Informed consent under the European Convention on Biomedicine and the UNESCO Declaration on Bioethics

Area of Science:

• Bioethics
• Medical Law
• Human Rights

Background:

• The universal acceptance of freely given consent contrasts with ongoing debates on informed consent's definition and application in bioethics.
• Ethical complexities arise at the intersection of informed consent, social justice, and international biomedical instruments.

Purpose of the Study:

• To critically analyze the concept of informed consent within key international bioethics documents.
• To explore the relationship between informed consent, social justice, and ethical theories in biomedical research.

Main Methods:

• Historical and critical analysis of the European Convention on Human Rights and Biomedicine (1997).
• Examination of The UNESCO Universal Declaration on Bioethics and Human Rights (2005).
• Application of three conceptions of justice to evaluate informed consent doctrine.

Main Results:

• The doctrine of informed consent significantly influences the ethos of human research and the physician-patient relationship.
• Casuistry and virtue theory are compatible with principle-based approaches to informed consent.
• International instruments highlight the tension between informed consent and social justice.

Conclusions:

• A nuanced understanding of justice is essential for navigating informed consent in international bioethics.
• Ethical theories beyond principalism can complement and enrich the understanding of informed consent.
• Reconciling informed consent with social justice remains a critical challenge in global health research.