Selected article for: "consent process and informed consent"

Author: Bugarín González, Rosendo; Romero-Yuste, Susana María; López Vázquez, Paula Mª; Casariego Rosón, Juan; Carballeda Feijóo, Nuria; Cruz Del Río, Juana Mª; Cueva Bañuelos, Juan Fernando; Fernández Rial, José Álvaro; Fernández Trisac, José Luis; Ferreira Díaz, Mª José; Millán Calenti, Rafael Álvaro; Pía Morandeira, Agustín; Prado Casal, Jorge; Rodríguez-Tenreiro Sánchez, Carmen; Santos García, Diego; Vázquez Lago, Juan Manuel; Verdejo González, Mª Asunción; Zarra Ferro, Irene
Title: [Ethics Committee experience during COVID-19 emergency. A brief report.]
  • Cord-id: kc0eg1ho
  • Document date: 2020_11_3
  • ID: kc0eg1ho
    Snippet: OBJECTIVE The health crisis caused by COVID-19 required the prompt launch of research in order to generate scientific evidence pertaining to the new disease oriented to control its devastating effects and continuous spread. Therefore, it was essential to adapt the work flow of Research Ethics Committees, to prioritize and to accelerate the evaluation of projects related to this disease. METHODS This work analyses the evaluation conducted by our Regional Ethics Committees during the initial perio
    Document: OBJECTIVE The health crisis caused by COVID-19 required the prompt launch of research in order to generate scientific evidence pertaining to the new disease oriented to control its devastating effects and continuous spread. Therefore, it was essential to adapt the work flow of Research Ethics Committees, to prioritize and to accelerate the evaluation of projects related to this disease. METHODS This work analyses the evaluation conducted by our Regional Ethics Committees during the initial period of the health emergency (between 13th March and 28th May 2020). RESULTS 81 research projects were evaluated, 73 of them of regional scope (62 single-centre), 4 national and 4 international. 57 projects obtained a favourable opinion, 4 were withdrawn by the sponsors, 6 did not require ethics approval and 14 did not respond to the clarifications requested up to the date of the study's closure. CONCLUSIONS The most important research procedures to be analysed in this context are those related to the methodology and informed consent process. It is also essential to address aspects related to the privacy of personal data, and to take into account the workload of the researchers. As an improvement proposal, we think that greater collaboration between the different research teams should be encourage to obtain more robust results.

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