ArticleHealth research policy and systems2017
The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines.
Article in Health research policy and systems, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04595123 (Impact of COVID-19 Pandemic in Perinatal Mental Health), which is not on this map. Cited by 66 papers, 7 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Impact of COVID-19 Pandemic in Perinatal Mental Health
Who cites it
66 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Research-Induced Distress Among Qualitative Researchers Who Engage in Research on Child Maltreatment: A Qualitative Systematic Review of Risk and Resilience.International journal of environmental research and public health · 2025Pooled it
- Vulnerability in research ethics: A systematic review of policy guidelines and documents.PloS one · 2025Pooled it
- Ethical Considerations in Research With People From Refugee and Asylum Seeker Backgrounds: A Systematic Review of National and International Ethics Guidelines.Journal of bioethical inquiry · 2024Pooled it
- Ethical Considerations for Engaging Children and Adolescents Living with HIV in Research in African Countries: A Systematic Review.Journal of empirical research on human research ethics : JERHRE · 2023Pooled it
- The concept of vulnerability in aged care: a systematic review of argument-based ethics literature.BMC medical ethics · 2022Pooled it
- Ethical considerations for research involving pregnant women living with HIV and their young children: a systematic review of the empiric literature and discussion.BMC medical ethics · 2021Pooled it
- Reporting of Research Ethics in Studies Focusing on Foot Health in Patients with Rheumatoid Arthritis - A Systematic Review.Journal of empirical research on human research ethics : JERHREPooled it
- Understanding the Unique Ethical Challenges in Randomized Controlled Trials of Delirium Interventions for Older Adults: A Rapid Review.Anesthesia and analgesia · 2026Review
- Why children's research assent matters: Exploring three dimensions of autonomy.Nursing ethics · 2026Article
- Vulnerability, protection and fairness: ethical and regulatory limits in small-N gene therapy trials.Trials · 2026Article
- Vulnerability and Pediatric Pain.Paediatric & neonatal pain · 2026Article
- Vulnerability in procedural ethics: A study of 44 national research ethics guidelines.Qualitative research : QR · 2026Article
- Article
- Implementing PROMs where care is complex: lessons from trauma-focused mental health services for refugees.Frontiers in psychiatry · 2026Article
- Rethinking ethical reflexivity and oversight in health research through an ecosystem approach: A workshop report.Research ethics · 2026Article
- The responsible conduct of police participatory research: A qualitative study of officers' ethical beliefs.Research ethics · 2025Article
- Chasing 'vulnerability' across six decades of the Declaration of Helsinki.Monash bioethics review · 2025Article
- Fitting a square peg in a round hole? A mixed-methods study on research ethics and collaborative health and social care research involving 'vulnerable' groups.Health research policy and systems · 2025Article
- The Importance of Including Underserved Populations in Research.Pharmaceutical medicine · 2025Review
- Black community member perceptions and ethics recommendations on epigenomic research.Clinical epigenetics · 2025Article
6 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsWe 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.
resultsFew 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.
conclusionsOur 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.