Summary of the i-CONSENT’s conversations on informed consent in the context of the COVID-19 second session

During his lecture on Monday, November 23rd 2020, Prof. d’Avack focused on informed consent in the context of trials currently in progress in the therapeutic field. 

He recalled main ethical and legal requirements of biomedical experimentation for therapeutic purposes. All these requirements, even in the context of the pandemic emergency, should be respected with particular attention to the criterion of justice in the allocation of resources at different levels (prevention, diagnosis and treatment of COVID-19 patients) and to the standards of quality and validity. 

The possibility of accelerating research by enhancing translational research from the laboratory to the patient’s bed should be carried on with adequate information to the patient on potential risks

In addition, the speaker focused on the off-label use of drugs and compassionate care. He emphasized the need for clear communication of the risks for patients and the importance that every effort should be made to proceed according to ordinary experimental designs. Furthermore, he explained that the experimentation aimed at therapeutic treatments for COVID-19 must include all subjects, without any exclusion. This should consider that the exclusion of particularly vulnerable people from the experimentation is contrary to the principle of justice.

Prof. L. d’Avack discussed as well the ethical issues related to research involving biological samples and to the use of health data. Another important issue mentioned was that of clinical research for a Covid-19 vaccine and, assuming a safe and effective vaccine, the opportunity to establish or not as mandatory a vaccination against Covid-19. 

Prof. L. d’Avack is the Chair of Italian Committee for Bioethics, which recently released an Opinion on “Biomedical research for novel therapeutic treatments within the Covid-19 Pandemic: ethical issues” (October 22nd, 2020).