Formalization of Informed Consent. From Ethical to Administrative Use



We explore the ethical issues derived from obtaining the Informed consent (IC) in medical practice and research in institutions from North Eastern Romania. We performed a content analysis of 11 IC forms (standardized hospital documents), retrieved from different medical care institutions involved in medical research activities. We also interviewed 10 professionals on how they are using the IC in their medical care practice and medical research. The research started from the presupposition that there is a lack of ethical understanding of inform consent both from the issuer of the IC documents as from the medical staff are using these documents in their relationship with the patients. The analysed IC documents show a formal respect for the legislative framework and for the protection of the doctor and the medical institution towards possible litigations. We conclude that the administrative meaning of the IC overlaps the ethical one, turning the IC from an instrument of ensuring the promotion of patient's autonomy to the institutionalization of the patient's mandatory trust in the medical team.

How to cite: Frunza, A., & Sandu, A. (2017). Formalization of Informed Consent. From Ethical to Administrative Use. Postmodern Openings, 8(3), 69-95.


Informed consent; ethical risks; Romanian medical practice; content analysis.

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