ICMR)","year":"2017"},{"key":"pone.0327086.ref015","volume-title":"National guidelines for research involving humans as research participants","author":"Uganda National Council for Science and Technology UNCST","year":"2014"},{"key":"pone.0327086.ref016","volume-title":"The ethical guidelines for research on human subject in Thailand","author":"(FERCIT) Forum for Ethical Review Committees in Thailand","year":"2007"},{"issue":"7","key":"pone.0327086.ref017","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1007\/s12603-013-0340-0","article-title":"Guidance synthesis. Medical research for and with older people in Europe: proposed ethical guidance for good clinical practice: ethical considerations","volume":"17","author":"L Diener","year":"2013","journal-title":"J Nutr Health Aging"},{"key":"pone.0327086.ref018","volume-title":"Good clinical practice guidelines","author":"National Agency for Food and Drug Administration and Control NAFDAC","year":"2020"},{"issue":"2","key":"pone.0327086.ref019","doi-asserted-by":"crossref","first-page":"138","DOI":"10.1016\/j.jamda.2018.11.008","article-title":"A Proposal for the Retrospective Identification and Categorization of Older People With Functional Impairments in Scientific Studies-Recommendations of the Medication and Quality of Life in Frail Older Persons (MedQoL) Research Group","volume":"20","author":"S Brefka","year":"2019","journal-title":"J Am Med Dir Assoc"},{"key":"pone.0327086.ref020","volume-title":"The ethics of research related healthcare in developing countries","author":"Nuffield Council on Bioethics","year":"2002"},{"key":"pone.0327086.ref021","volume-title":"Standards and operational guidance for ethics review of health-related research with human participants","author":"World Health Organization WHO","year":"2011"},{"key":"pone.0327086.ref022","doi-asserted-by":"crossref","DOI":"10.56759\/rgxl7405","volume-title":"International ethical guidelines for health-related research involving humans","author":"CIOMS Council for International Organizations of Medical Sciences","year":"2016"},{"key":"pone.0327086.ref023","volume-title":"Personal information in biomedical research","author":"Ministry of Health (MOH), Personal Data Protection Commission (PDPC), Bioethics Advisory Committee (BAC)","year":"2007"},{"key":"pone.0327086.ref024","volume-title":"Resolution CNS No. 466\/2012 on guidelines and rules for research involving human subjects","author":"National Health Council (CNS), National Commission on Research Ethics (CONEP)","year":"2012"},{"key":"pone.0327086.ref025","volume-title":"International code of marketing, opinion and social research and data analytics","author":"European Society for Opinion & Marketing Research ESOMAR","year":"2016"},{"key":"pone.0327086.ref026","volume-title":"Tri-council policy statement: ethical conduct for research involving humans","author":"Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada","year":"2022"},{"key":"pone.0327086.ref027","volume-title":"National ethical guidelines for health and health-related research","author":"PHREB Philippine Health Research Ethics Board","year":"2017"},{"key":"pone.0327086.ref028","volume-title":"A guide to internet research ethics","author":"National Committee for Research Ethics in the Social Sciences and the Humanities NESH","year":"2019"},{"issue":"3","key":"pone.0327086.ref029","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1097\/01.wad.0000137520.23370.56","article-title":"Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators","volume":"18","author":"Association Alzheimer\u2019s","year":"2004","journal-title":"Alzheimer Dis Assoc Disord"},{"key":"pone.0327086.ref030","author":"Council Malaysian Medical","year":"2006"},{"key":"pone.0327086.ref031","author":"Pensions Department for Work and","year":"2003"},{"key":"pone.0327086.ref032","volume-title":"Malaysian phase I clinical trial guidelines","author":"Ministry of Health Malaysia, National Pharmaceutical Regulatory Agency (NPRA), National Committee for Clinical Research (NCRC), Clinical Research Malaysia (CRM), Society of Clinical Research Professionals Malaysia (SCRPM)","year":"2017"},{"issue":"141","key":"pone.0327086.ref033","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1002\/cad.20042","article-title":"Doing no harm and getting it right: guidelines for ethical research with immigrant communities","volume":"2013","author":"MG Hern\u00e1ndez","year":"2013","journal-title":"New Dir Child Adolesc Dev"},{"key":"pone.0327086.ref034","unstructured":"UNAIDS\/WHO. Ethical considerations in biomedical HIV prevention trials. Geneva: UNAIDS\/WHO; 2012."},{"key":"pone.0327086.ref035","volume-title":"Guidelines of ethics for health research in Tanzania","author":"YJS Mashalla","year":"2009"},{"key":"pone.0327086.ref036","volume-title":"National guidelines for ethics committees reviewing biomedical and health research during COVID-19 pandemic","author":"Indian Council of Medical Research ICMR","year":"2020"},{"key":"pone.0327086.ref037","volume-title":"Recommendation No. R (99) 4 on principles concerning the legal protection of incapable adults","author":"Committee of Ministers","year":"1999"},{"key":"pone.0327086.ref038","volume-title":"Implementing regulations of the law of ethics of research on living creatures","author":"National Committee of BioEthics NCBE","year":"2022"},{"key":"pone.0327086.ref039","volume-title":"Medical products in human medicine act","author":"BDA Bulgarian Drug 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(BMRC)","year":"2013"},{"key":"pone.0327086.ref044","volume-title":"EU