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The Vaccine That Was Never Mentioned: A Comparative Medico-Legal Analysis of the Duty to Inform and Document
Sanit Thongsriratch1, Therdpong Thongseiratch2, Saratis Pairoh3
1Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand.
Abstract:
Background/Objectives: Vaccine-preventable disease may generate medico-legal disputes not only after an adverse event following immunization, but also when a clinician is alleged to have failed to mention, recommend, revisit, refer for, or document a clinically relevant vaccine. We examine this "unmentioned vaccine" problem while distinguishing existing law (lex lata) from proposed good practice (lex ferenda). Methods: We conducted a documented purposive narrative and comparative medico-legal review. PubMed/MEDLINE, PubMed Central, structured scholarly web searches, publicly accessible legal repositories, and official policy websites were searched from database inception through 21 July 2026 using combinations of vaccination, informed consent/refusal, failure to recommend or vaccinate, referral, documentation, negligence, causation, and LMIC terms. Authorities were selected for doctrinal relevance and jurisdictional contrast, with citation chaining. Results: In the selected jurisdictions, patient-centered disclosure of material risks and reasonable alternatives is recognized in differing forms. Vaccine-specific cases are sparse and fact-sensitive and do not establish a universal duty to recommend, refer, or revisit every vaccine. Provider recommendation influences uptake, but this behavioral evidence does not itself establish legal duty or causation, and direct empirical evidence linking counselling omissions to claims remains limited. We therefore present ADRR-assess, discuss and disclose, recommend or refer, and record and revisit-as proposed practice guidelines developed by the authors and presented in conceptual form, not as a validated legal or clinical standard. Conclusions: ADRR may support proportionate, system-level preparedness, especially in LMICs, but implementation must account for access, supply, workforce, financing, records, and legal context. Stakeholder co-design and empirical validation are required before routine adoption.
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