ReviewPathogens (Basel, Switzerland)2026
Biorisk Management in High-Containment Laboratories: Assessment of Certification Systems and Need for Global Standardization.
Review in Pathogens (Basel, Switzerland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
Laboratory-acquired infections (LAIs) and accidental pathogen escape from laboratory settings (APELS) are still a significant concern, even with biosafety guidelines and manuals in place. The actual number of these events is probably underestimated because there are no mandatory reporting systems or standard surveillance frameworks. In this review, a clear overview is given about the evolution of biosafety, the worldwide distribution and governance of high-containment laboratories (BSL-3 and BSL-4), and the key factors that lead to laboratory incidents. The focus is specifically on human error, inadequate training, and differences in standard operating procedures as primary causes of biosafety failures. Furthermore, current regulatory frameworks are described, pointing out the lack of consistency in laboratory practices, infrastructure needs, and national policies, especially the variances in biosafety level recommendations for high-risk pathogens. Certification systems as potential tools to improve standardization and consistency in operations are discussed. Among these, ISO 35001 is a detailed standard for managing biorisks, including risk assessment, staff training, incident reporting, and processes for ongoing improvement. However, its use is still limited, and certification is not mandatory for laboratory licensing everywhere. Additionally, existing standards do not fully cover structural aspects and national differences in how pathogens are handled. This review also highlights the limitations of current certification systems and proposes recommendations to strengthen and harmonize standardization procedures across high-containment laboratories. Overall, this work highlights the need for greater global consistency in biosafety practices, suggesting the establishment of an independent international auditing body as an important step toward enhancing global health security and laboratory readiness.
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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.