Rapporto ISS COVID-19 n. 47/2020 English version - Research ethics during the COVID-19 pandemic: observational and, in particular, epidemiological studies. Version of May 29, 2020
Rapporti ISS COVID-19 in English
Istituto Superiore di Sanità
Research ethics during the COVID-19 pandemic: observational and, in particular, epidemiological studies. Version of May 29, 2020.
ISS Bioethics COVID-19 Working Group
2020, v, 17 p. Rapporto ISS COVID-19 n. 47/2020 - English version
Biomedical research includes interventional or experimental research, and observational / epidemiological research. While the first types of research are governed by specific regulations, some of which are dedicated to the COVID-19 pandemic situation, for the latter there are no regulatory references except “soft law” documents. This report aims to offer references to researchers engaged in the study of SARS-CoV-2 and to the Ethics Committees (EC) engaged in the evaluation of observational / epidemiological research conducted in an emergency, starting from the literature and recommendations of International Organizations, relating to: values and principles of research ethics to be considered in the planning and evaluation of observational / epidemiological research in emergency COVID-19; role of the ECs and procedures to be adopted to respond promptly to requests for evaluation of observational / epidemiological research in the field of COVID-19 and non-COVID-19; specificity and exemptions from informed consent for observational / epidemiological research in COVID-19; collaboration between researchers and timely sharing of research results and data.
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