Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management
Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-11-01
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| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/10/11/1871 |
| _version_ | 1827645352977629184 |
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| author | Sînziana-Elena Bîrsanu Maria Cristina Plaiasu Codrut Andrei Nanu |
| author_facet | Sînziana-Elena Bîrsanu Maria Cristina Plaiasu Codrut Andrei Nanu |
| author_sort | Sînziana-Elena Bîrsanu |
| collection | DOAJ |
| description | Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical personnel at the vaccination centers were provided with informed consent forms that did not respect the existing legal requirements. In addition, the protocol for persons seeking vaccination stated that the patient was supposed to receive the informed consent form from the receptionist in order to read and sign it. We analyzed the legal implications and the malpractice litigation risk associated with this practice. Due to essential deficiencies and in the absence of an official enactment of new regulations, we conclude that the vaccination consent process did not comply with the legal requirements. Implications include medical personnel’s legal liability, loss of malpractice insurance coverage, and public mistrust that may have contributed to a low vaccination rate. Given the potential of future pandemics or other health crises, this may be a valuable lesson for developing better legal strategies. |
| first_indexed | 2024-03-09T18:34:09Z |
| format | Article |
| id | doaj.art-5d2ea0c387e64607a8615056dc7e17f4 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T18:34:09Z |
| publishDate | 2022-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-5d2ea0c387e64607a8615056dc7e17f42023-11-24T07:14:01ZengMDPI AGVaccines2076-393X2022-11-011011187110.3390/vaccines10111871Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad ManagementSînziana-Elena Bîrsanu0Maria Cristina Plaiasu1Codrut Andrei Nanu2School of Advanced Studies of the Romanian Academy, 125 Calea Victoriei, 010071 Bucharest, RomaniaDoctoral School, University of Medicine and Pharmacy of Craiova, 2 Petru Rares Street, 200349 Craiova, RomaniaDepartment No. 14 of Orthopedics, Anesthesia and Intensive Care, University of Medicine and Pharmacy “Carol Davila” Bucharest, 37 Dionisie Lupu Street, 020021 Bucharest, RomaniaInforming patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical personnel at the vaccination centers were provided with informed consent forms that did not respect the existing legal requirements. In addition, the protocol for persons seeking vaccination stated that the patient was supposed to receive the informed consent form from the receptionist in order to read and sign it. We analyzed the legal implications and the malpractice litigation risk associated with this practice. Due to essential deficiencies and in the absence of an official enactment of new regulations, we conclude that the vaccination consent process did not comply with the legal requirements. Implications include medical personnel’s legal liability, loss of malpractice insurance coverage, and public mistrust that may have contributed to a low vaccination rate. Given the potential of future pandemics or other health crises, this may be a valuable lesson for developing better legal strategies.https://www.mdpi.com/2076-393X/10/11/1871COVID-19vaccination campaignmedical liabilityinformed consentRomanian physicians |
| spellingShingle | Sînziana-Elena Bîrsanu Maria Cristina Plaiasu Codrut Andrei Nanu Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management Vaccines COVID-19 vaccination campaign medical liability informed consent Romanian physicians |
| title | Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management |
| title_full | Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management |
| title_fullStr | Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management |
| title_full_unstemmed | Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management |
| title_short | Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management |
| title_sort | informed consent in mass vaccination against covid 19 in romania implications of bad management |
| topic | COVID-19 vaccination campaign medical liability informed consent Romanian physicians |
| url | https://www.mdpi.com/2076-393X/10/11/1871 |
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