ABSTRACT
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.
ABSTRACT
BACKGROUND: In March 2020, the WHO declared the SARS CoV-2 pandemic. This had an immediate and dramatic impact on Romanian physicians. OBJECTIVES: To analyse SARS-CoV-2 risk perception among Romanian physicians following the official WHO pandemic announcement. METHODS: A questionnaire was sent to Romanian physicians (n = 319) between 13 and 27 of March 2020 to determine the perceived threat of exposure to SARS CoV-2 infection, the assessment COVID-19 sources of documentation, physicians' access to personal protective equipment and the attitude towards a prospective vaccine against SARS CoV-2. RESULTS: Confronted with a new and unknown disease, the lack of appropriate information regarding disease management, media pressure and the lack of protective equipment, physicians experiencing a highly stressful a period. We found a significant relationship between the perceived level of fear and the risk of infection with SARS CoV-2 among respondents. A relationship was also found between the perceived level of fear related to COVID-19 and the acceptance of future vaccines against SARS CoV-2. Our data show that doctors working in urban areas considered the medical research on COVID-19 as clearer than those working in rural locations did. CONCLUSION: Pandemic preparedness should focus on measures that make medical practice safe (supplies, working protocols, experience sharing with experts/colleagues from other countries).