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How Risky Can Biomedical Research Be?: On Setting an Upper Limit of Risk in Non-beneficial Research Involving Volunteers

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cris.lastimport.scopus2024-02-12T19:32:34Z
dc.abstract.enOne of the unmet challenges for risk–benefit assessment in biomedical research is whether there should be an upper limit of risk in non-beneficial studies involving competent and consenting participants, and if yes, how it should be defined. This chapter focuses on this second question. It examines the four dominant regulatory and conceptual approaches to setting a maximal risk threshold in research: no catastrophic harm/risk approach, pure procedural approach, numerical approach, and comparative approach. It then considers the pure procedural approach, which leaves the judgment of risk acceptability to RECs discretion. The approach has significant advantages, but it is not free from certain shortcomings, such as unwarranted diversity and arbitrariness of RECs judgments. The chapter concludes by sketching the outlines of what is referred to as the “ELS procedural approach” that provides RECs with procedural recommendations for identifying an ethically, legally and socially acceptable upper limit of risk in non-beneficial research on volunteers. The ELS procedural approach is an improvement over the pure procedural approach. It is more standardized and accountable, but still context-sensitive and flexible.
dc.affiliationUniwersytet Warszawski
dc.contributor.authorRóżyńska, Joanna
dc.date.accessioned2024-01-28T20:42:27Z
dc.date.available2024-01-28T20:42:27Z
dc.date.issued2023
dc.description.financeNie dotyczy
dc.identifier.doi10.1007/978-3-031-12692-5_14
dc.identifier.urihttps://repozytorium.uw.edu.pl//handle/item/153622
dc.identifier.weblinkhttps://link.springer.com/content/pdf/10.1007/978-3-031-12692-5_14
dc.languageeng
dc.pbn.affiliationphilosophy
dc.publisher.ministerialSpringer International Publishing
dc.relation.bookMedical Research Ethics: Challenges in the 21st Century
dc.relation.pages265-285
dc.rightsClosedAccess
dc.sciencecloudnosend
dc.subject.enresearch ethics
dc.subject.enresearch risks
dc.subject.enrisk limits
dc.titleHow Risky Can Biomedical Research Be?: On Setting an Upper Limit of Risk in Non-beneficial Research Involving Volunteers
dc.typeMonographChapter
dspace.entity.typePublication