Formalization of Informed Consent. From Ethical to Administrative Use

Ana FRUNZA, Antonio SANDU

Abstract


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. https://doi.org/10.18662/po/2017.0803.07


Keywords


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

Full Text:

View PDF

References


Alexander, L. (1996).The Moral Magic of Consent (II), Legal Theory 2, 165.

Beauchamp, T., & Childress, J. (1994). Principles of biomedical ethics (4th ed.). New York: Oxford University Press.

Bottrell, M.M., Alpert, H., Fischbach, R.L., Emanuel, L.L. (2000). Hospital Informed Consent for Procedure Forms Facilitating Quality Patient-Physician Interaction. Arch Surg., 135(1), 26-33. https://doi.org/10.1001/archsurg.135.1.26

Cambon-Thomsen, A. (2004). The Social and Ethical Issues of Post-Genomic Human Biobanks. Nature Review Genetics, 5, 6-13.

Cojocaru, D. (2008). Copilaria si constructia parentalitatii. Iasi: Editura Polirom.

Damian, S.I., Mihai, D., & Damian, R. F. (2008). Investigation of statistic data evolution with social impact. Revista medico-chirurgicala a Societatii de Medici si Naturalisti din Iasi, 112(3), 764-8.

Faden, R., & Beauchamp, T. (1986). A History and Theory of Informed Consent. New York: Oxford University Press.

Frunza, A., & Sandu, A. (2017a). Ethical acceptability of using generic consent for secondary use of data and biological samples in medical research. Acta Bioethica, 23(2). Retrieved from http://www.actabioethica.uchile.cl/index.php/AB/article/view/47480/49521

Frunza, A., Sandu, A. (2017b). Values Grounding the Informed Consent in Medical Practice: Theory and Practice, SAGE Open, 7(4): Article first published online: November 9, 2017; Issue published: October 1, 2017, https://doi.org/10.1177/2158244017740397

Romanian Law no. 46/2003 on patient's rights law (updated in 2015).

Romanian Law Nr. 95/2006 on healthcare reform.

Maclean, A. (2009). Autonomy, Informed Consent and Medical Law: A Relational Challenge. Cambridge University Press.

Matiasek, J., Wynia, M.K. (2008). Reconceptualizing the informed consent process at eight innovative hospitals. Joint Commission Journal on Quality and Patient Safety, Mar. 34(3), 127-37 (accessed May 18, 2017).

O'Neill, O. (2003). Symposium on Consent And Confidentiality, Some limits of informed consent, Journal of Medical Ethics, 29, 4-7

Bulger, R.E. (2002). Research with Human Beings. In Bulger, R.E., Heitman, I., & Reiser, J. Ed., The Ethical Dimensions of the Biological and Health Sciences. New York: Cambridge University Press, 2002: 117-125.

Romanian Minister of Public Health's Orders 903 and 904 from 2006; Available online at http://www.anm.ro/en/html/legislation_minister_orders.html, accessed on February 15, 2017

Scripcaru, C., Damian, S., Sandu, A., & Ioan, B. (2014). Ethical Considerations in the Medico-Legal Expert Approach of a Severe Untreated Psychiatric Disease. In Procedia - Social and Behavioral Sciences 149 (pp. 863-867). https://www.doi.org/10.1016/j.sbspro.2014.08.264

Sheehan, M. (2011). Can Broad Consent be Informed Consent?, Public Health Ethics, 4(3), 226-235.

The Joint Commission. (2016). Comprehensive Accreditation Manual glossary. Retrieved from: https://www.jointcommission.org/standards_information/edition.aspx


Refbacks

  • There are currently no refbacks.


Copyright (c) 2017 Ana FRUNZA, Antonio SANDU

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Copyright © POSTMODERN OPENINGS | A LUMEN Peer Reviewed Open Access Journal |

Journal covered in: Web of Sciences (WOS); EBSCO; ERIH+; Google Scholar; Index Copernicus; Ideas RePeC; Econpapers; Socionet; CEEOL; Ulrich ProQuest; Cabell, Journalseek; Scipio; Philpapers; SHERPA/RoMEO repositories; KVK; WorldCat; CrossRef; J-GATE