TY - JOUR

T1 - Informed Consent and Protection of Personal Data in Genetic Research on COVID-19

AU - Fedeli, Piergiorgio

AU - Scendoni, Roberto

AU - Cingolani, Mariano

AU - Corrales Compagnucci, Marcelo

AU - Cirocchi, Roberto

AU - Cannovo, Nunzia

PY - 2022

Y1 - 2022

N2 - Abstract: The particular characteristics of COVID-19 demand careful biomedical study of samples from patients who have shown different symptomatology, in order to understand the genetic foundations for its phenotypic expression. Research on genetic material from COVID-19 patients is indispensable for understanding the biological bases for its varied clinical manifestations. The issue of “informed consent” constitutes the crux of the problem in regulating research biobanks, because it concerns the relationship between the person and the parts separated from the body. There are several consensus models that can be adopted, varying from quite restricted models of specific informed consent, to forms allowing very broad authorization (open consent). Our current understanding of COVID-19 is incomplete. Thus, we cannot plan with precision the research to be conducted on biological samples that have been or will be collected from patients infected by the novel coronavirus. Therefore, we suggest utilizing the “Participation Pact” between researchers and donors, based on a new form of participation in research, that offers a choice based on the principle of solidarity and reciprocity, the communication of "values." In the last part the general data protection regulation concerning the matter is discussed. Treatment of personal data must be done with explicit goals, and donors must be provided clear, transparent explanation of the methods, goals and time of storage. The data must not be provided to unauthorized subjects. In conclusion, open informed consent forms will be necessary for research on individual patients and on populations.

AB - Abstract: The particular characteristics of COVID-19 demand careful biomedical study of samples from patients who have shown different symptomatology, in order to understand the genetic foundations for its phenotypic expression. Research on genetic material from COVID-19 patients is indispensable for understanding the biological bases for its varied clinical manifestations. The issue of “informed consent” constitutes the crux of the problem in regulating research biobanks, because it concerns the relationship between the person and the parts separated from the body. There are several consensus models that can be adopted, varying from quite restricted models of specific informed consent, to forms allowing very broad authorization (open consent). Our current understanding of COVID-19 is incomplete. Thus, we cannot plan with precision the research to be conducted on biological samples that have been or will be collected from patients infected by the novel coronavirus. Therefore, we suggest utilizing the “Participation Pact” between researchers and donors, based on a new form of participation in research, that offers a choice based on the principle of solidarity and reciprocity, the communication of "values." In the last part the general data protection regulation concerning the matter is discussed. Treatment of personal data must be done with explicit goals, and donors must be provided clear, transparent explanation of the methods, goals and time of storage. The data must not be provided to unauthorized subjects. In conclusion, open informed consent forms will be necessary for research on individual patients and on populations.

U2 - 10.3390/healthcare10020349

DO - 10.3390/healthcare10020349

M3 - Journal article

C2 - 35206963

VL - 10

JO - Healthcare

JF - Healthcare

SN - 2227-9032

IS - 2

M1 - 349

ER -