Waiver of Informed Consent-A Necessary Tool for Just Research in Minimal Risk Studies.

The article focuses on the ethical and practical considerations of using waivers of informed consent in pragmatic clinical trials within complex healthcare systems. It argues that such waivers are essential for conducting minimal-risk research that reflects real-world conditions, enhances equity and...

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Detalles Bibliográficos
Publicado en:American Journal of Bioethics Vol. 26; no. 7; pp. 95 - 99
Autor principal: Barwise, Amelia
Formato: Journal Article
Publicado: Taylor & Francis Ltd Jul2026
Acceso en línea:Ver este registro en EBSCOhost
Descripción
Sumario:The article focuses on the ethical and practical considerations of using waivers of informed consent in pragmatic clinical trials within complex healthcare systems. It argues that such waivers are essential for conducting minimal-risk research that reflects real-world conditions, enhances equity and inclusion, and improves the translation of research findings into practice. The discussion highlights the increasing complexity of healthcare delivery, the persistent gap between research evidence and clinical adoption, and the role of implementation science in addressing these challenges. Emphasizing the principle of justice, the article contends that research must fairly share burdens and benefits by producing actionable knowledge that improves patient outcomes, and that waivers of informed consent can facilitate this goal.