code for ethics for socio-economic research","author":"European Commission","year":"2004"},{"key":"pone.0327086.ref045","volume-title":"Framework for research ethics","author":"Economic and Social Research Council ESRC","year":"2015"},{"key":"pone.0327086.ref046","volume-title":"Guidelines for research among children and young people","author":"C Shaw","year":"2011"},{"key":"pone.0327086.ref047","volume-title":"Medical research involving children","author":"MRC Medical Research Council","year":"2004"},{"key":"pone.0327086.ref048","volume-title":"Nigerian code of health research ethics","author":"Federal Ministry of Health","year":"2007"},{"key":"pone.0327086.ref049","volume-title":"Research ethics framework","author":"Economic and Social Research Council ESRC","year":"2005"},{"key":"pone.0327086.ref050","volume-title":"Research ethics policy and procedures","author":"University of the West Indies \u2013 Cave Hill, 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Project on Informed Consent, Human Research Ethics Group","volume":"280","author":"J Moreno","year":"1998","journal-title":"JAMA"},{"issue":"2","key":"pone.0327086.ref075","doi-asserted-by":"crossref","first-page":"125","DOI":"10.4103\/0250-474X.91564","article-title":"Ethics in clinical research: the Indian perspective","volume":"73","author":"J Sanmukhani","year":"2011","journal-title":"Indian J Pharm Sci"},{"key":"pone.0327086.ref076","volume-title":"Regulations relating to research with human participants No. R719","author":"Department of Health (DH), Medical Research Council of South Africa (MRC), Human Sciences Research Council (HSRC), South African Health Products Regulatory Authority","year":"2014"},{"key":"pone.0327086.ref077","volume-title":"A model regulatory program for medical devices: An international guide","author":"PAHO Pan American Health Organization","year":"2001"},{"key":"pone.0327086.ref078","volume-title":"Guidelines for conducting clinical trials of medicines, food supplements, vaccines, and medical devices in Sierra Leone","author":"Ministry of Health PB of SL","year":"2014"},{"key":"pone.0327086.ref079","volume-title":"National ethical guidelines for biomedical research involving children","author":"Indian Council of Medical Research ICMR","year":"2017"},{"key":"pone.0327086.ref080","volume-title":"Handbook for good clinical research practice (GCP): guidance for implementation","author":"World Health Organization WHO","year":"2005"},{"key":"pone.0327086.ref081","volume-title":"National health research ethics review guideline","author":"Technology FDRE Ministry of Science and","year":"2014"},{"key":"pone.0327086.ref082","volume-title":"National statement on ethical conduct in human research","author":"National Health and Medical Research Council, Australian Research Council, Universities Australia","year":"2018"},{"key":"pone.0327086.ref083","article-title":"The framework of guidelines for research in the social sciences and humanities in Malawi","volume-title":"Issued with legislative anchorage to the Science and Technology Act No.16 of 2003","author":"National Commission for Science and Technology","year":"2011"},{"key":"pone.0327086.ref084","volume-title":"Research governance framework","author":"Department of Health","year":"2008"},{"key":"pone.0327086.ref085","volume-title":"Guidelines for phase I clinical trials","author":"Association of the British Pharmaceutical Industry ABPI","year":"2018"},{"key":"pone.0327086.ref086","volume-title":"Guidelines for research ethics in the social sciences and the humanities","author":"National Committee for Research Ethics in the Social Sciences and the Humanities","year":"2022"},{"key":"pone.0327086.ref087","doi-asserted-by":"crossref","DOI":"10.1111\/j.1471-8847.2005.00116.x","volume-title":"Universal declaration on bioethics and human rights","author":"United Nations Educational, Scientific and Cultural Organization UNESCO","year":"2005"},{"key":"pone.0327086.ref088","volume-title":"Guidelines on ethics for medical research: reproductive biology and genetic research","author":"Medical Research Council of South Africa MRC","year":"2022"},{"issue":"1","key":"pone.0327086.ref089","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1186\/s12910-022-00819-3","article-title":"The concept of vulnerability in aged care: a systematic review of argument-based ethics literature","volume":"23","author":"V Sanchini","year":"2022","journal-title":"BMC Med Ethics"},{"issue":"4","key":"pone.0327086.ref090","first-page":"100079","article-title":"People with Disabilities and Other Forms of Vulnerability to the COVID-19 Pandemic: Study Protocol for a Scoping Review and Thematic Analysis","volume":"2","author":"TS Jesus","year":"2020","journal-title":"Arch Rehabil Res Clin Transl"},{"key":"pone.0327086.ref091","first-page":"1","article-title":"Vulnerability, Disability, and Agency: Exploring Structures for Inclusive Decision-Making and Participation in a Responsive State","author":"M Mustaniemi-Laakso","year":"2022","journal-title":"Int J Semiot Law"},{"issue":"6","key":"pone.0327086.ref092","doi-asserted-by":"crossref","first-page":"333","DOI":"10.1111\/bioe.12032","article-title":"Vulnerability in research ethics: a way forward","volume":"27","author":"MM Lange","year":"2013","journal-title":"Bioethics"},{"key":"pone.0327086.ref093","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1017\/9781108620024.004","article-title":"Vulnerability.","volume-title":"The Cambridge Handbook of Health Research Regulation","author":"WA. 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